[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-acute-myeloid-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-acute-myeloid-leukemia":31},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,46,0,25,[9,47,72,93,115,141,161,195,216,236,261,280,302,321,344,374,400,425,446,468,486,508,545,565,583],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":32,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100580206","phase-1-cer-1236-in-patients-with-acute-myeloid-leukemia-aml-myelodysplastic-syndrome-mds-and-myelofibrosis-mf-100580206",false,"NCT06834282","CER-1236 in Patients With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), and Myelofibrosis (MF)","Phase 1\u002F1b First-in-human Study of Autologous Chimeric Engulfment Receptor T-Cell CER-1236 in Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, and Myelofibrosis (CertainT-1)","CertainT-1","Inclusion Criteria:\n\n* Patients need to have a confirmed diagnosis of de novo or secondary AML, or myelodysplastic syndrome (MDS)\u002FAML with 10% to 19% blasts, per the International Consensus Classification 2022 or the WHO 2022 classification.\n* Absolute lymphocyte count \\>0.3 x 109\u002FL prior to apheresis.\n* Eastern cooperative oncology group (ECOG) performance status 0 to 1.\n\nExclusion Criteria:\n\n* Prior therapy with a permanently integrated, genetically modified cell product.\n* No measurable leukemia on the screening bone marrow evaluation prior to any bridging therapy.\n* Active autoimmune disease or history of autoimmune disease requiring treatment within the prior 2 years. Patients with history of autoimmune thyroiditis or type 1 diabetes well controlled on replacement regimen are eligible.\n* A known hypersensitivity or severe allergy to fludarabine, cyclophosphamide, or study drug components or diluents.\n* Any other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the physician.\n* Primary immunodeficiency disorder.","ALL","18 Years","85 Years",{"count":22,"type":23},18,"ESTIMATED","INTERVENTIONAL",[26],"PHASE1","This is a first in human, multi center, open label, phase 1\u002F1b study to evaluate the safety and preliminary efficacy of CER-1236 in patients with relapsed\u002Frefractory (R\u002FR), measurable residual disease (MRD) positive acute myeloid leukemia (AML), or TP53mut disease.",[29,30,31],"AML","Acute Myeloid Leukemia","Refractory Acute Myeloid Leukemia",[33],"Relapsed Acute Myeloid Leukemia","RECRUITING","2026-08-20",{"date":37,"type":38},"2026-08-21","ACTUAL",{"date":40,"type":38},"2025-04-07",{"date":42,"type":23},"2029-12-31",{"name":44,"class":45},"CERo Therapeutics Holdings, Inc.","INDUSTRY",4,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":24,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100593869","phase-1-a-study-to-find-the-highest-dose-of-cedazuridine-and-decitabine-combination-with-filgrastim-as-a-treatment-option-after-hematopoietic-stem-cell-transplant-in-children-with-high-risk-acute-myeloid-leukemia-100593869","NCT07012044","A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With High-Risk Acute Myeloid Leukemia","A Phase 1 Study of Oral Cedazuridine and Decitabine Combination (ASTX727, NSC# 820631) and Filgrastim as Maintenance Therapy Post-Hematopoietic Stem Cell Transplant in Children With High-Risk Acute Myeloid Leukemia","Inclusion Criteria:\n\n* STEP 0: Patient must be ≤ 21 years of age\n\n  * PLEASE NOTE: Eligibility criteria to enroll onto Step 1 for the treatment trial is ≤ 21 years of age at the time of Step 1 enrollment. Please plan accordingly to ensure that patients who are screened with Step 0 will be at an eligible age at the time of enrollment onto Step 1. Patients who are 21 at the time of screening who turn 22 at the time of enrollment onto Step 1 will not be eligible to enroll onto the study\n* STEP 0: Patients with newly diagnosed high risk\\* de novo AML, newly diagnosed therapy-related AML, relapsed, or refractory AML. in complete remission at the time of transplant. Patients with a history of isolated or combined central nervous system (CNS) or extramedullary disease are eligible if they have no evidence of active CNS or extramedullary disease at the time of trial enrollment (Step 0) and treatment enrollment (Step 1). Eligible patients with histories of isolated or combined CNS or extramedullary disease at time of relapse are required to be in complete remission at time of transplant to be eligible for this study\n\n  * Based on risk criteria adopted by the AAML1831 study\n* STEP 0: Patient must plan to have bone marrow sample submitted to Hematologics within 14 days prior to the start of conditioning regimen for HCT.\n\n  * Note: In order to be eligible to enroll onto Step 1 to receive treatment on this study, pre-HCT disease status must be assessed prior to receiving HCT. AML must be in complete remission (Children's Oncology Group \\[COG\\]-complete remission \\[CR\\], COG-complete remission with partial recovery of platelelt count \\[CRp\\], COG-complete remission with incomplete blood count recovery \\[Cri\\], with or without detectable minimal residual disease \\[MRD\\]); bone marrow CR must be assessed by central flow cytometry performed at Hematologics prior to the start of the conditioning regimen\n* STEP 0: Human immunodeficiency virus (HIV)-infected patients are eligible for this trial if the following criteria are met:\n\n  * No history of HIV complications with the exception of CD4 count \\\u003C 200cells\u002Fmm\\^3\n  * No antiretroviral therapy with overlapping toxicity such as myelosuppression\n  * CD4 count \\> 500 cells\u002Fmm\\^3 prior to the diagnosis of newly diagnosed, relapsed, refractory AML.\n  * HIV viral loads below the limit of detection within 6 months, as long as the patient is NOT receiving anti-retroviral agents that may interact with ASTX727.\n  * No history of highly active antiretroviral therapy (HAART)-resistant HIV\n* STEP 0: Patients must be receiving an allogeneic (related, unrelated, and mismatched related, including haploidentical) marrow, peripheral blood, or cord blood transplant for the first time\n* STEP 0: HCT conditioning regimen must be planned to begin within 14 days after bone marrow assessment to determine disease status\n* STEP 0: Conditioning regimen must be myeloablative and include high dose busulfan, or treosulfan, or total body irradiation\n* STEP 0: Patients must not have received prior exposure to ASTX727. Note that patients may have had prior exposure to decitabine\n* STEP 1: Patient must be ≤ 21 years of age at the time of study enrollment to step 0 and step 1\n* STEP 1: Patients must have a body surface area ≥ 1m\\^2 at enrollment to step 1\n* STEP 1 (PRE-HCT): AML must be in complete remission (COG-CR, COG-CRp, COG-Cri), with or without detectable MRD; bone marrow CR must be assessed by central flow cytometry performed at Hematologics. Disease assessment must be performed within 14 days prior to the start of HCT conditioning regimen\n\n  * Patients with CNS or extramedullary disease within 14 days prior to the start of the HCT condition regimen are not eligible\n* STEP 1 (POST-HCT): AML must be in complete remission (COG-CR, COG-CRp, COG-CRi). Bone marrow evaluation must show CR with no detectable minimal residual disease (MRD negative by central flow cytometry at Hematologics)\n\n  * Note: Disease assessment is required to be performed within 14 days prior to enrollment onto Step 1\n  * Patients with CNS or extramedullary disease post-HCT are not eligible\n* STEP 1: Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \\> 16 years of age and Lansky for patients ≤ 16 years of age. Patients must have Karnofsky performance score ≥ 50 or Lansky play-performance scale score ≥ 50\n* STEP 1: Patients must have fully recovered from the acute toxicities related to the conditioning regimen and the transplant. If, after 42-100 days post-transplant, the eligibility criteria are met, the patient is considered to have recovered adequately\n* STEP 1: Platelet count ≥ 50,000 µL (without requirement for platelet transfusion within the last 7 days)\n* STEP 1: Hemoglobin ≥ 8.0 g\u002FdL at baseline (may receive red blood cell \\[RBC\\] transfusions)\n* STEP 1: Absolute neutrophil count ≥ 1,000 µL with no myeloid growth factor support within the last 3 days\n* Estimated glomerular filtration rate (GFR) (eGFR) ≥ 60 mL\u002Fmin\u002F1.73 m\\^2 \"Bedside\" Schwartz formula (2009) OR\n\n  * OR- A 24 hour urine creatinine clearance ≥ 60 mL\u002Fmin\u002F1.73 m\\^2\n  * A GFR ≥ 60 mL\u002Fmin\u002F1.73 m\\^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard)\n  * Note: Estimated GFR (eGFR) from cystatin C or other estimates not listed above are not acceptable for determining eligibility\n* STEP 1: Bilirubin (total or sum of conjugated + unconjugated) ≤ 1.5 x upper limit of normal (ULN) for age\n* STEP 1: Alanine aminotransferase (ALT) ≤ 3 x ULN\n* STEP 1: Aspartate aminotransferase (AST) ≤ 3 x ULN\n* STEP 1: Albumin ≥ 2 g\u002FdL\n\nExclusion Criteria:\n\n* STEP 0: Patients with known inherited marrow failure syndromes, including, but not limited to Fanconi Anemia, Dyskeratosis congenita, and Shwachman-Diamond syndrome\n* STEP 0: Known or suspected hypersensitivity to filgrastim, decitabine or cedazuridine (ASTX727)\n* STEP 0: Patients who have received a prior solid organ transplantation are not eligible\n* STEP 1: ASTX727 can cause fetal harm when administered to pregnant women. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use two effective methods of birth control, including a medically accepted barrier or contraceptive method (eg, male or female condom) for the duration of the study. Abstinence is an acceptable method of birth control. Women of childbearing potential must use highly effective contraception during treatment with ASTX727 and for at least 6 months after the last dose. Men with female partners of childbearing potential should be advised to practice highly effective contraceptive measures of birth control and not to father a child while receiving treatment with decitabine and for 3 months after the last dose. Breastfeeding is not allowed during the study and for at least 2 weeks after the last dose of study drug\n* STEP 1: Patients who are currently receiving another investigational drug are not eligible\n* STEP 1: Patients who are currently receiving other anti-cancer agents are not eligible. Patients receiving intrathecal chemotherapy in the prior 14 days are eligible\n* STEP 1: Patients receiving or for whom there is a plan to administer anticancer non-protocol therapy, radiation therapy or immunotherapy during the study period are not eligible (note that prophylactic use of chemotherapeutic agents for graft versus host disease \\[GVHD\\] is allowed, e.g. methotrexate for GVHD prophylaxis). Intrathecal cytarabine administered at the discretion of the treating physician throughout maintenance therapy is allowed\n* STEP 1: Drugs known to be metabolized by cytidine deaminase (CDA) should not be given (such drugs include cytarabine, gemcitabine, azacitidine, vidarabine, zalcitabine, zidovudine, telbivudine, didanosine, stavudine, lamivudine, abacavir, emtricitabine, entecavir, trifluridine, tenofovir and adefovir) on days when ASTX727 is administered and for 24 hours thereafter\n* STEP 1: Patients is not able to swallow intact tablets. Nasogastric or G tube administration is not allowed\n* STEP 1: Patient is not able to start ASTX727 and filgrastim (rh-GCSF) between day 42 and day 100 following completion of allo-HCT. If, after enrollment, protocol therapy is started more than 100 days following allo-HCT, the patient will be removed from protocol therapy\n* STEP 1: Patients with graft loss are not eligible\n* STEP 1: Patients with steroid refractory or dependent acute GVHD are not eligible. Patients must be on \\\u003C 1 mg\u002Fkg\u002Fday of methylprednisolone (or equivalent prednisone\u002Fprednisolone dose) that is being tapered. Patients must not be on any second line systemic therapies. Continued GVHD prophylaxis with calcineurin inhibitors, sirolimus, abatacept or mycophenolate mofetil is acceptable\n* STEP 1: Patients who have an uncontrolled viral, bacterial, fungal, or protozoal infection are not eligible\n* STEP 1: Patients with active transplant associated thrombotic microangiopathy with ongoing hemolysis and need treatment (e.g. eculizumab) are not eligible\n* STEP 1: Patients with sinusoidal obstruction syndrome with ongoing need for treatment (e.g. defibrotide, diuresis, supplemental oxygen) are not eligible\n* STEP 1: Idiopathic pneumonitis syndrome or other non-infectious lung injury requiring ongoing treatment (corticosteroids, tumor necrosis factor \\[TNF\\] inhibitors, or other biologics) or supplemental oxygen are not eligible\n* STEP 1: Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible","21 Years",{"count":56,"type":23},47,[26],"This phase I trial tests the safety, side effects, and best dose of ASTX727 and filgrastim for the treatment of children with high risk acute myeloid leukemia that has come back after a period of improvement (recurrent) or that does not respond to treatment (refractory) who have undergone allogenic hematopoietic stem cell transplantation. ASTX727 is a combination of cedazuridine and decitabine. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine when taken by mouth, making it more available in the body so that decitabine will have a greater effect. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Filgrastim works in synergy with decitabine and enhances its activity. Giving ATSX727 and filgrastim may be safe and tolerable in treating children with high risk, recurrent or refractory acute myeloid leukemia who have undergone allogenic hematopoietic stem cell transplantation.",[60,61,31],"Acute Myeloid Leukemia Post Cytotoxic Therapy","Recurrent Acute Myeloid Leukemia","2026-08-19",{"date":35,"type":38},{"date":65,"type":38},"2026-06-09",{"date":67,"type":23},"2027-03-31",{"name":69,"class":70},"National Cancer Institute (NCI)","NIH",11,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":24,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":84,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":92},"100459489","phase-1-8-chloroadenosine-in-combination-with-venetoclax-for-the-treatment-of-patients-with-relapsedrefractory-acute-myeloid-leukemia-100459489","NCT05263284","8-Chloroadenosine in Combination With Venetoclax for the Treatment of Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","A Phase 1 Trial of 8-Chloro-Adenosine in Combination With Venetoclax in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative.\n* Age: \\>= 18 years.\n* Eastern Cooperative Oncology Group (ECOG) =\\\u003C 2.\n* Life expectancy \\> 3 months.\n* Patients with histologically confirmed acute myeloid leukemia (AML), according to World Health Organization (WHO) criteria, with relapsed\u002Frefractory disease.\n* Patients must have any one of the following treatment history criteria:\n\n  * Relapsed AML\n\n    * Failed at least 1 line of salvage therapy or\n    * Untreated relapse and are not candidates for allogeneic hematopoietic stem cell transplantation (alloHCT)\n  * De novo AML\n\n    * have not achieved complete response (CR) after 2 lines of therapy or\n    * refractory to frontline therapy and not eligible for alloHCT\n  * AML evolving from myelodysplastic syndrome (MDS) or myeloproliferative disorder who have failed hypomethylating agents (HMA) or induction chemotherapy\n  * Patients who have relapsed after allo-HCT are eligible if they are at least 3 months after HCT, do not have active graft versus host disease (GVHD) and are off immunosuppression except for maintenance dose of steroids (prednisone 10 mg\u002Fday or less).\n* Male subjects must agree to not donate sperm while taking protocol therapy through at least 90 days after the last dose.\n* White blood cell (WBC) =\\\u003C 25 x 10\\^9\u002FL prior to initiation of venetoclax. Cytoreduction with hydroxyurea prior to treatment and\u002For during cycle 1 may be required.\n* Total bilirubin =\\\u003C 1.5 X upper limit of normal (ULN) (unless has Gilbert's disease).\n* Aspartate aminotransferase (AST) =\\\u003C 2.5 x ULN.\n* Alanine aminotransferase (ALT) =\\\u003C 2.5 x ULN.\n* Creatinine clearance of \\>= 50 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula.\n* QTc =\\\u003C 480 ms.\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n* Agreement by females and males of childbearing potential\\* to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months (females) and 3 months (males) after the last dose of protocol therapy.\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only).\n\nExclusion Criteria:\n\n* Current or planned use of other investigational agents, antineoplastic, biological, chemotherapy, or radiation therapy during the study treatment period, or within 2 weeks prior to day 1 of protocol therapy, with the following exception:\n\n  * Hydroxyurea which may be continued through cycle 1.\n* Expected to undergo HCT within 120 days of enrollment.\n* Current or planned use of agents that prolong or suspected to prolong QTc.\n* Received strong or moderate CYP3A inducers or St. John's Wort within 7 days prior to day 1 of protocol therapy.\n* Received strong or moderate CYP3A inhibitors, or consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Star fruit within 3 days prior to day 1 of protocol therapy.\n* P-glycoprotein (P-gp) inhibitors within 7 days prior to day 1 of protocol therapy.\n* Narrow therapeutic index P-gp substrates within 7 days prior to day 1 of protocol therapy.\n* Acute promyelocytic leukemia.\n* Active central nervous system (CNS) leukemia.\n* Active fungal infection or bacterial sepsis.\n* Class III\u002FIV cardiovascular disability according to the New York Heart Association classification.\n* Participants with clinically significant arrhythmia or arrhythmias not stable on medical management within two weeks of enrollment. Subjects with controlled, asymptomatic atrial fibrillation can enroll.\n* History of acute cardiovascular ischemic event, i.e., myocardial infarction or unstable angina within 6 months of enrollment.\n* History of unexplained syncope, significant histories of CAD (requiring revascularization by percutaneous coronary intervention \\[PCI\\] or coronary artery bypass grafting \\[CABG\\]), cardiomyopathy (ejection fraction \\[EF\\] \\\u003C 50%).\n* Prior surgery or gastrointestinal dysfunction that may affect drug absorption (e.g., gastric bypass surgery, gastrectomy).\n* Unable to swallow capsules, has a partial or small bowel obstruction, or has a gastrointestinal condition resulting in a malabsorptive syndrome (e.g. small bowel resection with malabsorption).\n* Active peptic ulcer disease.\n* Other active malignancy except for localized skin cancer, bladder, prostate, breast or cervical carcinoma in situ.\n* Females only: Pregnant or breastfeeding.\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures.\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).",{"count":80,"type":23},30,[26],"This phase I trial tests the safety, side effects, and best dose of a new 8-chloroadenosine in combination with venetoclax in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). 8-Chloroadenosine may help block the formation of growths that may become cancer. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving 8-chloroadenosine in combination with venetoclax may help prevent the disease from coming back in patients with acute myeloid leukemia.",[30,61,31],{"date":37,"type":38},{"date":86,"type":38},"2022-10-31",{"date":88,"type":23},"2029-01-25",{"name":90,"class":91},"City of Hope Medical Center","OTHER",1,{"id":94,"slug":95,"hasResults":12,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":24,"phases":102,"briefSummary":104,"conditions":105,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":108,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":92},"100336506","phase-1-quizartinib-decitabine-and-venetoclax-in-treating-participants-with-untreated-or-relapsed-acute-myeloid-leukemia-or-high-risk-myelodysplastic-syndrome-100336506","NCT03661307","Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome","A Phase I\u002FII Study of Quizartinib in Combination With Decitabine and Venetoclax for the Treatment of Patients With Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n* Diagnosis of 1) AML (World Health Organization \\[WHO\\] classification definition of \\>= 20% blasts) excluding acute promyelocytic leukemia (APL) or 2) MDS with \\> 10% blasts (defined by the International Prognostic Scoring System \\[IPSS\\] classification).\n* For frontline Cohort: Patients aged \\>= 60 years old who are not candidates for intensive induction therapy and agree to receive the proposed combination therapy will be enrolled.\n* Not considered candidates for intensive remission induction chemotherapy at time of enrollment based on EITHER:\n\n  * 75 years of age OR\n  * \\\u003C 75 years of age with at least 1 of the following:\n\n    * Poor performance status (Eastern Cooperative Oncology Group \\[ECOG\\]) score of 2-3.\n    * Clinically significant heart or lung comorbidities, as reflected by at least 1 of:\n\n      * Left ventricular ejection fraction (LVEF) =\\\u003C 50%.\n      * Lung diffusing capacity for carbon monoxide (DLCO) =\\\u003C 65% of expected.\n      * Forced expiratory volume in 1 second (FEV1) =\\\u003C 65% of expected.\n      * Chronic stable angina or congestive heart failure controlled with medication.\n  * Liver transaminases \\> 3 x upper limit of normal (ULN).\n  * Other contraindication(s) to anthracycline therapy (must be documented).\n  * Other comorbidity the investigator judges incompatible with intensive remission induction chemotherapy, which must be documented and approved by the principal investigator (PI).\n* Patients with newly diagnosed AML with poor risk complex karyotype and\u002For TP53 deletions\u002Fmutations equal or younger than 60 year old\n* For relapsed cohort: Patients aged \\>= 18 years old. (Patients who are candidates for relapse cohort will be enrolled into the study regardless of their fitness for intensive chemotherapy). (a) Patients with relapsed\u002Frefractory AML are eligible if they are not eligible for potentially curative therapy such as effective salvage therapy or hematopoietic stem cell transplantation or who refuse these options at the time of enrollment.\n* Detection of FLT3-ITD mutation or FLT3-ITD\u002FTKD co-mutations in bone marrow and\u002For peripheral blood samples within 30 days prior to study enrollment.\n* For frontline cohort: Patients must be chemonaive, i.e. not have received any chemotherapy (except hydrea or 1-2 doses of ara-C for transient control of hyperleukocytosis) for AML or MDS. They may have received transfusions, hematopoietic growth factors or vitamins for an antecedent hematological disorder (AHD) or for AML. Temporary prior measures such as apheresis, all-trans-retinoic acid (ATRA), steroids or hydrea while diagnostic work-up is being performed are allowed and not counted as a prior salvage. Supportive care therapy for MDS (growth factors, transfusions) will not be considered as prior therapy for MDS\u002FAML and these patients will be enrolled to the frontline cohort of the study if they are otherwise eligible.\n* For relapsed cohort: Patients who have received at least one prior therapy for AML or for MDS with \\> 10% blasts will be eligible. Patients may have received up to 4 prior salvages for AML and\u002For MDS (defined by the IPSS classification). Prior therapy for AML or MDS will be counted as a prior salvage. Patients who receive MDS directed therapies considered not purely supportive such as HMAs, lenalidomide, investigational therapies, will be enrolled to the salvage cohort if they are otherwise eligible.\n* In the absence of rapidly progressing disease, the interval from prior treatment to time of initiation of protocol therapy will be at least 2 weeks for cytotoxic agents or at least 5 half-lives for cytotoxic\u002Fnoncytotoxic agents. The half-life for the therapy in question will be based on published pharmacokinetic literature (abstracts, manuscripts, investigator brochure's, or drug-administration manuals) and will be documented in the protocol eligibility document\n* The use of chemotherapeutic or anti-leukemic agents is not permitted during the study with the following exceptions: (1) intrathecal (IT) therapy for patients with controlled central nervous system (CNS) leukemia at the discretion of the PI a (2) Use of one dose of cytarabine (up to 2 g\u002Fm\\^2) or hydroxyurea for patients with rapidly proliferative disease is allowed before the start of study therapy and for the first four weeks on therapy. These medications will be recorded in the case-report form.\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2.\n* Serum biochemical values with the following limits unless considered due to leukemia, hemolysis or congenital disorder (creatinine \\\u003C 1.8 mg\u002Fdl, total bilirubin \\\u003C 1.8 mg\u002FdL, \\[serum glutamate pyruvate transaminase (SGPT)\\] \\\u003C 2.5 x upper limit of normal).\n* White blood cell count \\\u003C 25 x 10\\^9\u002FL\n* Potassium, magnesium, and calcium (normalized for albumin) levels should be within institutional normal limits.\n* Ability to take oral medication.\n* Ability to understand and provide signed informed consent.\n* Baseline left ventricular ejection fraction by echocardiogram (ECHO) or multigated acquisition (MUGA) \\>= 50%.\n* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 7 days. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.\n* WOCBP must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy until at least 3 months after the last dose of investigational drug. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) as well as men with azoospermia do not require contraception.\n* Negative urine or serum pregnancy test.\n* Investigational agents that are not used for treatment of the leukemia per se (e.g. anti-infective prophylaxis or therapy) will be allowed. Other supportive care studies are allowed, even if under an Investigational New Drug (IND).\n\nExclusion Criteria:\n\n* Patients with known allergy or hypersensitivity to quizartinib, mannitol, decitabine or any of their components.\n* Prior quizartinib use.\n* Patients with known uncontrolled CNS leukemia.\n* Only for frontline cohort: patients who are fit for intensive chemotherapy.\n* Patients with electrolyte abnormalities at study entry defined as follows: Serum potassium \\\u003C 3.5 mEq\u002FL despite supplementation, or \\> 5.5 mEq\u002FL Serum magnesium above or below the institutional normal limit despite adequate management. Serum calcium (corrected for albumin levels) above or below institutional normal limit despite adequate management.\n* Patients with known significant impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of quizartinib.\n* Patients with any other known concurrent severe and\u002For uncontrolled medical condition including but not limited to diabetes, cardiovascular disease including hypertension, renal disease, or active uncontrolled infection, which could compromise participation in the study. Patients on active antineoplastic or radiation therapy for a concurrent malignancy at the time of screening. Maintenance therapy, hormonal therapy, or steroid therapy for well-controlled malignancy is allowed.\n* Patients with a known human immunodeficiency virus (HIV) infection.\n* Patients with known positive hepatitis B or C infection by serology, with the exception of those with an undetectable viral load within 3 months. (Hepatitis B or C testing is not required prior to study entry). Subjects with serologic evidence of prior vaccination to HBV \\[i.e., hepatitis B surface antigen \\[HBs Ag\\]-, and anti-HBs+\\] may participate.\n* Patients who have consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges) or Starfruit within 3 days prior to the initiation of study treatment.\n* Patients who have had any major surgical procedure within 14 days of day 1.\n* Impaired cardiac function including any of the following: Screening ECG with a Fridericia's correction formula (QTcF) \\> 450 msec. The QTcF interval will be calculated by Fridericia's correction factor (QTcF). The QTcF will be derived from the average QTcF in triplicate. Patients are excluded if they have QTcF \\>= 450. Subjects with prolonged QTcF interval in the setting of RBBB (right bundle branch block) may participate upon review and approval by the medical monitor. RBBB for patients' triplicate EKGs can show false corrected QT (QTc) prolongation; therefore, the Cardiology collaborator for this study will manually review to provide an accurate reading of the QTc. Patients with congenital long QT syndrome. History or presence of sustained ventricular tachycardia requiring medical intervention. Any history of clinically significant ventricular fibrillation or torsades de pointes. Known history of second or third degree heart block (may be eligible if the patient currently has a pacemaker). Sustained heart rate of \\\u003C 50\u002Fminute on pre-entry ECG. Right bundle branch block + left anterior hemiblock (bifascicular block). Complete left bundle branch block. Patients with myocardial infarction or unstable angina within 6 months prior to starting study drug. Congestive heart failure (CHF) New York (NY) Heart Association class III or IV. Atrial fibrillation documented within 2 weeks prior to first dose of study drug. Patients who are actively taking a strong CYP3A4 inducing medication.\n* Patients who require treatment with concomitant drugs that prolong QT\u002FQTc interval or strong CYP3A4 inhibitors with the exception of antibiotics, antifungals, and antivirals that are used as standard of care to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the subject or if the Investigator believes that beginning therapy with a potentially QTc-prolonging medication (such as anti-emetic except for prochlorperazine) is vital to an individual subject's care while on study.\n* Known family history of congenital long QT syndrome.\n* Patients who are on strong CYP3A4 inhibitor will be excluded.",{"count":101,"type":23},73,[26,103],"PHASE2","This phase I\u002FII trial studies how well quizartinib, decitabine, and venetoclax work in treating participants with acute myeloid leukemia or high risk myelodysplastic syndrome that is untreated or has come back (relapsed). Quizartinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as decitabine and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving quizartinib and decitabine may work better at treating acute myeloid leukemia and myelodysplastic syndrome.",[30,106,61,107,31],"Myelodysplastic Syndrome","Recurrent Myelodysplastic Syndrome",{"date":35,"type":38},{"date":110,"type":38},"2018-10-31",{"date":112,"type":23},"2028-01-01",{"name":114,"class":91},"M.D. Anderson Cancer Center",{"id":116,"slug":117,"hasResults":12,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":24,"phases":124,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":92},"100639858","phase-2-total-marrow-and-lymphoid-irradiation-in-combination-with-fludarabine-and-melphalan-as-conditioning-for-allogeneic-peripheral-blood-stem-cell-hematopoietic-cell-transplant-in-older-patients-with-refractory-and-relapsed-acute-myeloid-leukemia-and-high-risk-myelodysplastic-syndrome-100639858","NCT07582172","Total Marrow and Lymphoid Irradiation in Combination With Fludarabine and Melphalan as Conditioning for Allogeneic Peripheral Blood Stem Cell Hematopoietic Cell Transplant in Older Patients With Refractory and Relapsed Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome","Phase 2 Trial of Total Marrow and Lymphoid Irradiation (TMLI) as Conditioning for Allogeneic Peripheral Blood Stem Cell Hematopoietic Cell Transplantation (PBSC-HCT) From a Match Donor With Fludarabine and Melphalan in Older Patients With Refractory Acute Myeloid Leukemia and MDS","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n\n  * Assent, when appropriate, will be obtained per institutional guidelines\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies\n\n  * If unavailable, exceptions may be granted with study principal investigator (PI) approval\n* Age: ≥ 50 years (no upper age limit)\n\n  * Note: Patients ≥ 18 years and \\\u003C 50 years are also included if they are not candidates for myeloablative conditioning regimens due to comorbidities or active disease\n* Karnofsky or Lansky performance status ≥ 70\n* Eligible patients will have a histopathological confirmed diagnosis of hematologic malignancy in one of the following categories:\n\n  * Acute myeloid leukemia (AML):\n\n    * Patients with de novo or secondary disease in unfavorable risk group including poor risk cytogenetics according to National Comprehensive Cancer Network (NCCN) guidelines for AML i.e., monosomal karyotype, -5,5q-,-7,7q-,11q23-non t(9;11), inv (3), t(3;3), t(6;9), t(9;22) and complex karyotypes (≥ 3 unrelated abnormalities), or all patient in intermediate risk groups\n    * Patients with active disease:\n\n      * Morphologically\n      * Minimal residual disease (MRD) testing (MRD+ through flow cytometry, cytogenetics, or molecular assays)\n  * Myelodysplastic syndrome\u002Fchronic myelomonocytic leukemia (CMML) (MDS) with ≥ 10% blast\n* Patients must have an human leukocyte antigen (HLA) (A, B, C, and DRB1) identical sibling or a 8\u002F8 (A, B, C, and DR) allele matched unrelated donor who is willing to donate primed blood stem cells\n* Serum direct bilirubin ≤ 2.0 x upper limit of normal (ULN) (unless has Gilbert's disease) (within 35 days prior to day 1 of protocol therapy unless otherwise stated)\n* Aspartate aminotransferase (AST) ≤ 2.5 x ULN (within 35 days prior to day 1 of protocol therapy unless otherwise stated)\n* Alanine aminotransferase (ALT) ≤ 2.5 x ULN (within 35 days prior to day 1 of protocol therapy unless otherwise stated)\n* Creatinine clearance of ≥ 60 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula (within 35 days prior to day 1 of protocol therapy unless otherwise stated)\n* Left ventricular ejection fraction (LVEF) ≥ 50%\n\n  * Note: To be performed within 35 days prior to day 1 of protocol therapy\n* If able to perform pulmonary function tests: Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and DLCO (diffusion capacity) ≥ 50% of predicted (corrected for hemoglobin)\n\n  * Note: To be performed within 35 days prior to day 1 of protocol therapy\n* If unable to perform pulmonary function tests: Oxygen (O2) saturation \\> 92% on room air\n\n  * Note: To be performed within 35 days prior to day 1 of protocol therapy\n* Seronegative for HIV antigen (Ag)\u002Fantibody (Ab) combo, hepatitis C virus (HCV), active hepatitis B virus (HBV) (surface antigen negative) (within 35 days prior to day 1 of protocol therapy unless otherwise stated)\n\n  * If seropositive for HIV, HCV or HBV, nucleic acid quantitation must be performed. Viral load must be undetectable\n  * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Meets institutional and federal requirements for infectious disease titer requirements\n\n  * Note: Infectious disease testing to be performed within 28 days prior to day 1 of protocol therapy\n* Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test (within 35 days prior to day 1 of protocol therapy unless otherwise stated)\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Allogeneic stem cell transplant or autologous HCT within 1 year prior to day 1 of protocol therapy\n* Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days of day 1 of protocol therapy\n\n  * Note: Low dose chemotherapy or maintenance chemotherapy given within 7 days of planned study enrollment is permitted. These include hydroxyurea, 6-meraptopurine, oral methotrexate, vincristine, oral etoposide, and tyrosine kinase inhibitors (TKIs). TKIs can also be given up to 3-5 days before conditioning regimen\n* More than three previous lines of intensive chemotherapy, where the regimen intent was to induce remission\n* Co-enrollment in other clinical trials involving post-HCT maintenance interventions or any study with potential to affect disease-free survival is not allowed\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* Clinically significant uncontrolled illness\n* Active infection not responding to antibiotics\n* Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":123,"type":23},35,[103],"This phase II trial tests the effect of total marrow and lymphoid irradiation (TMLI) in combination with fludarabine and melphalan as conditioning regimen in older patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that has not responded to previous treatment (refractory) and that has come back after a period of improvement (relapsed) and are undergoing a donor (allogeneic) peripheral blood stem cell (PBSC) hematopoietic cell transplant (HCT) from a matched related or unrelated donor. HCT is the only curative treatment for high-risk patients, but the side effects related to the current conditioning treatments limit the use to younger and more fit patients. TMLI is a targeted form of total body radiation that uses intensity-modulated radiation therapy to target marrow, lymph node chains, and the spleen. It is designed to reduce radiation-associated side effects and maximize the radiation therapeutic effect. Fludarabine blocks cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. It is a type of purine antagonist and a type of ribonucleotide reductase inhibitor. Melphalan is in a class of medications called alkylating agents. It may kill cancer cells by damaging their DNA and stopping them from dividing. Giving chemotherapy, such as fludarabine and melphalan, and TMLI before an allogeneic transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells to grow. When healthy stem cells from a related or unrelated donor, such as PBSC HCT, that closely match the patient's blood, are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets, an may help destroy any remaining cancer cells. Giving TMLI in combination with fludarabine and melphalan as conditioning treatment for an allogeneic PBSC HCT from a matched related or unrelated donor may be safe, tolerable, and\u002For effective in treating high-risk older patients with relapsed and refractory acute myeloid leukemia or high-risk myelodysplastic syndrome.",[127,128,106,61,129,107,130,31,131,132,133],"Acute Myeloid Leukemia With Complex Karyotype","Myelodysplastic Chronic Myelomonocytic Leukemia","Recurrent Myelodysplastic Chronic Myelomonocytic Leukemia","Recurrent Secondary Acute Myeloid Leukemia","Refractory Myelodysplastic Chronic Myelomonocytic Leukemia","Refractory Myelodysplastic Syndrome","Refractory Secondary Acute Myeloid Leukemia","2026-08-18",{"date":35,"type":38},{"date":137,"type":23},"2027-04-05",{"date":139,"type":23},"2029-04-05",{"name":90,"class":91},{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":148,"targetDuration":4,"studyType":24,"phases":150,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":155,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":46},"100321927","phase-1-ivosidenib-and-venetoclax-with-or-without-azacitidine-in-treating-patients-with-idh1-mutated-hematologic-malignancies-100321927","NCT03471260","Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies","Phase Ib\u002FII Investigator Initiated Study of the IDH1-Mutant Inhibitor Ivosidenib (AG120) With the BCL2 Inhibitor Venetoclax +\u002F- Azacitidine in IDH1-Mutated Hematologic Malignancies","Inclusion Criteria:\n\n1. Age \\> 18 years.\n2. ECOG performance status of \\\u003C 2.\n3. IDH1-R132 mutated disease status as assessed by local laboratory. 2HG-producing IDH1 variants outside of R132 (i.e. R100) may be eligible after discussion with the PI.\n4. Relapsed\u002Frefractory AML, or treatment-naïve patients with AML who are not eligible for standard induction chemotherapy. Patients with high-risk MDS, MDS\u002FMPN or MPN (defined as \\> 10% bone marrow blasts, or intermediate or high risk by IPSS, R-IPSS or D-IPSS) that have failed standard therapy may also be eligible after discussion with the PI.\n5. Adequate hepatic function (direct bilirubin \\\u003C 2 x ULN, ALT and\u002For AST \\\u003C 3x ULN) unless deemed to be related to underlying leukemia.\n6. Adequate renal function including creatinine clearance \\> 30 ml\u002Fmin based on the Cockcroft-Gault equation.\n7. Willing and able to provide informed consent\n8. In the absence of rapidly proliferative disease, the interval from prior treatment to time of initiation will be at least 7 days for cytotoxic or non-cytotoxic (immunotherapy) agents.\n9. Male subjects must agree to refrain from unprotected sex and sperm donation from initial study drug administration until 90 days after the last dose of study drug.\n\nExclusion Criteria:\n\n1. Patients with known allergy or hypersensitivity to ivosidenib or venetoclax.\n2. Patients who have previously received either ivosidenib or venetoclax.\n3. Patients with any concurrent uncontrolled clinically significant medical condition including infection, laboratory abnormality, or psychiatric illness, which could place the patient at unacceptable risk of study treatment.\n4. The use of other chemotherapeutic agents or anti-leukemic agents is not permitted during study with the following exceptions (1) intrathecal chemotherapy for prophylactic use or for controlled CNS leukemia. (2) use of hydroxyurea and\u002For one dose of cytarabine (up to 2 g\u002Fm2) for patients with rapidly proliferative disease is allowed before the start of study therapy and for the first four weeks on therapy.\n5. Patients receiving concomitant strong CYP3A inducers (avasimibe, carbamazepine, phenytoin, rifampin, rifabutin, St. John's wort) within 3 days of start of study therapy.\n6. Patients with active graft-versus-host-disease (GVHD) status post stem cell transplant (patients without active GVHD on chronic suppressive immunosuppression and\u002For phototherapy for chronic skin GVHD are permitted after discussion with the PI).\n7. Patients with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.\n8. Patients with a concurrent active malignancy under treatment.\n9. QTc interval using Fridericia's formula (QTcF) \\> 450 msec. Bundle branch block and prolonged QTc interval are permitted after discussion with the PI.\n10. Known active hepatitis B (HBV) or Hepatitis C (HCV) infection or known HIV infection.\n11. Subject has a white blood cell count \\> 25 x 10⁹\u002FL. (Note: Hydroxyurea is permitted to meet this criterion.)\n12. Nursing women, women of childbearing potential (WOCBP) with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception a. Appropriate highly effective method(s) of contraception include oral or injectable hormonal birth control, IUD, and double barrier methods (for example a condom in combination with a spermicide).",{"count":149,"type":23},96,[26,103],"This phase Ib\u002FII trial studies the side effects and best dose of venetoclax and how well it works when given together with ivosidenib with or without azacitidine, in treating patients with IDH1-mutated hematologic malignancies. Venetoclax and ivosidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ivosidenib and venetoclax with azacitidine may work better in treating patients with hematologic malignancies compared to ivosidenib and venetoclax alone.",[30,153,106,154,61,31],"Hematopoietic and Lymphoid System Neoplasm","Myeloproliferative Neoplasm",{"date":35,"type":38},{"date":157,"type":38},"2018-03-19",{"date":159,"type":23},"2027-09-30",{"name":114,"class":91},{"id":162,"slug":163,"hasResults":12,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":12,"sex":18,"minAge":168,"maxAge":169,"enrollmentInfo":170,"targetDuration":4,"studyType":24,"phases":171,"briefSummary":172,"conditions":173,"keywords":183,"overallStatus":186,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":4},"100652162","phase-1-a-study-of-sonrotoclax-bgb-11417-in-children-with-relapsed-or-refractory-acute-myeloid-leukemia-and-b-cell-acute-lymphoblastic-leukemia-100652162","NCT07770698","A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia","A Phase 1\u002F2a, Open-Label, Dose Finding and Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of Sonrotoclax (BGB-11417) in Combination With Other Agents in Pediatric Patients Aged 6 Months to 17 Years, With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia","Key Inclusion Criteria\n\nParticipants must meet all of the following criteria to be eligible for participation:\n\n1. Have a performance status of Lansky ≥50 for participants ≤16 years of age or Karnofsky ≥50 for participants \\>16 years of age.\n2. Have adequate renal function, defined as an estimated or measured glomerular filtration rate (GFR) ≥60 mL\u002Fmin.\n3. Have adequate hepatic function, defined as:\n\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C2.5 × the institutional upper limit of normal (ULN)\n   * Total bilirubin ≤1.5 × the institutional ULN.\n4. Have minimum cardiac function as defined in the study protocol.\n\nAcute Myeloid Leukemia (AML)-Specific Inclusion Criteria\n\n1. Have a histologically confirmed diagnosis of acute myeloid leukemia (AML) that is relapsed or refractory (R\u002FR) after ≥2 prior lines of systemic therapy.\n2. Have ≥5% blasts in a bone marrow aspirate or biopsy sample, as assessed by morphology. Participants with extramedullary, non-central nervous system (CNS) disease are eligible.\n\nB-Cell Precursor Acute Lymphoblastic Leukemia (ALL)-Specific Inclusion Criteria\n\n1. Have a histologically confirmed diagnosis of B-cell precursor acute lymphoblastic leukemia (ALL) that is R\u002FR after ≥2 prior lines of systemic therapy, including at least 1 line of blinatumomab-based therapy.\n2. Have ≥5% blasts in a bone marrow aspirate or biopsy sample, as assessed by morphology.\n3. Have leukemic blasts expressing cluster of differentiation 22 (CD22) on the cell surface, as assessed by flow cytometry of a bone marrow aspirate.\n\nKey Exclusion Criteria\n\nParticipants will be excluded from participation if any of the following apply:\n\n1. Have central nervous system (CNS) 2 or CNS 3 disease at screening.\n2. Have toxicity from prior anticancer therapy that has not recovered to ≤Grade 1, as defined by the applicable toxicity grading criteria.\n3. Have a history of prior allogeneic stem cell transplantation \\\u003C90 days from enrollment or if if ≥ 90 days from enrollment, with active graft-versus-host disease (GVHD), or requiring immunosuppressive drugs for treatment of GVHD, or have taken calcineurin inhibitors within 4 weeks prior to consent.\n\nAML-Specific Exclusion Criteria\n\n1. Have a diagnosis of acute promyelocytic leukemia (APL) or juvenile myelomonocytic leukemia (JMML).\n2. Have AML with fms-like tyrosine kinase 3 internal tandem duplication (FLT3-ITD), as determined by local assessment.\n\nALL-Specific Exclusion Criteria\n\n1. Have Philadelphia chromosome-positive (Ph+) ALL with a breakpoint cluster region::Abelson murine leukemia viral oncogene homolog 1 (BCR::ABL1) fusion.\n2. Have received prior therapy with a B-cell lymphoma 2 (BCL-2) inhibitor.\n\nNote: Other eligibility criteria may apply.","6 Months","17 Years",{"count":80,"type":23},[26,103],"The goal of this clinical trial is to learn if sonrotoclax (BGB-11417) is safe and may help treat children and adolescents with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) that has come back after treatment or has not responded to treatment. The study will also learn how the body processes sonrotoclax when it is given with other medicines. The main questions it aims to answer are:\n\n* Is sonrotoclax safe and well tolerated when given with other anti-cancer medicines?\n* How does the body absorb, process, and remove sonrotoclax?\n* Does treatment with sonrotoclax, in combination with other medicines, help reduce or eliminate leukemia?\n\nResearchers will give sonrotoclax together with other anti-cancer medicines to participants with relapsed or refractory AML or ALL. Participants will:\n\n* Take sonrotoclax in combination with other anti-cancer medicines\n* Have regular clinic visits for physical exams, blood tests, heart monitoring, and other safety assessments.\n* Provide blood samples to measure how the body processes sonrotoclax.\n* Have tests to evaluate how their leukemia responds to treatment.\n* Continue treatment as long as it is helping and side effects remain manageable, according to the study plan.",[33,31,174,175,176,177,178,30,179,180,181,182],"B-cell Acute Lymphoblastic Leukemia","Pediatric Cancer","Pediatric ALL, Relapsed","Pediatric ALL","Pediatric ALL, B Cell","Acute Lymphoblastic Leukemia","Pediatric AML","R\u002FR AML","R\u002FR B-cell ALL",[182,181,180,179,30,178,177,176,175,33,31,184,185],"Sonrotoclax","Pediatric","NOT_YET_RECRUITING","2026-08-17",{"date":134,"type":38},{"date":190,"type":23},"2026-10",{"date":192,"type":23},"2031-09",{"name":194,"class":45},"BeOne Medicines",{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":24,"phases":204,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":208,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":215},"100546798","phase-1-eltanexor-and-venetoclax-in-relapsed-or-refractory-myelodysplastic-syndrome-and-acute-myeloid-leukemia-100546798","NCT06399640","Eltanexor and Venetoclax in Relapsed or Refractory Myelodysplastic Syndrome and Acute Myeloid Leukemia","Phase Ib Study of Eltanexor and Venetoclax in Relapsed or Refractory Myelodysplastic Syndrome and Acute Myeloid Leukemia","Inclusion Criteria:\n\n\\- Age \\>\u002F= 18 years at the time of signing the Informed Consent Form (ICF); must voluntarily sign an ICF; and must be able to meet all study requirements.\n\nFor Myelodysplastic Syndrome (MDS):\n\nMorphologically confirmed diagnosis of MDS with increased blasts (\\>\u002F= 5%), with a prior DNA methyltransferase inhibitor (DNMTi) treatment and progression after 2 cycles or stable disease after 4 cycles\n\nFor Acute Myeloid Leukemia (AML):\n\nMorphologically confirmed diagnosis of AML in accordance with WHO diagnostic criteria that is relapsed or refractory following \\>\u002F= 1 line(s) of therapy.\n\n* WBC must be less than 25,000\u002Ful prior to study start (hydroxyurea allowed).\n* A bone marrow aspirate must be performed, and tissue collected for entrance to the trial unless circulating blasts \\>\u002F= 5% in which case, peripheral blood can be used.\n* Eastern Cooperative Oncology Group Performance Status of 0 - 2.\n* Must have adequate hepatic and renal function as demonstrated by the following:\n\nALT(SGPT) and\u002For AST (SGOT) \\\u003C\u002F= 3x upper limit of normal (ULN); Total bilirubin \\\u003C\u002F= 1.5x ULN; Calculated creatinine clearance \\> 50 ml\u002Fmin (per the Cockroft-Gault formula).\n\n\\- Willingness to abide by all study requirements, including contraception, maintenance of a pill diary, and acceptance of recommended supportive care medications.\n\nExclusion Criteria:\n\n* Anticancer therapy, including investigational agents \\\u003C\u002F= 2 weeks or \\\u003C\u002F= 5 half-lives of the drug, whichever is shorter, prior to C1D1. (Use of hydroxyurea is permitted).\n* Inadequate recovery from toxicity attributed to prior anti-cancer therapy to \\\u003C\u002F= Grade 1 (NCI CTCAE v5.0), excluding alopecia or fatigue.\n* Prior treatment with SINE compounds or other inhibitors of XPO1.\n* History of allogeneic hematopoietic stem cell transplant (HCT), or other cellular therapy product, within 3 months.\n* Active acute or chronic GVHD requiring calcineurin inhibitors or steroid dosing \\>\u002F= 10mg\u002Fday or patients within 4 weeks of stopping calcineurin inhibitors for GVHD.\n* Radiation therapy or major surgery within 3 weeks.\n* Active, uncontrolled infection. Patients with infection under active treatment and controlled with antibiotics are eligible. Prophylaxis, even if parenteral, is acceptable.\n* Inability to swallow oral medications.\n* Active documented central nervous system leukemia.\n* Second active malignancy within past 2 years except for basal or squamous cell carcinoma of the skin, ductal carcinoma of breast in situ or cervical carcinoma in situ.\n* Women of childbearing age or potential must have negative pregnancy test and must not be actively breastfeeding to enroll on the study\n* Clinically significant cardiovascular disease with major event or cardiac intervention within the past 6 months (e.g. percutaneous intervention, coronary artery bypass graft, documented cardiac heart failure) as determined by the investigator.\n* QT interval corrected by Fridericia's formula (QTcF)\\>470msec for both males and females on screening ECG. Patients with a bundle branch block or in-situ pacemaker must have appropriate QT interval corrections for these conditions.\n* Any condition not listed but deemed by the investigator to make the patient a poor candidate for clinical trial and\u002For treatment with investigational agents.",{"count":203,"type":23},60,[26],"This phase I trial tests the safety, side effects, and best dose of eltanexor in combination with venetoclax for the treatment of patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Eltanexor works by trapping \"tumor suppressing proteins\" within the cell, thus causing the cancer cells to die or stop growing. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving eltanexor together with venetoclax may be safe, tolerable and\u002For effective in treating patients with relapsed or refractory MDS or AML.",[207,132,30,61,31],"Relapsed Myelodysplastic Syndrome",{"date":62,"type":38},{"date":210,"type":38},"2024-08-14",{"date":212,"type":23},"2027-10-01",{"name":214,"class":91},"Vanderbilt-Ingram Cancer Center",2,{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":24,"phases":225,"briefSummary":226,"conditions":227,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":92},"100583060","phase-1-genetically-engineered-cells-cd83-car-t-cells-for-the-treatment-of-relapsed-or-refractory-acute-myeloid-leukemia-100583060","NCT06871410","Genetically Engineered Cells (CD83 CAR T Cells) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia","CD83 CAR T in Relapsed or Refractory Acute Myeloid Leukemia (AML): A Phase I Trial","Inclusion Criteria:\n\n* Age ≥ 18 years old.\n* Karnofsky performance status score ≥ 70%.\n* Relapsed or refractory AML based upon ELN 2022 criteria.\n* Creatinine clearance: ≥ 40 mL\u002Fmin (Cockroft-Gault).\n* Total bilirubin: ≤ 2mg\u002FdL except for patients with Gilbert's syndrome, hemolysis, or related to disease.\n* Aspartate aminotransferase (AST) and alanine transaminase (ALT) \\\u003C 3.0 x upper limit of normal (ULN).\n* Left ventricular (LV) ejection fraction: \\> 45% and be free of symptomatic congestive heart failure or uncontrolled arrhythmia.\n* Oxygen (O2) saturation: ≥ 92% on room air without needs for supplemental O2.\n* Absolute lymphocyte count: ≥ 0.2 x 10\\^9\u002FL, HCT of ≥ 27% and platelets of ≥ 20 x 10\\^9\u002FL. Transfusion support is allowed to meet HCT and platelet parameters prior to apheresis.\n* Life expectancy ≥12 weeks from the time of enrollment, per clinical judgment.\n* Negative serum pregnancy test in females of child-bearing potential (FOCBP). FOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal.\n* If history of allogeneic HCT, must have completed transplant at least 3 months prior, be off immunosuppression, including ruxolitinib, at least 2 weeks prior to apheresis, and have no evidence of GVHD requiring treatment at enrollment.\n* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for 12 months following duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n* Participants must be considered preliminarily eligible for an allogeneic hematopoietic cell transplantation, with potential donors identified per a transplant and cellular therapy consult at Roswell Park Comprehensive Cancer Center.\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure.\n\nExclusion Criteria:\n\n* Concomitant systemic glucocorticoid use at a dose equivalent to \\> 10 mg daily prednisone at the time of apheresis and\u002For within 4 weeks of CD83 CAR T infusion for any reasons other than GVHD.\n* Diagnosis of acute promyelocytic leukemia (APL; AML M3 by French-American-British \\[FAB\\] classification).\n* Active central nervous system (CNS) leukemia; patients with history of CNS leukemia in complete response (CR) are eligible.\n* Patients enrolled in another investigational therapy protocol for their disease within 14 days or 5 half-lives prior to leukapheresis, whichever is shorter.\n* Patients requiring agents or any treatments other than hydroxyurea, single agent cytarbine,hypomethylating agents with or without ventoclax and\u002For targeted agents (i.e., FLT3, IDH2 or IDH1 inhibitors) to control blast counts within 14 days or 5 half-lives (whichever is shorter) prior to lymphodepletion.\n* Ongoing uncontrolled serious infection, pulmonary disease or psycho\u002Fsocial concerns.\n* HIV seropositivity or active hepatitis B or C infection within (defined by positive polymerase chain reaction \\[PCR\\]) 4 weeks of enrollment.\n* Other active malignancy within 2 years of study entry, except for basal cell cancer of skin, cervical cancer treated surgically with curative intent or localized prostate cancer managed with observational approach.\n* Active grade II-IV acute GVHD in patients with relapsed AML after HCT requiring treatment.\n* Prior solid organ transplant.\n* Active autoimmune disease requiring immunosuppressive therapy.\n* Pregnant or nursing female participants.\n* Unwilling or unable to follow protocol requirements.\n* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug.",{"count":224,"type":23},26,[26],"This phase I trial tests the safety, side effects, and best dose of genetically engineered cells (CD83 chimeric antigen receptor \\[CAR\\] T cells) in treating patients with acute myeloid leukemia (AML) that has come back after a period of improvement (relapsed) or has not responded to previous treatment (refractory). CD83 is a protein that is found on AML blasts. Blasts are abnormal immature white blood cells that can multiply uncontrollably: filling up the bone marrow and preventing the production of other cells important for survival. CD83 CAR T cells represent a new cell therapy to eliminate AML blasts, while avoiding the risk for graft versus host disease (GVHD) after stem cell transplant to replace bone marrow or, tumor toxicity like myeloid aplasia where the body's own immune system causes damage to the bone marrow stem cells. Therefore, human CD83 CAR T cells are a promising cell-based approach to preventing two critical complications of stem-cell transplant - GVHD and relapse. Giving CD83 CAR T cells may be safe, tolerable, and\u002For effective in treating patients with relapsed or refractory AML.",[61,31],"2026-08-14",{"date":187,"type":38},{"date":231,"type":38},"2026-02-02",{"date":233,"type":23},"2028-04-01",{"name":235,"class":91},"Roswell Park Cancer Institute",{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":18,"minAge":243,"maxAge":244,"enrollmentInfo":245,"targetDuration":4,"studyType":24,"phases":247,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":260},"100529691","phase-1-study-of-revumenib-azacitidine-and-venetoclax-in-pediatric-and-young-adult-patients-with-refractory-or-relapsed-acute-myeloid-leukemia-100529691","NCT06177067","Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia","A Phase 1 Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia","Inclusion Criteria: Participants must have a diagnosis of AML or ALAL and meet the criteria below:\n\n* Refractory leukemia, defined as persistent leukemia after at least two courses of induction chemotherapy (one course for secondary AML), or relapsed leukemia, defined as the re-appearance of leukemia after the achievement of remission. Patients must have ≥5% blasts in the bone marrow as assessed by morphology or ≥1% blasts flow cytometry.\n\nHowever, if an adequate bone marrow sample cannot be obtained (e.g., in a patient with acute megakaryoblastic leukemia with marrow fibrosis), patients may be enrolled if there is unequivocal evidence of leukemia with ≥5% blasts by morphology or ≥1% blasts flow cytometry in the blood.\n\n* Presence of KMT2A rearrangement (KMT2Ar), NUP98 rearrangement (NUP98r), NPM1 mutation or fusion, PICALM::MLLT10, DEK::NUP214, UBTF-TD, KAT6A rearrangement (KAT6Ar), or SET::NUP214\n* Adequate organ function, defined as total bilirubin \\\u003C 1.5 × institutional upper limit of normal for age or normal conjugated bilirubin (for patients with known Gilbert's syndrome, total bilirubin \\\u003C3 × the ULN) unless attributed to leukemia, calculated creatinine clearance ≥60 mL\u002Fmin\u002F1.73 m\\^2, and left ventricular ejection fraction ≥ 40%\n* QTcF \\\u003C 480 msec (average of triplicate)\n* Age ≥ 1 year and ≤ 30 years. The upper age limit may be defined by each institution, but may not exceed 30 years.\n* Lansky ≥ 60 for patients who are \\\u003C 16 years old and Karnofsky ≥ 60% for patients who are \\> 16 years old.\n* At least 14 days or 5 half-lives (whichever is longer) must have elapsed since the completion of myelosuppressive therapy, with the exception of low-dose therapy used for cytoreduction according to institutional standards, such as hydroxyurea or low-dose cytarabine (up to 200 mg\u002Fm\\^2\u002Fday). In addition, all toxicities must have resolved to grade 1 or less.\n* Patients must have a leukocyte count \\\u003C25,000 cells\u002FuL. Low-dose therapy, such as hydroxyurea or cytarabine as described above, to achieve this limit is acceptable.\n* For patients who have received prior HCT, there can be no evidence of GVHD and greater than 60 days must have elapsed since the HCT, and patients should be off calcineurin inhibitors for at least 28 days prior to the start of protocol therapy. Physiologic prednisone for the treatment of adrenal insufficiency is acceptable..\n* Patients must be taking posaconazole or voriconazole, which must be started at least 24 hours prior to the start of therapy.\n* Patients of reproductive potential must agree to use effective contraception for the duration of study participation.\n\nPatients who meet the criteria listed above are eligible for enrollment and treatment on the trial. However, patients in first relapse who are suitable for and willing to receive intensive remission induction therapy should be offered such therapy if deemed appropriate by the treating physician.\n\nExclusion Criteria:\n\n* Patients who are pregnant or breastfeeding are not eligible.\n* Patients with Down syndrome, acute promyelocytic leukemia, juvenile myelomonocytic leukemia, or bone marrow failure syndromes are not eligible.\n* Patients with uncontrolled infection are not eligible. Patients with infections that are controlled on concurrent anti-microbial agents are eligible.","1 Year","30 Years",{"count":246,"type":23},24,[26],"This is a research study to find out if adding a new study drug called revumenib to commonly used chemotherapy drugs is safe and if they have beneficial effects in treating patients with acute myeloid leukemia (AML) or acute leukemia of ambiguous lineage (ALAL) that did not go into remission after treatment (refractory) or has come back after treatment (relapsed), and to determine the total dose of the 3-drug combination of revumenib, azacitidine and venetoclax that can be given safely in participants also taking an anti-fungal drug.\n\nPrimary Objective\n\n* To determine the safety and tolerability of revumenib + azacitidine + venetoclax in pediatric patients with relapsed or refractory AML or ALAL.\n\nSecondary Objectives\n\n* Describe the rates of complete remission (CR), complete remission with incomplete count recovery (CRi), and overall survival for patients treated with revumenib + azacitidine + venetoclax at the recommended phase 2 dose (RP2D).",[31,33,250],"Acute Leukemia of Ambiguous Lineage","2026-07-31",{"date":253,"type":38},"2026-08-03",{"date":255,"type":38},"2024-04-19",{"date":257,"type":23},"2027-04",{"name":259,"class":91},"St. Jude Children's Research Hospital",10,{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":24,"phases":269,"briefSummary":270,"conditions":271,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":92},"100574750","phase-1-a-phase-1-study-of-aoh1996-in-patients-with-relapsedrefractory-acute-myeloid-leukemia-100574750","NCT06763341","A Phase 1 Study of AOH1996 in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Documented informed consent of the participant and\u002For legally authorized representative\n* Age: ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) ≤ 2\n* Life expectancy \\> 3 months\n* Patients with histologically confirmed AML, according to International Consensus Classification (ICC) or World Health Organization (WHO) criteria, with refractory\u002Frelapsed (R\u002FR) disease who have failed treatment with, or are ineligible for, available therapies known to be effective for treatment of their AML\n\n  * Patients with extramedullary disease may be included if they also have marrow involvement\n  * Patients with acute promyelocytic leukemia (APL) will not be eligible\n* Fully recovered from the acute toxic effects (except alopecia) to ≤ grade 1 to prior anti-cancer therapy\n* Ability to swallow pills\n* White blood cell (WBC) ≤ 25 x 10\\^9\u002FL prior to initiation of study therapy. Cytoreduction with hydroxyurea prior to treatment and\u002For during cycle 1 may be required (within 14 days prior to day 1 of protocol therapy)\n* Total bilirubin ≤ 1.5 X upper limit of normal (ULN) (within 14 days prior to day 1 of protocol therapy)\n* Aspartate aminotransferase (AST) =\\\u003C 3.0 x ULN (within 14 days prior to day 1 of protocol therapy)\n* Alanine aminotransferase (ALT) =\\\u003C 3.0 x ULN (within 14 days prior to day 1 of protocol therapy)\n* Creatinine clearance of ≥ 50 mL\u002Fmin per 24 hour urine test or the Cockcroft-Gault formula (within 14 days prior to day 1 of protocol therapy)\n* International normalized ratio (INR) OR prothrombin (PT) ≤ 1.5 x ULN (within 14 days prior to day 1 of protocol therapy)\n* Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN (within 14 days prior to day 1 of protocol therapy)\n* Corrected QT interval (QTc)F ≤ 480 ms based on Fridericia's formula\n\n  * Note: To be performed within 28 days prior to day 1 of protocol therapy\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (within 14 days prior to day 1 of protocol therapy)\n\n  * If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required\n* Agreement by females and males of childbearing potential\\* to use an effective method of birth control (nonhormonal) or abstain from heterosexual activity for the course of the study through at least 2 months after the last dose of protocol therapy\n\n  * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \\> 1 year (women only)\n\nExclusion Criteria:\n\n* Hematopoietic stem cell transplant within 100 days prior to day 1 of protocol therapy. Patients who have stopped calcineurin inhibitors (CNI) must be off CNIs for at least 2 weeks prior to day 1 of protocol therapy\n* Chemotherapy, radiation therapy, biological therapy, immunotherapy within 14 days prior to day 1 of protocol therapy with the following exception of hydroxyurea which is allowed prior to treatment and through cycle 1 for control of rapidly progressing leukemia\n* Strong inducers or strong inhibitors of CYP enzymes (e.g., 1A2, 2B6, 2C8, 2C9, 2C19, and 3A4), other than azole antifungals with CYP3A4 inhibition potential, or drug transporters (e.g., organic anions \\[OATP1B1\u002F1B3\\], BCRP, P-gp, organic cations \\[OCT1, OCT2, OCT3\\], MATE1 or MATE2K), or sensitive substrates of these CYPs or drug transporters, within 4-5 half-lives or 14 days prior to the first dose of study drug, whichever is longer.\n* Foods\u002Fsupplements that are strong inhibitors or strong or moderate inducers of CYP3A (such as St. John's wort) within 3 days prior to initiation of and during study treatment\n* Systemic steroid therapy \\> 10 mg\u002Fday (≤ 10mg\u002Fday prednisone equivalent ok) or any other form of immunosuppressive medication within 14 days. Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted\n* Must not have received or planning to receive live vaccine while being on study or 4 weeks before and after completion of treatment\n* Patients with blast phase chronic myeloid leukemia (CML)\n* Patients with translocation (t)(15;17) karyotypic abnormality or acute promyelocytic leukemia (French-American-British \\[FAB\\] class M3-AML)\n* Active central nervous system (CNS) disease\n* Active graft versus (vs) host disease (GVHD)\n* Unstable cardiac disease as defined by one of the following:\n\n  * Cardiac events such as myocardial infarction (MI) within the past 6 months\n  * Uncontrolled atrial fibrillation or hypertension\n* No measurable disease in the bone marrow\n* Gastrointestinal disorder that interferes with oral drug absorption such as malabsorption syndrome\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent\n* Uncontrolled active infection\n* Clinically significant uncontrolled illness\n* Other active malignancy. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* Females only: Pregnant or breastfeeding\n* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures\n* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics)",{"count":268,"type":23},12,[26],"This phase 1 trial tests safety, side effects, and best dose of AOH1996 for the treatment of patients with acute myeloid leukemia (AML) that has come back after a period of improvement (relapsed) or AML that has not responded to previous treatment (refractory). AOH1996 is in a class of medications called PCNA inhibitors. It inhibits cancer growth and induces deoxyribonucleic acid (DNA) damage. This may help keep cancer cells from growing and damage cancer cell DNA. Giving AOH1996 may be safe, tolerable and\u002For effective in treating patients with AML.",[61,31],"2026-07-24",{"date":274,"type":38},"2026-07-27",{"date":276,"type":38},"2025-07-30",{"date":278,"type":23},"2027-01-16",{"name":90,"class":91},{"id":281,"slug":282,"hasResults":12,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":24,"phases":289,"briefSummary":290,"conditions":291,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":301},"100348401","phase-1-tak-243-in-treating-patients-with-relapsed-or-refractory-acute-myeloid-leukemia-or-myelodysplastic-syndromes-with-increased-blasts-100348401","NCT03816319","TAK-243 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes With Increased Blasts","A Phase 1 Study of TAK-243 for Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes With Increased Blasts","Inclusion Criteria:\n\n* Diagnosis of AML or MDS with increased blasts (MDS-IB) assessed by local laboratory review according to the 2022 World Health Organization (WHO) criteria for myeloid neoplasms. Both patients with MDS-IB1 (5-9% bone marrow blasts) and MDS-IB2 (10-19% bone marrow blasts) are eligible.\n* Patients must have relapsed or refractory disease after receiving at least one prior line of therapy\n* AML-specific inclusion criteria: Patients with relapsed or refractory AML with \\>= 5% bone marrow blasts after receiving at least two courses of intensive induction chemotherapy (including, but not limited to, 7+3 regimen, fludarabine, cytarabine, idarubicin and filgrastim \\[FLAG-Ida\\] and mitoxantrone, etoposide, and cytarabine \\[MEC\\]) or 2 cycles of venetoclax-based lower intensity regimen (azacitidine plus venetoclax or low-dose cytarabine plus venetoclax), and without any other approved therapies available that would be more appropriate in the investigator's judgment. Patients who have received only one course of intensive induction chemotherapy but are not eligible for a second course because of decreased performance status or clear disease progression may be eligible for participation after discussion with the study principal investigator (PI). Patients with concomitant extramedullary disease relapse are eligible to participate, but not patients with isolated extramedullary relapse without bone marrow disease.\n* MDS-specific inclusion criteria: Patients with relapsed or refractory MDS-IB with \\>= 5% bone marrow blasts after at least 4 cycles of hypomethylating agent (HMA)-based therapy or at least two courses of intensive induction chemotherapy and meet criteria for stable disease (SD), progressive disease (PD) or disease relapse according to the International Working Group 2023 response criteria for higher-risk MDS. Patients must not have access to any other approved therapies that would be more appropriate in the investigator's judgment. Patients who have received less than 4 cycles of HMA-based therapy may be eligible to participate after discussion with the study PI if there is clear evidence of progression or intolerance to HMA-based therapy that precludes its continuation.\n* Patients must have recovered from the effects of any prior systemic therapy, radiotherapy or surgery:\n\n  * Patients should not have received other investigational therapy within 2 weeks.\n  * Patients should not have received standard chemotherapy within 1 week of administration of study drug; hydroxyurea administration (for leukocyte count control) is permitted.\n* Age \\>=18 years. Because no dosing or adverse event data are currently available on the use of TAK-243 in patients \\\u003C 18 years of age, children are excluded from this study.\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 (Karnofsky \\>= 50%).\n* Serum bilirubin =\\\u003C 1.5 × institutional upper limit of normal (ULN).\n\n  * Patients with a known history of Gilbert's syndrome may enroll.\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3 × institutional ULN.\n* Serum creatinine \\\u003C 176 mcmol\u002FL (2 mg\u002FdL) OR\n* Creatinine clearance ≥ 60 mL\u002Fmin based on the Cockcroft-Gault equation.\n* Documented normal cardiac function (\\>= 50%) by echocardiogram or multi-gated acquisition (MUGA) scan.\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load withing 6 months are eligible for this trial.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* The effects of TAK-243 on the developing human fetus are unknown and ubiquitin-activating enzyme inhibitors are known to be teratogenic. For this reason, female patients must be:\n\n  * Postmenopausal (age-related amenorrhea \\>= 12 consecutive months or follicle-stimulating hormone \\> 40 mIU\u002FmL), for at least 1 year before the screening visit, OR\n  * Surgically sterile (i.e., who had undergone hysterectomy or bilateral oophorectomy), OR\n\nIf they are of childbearing potential:\n\n* Agree to practice 1 highly effective method and 1 additional effective (barrier) method of contraception, at the same time, from the time of signing the informed consent through 4 months after the last dose of study drug (female and male condoms should not be used together), OR\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, postovulation methods\\] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.) Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n\n  * Male patients, even if surgically sterilized (i.e., status post-vasectomy), who:\n* Agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug (female and male condoms should not be used together), OR\n* Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner\\] withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception.)\n\n  * Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n  * Patients should have a minimum life expectancy of 1 month.\n\nExclusion Criteria:\n\n* Patients with acute promyelocytic leukemia (APL) or AML with t(15;17)(q22;q12) - PML::RARA).\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1), except anemia, neutropenia or thrombocytopenia of any grade and grade 2 peripheral neuropathy.\n* Presence of any other malignancy requiring active therapy.\n* Patients who are receiving any other investigational agents.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to TAK-243.\n* Concomitant treatment with organic anion transport protein (OATP) and BCRP inhibitors or strong inducers\u002Finhibitors of cytochrome P450 (CYP)3A4\u002F5. Treatment with these agents must be discontinued at least 14 days prior to TAK-243 dosing. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated medical reference. As part of the enrollment\u002Finformed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product.\n* Presence of an active uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, or septicemia.\n* Presence of active graft-versus-host disease (GVHD) or continued treatment with systemic immunosuppressive agents following allogeneic hematopoietic stem cell transplantation (HSCT).\n* Presence of any co-morbid condition that, in the opinion of the investigator, might compromise the patient's safety, might interfere with participation in the trial or might interfere with the interpretation of trial results.\n* Pregnant and lactating\u002Fbreast-feeding women are excluded from this study because TAK-243 is a UAE-inhibiting agent with the potential for teratogenic or abortifacient effects and there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with TAK-243. Females of child-bearing potential must have a negative serum pregnancy test within 7 days before enrollment and should not be lactating\u002Fbreast-feeding. Breastfeeding should be discontinued if the mother is treated with TAK-243.\n* Major surgery within 14 days before the first dose of any study drug or a scheduled surgery during study period.\n* Patients with uncontrolled coagulopathy or bleeding disorder.\n* Patients with known hepatic cirrhosis.\n* Patients with known active cardiopulmonary disease defined as:\n\n  * Unstable angina withing 3 months prior to first dose of TAK-243;\n  * Myocardial infarction (MI) within 6 months prior to first dose of TAK-243 (patients who had MI and\u002For coronary revascularization more than 6 months before screening and who are without cardiac symptoms may enroll);\n  * Congestive heart failure (New York Heart Association \\[NYHA\\] Class III or IV;\n  * Cardiomyopathy with left ventricular ejection fraction (LVEF) \\\u003C 50%;\n  * Symptomatic pulmonary hypertension.\n* Presence of active central nervous system (CNS) involvement (patients with prior CNS leukemia who have negative CNS cytology and who receive periodic prophylactic intrathecal chemotherapy are eligible).\n* Patients with clinically significant arrhythmia:\n\n  * History of ventricular fibrillation or torsade de pointes at any time,\n  * Episode of grade \\>= 3 atrial fibrillation or flutter in the last 3 months, defined as symptomatic episode, requiring urgent intervention (cardioversion, pacemaker or ablation) or with life-threatening consequences.\n* Uncontrolled high blood pressure (i.e., systolic blood pressure \\> 180 mm Hg, diastolic blood pressure \\> 95 mm Hg).\n* Prolonged rate corrected QT (QTc) interval \\>= 480 msec, calculated using the Fridericia method.\n* Patients with known severe or very severe chronic obstructive pulmonary disease (defined as forced expiratory volume in one second (FEV1) less than 30% or less than 50% of predicted), interstitial lung disease, or pulmonary fibrosis.\n* Female patients who intend to donate eggs (ova) during the course of this study or 4 months after receiving their last dose of study drug(s).\n* Male patients who intend to donate sperm during the course of this study or 4 months after receiving their last dose of study drug(s).\n* Patients with history of neutrophilic dermatosis (e.g. Sweet syndrome, pyoderma gangrenosum), relapsing polychondritis, polyarteritis nodosa and\u002For giant cell arteritis.\n* Patients with VEXAS syndrome (Vacuoles, E1 enzyme, X-linked, Autoinflammatory, Somatic syndrome) or any other autoinflammatory disease.",{"count":288,"type":23},42,[26],"This phase I trial studies the side effects and best dose of TAK-243 in treating patients with acute myeloid leukemia or myelodysplastic syndromes with increased blasts that has come back (relapsed) or that is not responding to treatment (refractory). TAK-243 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.",[292,61,107,293,31,132,294],"Myelodysplastic Syndrome With Excess Blasts","Recurrent Myelodysplastic Syndrome\u002FAcute Myeloid Leukemia","Refractory Myelodysplastic Syndrome\u002FAcute Myeloid Leukemia",{"date":274,"type":38},{"date":297,"type":38},"2025-03-12",{"date":299,"type":23},"2026-10-24",{"name":69,"class":70},5,{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":4,"eligibilityCriteria":308,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":309,"targetDuration":4,"studyType":24,"phases":310,"briefSummary":311,"conditions":312,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":92},"100440040","phase-1-astx727-venetoclax-and-gilteritinib-for-the-treatment-of-newly-diagnosed-relapsed-or-refractory-flt3-mutated-acute-myeloid-leukemia-or-high-risk-myelodysplastic-syndrome-100440040","NCT05010122","ASTX727, Venetoclax, and Gilteritinib for the Treatment of Newly Diagnosed, Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome","A Phase I\u002FII Study of ASTX727, Venetoclax, and Gilteritinib for Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome With an Activating FLT3 Mutation","Inclusion Criteria:\n\n* Diagnosis:\n\n  * Phase I cohort: Adults \\>= 18 years with relapsed\u002Frefractory FLT3-mutated AML or myelodysplastic syndrome (MDS) that is intermediate-2 or high-risk by the International Prognostic Scoring System\n  * Phase II cohort A: Adults \\>= 18 years with newly diagnosed FLT3-mutated AML. Patients should meet the following criteria:\n\n    * Confirmed newly diagnosed AML with FLT3 mutation\n    * Ineligible for induction therapy defined as\n\n      * Either age \\>= 75\n      * Or 18-74 with at least one comorbidity (congestive heart failure \\[CHF\\] requiring therapy or ejection fraction \\[EF\\] =\\\u003C 50%, diffusion capacity of the lung for carbon monoxide \\[DLCO\\] =\\\u003C 65% or forced expiratory volume in 1 second \\[FEV1\\] =\\\u003C 65%, or Eastern Cooperative Oncology Group \\[ECOG\\] 2 or 3, or other significant co-morbidity precluding use of cytotoxic chemotherapy as approved by the principal investigator (PI)\n  * Phase II cohort B: Adults \\>= 18 years with relapsed\u002Frefractory FLT3-mutated AML or MDS that is intermediate-2 or high-risk by the International Prognostic Scoring System who have received 1 prior therapy\n  * For all cohorts, patients with either FLT3-ITD or FLT3 D835 mutations will be eligible\n* Performance status =\\\u003C 3 (Eastern Cooperative Oncology Group \\[ECOG\\] scale)\n* Total serum bilirubin =\\\u003C 2.5 x upper limit of normal (ULN), unless due to Gilbert's syndrome, hemolysis or the underlying leukemia approved by the PI\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =\\\u003C 3 x ULN, unless due to the underlying leukemia approved by the PI\n* Creatinine clearance \\>= 30 mL\u002Fmin\n* Ability to swallow\n* Signed informed consent\n* Hydroxyurea or one dose of cytarabine up to 1000 mg is allowed to reduce the white blood cell (WBC) to less than 25 x 10\\^9\u002FL prior to initiation of study treatment\n\nExclusion Criteria:\n\n* Prior therapies\n\n  * Phase I cohort: No restriction based on prior therapies\n  * Phase II cohort A: Patients with prior therapy for AML are not eligible. Prior therapy for antecedent hematologic disorder is allowed including prior hypomethylating agent (HMA) therapy for MDS. Prior hydroxyurea or cytarabine given for purposes of cytoreduction is also allowed. Prior all trans-retinoic acid given for presumed acute promyelocytic leukemia is also allowed\n  * Phase II cohort B: Patients with \\>= 3 prior lines of therapy are not eligible. Stem cell transplantation, treatment given only for cytoreductive purposes (e.g. hydroxyurea), and growth factors do not count as lines of therapy for this purpose. Prior therapy with venetoclax and gilteritinib is allowed\n* Patients suitable for and willing to receive intensive induction chemotherapy (for Phase II cohort A only)\n* Congenital long QT syndrome or corrected QT (QTc) \\> 450 msec. Repeat electrocardiograms (EKGs) after correction of electrolytes or discontinuation of QT prolonging medications are allowed to meet entry criteria\n* Active serious infection not controlled by oral or intravenous antibiotics (e.g. persistent fever or lack of improvement despite antimicrobial treatment)\n* Active grade III-V cardiac failure as defined by the New York Heart Association Criteria\n* Active central nervous system leukemia\n* Known hepatitis B surface antigen seropositive or known or suspected active hepatitis C infection\n\n  * Note: Patients who have isolated positive hepatitis B core antibody (i.e., in the setting of negative hepatitis B surface antigen and negative hepatitis B surface antibody) must have an undetectable hepatitis B viral load. Patients who have positive hepatitis C antibody may be included if they have an undetectable hepatitis C viral load\n* Patients with a prior or concurrent malignancy whose natural history or treatment is not anticipated to interfere with the safety or efficacy assessment of the investigational regimen may be included only after discussion with the PI\n* Consumed strong inducer of CYP3A or p-glycoprotein within 3 days of study enrollment. Agents include but are not limited to: carbamazepine, phenytoin, rifampin, and St. John's wart\n* Treatment with any investigational antileukemic agents or chemotherapy agents in the last 7 days before study entry, unless full recovery from side effects has occurred or patient has rapidly progressive disease judged to be life-threatening by the investigator. Prior recent treatment with corticosteroids, hydroxyurea and\u002For cytarabine (given for cytoreduction) permitted. Use of hydroxyurea or one dose cytarabine to reduce WBC below 25 prior to initiation of study treatment is recommended\n* Pregnant women will not be eligible; women of childbearing potential should have a negative pregnancy test prior to entering on the study and be willing to use effective methods of contraception throughout the study period and for at least 6 months after the last dose of study drugs. Women do not have childbearing potential if they have had a hysterectomy or are postmenopausal without menses for 12 months. In addition, men enrolled on this study should understand the risks to any sexual partner of childbearing potential and should practice an effective method of birth control throughout the study period and for at least 4 months after the last dose of study drugs. Lactating women (or those planning to breastfeed) should not breastfeed during treatment of gilteritinib and for at least 2 months after the last dose of gilteritinib\n* Medical, psychiatric, cognitive or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol or to complete the study",{"count":288,"type":23},[26,103],"This phase I\u002FII trial studies the best dose of gilteritinib given together with ASTX727 and venetoclax and the effect of ASTX727, venetoclax, and gilteritinib in treating patients with FLT3-mutated acute myeloid leukemia that is newly diagnosed, has come back (relapsed) or does not respond to treatment (refractory) or high-risk myelodysplastic syndrome. Chemotherapy drugs, such as ASTX727, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Gilteritinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving ASTX727, venetoclax, and gilteritinib may help to control the disease.",[30,106,61,31],"2026-07-14",{"date":315,"type":38},"2026-07-16",{"date":317,"type":38},"2021-07-08",{"date":319,"type":23},"2028-01-30",{"name":114,"class":91},{"id":322,"slug":323,"hasResults":12,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":4,"eligibilityCriteria":327,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":328,"targetDuration":4,"studyType":24,"phases":330,"briefSummary":331,"conditions":332,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":343},"100352836","phase-1-ruxolitinib-in-combination-with-venetoclax-with-and-without-azacitidine-in-treating-patients-with-relapsed-or-refractory-acute-myeloid-leukemia-100352836","NCT03874052","Ruxolitinib in Combination With Venetoclax With and Without Azacitidine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia","Phase I Study to Evaluate Safety of Ruxolitinib in Combination With Azacitidine + Venetoclax in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Ability to understand and the willingness to sign a written informed consent document\n* Age \\>= 18 years at time of informed consent. Persons of all genders and gender identities, and members of all races and ethnic groups will be included\n* Morphologically documented relapsed\u002Frefractory (R\u002FR) AML or R\u002FR secondary AML (sAML) that has progressed after at least 1 prior therapy for AML\n\n  * Prior treatment with venetoclax and azacitidine is allowed\n  * Treatment with hydroxyurea will not be considered a line of therapy\n  * Patients with morphologically documented myelodysplastic syndrome (MDS) that has progressed on hypomethylating agent (HMA) therapy also will be considered if the patient is ineligible for induction with intensive chemotherapy (IC), defined for this study as meeting one or more of the following criteria:\n\n    * Severe cardiac disorder (e.g., congestive heart failure requiring treatment, left ventricular ejection fraction (LVEF) of ≤ 50%, or chronic stable angina)\n    * Severe pulmonary disorder, certified by the managing physician\n    * Creatinine clearance of \\\u003C 45 ml\u002Fmin or\n    * Hepatic disorder with total bilirubin \\> 1.5 x upper limit of normal (ULN)\n    * Eastern Cooperative Oncology Group (ECOG) equal to 2\n    * Other comorbidity(ies) judged to be incompatible with high dose chemotherapy by the managing physician will be considered, at the discretion of the principal investigator (PI)\n* ECOG performance status 0 to 2\n* Persons of childbearing potential (PCBP) must have a negative serum or urine pregnancy test within 14 days prior to start of study drug administration\n* Patients must agree to use an adequate method of contraception while on study treatment and for 120 days after the last dose of ruxolitinib for Arm 1 and 6 months after the last dose of azacitidine for Arm 2\n* Must be able to take and absorb oral medications\n* Creatinine clearance ≥ 30 mL\u002Fmin; calculated by the Cockcroft Gault formula or measured by 24 hour urine collection\n* Total serum bilirubin ≤ 1.5 x ULN unless thought to be due to leukemic involvement\n* Serum aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) ≤ 3.0 x ULN unless thought to be due to leukemic involvement\n\nExclusion Criteria:\n\n* Diagnosis of acute promyelocytic leukemia (APL or AML M3 subtype)\n* Active central nervous system involvement with AML\n* Chemotherapy or therapy with a non-investigational agent other than a biologic intended to within 1 week of the planned start of study therapy, with the exception of hydroxyurea for cytoreduction of proliferative disease, or at the discretion of the principal investigator (PI)\n* Therapy with a non-biologic investigational agent within 14 days or 5 half lives, whichever is longer, of the planned start of study therapy, or for the period recommended by the institution's research pharmacy service, or at the discretion of the PI\n* Therapy with a biologic investigational or non-investigational agent (e.g., monoclonal antibody) within 30 days of the planned start of study therapy, or for the period recommended by the institution's research pharmacy service, or at the discretion of the PI\n* Concurrent active malignancy with expected survival of less than 1 year, at the discretion of the investigator. For example, candidates with treated skin cancers, prostate cancer, breast cancer, etc. without metastatic disease are candidates for therapy since their expected survival exceeds that of relapsed or refractory AML\n* Clinically significant graft versus host disease (GVHD) or active GVHD requiring initiation or escalation of treatment within 28-day screening period\n* Participants with rapidly progressive disease (defined by blast count doubles within 48 hours) or organ dysfunction\n* Documented cardiac insufficiency (e.g., symptomatic heart failure, left ventricular ejection fraction of ≤ 40%)\n* Symptomatic shortness of breath or patient requires supplemental oxygen support\n* Clinically significant coagulation abnormality, such as disseminated intravascular coagulation\n* Known history of cerebrovascular accident, myocardial infarction, or intracranial hemorrhage within 2 months of enrollment\n* Known clinically significant liver disease defined as ongoing drug-induced liver injury, chronic active hepatitis C (hepatitis C virus \\[HCV\\]), chronic active hepatitis B (hepatitis B virus \\[HBV\\]), alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, portal hypertension, or history of autoimmune hepatitis\n* Untreated HIV or active hepatitis C detectable by polymerase chain reaction (PCR), or chronic hepatitis B (patients positive for hepatitis B core antibody who are receiving intravenous immunoglobulin therapy \\[IVIG\\] are eligible if hepatitis B \\[HepB\\] PCR is negative)\n* Per PI discretion, active infection that is not well controlled by antibacterial or antiviral therapy\n\n  \\*Patients with a known history of tuberculosis (TB; Mycobacterium tuberculosis) are not eligible for participation. At investigator discretion, latent TB test should be performed for individuals considered to be at high-risk (e.g., immune compromised, persons that have traveled to, or emigrated from, regions with high rates of TB)\n* Clinically significant surgery within 2 weeks of enrollment\n* Unwillingness to receive infusion of blood products\n* Requires use of medications interact with study drug and that cannot be terminated or adjusted. Use of the following therapies requires review by the sponsor investigator:\n\n  * Strong and moderate CYP3A inhibitors\n  * Strong and Moderate CYP3A inducers\n* Patients with uncontrolled white blood cell (WBC) count (defined as \\> 25 K\u002Fmm\\^3 and not controlled with hydroxyurea)\n* Patients with known sensitivity to ruxolitinib, venetoclax, or azacitidine\n* Since it is unknown whether ruxolitinib, venetoclax, or azacitidine (or their metabolites) are excreted in human milk and because of the potential for serious adverse reactions in the nursing infant, breastfeeding concurrent with study participation is prohibited",{"count":329,"type":23},51,[26],"This phase I trial studies the side effects and best dose of ruxolitinib when given together with venetoclax and compares the effect of ruxolitinib in combination with venetoclax to venetoclax and azacitidine in treating patients with acute myeloid leukemia (AML) that has come back (relapsed) or has not responded to treatment (refractory). Ruxolitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Azacitidine stops cells from making deoxyribonucleic acid and may kill cancer cells. It is a type of antimetabolite. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving ruxolitinib in combination with venetoclax and azacitidine may be safe, tolerable, and\u002For effective compared to ruxolitinib with venetoclax in treating patients with relapsed or refractory AML.",[333,61,130,31,133],"Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome","2026-07-01",{"date":336,"type":38},"2026-07-06",{"date":338,"type":38},"2019-08-16",{"date":340,"type":23},"2027-12-31",{"name":342,"class":91},"Jennifer Saultz",3,{"id":345,"slug":346,"hasResults":12,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":12,"sex":18,"minAge":243,"maxAge":4,"enrollmentInfo":351,"targetDuration":4,"studyType":24,"phases":353,"briefSummary":354,"conditions":355,"keywords":358,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":373},"100517416","phase-1-a-study-of-cd371-ysnvzil-18-car-t-cells-in-people-with-acute-myeloid-leukemia-100517416","NCT06017258","A Study of CD371-YSNVZIL-18 CAR T Cells in People With Acute Myeloid Leukemia","Phase I Trial of CLEc12a (CD371) Targeted ArmoRed Immune Effector Cells in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia (CLEAR-AML)","Inclusion Criteria:\n\nSubject Inclusion: Collection of T cells (Part A)\n\n* History of CD371+ AML\n\n  * Any disease status is eligible for collection\n  * Expression of CD371 at any level on AML blasts (any method of detection including IHC and\u002For flow cytometry)\n* Age\u002FWeight\n\n  * Pediatrics: ≥ 1 year and ≥ 10kg for collection\n  * Adults: no limit on age\u002Fweight for collection\n* Patients with history of allo-HCT are eligible for collection if:\n\n  * ≥ 100 days post-transplant\n  * no evidence of active GVHD\n  * off any immunosuppressive agents for 30 days prior to collection (physiologic dose of corticosteroids is acceptable)\n\nSubject Inclusion: Treatment with CD371-specific\u002FYSNVz\u002FIL-18 CAR T cells (Part B)\n\n* Relapsed\u002FRefractory CD371+ AML (meeting criteria defined below) for primary refractory AML, late first relapse, and\u002For advanced disease:\n\n  o Primary refractory AML: Patients are eligible from disease perspective in the event of failure to achieve a CR, CRh or CRi after one or more of the following regimens:\n* Two or more courses of standard intensive induction chemotherapy (e.g., cytarabine and daunorubicin given as \"7+3,\" MEC, HiDAC, FLAG+idarubicin, etc.);\n* Two or more cycles of venetoclax in combination with one of the following (azacitidine OR decitabine OR low-dose cytarabine), with or without other agents;\n* Six or more cycles of azacitidine monotherapy OR four or more courses of decitabine monotherapy\n\n  * Early first relapse: Patients are eligible from disease perspective in the event of first morphologic relapse or new extramedullary disease less than 12 months after previously having achieved CR, CRh, or CRi following AML-directed therapy\n  * Late first relapse: Patients with first morphologic relapse or new extramedullary disease ≥12 months after previously having achieved CR, CRh, or CRi following AML-directed therapy may respond to intensive re-induction using the initial induction regimen and not eligible from a disease perspective unless the treating investigator feels the patient is unlikely to benefit from repeating the initial induction regimen (for example, relapse occurring 12 months into CR on continuous azacitidine\u002Fvenetoclax therapy), in which case the rationale for considering enrollment must be clearly documented and risks, benefits, and alternatives discussed with the patient.\n  * Advanced disease: Patients are eligible from disease perspective in the event of relapsed AML refractory to reinduction therapy, relapse following alloHCT, or second or later relapse.\n  * Disease eligibility considerations for all patients: Patients with relapsed or refractory AML with susceptible mutations for which there is an FDA approved therapy (for example, IDH1 mutation, ivosidenib; IDH2 mutation, enasidenib; FLT3-ITD\u002FTKD, gilteritinib) are not eligible from a disease perspective unless they meet one or more of the below criteria:\n* Failure to achieve CR, CRh, or CRi following therapy with one or more targeted therapies for relapsed or refractory AML directed to the actionable mutation(s);\n* Intolerance of one or more targeted therapies for relapsed or refractory AML directed to the actionable mutation(s);\n* Treating investigator feels the patient would be unlikely to benefit from FDA-approved targeted therapy based on disease characteristics, in which case the rationale for considering enrollment must be clearly documented and risks, benefits, and alternatives discussed with the patient Age: any age is eligible for treatment if eligible for collection\n\n  o The first 3 patients in the first dose cohort must be ≥ 16 years of age, while the first 2 patients in subsequent cohorts must be ≥ 16 years of age (see Section 10.4)\n* Adequate performance status:\n\n  * Age ≥ 16 years: ECOG ≤ 1 or Karnosfsky ≥ 60\n  * Age \\\u003C 16 years: Lansky ≥ 60\n* Patients with history of allo-HCT are eligible for treatment if:\n\n  * ≥ 100 days post-transplant\n  * no evidence of active GVHD\n  * off any systemic immunosuppressive agents for 30 days prior to treatment (physiologic dose of corticosteroids is acceptable)\n  * Treating physician considers the patient to be a candidate for second alloHCT\n* Identification of a suitable donor\u002Fsource for alloHCT as determined by the treating physician.\n* Adequate organ function is required, defined as follows:\n\n  * Hepatic: Serum total bilirubin ≤ 1.5 mg\u002FdL, unless benign congenital hyperbilirubinemia or unless thought to be disease related.\n  * Hepatic: ALT and AST \\\u003C 3 times the upper limit of normal unless thought to be disease-related.\n  * Renal: serum creatinine \\\u003C 2.0 mg\u002F100 ml (\\> 18 years) or ≤ 2.5 x institutional upper limit of normal (ULN) for age\n* If serum creatinine is outside the normal range, then CrCl \\> 40 mL\u002Fmin\u002F1.73m2 (calculated or estimated) or GFR (mL\u002Fmin\u002F1.73m2) \\> 40% of predicted normal for age.\n\nNormal GFR by Age Age: 1 week \u002F Mean GFR +\u002F-SD (mL\u002Fmin\u002F1.73 m2): 40.6 + \u002F - 14.8 Age: 2 - 8 weeks \u002F Mean GFR +\u002F-SD (mL\u002Fmin\u002F1.73 m2): 65.8 + \u002F - 24.8 Age: \\> 8 weeks \u002F Mean GFR +\u002F-SD (mL\u002Fmin\u002F1.73 m2): 95.7 +\u002F- 21.7 Age: 2 - 12 years \u002F Mean GFR +\u002F-SD (mL\u002Fmin\u002F1.73 m2): 133 +\u002F- 27 Age: 13 - 21 years (males) \u002F Mean GFR +\u002F-SD (mL\u002Fmin\u002F1.73 m2): 140 +\u002F- 30 Age: 13 - 21 years (females) \u002F Mean GFR +\u002F-SD (mL\u002Fmin\u002F1.73 m2): 126.0 + \u002F - 22.0 Abbreviations: GFR, glomerular f filtration rate; SD, standard deviation\n\n* Greater than 2 years old: Normal GFR is 100 mL\u002Fmin\u002F1.73m2.\n* Infants: GFR must be corrected for body surface area.\n\n  * Cardiac: LVEF ≥ 50% by MUGA or resting echocardiogram.\n  * Pulmonary: Adequate pulmonary function as assessed by ≥ 92% oxygen saturation on room air by pulse oximetry\n\nExclusion Criteria:\n\nSubject Exclusion: Collection of T cells (Part A)\n\n* Pregnant or lactating women; women of childbearing age, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception while receiving study treatment and for at least 12 months after all treatment is finished\n* Sexually active males, unless they are willing to use a condom during intercourse while receiving study treatment and for at least 12 months after all treatment is finished\n* Radiographically-detected or symptomatic CNS disease or CNS 3 disease (i.e., presence of ≥ 5\u002Ful WBC in CSF). Subjects with adequately treated CNS leukemia are eligible.\n* Uncontrolled, symptomatic, intercurrent illness including but not limited to infection, psychiatric illness, or social situations that would limit compliance with study requirements or in the opinion of the PI would pose an unacceptable risk to the subject\n* Impaired cardiac function (LVEF \\\u003C 50%) as assessed by ECHO or MUGA scan\n* Patients with following cardiac conditions will be excluded:\n\n  * New York Heart Association (NYHA) stage III or IV congestive heart failure\n  * Myocardial infarction ≤ 6 months prior to enrollment\n  * History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration\n* Positive serologic test results for HIV\n* Acute or chronic HBV infection as assessed by serologic (HBVsAg) or PCR results, defined as HBVsAg+, HBVcAb+, HBV PCR+.\n* Acute or chronic HCV infection as assessed by serologic (HCV ab) or PCR results, defined as HCV Ab+ with reflex to positive HCV PCR\n* Patient\u002Fparent\u002FLAR unable to give informed consent\u002F\n\nSubject Exclusion: Treatment with CD371-specific\u002FYSNVz\u002FIL-18 CAR T cells (Part B)\n\n* Bridging chemotherapy occurring \\\u003C 1 week prior to administration of LDC\n\n  o Exception: hydroxyurea can be continued up to 72 hours prior to leukapheresis or 24 hours prior to LDC\n* Pregnant or lactating women\n* Radiographically-detected or symptomatic CNS disease or CNS 3 disease (i.e., presence of ≥ 5\u002Ful WBC in CSF). Subjects with adequately treated CNS leukemia are eligible.\n* Isolated extramedullary disease\n* Lack of a suitable donor\u002Fsource for allogeneic HSCT as determined by the treating physician.\n* Patients with prior alloHCT are allowed as long as alloHCT occurred ≥100 days prior to date of treatment with CD371-specific\u002FYSNVz\u002FIL-18 CAR T cells and as long as the patient is without ongoing requirement for systemic graft-versus-host therapy\n* Uncontrolled, symptomatic, intercurrent illness including but not limited to infection, psychiatric illness, or social situations that would limit compliance with study requirements or in the opinion of the PI would pose an unacceptable risk to the subject\n* Impaired cardiac function (LVEF \\\u003C 50%) as assessed by ECHO or MUGA scan.\n* Patients with following cardiac conditions will be excluded:\n\n  * New York Heart Association (NYHA) stage III or IV congestive heart failure\n  * Myocardial infarction ≤ 6 months prior to enrollment\n  * History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration\n* Positive serologic test results for HIV.\n* Acute or chronic HBV infection as assessed by serologic (HBVsAg) or PCR results, defined as HBVsAg+, HBVcAb+, HBV PCR+.\n* Acute or chronic HCV infection as assessed by serologic (HCV ab) or PCR results, defined as HCV Ab+ with reflex to positive HCV PCR\n* Active second malignancy that requires systemic treatments, with the exception of malignancy treated with curative intent and without evidence of disease for \\> 2 years before screening\n* Patient\u002Fparent\u002FLAR unable to give informed consent\n* Any other condition\u002Fissue which, in the opinion of the treating physician, would make the patient ineligible for the study; conditions that in the Principal Investigator's opinion might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate.",{"count":352,"type":23},15,[26],"The purpose of this study is to find out whether CD371-YSNVZ-IL18 CAR T cells are safe, and to look for the highest dose of CD371-YSNVZ-IL18 CAR T cells that cause few or mild side effects in participants.",[31,33,30,356,357],"Acute Myeloid Leukemia, in Relapse","Acute Myeloid Leukemia Refractory",[31,33,30,356,357,359,360,361,362,363,364],"ArmoRed","CLEAR-AML","CLEc12a","CD371","Memorial Sloan Kettering Cancer Center","23-016","2026-06-18",{"date":367,"type":38},"2026-06-22",{"date":369,"type":38},"2023-09-01",{"date":371,"type":23},"2026-12-17",{"name":363,"class":91},7,{"id":375,"slug":376,"hasResults":12,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":4,"eligibilityCriteria":380,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":381,"enrollmentInfo":382,"targetDuration":4,"studyType":24,"phases":384,"briefSummary":385,"conditions":386,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":393,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":92},"100295600","phase-1-211at-bc8-b10-before-donor-stem-cell-transplant-in-treating-patients-with-high-risk-acute-myeloid-leukemia-acute-lymphoblastic-leukemia-myelodysplastic-syndrome-or-mixed-phenotype-acute-leukemia-100295600","NCT03128034","211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia","A Study Evaluating Escalating Doses of 211^At-Labeled Anti-CD45 MAb BC8-B10 (211^At-BC8-B10) Followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), or Myelodysplastic Syndrome (MDS)","Inclusion Criteria:\n\n* Patients must have AML, ALL, high-risk MDS, or MPAL (also known as biphenotypic) meeting one of the following descriptions:\n\n  * AML, ALL, or MPAL in first remission with evidence of measurable residual disease (MRD) by flow cytometry\n  * AML, ALL, or MPAL beyond first remission (i.e., having relapsed at least one time after achieving remission in response to a treatment regimen)\n  * AML, ALL, or MPAL representing primary refractory disease (i.e., having failed to achieve remission at any time following one or more prior treatment regimens)\n  * AML evolved from myelodysplastic or myeloproliferative syndromes\n  * MDS expressed as refractory anemia with excess blasts (RAEB)\n  * Chronic myelomonocytic leukemia (CMML) by French-American-British (FAB) criteria\n* Patients not in remission must have CD45-expressing leukemic blasts. Patients in remission do not require phenotyping and may have leukemia previously documented to be CD45 negative (because in remission patients, virtually all antibody binding is to non-malignant cells which make up \\>= 95% of nucleated cells in the marrow)\n* Patients must be \\>= 18 and =\\\u003C 75 years of age\n* Patients should have a circulating blast count of less than 10,000\u002Fmm\\^3 (control with hydroxyurea or similar agent is allowed)\n* Patients must have an estimated creatinine clearance greater than 50\u002Fml per minute by the following formula (Cockcroft-Gault); serum creatinine value must be within 28 days prior to registration\n* Patients must have normal hepatic function (bilirubin within normal limits, aspartate aminotransferase \\[AST\\] and alanine aminotransferase \\[ALT\\] \\\u003C 2 times the upper limit of normal) within 2 months prior to the astatine-211 infusion date (with the exception of patients that are known to have Gilbert's disease, for whom total bilirubin is allowed up to 3 x upper limit of normal \\[ULN\\])\n* Eastern Cooperative Oncology Group (ECOG) \\\u003C 2 or Karnofsky \\>= 70\n* Patients must be free of uncontrolled infection\n* Patients with prior non-myeloablative or reduced-intensity conditioning allogeneic-hematopoietic cell transplant (HCT) must have no evidence of ongoing GVHD and be off GVHD treatment immunosuppression for at least 6 weeks at time of enrollment\n* Patients must have normal elastography\n* If ferritin is elevated, patient must have less than 7 mg\u002Fg liver iron concentration on liver T2\\* MRI\n* Patients should have an official gastrointestinal (GI) consult prior to the transplant for full evaluation\n* Patients must have an HLA-matched related donor or an HLA-matched unrelated donor who meets standard Fred Hutch and\u002For National Marrow Donor Program (NMDP) or other donor center criteria for peripheral blood stem cell (PBSC) or bone marrow donation, as follows:\n\n  * Related donor: related to the patient and genotypically or phenotypically identical for HLA-A, B, C, DRB1 and DQB1; phenotypic identity must be confirmed by high-resolution typing\n  * Unrelated donor:\n\n    * Matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing; OR\n    * Mismatched for a single allele without antigen mismatching at HLA-A, B, or C as defined by high resolution typing but otherwise matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing\n    * Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment; the recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain panel reactive antibody (PRA) screens to class I and class II antigens for all patients before HCT; if the PRA shows \\> 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained; the donor should be excluded if any of the cytotoxic cross match assays are positive; for those patients with an HLA Class I allele mismatch, flow cytometric or B and T cell cytotoxic cross matches should be obtained regardless of the PRA results; a positive anti-donor cytotoxic crossmatch is an absolute donor exclusion\n  * Patient and donor pairs homozygous at a mismatched allele in the graft rejection vector are considered a two-allele mismatch, i.e., the patient is A\\*0101 and the donor is A\\*0102, and this type of mismatch is not allowed\n\nExclusion Criteria:\n\n* Patients may not have symptomatic coronary artery disease and may not be on cardiac medications for anti-arrhythmic or inotropic effects\n* Left ventricular ejection fraction \\\u003C 35%\n* Corrected diffusing capacity of the lungs for carbon monoxide (DLCO) \\\u003C 35% or receiving supplemental continuous oxygen; when pulmonary function test (PFT)s cannot be obtained, the 6-minute walk test (6MWT, also known as exercise oximetry) will be used: Any patient with oxygen saturation on room air of \\\u003C 89% during a 6MWT will be excluded\n* Liver abnormalities: fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction as evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis, or symptomatic biliary disease\n* Patients who are known to be seropositive for human immunodeficiency virus (HIV)\n* Perceived inability to tolerate diagnostic or therapeutic procedures\n* Active central nervous system (CNS) leukemia at time of treatment\n* Patients with prior myeloablative allogeneic-HCT\n* Women of childbearing potential who are pregnant (beta-human chorionic gonadotropin positive \\[beta-HCG+\\] or breast feeding\n* Fertile men and women unwilling to use contraceptives during and for 12 months post-transplant\n* Inability to understand or give an informed consent\n* Allergy to murine-based monoclonal antibodies\n* Known contraindications to radiotherapy","75 Years",{"count":383,"type":23},75,[26,103],"This phase I\u002FII trial studies the side effects and best dose of 211\\^astatine(At)-BC8-B10 before donor stem cell transplant in treating patients with high-risk acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, or mixed-phenotype acute leukemia. Radioactive substances, such as astatine-211, linked to monoclonal antibodies, such as BC8, can bind to cancer cells and give off radiation which may help kill cancer cells and have less of an effect on healthy cells before donor stem cell transplant.",[179,333,30,387,292,61,388,389,390,31,391,392],"Chronic Myelomonocytic Leukemia","Refractory Acute Lymphoblastic Leukemia","Recurrent Acute Lymphoblastic Leukemia","Recurrent Mixed Phenotype Acute Leukemia","Refractory Mixed Phenotype Acute Leukemia","Mixed Phenotype Acute Leukemia",{"date":367,"type":38},{"date":395,"type":38},"2017-10-24",{"date":397,"type":23},"2029-03-31",{"name":399,"class":91},"Fred Hutchinson Cancer Center",{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":381,"enrollmentInfo":407,"targetDuration":4,"studyType":24,"phases":408,"briefSummary":409,"conditions":410,"keywords":414,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":92},"100337247","phase-1-211at-bc8-b10-followed-by-donor-stem-cell-transplant-in-treating-patients-with-relapsed-or-refractory-high-risk-acute-leukemia-or-myelodysplastic-syndrome-100337247","NCT03670966","211At-BC8-B10 Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory High-Risk Acute Leukemia or Myelodysplastic Syndrome","A Phase I\u002FII Study Evaluating Escalating Doses of 211At-Labeled Anti-CD45 MAb BC8-B10 (211At-BC8-B10) Followed by Related Haplo-Identical Allogeneic Hematopoietic Cell Transplantation for High-Risk Acute Leukemia or Myelodysplastic Syndrome (MDS)","Inclusion Criteria:\n\n* Patients must have AML, ALL, high-risk MDS, or MPAL (also known as biphenotypic) meeting one of the following descriptions:\n\n  * AML, ALL, or MPAL in first remission with evidence of measurable residual disease (MRD) by flow cytometry;\n  * AML, ALL, or MPAL beyond first remission (i.e., having relapsed at least one time after achieving remission in response to a treatment regimen);\n  * AML, ALL, or MPAL representing primary refractory disease (i.e., having failed to achieve remission at any time following one or more prior treatment regimens);\n  * AML evolved from myelodysplastic or myeloproliferative syndromes;\n  * MDS expressed as refractory anemia with excess blasts (RAEB)\n  * Chronic myelomonocytic leukemia (CMML) by French-American-British (FAB) criteria.\n* Patients not in remission must have CD45-expressing leukemic blasts. Patients in remission do not require phenotyping and may have leukemia previously documented to be CD45 negative (because in remission patients, virtually all antibody binding is to non-malignant cells which make up \\>= 95% of nucleated cells in the marrow).\n* Patients must be \\>= 18 and =\\\u003C 75 years of age.\n* Patients should have a circulating blast count of less than 10,000\u002Fmm\\^3 (control with hydroxyurea or similar agent is allowed).\n* Patients must have an estimated creatinine clearance greater than 50\u002Fml per minute by the following formula (Cockcroft-Gault). Serum creatinine value must be within 28 days prior to registration.\n* Total bilirubin within normal limits\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 2 times the upper limit of normal.\n* Eastern Cooperative Oncology Group (ECOG) \\\u003C 2 or Karnofsky \\>= 70.\n* Patients must be free of uncontrolled infection.\n* Patients with prior non-myeloablative or reduced-intensity conditioning allogeneic-HCT must have no evidence of ongoing GVHD and be off all immunosuppression for at least 6 weeks at time of enrollment.\n* Patients must have normal elastography.\n* If ferritin is elevated, patient must have less than 7 mg\u002Fg liver iron concentration on liver T2 magnetic resonance imaging (MRI).\n* Patients should have an official gastrointestinal (GI) consult prior to the transplant for full evaluation.\n* Patients must have a related donor who is identical for one HLA haplotype and mismatched at the HLA-A, -B or DRB1 loci of the unshared haplotype with the exception of single HLA-A, -B or DRB1 mismatches.\n* DONOR: Donors must meet HLA matching criteria as well as standard Seattle Cancer Care Alliance (SCCA) criteria for PBSC or bone marrow donation. Preference should be given to donors who are mismatched at the HLA-A, -B and -DRB1 loci.\n\nExclusion Criteria:\n\n* Patients may not have symptomatic coronary artery disease and may not be on cardiac medications for anti-arrhythmic or inotropic effects.\n* Left ventricular ejection fraction \\\u003C 45%.\n* Corrected diffusion capacity of the lung for carbon monoxide (DLCO) \\\u003C 35% or receiving supplemental continuous oxygen. When pulmonary function tests (PFTs) cannot be obtained, the 6-minute walk test (6MWT, also known as exercise oximetry) will be used: Any patient with oxygen saturation on room air of \\\u003C 89% during a 6MWT will be excluded\n* Liver abnormalities: fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction as evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis, or symptomatic biliary disease.\n* Patients who are known to be seropositive for human immunodeficiency virus (HIV).\n* Perceived inability to tolerate diagnostic or therapeutic procedures.\n* Active central nervous system (CNS) leukemia at time of treatment.\n* Patients with prior myeloablative allogeneic-HCT.\n* Women of childbearing potential who are pregnant (beta human chorionic gonadotropin \\[B-HCG\\]+) or breast feeding.\n* Fertile men and women unwilling to use contraceptives during and for 12 months post-transplant.\n* Inability to understand or give an informed consent.\n* Allergy to murine-based monoclonal antibodies.\n* Known contraindications to radiotherapy.",{"count":80,"type":23},[26,103],"This phase I\u002FII trial studies the side effects and best dose of a radioactive agent linked to an antibody (211At-BC8-B10) followed by donor stem cell transplant in treating patients with high-risk acute leukemia or myelodysplastic syndrome that has come back (recurrent) or isn't responding to treatment (refractory). 211At-BC8-B10 is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving chemotherapy and total body irradiation before a stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can attack the body's normal cells, called graft versus host disease. Giving cyclophosphamide, mycophenolate mofetil, and tacrolimus after a transplant may stop this from happening.",[411,333,412,387,292,389,61,388,31,390,391,413],"Acute Lymphoblastic Leukemia in Remission","Acute Myeloid Leukemia in Remission","Hematopoietic and Lymphoid Cell Neoplasm",[415,416,417],"Lymphoid Leukemia","Myeloid and Monocytic Leukemia","Other Hematopoietic","2026-06-17",{"date":367,"type":38},{"date":421,"type":38},"2019-07-10",{"date":423,"type":23},"2029-10-20",{"name":399,"class":91},{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":432,"targetDuration":4,"studyType":24,"phases":433,"briefSummary":434,"conditions":435,"keywords":436,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":373},"100641694","phase-1-a-study-of-crd3874-si-in-people-with-leukemia-100641694","NCT07661095","A Study of CRD3874-SI in People With Leukemia","A Phase 1 Study of the STING Agonist CRD3874-SI for Relapsed and Refractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Documentation of Disease\n\n  o Participant has relapsed or refractory acute myeloid leukemia, defined as bone marrow blasts ≥ 5%, and\u002For reappearance of blasts in the blood in at least 2 peripheral blood samples at least one week apart, and\u002For development of extramedullary disease; or, no CR, CRh or CRi at response assessment after at least 1 line of therapy, as defined by standardized European LeukemiaNet 2022 Criteria. Patients must have failed treatment with available therapies known to be active for treatment of their AML.\n* Participant must be ≥ 18 years of age at the time of signing the informed consent form (ICF).\n* Participant must weigh at least 40 kg\n* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score 0-2 (See Appendix I for performance status criteria)\n* For patients with known HIV, HBV, and\u002For HCV infection \\[HIV, HBV, and HCV testing do not need to be performed as part of the study; the below language provides guidelines for inclusivity of patients with known HIV, HBV, and\u002For HCV infection\\]:\n\n  * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n  * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n  * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Required Organ Function\n\n  * Serum aspartate aminotransferase\u002Fserum glutamic oxaloacetic transaminase (AST\u002FSGOT) and alanine aminotransferase (ALT\u002FSGPT) ≤ 3 x ULN, unless considered due to leukemic organ involvement.\n  * Serum total bilirubin \\\u003C 1.5 x ULN. Higher levels are acceptable if these can be attributed to ineffective erythropoiesis, leukemia organ involvement or Gilbert's syndrome.\n  * Calculated creatinine clearance (CrCl) ≥ 60 mL\u002Fmin by Cockcroft-Gault formula or CKD-EPI 2021 or estimated glomerular filtration rate 60 mL\u002Fmin or greater based on local institutional practice for age-appropriate determination (e.g, Schwartz formula for pediatric patients or Cockcroft Gault formula for adults).\n  * Adequate cardiac function defined as ejection fraction of ≥ 50% by echocardiogram.\n\nExclusion Criteria:\n\n* Participants with acute promyelocytic leukemia\n* Participants with isolated myeloid sarcoma\n* Blast phase of chronic myeloid leukemia\n* Known active central nervous system leukemia\n* Participants with immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, disseminated intravascular coagulation, or uncontrolled tumor lysis syndrome.\n* Participant has presence of any other condition that may increase the risk associated with study participation, and in the opinion of the treating investigator, would make the patient inappropriate for entry into the study.\n* Participants with concurrent other malignancy that will confound interpretation of study endpoints.\n* Participants who have received other anti-leukemia therapy within 5 half-lives of the agent or 14 days, whichever is sooner, prior to study treatment and if toxicity related to said agent has not resolved; exceptions of acceptable concomitant therapies are listed below\n\n  1. Concomitant cytoreductive therapy in the form of hydroxyurea, corticosteroids, or cytarabine is permitted.\n  2. Concomitant therapy in the form of intrathecal chemotherapy for CNS treatment, is permitted.\n  3. Radiation therapy is not permitted except for localized palliative radiation to focal lesions after discussion with the Medical Monitor for patients who have progressed but remain on the study due to perceived clinical benefit per Investigator assessment\n* Participants with active graft versus host disease (GVHD) of grade 2 or higher requiring systemic treatment. Skin GVHD solely managed with topical corticosteroids would not be exclusionary.\n* Known prior severe hypersensitivity to an investigational product or any component of the study drug therapy's formulations including polyethylene glycol (PEG; National Cancer Institute Common Terminology Criteria for Adverse Events \\[NCI CTCAE\\] v6.0 Grade ≥ 3)\n* Prior organ transplantation, other than allogeneic or autologous hematopoietic stem cell transplantation.\n* Received a live vaccine within 30 days of the planned start of study drug.\n\n  a. (Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines and are not allowed.)\n* Evidence of clinically significant immunosuppression including the following:\n\n  a. Primary immunodeficiency state such as SCID b. Concurrent opportunistic infection c. Receiving systemic immunosuppressive therapy (\\>2 weeks) including oral steroid doses \\> 10 mg\u002Fday of prednisone or equivalent within seven days prior to enrollment. In the setting of non-immune mediated indications for use, chronic\u002Factive low dose steroid use (equivalent to ≤ 10 mg\u002Fday prednisone) may be permitted at the discretion of the Principal Investigator i. (Note: Other steroid formulations or steroid use for other indications may be permitted and include: 1) Intranasal, inhaled, ocular, or topical steroids, or local steroid injection (e.g., intra-articular injection); 2) Systemic corticosteroids at physiologic doses ≤ 10 mg\u002Fday of prednisone or equivalent; 3) Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)\n* History or evidence of symptomatic autoimmune disease (e.g., pneumonitis, glomerulonephritis, vasculitis, or other), or history of active autoimmune disease that has required systemic treatment (i.e., use of corticosteroids, immunosuppressive drugs or biological agents used for treatment of autoimmune diseases) in past two years prior to enrollment\n\n  a. (Note: Replacement therapy \\[e.g., thyroxine for hypothyroidism, insulin for diabetes or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency\\] is not considered a form of systemic treatment for autoimmune disease.)\n* Evidence of clinically significant interstitial lung disease, history of interstitial lung disease, or active, noninfectious pneumonitis related to prior immunotherapy treatment\n* Participant has significant active cardiac disease within 6 months prior to start of study treatment, including New York Heart Association (NYHA) class III or IV congestive heart failure; acute coronary syndrome (ACS); and\u002For stroke.\n* Participant has QTc interval (i.e., Fridericia's correction \\[QTcF\\]) ≥ 470 ms. Patients with a QTcF over 470 ms due to a bundle branch block or a pacemaker may participate in the study with approval of the study principal investigator.\n* Participant has active viral infection with human immunodeficiency virus (HIV), or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)\n* Participant is known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.\n* Participant has active uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and\u002For other treatment).\n* Participant with active use of strong or moderate CYP3A4 inhibitors.\n* Female participant who is pregnant or lactating.\n* Because STING agonist agents impact immune and cellular functioning posing potential risk for impacting normal embryonic development, and because other therapeutic agents used in this trial are known to be teratogenic, participants of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during study therapy and for 6 months (females) or 3 months (males) following the completion of study therapy. Male or female participants not willing to comply with contraceptive requirements will be excluded, which adequate contraception (hormonal or barrier method of birth control; abstinence) during study therapy and for 6 months (females) or 3 months (males) following the completion of study therapy",{"count":246,"type":23},[26],"The purpose of this study is to find out whether CRD3874-SI is a safe treatment for participants with acute myeloid leukemia (AML).",[30,29,31],[30,29,31,437,363,438],"CRD3874-SI","26-144","2026-06-16",{"date":367,"type":38},{"date":442,"type":38},"2026-06-15",{"date":444,"type":23},"2028-06-15",{"name":363,"class":91},{"id":447,"slug":448,"hasResults":12,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":4,"eligibilityCriteria":452,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":453,"targetDuration":4,"studyType":24,"phases":455,"briefSummary":456,"conditions":457,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":467},"100553282","phase-1-testing-the-anti-cancer-drug-cirtuvivint-and-its-combination-with-astx727-to-improve-outcomes-in-patients-with-acute-myeloid-leukemia-and-myelodysplastic-syndromes-100553282","NCT06484062","Testing the Anti-cancer Drug, Cirtuvivint, and Its Combination With ASTX727 to Improve Outcomes in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndromes","A Phase I Study Evaluating the Safety of Cirtuvivint as Monotherapy and in Combination With ASTX727 in Patients With Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n* In Cohorts I and II, patients must have R\u002FR AML or MDS (venetoclax naïve or venetoclax exposed)\n\n  * Relapsed AML is defined as the appearance of 5% or greater myeloblasts in the bone marrow or peripheral blood after achieving a complete remission (CR), CR with partial hematologic recovery (CRh), or CR with incomplete hematologic recovery (CRi). Patients with a mutation in FLT3, IDH1 or IDH2 must have failed or been intolerant of a corresponding Food and Drug Administration (FDA) approved FLT3, IDH1 or IDH2 inhibitor before enrolling on study. The initial diagnosis of AML is defined by the ELN 2022 criteria, and therefore patients with either AML (peripheral blood or bone marrow blasts ≥ 20% or blasts ≥ 10% with recurrent genetic abnormalities) or MDS\u002FAML (peripheral blood or bone marrow blasts 10-19%) are eligible\n  * Refractory AML is defined as failure to achieve a CR, CRh, or CRi after one of the following regimens: (i) ≥ 2 cycles of intensive induction chemotherapy with a cytarabine containing regimen (e.g., 7+3, mitoxantrone, etoposide, cytarabine \\[MEC\\], high-dose cytarabine \\[HIDAC\\], reinduction chemotherapy such as 5 + 2, etc.) or, (ii) ≥ 2 cycles of hypomethylating agent (HMA)\u002Fvenetoclax or low-dose cytarabine (LDAC)\u002Fglasdegib or, (iii) ≥ 4 cycles of HMA monotherapy. The initial diagnosis of AML is defined by the ELN 2022 criteria, and therefore patients with either AML (peripheral blood or bone marrow blasts ≥ 20% or blasts ≥ 10% with recurrent genetic abnormalities) or MDS\u002FAML (peripheral blood or bone marrow blasts 10-19%) are eligible\n  * Patients with MDS\u002FAML (blasts 10-19%) who progress to AML (blasts ≥ 20%) after treatment will be considered relapsed or refractory MDS\u002FAML, and not as newly-diagnosed AML (i.e. the patients' treatment history for eligibility purposes does not reset)\n  * Relapsed MDS is defined as: (i) Intermediate, high, or very high-risk disease by International Prognostic Scoring System-Revised (IPSS-R) and, (ii) Any relapse after achieving any 2023 IWG MDS defined response\n  * Refractory MDS is defined as: (i) Intermediate, high, or very high-risk disease by IPSS-R and \\> 5% blasts in the bone marrow or peripheral blood, (ii) Failure to achieve a response (as per IWG 2006 criteria) after ≥ 4 cycles of HMA monotherapy, or (iii) ≥ 2 cycles of HMA + venetoclax\n* In Cohort III, patients must have prior untreated high-risk MDS\n\n  * MDS with \\> 5% blasts in the bone marrow or peripheral blood AND\n  * IPSS-R high or very high-risk disease OR\n  * Molecular International Prognostic Scoring System (IPSS-M) high or very high-risk disease\n  * No more than one single prior cycle of DNMTi therapy\n  * Prior use of erythropoiesis stimulating agents (ESA), thrombopoietin agonists, lenalidomide, and luspatercept are allowed\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of SM08502 (cirtuvivint) in combination with ASTX727 in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3\n* Total bilirubin ≤ 2 x institutional upper limit of normal (ULN) (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin; in that case a cut off of ≤ 4 × institutional ULN will be used)\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 x institutional ULN (unless considered due to organ involvement by the patient's myeloid malignancy; in that case a cut off of ≤ 5 x institutional ULN will be used)\n* Glomerular filtration rate (GFR) ≥ 45 mL\u002Fmin\u002F1.73m\\^2\n* If female, patient must be either:\n\n  * Postmenopausal (surgically sterile or age \\> 55 years with no menses for 12 or more months without an alternative medical cause or age equal to 55 or less with no menses for 12 or more months without an alternative medical cause and a follicle stimulating hormone \\[FSH\\] level \\> 40 IU\u002FL); or\n  * Of children bearing potential. These patients must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Patient must agree to have a negative urine or serum beta-human chorionic gonadotropin (HCG) test result during screening and repeated within 7 days prior to study drug (local labs are allowed) to be eligible\n* The effects of SM08502 (cirtuvivint) and ASTX727 on the developing human fetus are unknown. For this reason, and because these agents are known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and during the treatment therapy. Women of childbearing age should agree to use adequate contraception for 7 months after completion of SM08502 (cirtuvivint) administration. For ASTX727, adequate contraception must continue for at least 6 months after last dose of ASTX727. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study and for the duration of the study and at least 4 months after the last dose of SM08502 (cirtuvivint) and 3 months after last dose of ASTX727. Women who are lactating must refrain from breastfeed during the study and at least for two weeks after last dose of ASTX727\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia or abnormal blood counts\n* Patients who are receiving any other investigational agents\n* Systemic anti-leukemic or other antineoplastic therapy within 14 days of first day of study treatment. Hydroxyurea may be continued through cycle 1 of treatment. Hydroxyurea is discouraged in subsequent cycles and should be discussed beforehand with principal investigator. If on venetoclax, then a wash-out period of at least five times the half-life of venetoclax is required. Exceptions: No wash-out required for intrathecal chemotherapy, hydroxyurea, cytarabine (Ara-C), or palliative radiation therapy to painful sites of leukemic disease. Patients are not allowed to receive concurrent therapy such as cytotoxic chemotherapy or radiation therapy for another cancer. Patients on hormonal adjuvant therapy for non-metastatic breast and prostate cancer or other minimally-myelosuppressive maintenance therapies for non-metastatic cancer may be eligible at the discretion of the study principal investigator (PI)\n* Patient is receiving known inhibitors or activators of flavin-containing monooxygenases (FMO1 or FMO3), and these cannot be stopped at least 5 days prior to SM08502 (cirtuvivint) treatment start. Known inhibitors of FOMO are chlorpromazine and imipramine\n* Patient is receiving strong inhibitors or strong inducers of CYP3A4\u002F5 and these cannot be stopped at least 5 days prior to SM08502 (cirtuvivint) treatment start\n\n  * Strong inhibitors include grapefruit juice or grapefruit\u002Fgrapefruit related citrus fruits (e.g., Seville oranges, pomelos), ketoconazole, miconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin, indinavir, saquinavir, ritonavir, nelfinavir, amprenavir, fosamprenavir, nefazodone, lopinavir, troleandomycin, mibefradil, and conivaptan. Examples may be found at the FDA website. Refer to the prescribing information of concomitant medications if in doubt or consult the sponsor for guidance\n  * Strong inducers include phenobarbital, rifampin, phenytoin, carbamazepine, rifabutin, rifapentin, clevidipine, and St. John's Wort. Examples may be found at the FDA website. Refer to the prescribing information of concomitant medications if in doubt or consult the sponsor for guidance.\n  * While moderate inhibitors or moderate inducers of CYP3A4\u002F5 are not an exclusion criteria for the trial, it is preferred that moderate inhibitors or moderate inducers of CYP3A4\u002F5 be replaced prior to the first dose of SM08502 (cirtuvivint) and during study conduct where this is possible.\n\n    * Moderate inhibitors include erythromycin, ciprofloxacin, verapamil, diltiazem, atazanavir, fluconazole, darunavir, delavirdine, amprenavir, fosamprenavir, aprepitant, imatinib, tofisopam, and cimetidine. Examples may be found at the FDA website. Refer to the prescribing information of concomitant medications if in doubt or consult the sponsor for guidance\n    * Moderate inducers include bosentan, efavirenz, etravirine, modafinil, and nafcillin. Examples may be found at the FDA website. Refer to the prescribing information of concomitant medications if in doubt or consult the sponsor for guidance\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to SM08502 (cirtuvivint) or ASTX727\n* Chronic, active hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: patients with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface \\[HBs\\] antigen negative, anti-HBs antibody positive and anti-hepatitis B core \\[HBc\\] antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate. Patients who had prior HCV that has been definitively treated with negative HCV viral load prior to study initiation and no evidence of cirrhosis, are allowed to participate. If there is no known history of HBV infection no HBV studies need to be obtained. If there is no known history of HCV infection, no HCV studies need to be obtained\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Pregnant and lactating women are excluded from this study because SM08502 (cirtuvivint) is a small molecule inhibitor of CLK DYRK with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with SM08502 (cirtuvivint), breastfeeding should be discontinued if the mother is treated with SM08502 (cirtuvivint). These potential risks may also apply to other agents used in this study\n* Patients with acute promyelocytic leukemia\n* Subject has symptomatic central nervous system (CNS) involvement with AML\n* Patient has immediate life-threatening, severe complications of their myeloid malignancy such as uncontrolled bleeding and\u002For uncontrolled infection\n* Patient has significant active cardiac disease within 6 months prior to the start of study treatment, including uncontrolled New York Heart Association (NYHA) class III or IV congestive heart failure; acute coronary syndrome (ACS); and\u002For stroke\n* Left ventricular ejection fraction (LVEF) \\\u003C 40% by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan obtained within 30 days prior to the start of study treatment\n* Patient is known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally. Patient needs to be able to swallow pills\n* Patient has active uncontrolled systemic fungal, bacterial, or viral infection (defined as ongoing signs\u002Fsymptoms related to the infection without improvement despite appropriate antibiotics, antiviral therapy, and\u002For other treatment)\n* Subject has prolonged corrected QC (QTc) interval (Fridericia's correction \\[QTcF\\]) ≥ 480 ms or known family history of long QT interval syndrome at screening",{"count":454,"type":23},54,[26],"This phase I trial tests the safety, side effects, and best dose of SM08502 (cirtuvivint) alone and in combination with ASTX727 in treating patients with acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). Cirtuvivint may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. ASTX727 is a combination of two drugs, decitabine and cedazuridine. Decitabine is in a class of medications called hypomethylation agents. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. Cedazuridine is in a class of medications called cytidine deaminase inhibitors. It prevents the breakdown of decitabine, making it more available in the body so that decitabine will have a greater effect. Giving cirtuvivint alone or in combination with ASTX727 may be safe, tolerable, and\u002For effective in treating patients with AML and MDS.",[30,106,458,61,107,293,31,132,294],"Myelodysplastic Syndrome\u002FAcute Myeloid Leukemia","2026-06-10",{"date":461,"type":38},"2026-06-11",{"date":463,"type":38},"2025-08-15",{"date":465,"type":23},"2028-06-01",{"name":69,"class":70},22,{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":473,"acronym":4,"eligibilityCriteria":474,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":475,"targetDuration":4,"studyType":24,"phases":476,"briefSummary":477,"conditions":478,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":480,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":485,"locationsCount":92},"100400356","phase-2-cpx-351-and-ivosidenib-for-the-treatment-of-idh1-mutated-acute-myeloid-leukemia-or-high-risk-myelodysplastic-syndrome-100400356","NCT04493164","CPX-351 and Ivosidenib for the Treatment of IDH1 Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome","Phase II Investigator Sponsored Study of CPX-351 in Combination With Ivosidenib for Patients With IDH1 Mutated Acute Myeloid Leukemia or High-Risk MDS","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n* IDH1-R132 mutated disease status as assessed by local laboratory. 2HG-producing IDH1 variants outside of R132 (i.e. R100) may be eligible after discussion with the principal investigator (PI)\n* Treatment naive or relapsed\u002Frefractory AML who are eligible for intensive chemotherapy. Patients with high-risk MDS or MPN (defined as International Prognostic Scoring System Revised \\[IPSS-R\\] score ≥ 4 or dynamic \\[D\\]-IPSS ≥ 3) may also be eligible after discussion with the PI\n* Adequate hepatic function (direct bilirubin ≤ 2 x upper limit of normal (ULN), Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) ≤ 3 x ULN unless deemed to be related to underlying leukemia\n* Adequate renal function including creatinine clearance ≥ 30 ml\u002Fmin based on the Cockcroft-Gault equation.\n* Willing and able to provide informed consent\n* In the absence of rapidly proliferative disease, the interval from prior treatment to time of initiation will be at least 7 days for cytotoxic or non-cytotoxic (immunotherapy) agents.\n* Male subjects must agree to refrain from unprotected sex and sperm donation from initial study drug administration until 90 days after the last dose of study drug\n\nExclusion Criteria:\n\n* Patients who have previously received CPX-351.\n* Patients with any concurrent uncontrolled clinically significant medical condition including infection, laboratory abnormality, or psychiatric illness, which could place the patient at unacceptable risk of study treatment.\n* The use of other chemotherapeutic agents or anti-leukemic agents is not permitted during study with the following exceptions (1) intrathecal chemotherapy for prophylactic use or for controlled CNS leukemia. (2) use of hydroxyurea, and\u002For cytarabine (1 or 2 doses; up to 2 g\u002Fm2) for patients with rapidly proliferative disease is allowed before the start of study therapy.\n* Patients with active graft-versus-host-disease (GVHD) status post stem cell transplant (patients without active GVHD on chronic suppressive immunosuppression and\u002For phototherapy for chronic skin GVHD are permitted after discussion with the PI).\n* Patients with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.\n* Patients with symptomatic congestive heart failure (NYHA Class III or IV), unstable angina, or an ejection fraction \\\u003C 45%.\n* Patients with prior anthracycline exposure of \\> 360 mg\u002Fm2 daunorubicin (or equivalent), or \\> 210 mg\u002Fm2 daunorubicin (or equivalent) in patients with prior mediastinal radiation.\n* QTc interval using Fridericia's formula (QTcF) \\> 470 msec. A prolonged QTc interval in the setting of right bundle branch block is permitted after discussion with the PI.\n* Nursing women, women of childbearing potential (WOCBP) with positive urine or serum pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception\n\n  a. Appropriate highly effective method(s) of contraception include oral or injectable hormonal birth control, IUD, and double barrier methods (for example a condom in combination with a spermicide).\n* Subjects with a known medical history of progressive multifocal leukoencephalopathy (PML).\n* Subjects taking strong CYP3A4 inducers are excluded from the study unless they can be transferred to other medications within ≥ 5 half-lives prior to dosing\n* Patients with a diagnosis of acute promyelocytic leukemia (APL).\n* Unresolved toxicities \\> grade 1 from prior treatment including chemotherapy, targeted therapy, immunotherapy, experimental agents, radiation, or surgery.",{"count":80,"type":23},[103],"This phase II trial investigates how well CPX-351 and ivosidenib work in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that has IDH1 mutation. The safety of this drug combination will also be studied. IDH1 is a type of genetic mutation (change). Chemotherapy drugs, such as CPX-351, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ivosidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. The purpose of this trial is to learn if CPX-351 in combination with ivosidenib can help to control IDH1-mutated acute myeloid leukemia or high-risk myelodysplastic syndrome.",[479,106,154,61,31],"Acute Myeloid Leukemia With Gene Mutations",{"date":481,"type":38},"2026-06-12",{"date":483,"type":38},"2020-12-30",{"date":465,"type":23},{"name":114,"class":91},{"id":487,"slug":488,"hasResults":12,"nctId":489,"briefTitle":490,"officialTitle":491,"acronym":4,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":493,"targetDuration":4,"studyType":24,"phases":495,"briefSummary":496,"conditions":497,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":503,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":507,"locationsCount":92},"100366159","phase-1-cladribine-idarubicin-cytarabine-and-quizartinib-in-treating-patients-with-newly-diagnosed-relapsed-or-refractory-acute-myeloid-leukemia-or-high-risk-myelodysplastic-syndrome-100366159","NCT04047641","Cladribine, Idarubicin, Cytarabine, and Quizartinib in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome","A Combination of Cladribine, Idarubicin, Cytarabine (CLIA) and Quizartinib for the Treatment of Patients With Newly Diagnosed or Relapsed\u002FRefractory Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS))","Inclusion Criteria:\n\n* Diagnosis of\n\n  * AML (World Health Organization \\[WHO\\] classification definition of \\>= 20% blasts, excluding Acute promyelocytic leukemia),\n  * Acute biphenotypic leukemia or\n  * High-risk MDS (\\> 10% bone marrow blasts)\n* Frontline cohort: Patients aged 18 to 65 years\n* Relapse cohort: Patients aged \\>=18 years old\n* Patients may be newly diagnosed (Frontline cohort) or with prior therapy (Relapsed cohort) as follows:\n\n  * For frontline cohort: Patients must be chemonaive, i.e., not have received any chemotherapy (except hydroxyurea \\[Hydrea\\] \\[no dose limit\\], tretinoin \\[atra\\] \\[no dose limit\\] or ara-C \\[one or two doses (max 2 gr\u002Fm\\^2 per dose)\\] for transient control of hyperleukocytosis) for AML or MDS. They may have received hypomethylating agents for prior MDS and transfusions, hematopoietic growth factors or vitamins. Temporary prior measures such as apheresis or Hydrea are allowed\n  * For relapsed cohort: Patients with previously treated, relapsed or refractory AML, acute biphenotypic leukemia or high-risk MDS (\\> 10% bone marrow blasts)\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2\n* Creatinine \\\u003C 1.5 mg\u002Fdl\n* Total bilirubin \\\u003C 1.5 mg\u002FdL, unless increase is due to hemolysis or congenital disorder\n* Transaminases (serum glutamate pyruvate transaminase \\[SGPT\\]) \\\u003C 2.5 x upper limit of normal (ULN)\n* Potassium, magnesium, and calcium (normalized for albumin) levels should be at least within institutional normal limits\n* Ability to take oral medication\n* Ability to understand and provide signed informed consent\n* Baseline test of left ventricular ejection fraction \\>= 50%\n* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 7 days\n* WOCBP must use appropriate method(s) of contraception such as oral contraceptive pills (OCP), birth control shots, intrauterine device (IUD) etc. WOCBP should use an adequate method to avoid pregnancy until 30 days after the last dose of investigational drug. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential. Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) as well as men with known azoospermia do not require contraception\n* Patients with isolated extramedullary myeloid neoplasm will be eligible\n\nExclusion Criteria:\n\n* Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results\n* Breastfeeding women\n* Patients with current active malignancies or any remission for \\\u003C 6 months, except patients with carcinoma in situ or with non-melanoma skin cancer who may be in remission for less than 6 months or have active disease\n* Active clinically serious and uncontrolled infection. Patients with recent infections must have no temperature of \\>= 101 degrees Fahrenheit (F) for at least 48 hours (hrs) (before first dose, day 1)\n* Patients with known significant impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of quizartinib\n* Documented active central nervous system leukemia (patients with history of central nervous system \\[CNS\\] leukemia without active disease are allowed)\n* Patients with a known confirmed diagnosis of human immunodeficiency virus (HIV) infection or active viral hepatitis\n* Patients who have had any major surgical procedure within 14 days of day 1\n* Impaired cardiac function including any of the following:\n\n  * Screening electrocardiography (ECG) with a corrected QT (QTc) \\> 450 msec. The QTc interval will be calculated by Fridericia's correction factor (QTcF). The QTcF will be derived from the average QTcF in triplicate. Patients are excluded if they have QTcF \\>= 450. Subjects with prolonged QTcF interval in the setting of RBBB (right bundle branch block) may participate upon review and approval by the medical monitor. RBBB for patients' triplicate electrocardiograms (EKGs) can show false QTc prolongation; therefore, the cardiology collaborator for this study will manually review to provide an accurate reading of the QTc\n  * Patients with congenital long QT syndrome\n  * Sustained ventricular tachycardia requiring medical intervention\n  * Any history of clinically significant ventricular fibrillation or torsades de pointes\n  * Known history of second or third degree heart block (may be eligible if the patient currently has a pacemaker)\n  * Heart rate of \\\u003C 50\u002Fminute on pre-entry ECG\n  * Left bundle branch block\n  * Right bundle branch block + left anterior hemiblock (bifascicular block)\n  * Patients with myocardial infarction or unstable angina within 6 months prior to starting study drug\n  * Congestive heart failure (CHF) New York (NY) Heart Association class III or IV\n  * Atrial fibrillation documented within 2 weeks prior to first dose of study drug\n  * Known family history of congenital long QT syndrome\n  * Patients who are actively taking a strong CYP3A4 inducing medication",{"count":494,"type":23},80,[26,103],"This phase I\u002FII trial studies the side effects and how well cladribine, idarubicin, cytarabine, and quizartinib work in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndrome that is newly diagnosed, has come back (relapsed), or does not respond to treatment (refractory). Drugs used in chemotherapy, such as cladribine, idarubicin, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Quizartinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving quizartinib with cladribine, idarubicin, and cytarabine may help to control acute myeloid leukemia or high-risk myelodysplastic syndrome.",[30,498,499,500,61,501,31,502],"Blasts 20 Percent or More of Bone Marrow Nucleated Cells","High Risk Myelodysplastic Syndrome","Recurrent Acute Biphenotypic Leukemia","Recurrent High Risk Myelodysplastic Syndrome","Refractory High Risk Myelodysplastic Syndrome",{"date":481,"type":38},{"date":505,"type":38},"2019-10-22",{"date":340,"type":23},{"name":114,"class":91},{"id":509,"slug":510,"hasResults":12,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":4,"eligibilityCriteria":514,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":515,"targetDuration":4,"studyType":24,"phases":517,"briefSummary":518,"conditions":519,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":538,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":215},"100287143","phase-1-a-vaccine-vsv-hifn-nis-with-or-without-cyclophosphamide-and-combinations-of-ipilimumab-nivolumab-and-cemiplimab-in-treating-relapsed-or-refractory-multiple-myeloma-acute-myeloid-leukemia-or-lymphoma-100287143","NCT03017820","A Vaccine (VSV-hIFNβ-NIS) With or Without Cyclophosphamide and Combinations of Ipilimumab, Nivolumab, and Cemiplimab in Treating Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia or Lymphoma","MC1684 Phase I Trial of Systemic Administration of Vesicular Stomatitis Virus Genetically Engineered to Express NIS and Human Interferon, in Patients With Relapsed or Refractory Multiple Myeloma, Acute Myeloid Leukemia, Lymphomas, or Histiocytic\u002FDendritic Cell Neoplasms","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Relapsed or refractory disease as follows:\n\n  * Groups A, B, C or D: Multiple myeloma (MM) previously treated with an immunomodulatory imide drug (IMID), a proteosome inhibitor, and an alkylating agent\n  * All Groups except D: Relapsed peripheral T-cell lymphoma (PTCL) of the following histologies: peripheral T-cell lymphoma-NOS (PTCL-NOS); angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell (ALCL), and mycosis fungoides (MF). Patients should have failed standard therapy and in the case of PTCL-NOS, AITL, and ALCL either have failed or be ineligible for high-dose therapy with autologous stem cell transplant\n  * Group B and C only: B-cell lymphoma (other than Burkitt's lymphoma), or histiocytic\u002Fdendritic cell neoplasms (HCN) at any stage\n  * Group E only: Relapsed peripheral T-cell lymphoma (PTCL) of the following histologies: peripheral T-cell lymphoma-NOS (PTCL-NOS); anaplastic large cell (ALCL), and mycosis fungoides (MF)\n  * Group F only: Expansion Cohort for B-cell lymphoma (other than Burkitt's lymphoma) with low tumor burden\n  * Group G only: Expansion Cohort for peripheral T cell lymphoma (PTCL) with low tumor burden\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\\\u003C 2 times upper limit of normal (ULN) (obtained =\\\u003C 15 days prior to registration)\n* Creatinine =\\\u003C 2.0 mg\u002FdL (obtained =\\\u003C 15 days prior to registration)\n* Direct bilirubin =\\\u003C 1.5 x ULN (obtained =\\\u003C 15 days prior to registration)\n* International normalized ratio (INR)\u002Fprothrombin time (PT) and activated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN (obtained =\\\u003C 15 days prior to registration)\n* If baseline liver disease, Child Pugh score not exceeding class A (obtained =\\\u003C 15 days prior to registration)\n* Negative pregnancy test for persons of child-bearing potential (obtained =\\\u003C 15 days prior to registration)\n* FOR MULTIPLE MYELOMA ONLY: Measurable disease of multiple myeloma as defined by at least ONE of the following:\n\n  * Serum monoclonal protein \\>= 1.0 g\u002FdL by protein electrophoresis\n  * \\>= 200 mg of monoclonal protein in the urine on 24-hour electrophoresis\n  * Serum immunoglobulin free light chain \\>= 10 mg\u002FdL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio\n* FOR MULTIPLE MYELOMA ONLY: Absolute neutrophil count (ANC) \\>= 1000\u002FuL (obtained =\\\u003C 14 days prior to registration)\n* FOR MULTIPLE MYELOMA ONLY: Platelet (PLT) \\>= 100,000\u002FuL (obtained =\\\u003C 14 days prior to registration)\n* FOR MULTIPLE MYELOMA ONLY: Hemoglobin \\>= 8.5 g\u002Fdl (obtained =\\\u003C 14 days prior to registration)\n* FOR AML ONLY: No ANC restriction (obtained =\\\u003C 14 days prior to registration)\n* FOR AML ONLY: PLT \\>= 10,000\u002FuL (transfusion to get platelets \\>= 10,000 is allowed) (obtained =\\\u003C 14 days prior to registration)\n* FOR AML ONLY: Hemoglobin \\>= 7.5 g\u002Fdl (obtained =\\\u003C 14 days prior to registration)\n* FOR AML ONLY: Absence of uncompensated disseminated intravascular coagulation (DIC- as diagnosed by standard International Society on Thrombosis and Hemostasis \\[ISTH\\] criteria)\n* FOR TCL\u002FBCL ONLY: ANC \\>= 1,000\u002FuL (obtained =\\\u003C 14 days prior to registration)\n* FOR TCL\u002FBCL ONLY: PLT \\>= 100,000\u002FuL (obtained =\\\u003C 14 days prior to registration)\n* FOR TCL\u002FBCL ONLY: Hemoglobin \\>= 8.5 g\u002Fdl (obtained =\\\u003C 14 days prior to registration)\n* FOR TCL\u002FBCL ONLY: Measurable disease by CT or magnetic resonance imaging (MRI): must have at least one lesion that has a single diameter of \\> 2 cm or tumor cells in the blood \\> 5 x 10\\^9\u002FL; NOTE: skin lesions can be used if the area is \\> 2 cm in at least one diameter and photographed with a ruler and the images are available in the medical record\n* FOR HCN ONLY: ANC \\>= 1,000\u002FuL obtained =\\\u003C 15 days prior to registration\n* FOR HCN ONLY: PLT \\>= 100,000\u002FuL obtained =\\\u003C 15 days prior to registration\n* FOR HCN ONLY: Hemoglobin \\>= 8.0 g\u002Fdl obtained =\\\u003C 15 days prior to registration\n* FOR HCN ONLY: Measurable disease by CT or MRI: Must have at least one lesion that has a single diameter of \\>= 1.5 cm or tumor cells in the blood \\>5 x10\\^9\u002FL. NOTE: Skin lesions can be used if the area is \\>= 1.5 cm in at least one diameter and photographed with a ruler and the images are available in the medical record\n* Absence of active central nervous system (CNS) involvement; NOTE: pre-enrollment lumbar puncture not mandatory\n* Ability to provide written informed consent\n* Willingness to return to Mayo Clinic for follow-up\n* Life expectancy \\>= 12 weeks\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2\n* Willing to provide mandatory biological specimens for research purposes\n\nExclusion Criteria:\n\n* Availability of and patient acceptance of curative therapy\n* Uncontrolled infection\n* Active tuberculosis or hepatitis, or chronic hepatitis\n* Any of the following prior therapies:\n\n  * Chemotherapy (IMIDs, alkylating agents, proteosome inhibitors) =\\\u003C 2 weeks prior to registration\n  * Immunotherapy (monoclonal antibodies) =\\\u003C 4 weeks prior to registration\n  * Experimental agent in case of AML or TCL within 4 half-lives of the last dose of the agent\n* New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or known cardiac arrhythmias (atrial fibrillation or supraventricular tachycardia \\[SVT\\])\n* Active CNS disorder or seizure disorder or known CNS disease or neurologic symptomatology; in case of AML active CNS involvement as detected by lumbar puncture or neuro-imaging (only to be done if clinically indicated)\n* Human immunodeficiency virus (HIV) positive test result or other immunodeficiency or immunosuppression\n* Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (used for a non-Food and Drug Administration \\[FDA\\] approved indication and in the context of a research investigation);\n\n  * NOTE: in AML, the concurrent use of hydroxyurea to help control proliferative counts is allowed throughout the treatment protocol;\n  * NOTE: in TCL, patients may use topical emollients or corticosteroids, acetic acid soaks, etc. to control pruritus and prevent infection; no topical chemotherapy is allowed (no topical nitrogen mustard)\n* Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:\n\n  * Pregnant women or women of reproductive ability who are unwilling to use effective contraception\n  * Nursing women\n  * Men who are unwilling to use a condom (even if they have undergone a prior vasectomy) while having intercourse with any woman, while taking the drug and for 4 weeks after stopping treatment\n* AML ONLY: Current disseminated intravascular coagulopathy (DIC)\n* ADDITIONAL EXCLUSION CRITERIA FOR GROUP A (LOW TUMOR BURDEN) ONLY:\n\n  * Diagnosis of AML\n  * Multiple myeloma only: \\> 25% plasma cells or plasmacytoma \\> 5cm in largest diameter\n  * Lymphoma or HCN only: Any mass \\>5cm\n  * Diagnosis of Burkitt's lymphoma\n* ADDITIONAL EXCLUSION CRITERIA FOR GROUP B (HIGH TUMOR BURDEN) ONLY:\n\n  * Diagnosis of AML\n  * Diagnosis of Burkitt's lymphoma\n* ADDITIONAL EXCLUSION CRITERIA FOR GROUP C (COMBINATION WITH CYCLOPHOSPHAMIDE) ONLY:\n\n  * Diagnosis of AML\n  * Diagnosis of Burkitt's lymphoma\n* ADDITIONAL EXCLUSION CRITERIA FOR GROUP E (COMBINATION WITH CEMIPLIMAB) ONLY:\n\n  * Diagnosis of AML\n  * Diagnosis of AITL\n* ADDITIONAL EXCLUSION CRITERIA FOR GROUP F (BCL EXPANSION COHORT) ONLY:\n\n  * Diagnosis of Burkitt's lymphoma\n* ADDITIONAL EXCLUSION CRITERIA FOR GROUP G (PTCL EXPANSION COHORT) ONLY:\n\n  * Diagnosis of cutaneous TCL",{"count":516,"type":23},99,[26],"This phase I trial studies the best dose and side effects of the VSV-hIFNβ-NIS vaccine with or without cyclophosphamide and combinations of ipilimumab, nivolumab, and cemiplimab in treating patients with multiple myeloma, acute myeloid leukemia or lymphoma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). VSV-IFNβ-NIS is a modified version of the vesicular stomatitis virus (also called VSV). This virus can cause infection and when it does it typically infects pigs, cattle, or horses but not humans. The VSV used in this study has been altered by having two extra genes (pieces of DNA) added. The first gene makes a protein called NIS that is inserted into the VSV. NIS is normally found in the thyroid gland (a small gland in the neck) and helps the body concentrate iodine. Having this additional gene will make it possible to track where the virus goes in the body (which organs). The second addition is a gene for human interferon beta (β) or hIFNβ. Interferon is a natural anti-viral protein, intended to protect normal healthy cells from becoming infected with the virus. VSV is very sensitive to the effect of interferon. Many tumor cells have lost the capacity to either produce or respond to interferon. Thus, interferon production by tumor cells infected with VSV-IFNβ-NIS will protect normal cells but not the tumor cells. The VSV with these two extra pieces is referred to as VSV-IFNβ-NIS. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Immunotherapy with monoclonal antibodies, such as ipilimumab, nivolumab, and cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving VSV-IFNβ-NIS with or without cyclophosphamide and combinations of ipilimumab, nivolumab, and cemiplimab may be safe and effective in treating patients with recurrent peripheral T-cell lymphoma.",[520,521,106,522,523,524,525,526,527,528,529,31,530,531,532,533,534,535,536],"B-Cell Non-Hodgkin Lymphoma","Histiocytic and Dendritic Cell Neoplasm","Previously Treated Myelodysplastic Syndrome","Recurrent Adult Acute Myeloid Leukemia","Recurrent Anaplastic Large Cell Lymphoma","Recurrent Angioimmunoblastic T-Cell Lymphoma","Recurrent Mycosis Fungoides","Recurrent Plasma Cell Myeloma","Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma","Recurrent T-Cell Non-Hodgkin Lymphoma","Refractory Anaplastic Large Cell Lymphoma","Refractory Angioimmunoblastic T-Cell Lymphoma","Refractory Mycosis Fungoides","Refractory Peripheral T-Cell Lymphoma, Not Otherwise Specified","Refractory Plasma Cell Myeloma","Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma","Refractory T-Cell Non-Hodgkin Lymphoma","2026-06-08",{"date":459,"type":38},{"date":540,"type":38},"2017-04-04",{"date":542,"type":23},"2032-04-01",{"name":544,"class":91},"Mayo Clinic",{"id":546,"slug":547,"hasResults":12,"nctId":548,"briefTitle":549,"officialTitle":550,"acronym":4,"eligibilityCriteria":551,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":552,"targetDuration":4,"studyType":24,"phases":554,"briefSummary":555,"conditions":556,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":92},"100421944","phase-1-decitabinecedazuridine-and-venetoclax-in-combination-with-ivosidenib-or-enasidenib-for-the-treatment-of-relapsed-or-refractory-acute-myeloid-leukemia-100421944","NCT04774393","Decitabine\u002FCedazuridine and Venetoclax in Combination With Ivosidenib or Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia","Phase 1b\u002F2 Study of Oral Decitabine\u002FCedazuridine (ASTX727) and Venetoclax in Combination With the Targeted Mutant IDH1 Inhibitor Ivosidenib or the Targeted Mutant IDH2 Inhibitor Enasidenib","Inclusion Criteria:\n\n* Patients with a diagnosis of relapsed or refractory acute myeloid leukemia (AML) (including biphenotypic or bilineage leukemia including a myeloid component or isolated extramedullary AML); OR\n* Patients (\\> 60 year old) with newly diagnosed AML not eligible for intensive chemotherapy are also eligible\n* To be considered not eligible for intensive chemotherapy, participants must be defined by the following: Age 75 years or older, or Age 18 to 74 years with at least one of the following comorbidities:\n* Severe cardiac disorder (eg, congestive heart failure requiring treatment, ejection fraction ≤50%, or chronic stable angina).\n* Severe pulmonary disorder (eg, DLCO ≤65% or forced expiratory volume in 1 second \\[FEV1\\] ≤65%).\n* Creatinine clearance ≥30 mL\u002Fmin to \\\u003C45 mL\u002Fmin.\n* Moderate hepatic impairment with total bilirubin \\>1.5 to ≤3.0 × upper limit of normal (ULN)\n* ECOG performance status of 2 or 3\n* Age \\>= 18 years\n* Subjects must have documented IDH1 or IDH2 gene mutation\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2\n* Adequate renal function including creatinine \\\u003C 2 unless related to the disease\n* Direct bilirubin \\\u003C 2 x upper limit of normal (ULN) unless increase is due to Gilbert's disease or leukemic involvement\n* Aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) \\\u003C 3 x ULN unless considered due to leukemic involvement, in which case direct bilirubin or AST and\u002For ALT \\\u003C 5 x ULN will be considered eligible)\n* In the absence of rapidly proliferative disease, the interval from prior treatment to time of initiation will be at least 7 days for cytotoxic or non-cytotoxic (immunotherapy agent(s). Oral hydroxyurea and\u002For cytarabine (up to 2 g\u002Fm\\^2) for patients with rapidly proliferative disease is allowed before the start of study therapy, as needed, for clinical benefit and after discussion with the principle investigator (PI). Concurrent therapy for central nervous system (CNS) prophylaxis or continuation of therapy for controlled CNS disease is permitted\n* Male subjects who are sexually active with a women of childbearing potential (WOCBP) and who have not had vasectomies must be willing to use a barrier method of contraception and refrain from sperm donation from initial study drug until 90 days after last dose of study drug\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Patients with t(15;17) karyotypic abnormality or acute promyelocytic leukemia (French-American-British \\[FAB\\] class M3-AML)\n* Patients with any concurrent uncontrolled clinically significant medical condition including life-threatening severe infection, or psychiatric illness, which could place the patient at unacceptable risk of study treatment\n* Patients with active graft-versus-host-disease (GVHD) status post stem cell transplant (patients without active GVHD on chronic suppressive immunosuppression and\u002For phototherapy for chronic skin GVHD are permitted after discussion with the PI)\n* Patients with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications\n* Corrected QT (QTc) interval using Fridericia's formula (QTcF) \\>= 450 msec. Bundle branch block and prolonged QTc interval are permitted after discussion with the PI\n* Known active hepatitis B (HBV) or hepatitis C (HCV) infection or known human immunodeficiency virus (HIV) infection\n* Subject has a white blood cell count \\> 25 x 10\\^9\u002FL. (Note: Hydroxyurea is permitted to meet this criterion)\n* Nursing women, women of childbearing potential (WOCBP) with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception\n\n  * Appropriate highly effective method(s) of contraception include oral or injectable hormonal birth control, intrauterine device (IUD), and double barrier methods (for example a condom in combination with a spermicide)",{"count":553,"type":23},84,[26,103],"This phase Ib\u002FII trials studies the side effects of decitabine\u002Fcedazuridine (ASTX727) and venetoclax in combination with ivosidenib or enasidenib, and how well they work in treating patients with acute myeloid leukemia that has come back (relapsed) or does not respond to treatment (refractory). ASTX727 is the combination of a fixed dose of 2 drugs, cedazuridine and decitabine. Cedazuridine may slow down how fast decitabine is broken down by the body, and decitabine may block abnormal cells or cancer cells from growing. Venetoclax may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Enasidenib and ivosidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving decitabine\u002Fcedazuridine and venetoclax in combination with ivosidenib or enasidenib may help control acute myeloid leukemia.",[30,61,31],"2026-05-18",{"date":559,"type":38},"2026-05-20",{"date":561,"type":38},"2021-05-24",{"date":563,"type":23},"2027-11-29",{"name":114,"class":91},{"id":566,"slug":567,"hasResults":12,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":4,"eligibilityCriteria":571,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":572,"targetDuration":4,"studyType":24,"phases":574,"briefSummary":575,"conditions":576,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":577,"startDateStruct":578,"completionDateStruct":580,"leadSponsor":582,"locationsCount":92},"100334039","phase-2-liposome-encapsulated-daunorubicin-cytarabine-and-venetoclax-in-treating-participants-with-relapsed-refractory-or-untreated-acute-myeloid-leukemia-100334039","NCT03629171","Liposome-encapsulated Daunorubicin-Cytarabine and Venetoclax in Treating Participants With Relapsed, Refractory or Untreated Acute Myeloid Leukemia","Phase II Study of CPX-351 in Combination With Venetoclax in Patients With Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n* For the lead in phase: Patients \\>= 18 years of age with a diagnosis of relapsed and\u002For refractory AML will be eligible. Patients who have had prior treatment with venetoclax will be allowed to participate in the lead in phase and cohort A\n* For the dose expansion cohort A (relapsed\u002Frefractory \\[R\u002FR\\] AML): Patients \\>= 18 years of age with a diagnosis of relapsed and\u002For refractory AML will be eligible\n* For the dose expansion cohort B (de novo AML): Patients \\>= 18 years to 69 years of age; patients in this cohort must have received no prior therapy for AML\n* Prior therapy with hydroxyurea, hematopoietic growth factors, or tretinoin (ATRA) (for emergency use for stabilization) is allowed with no washout. A cumulative dose of ara-C of up to 3 g for emergency stabilization in patients with rapidly proliferating disease is also allowed provided it was administered \\> 48 hrs prior to enrollment\n* Bilirubin =\\\u003C 2 mg\u002FdL\n* Aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT) =\\\u003C 3 x upper limit of normal (ULN) or \\\u003C 5 x ULN if related to leukemic involvement\n* Creatinine =\\\u003C 1.5 x ULN\n* Known cardiac ejection fraction of \\> or = 45% within the past 3 months\n* Eastern Cooperative Oncology Group (ECOG) performance status of =\\\u003C 2\n* A negative urine or serum pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial. A woman of childbearing potential is defined as a woman who has not been naturally postmenopausal for at least 12 consecutive months, or who had no previous surgical sterilization\n* Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol\n\nExclusion Criteria:\n\n* Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided\n* Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] class III or IV), unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Patient with documented hypersensitivity to any of the components of the chemotherapy program\n* Patients with acute promyelocytic leukemia (M3) or core-binding factor AML\n* Patients with active central nervous system (CNS) leukemia are excluded since the antileukemia activity of the treatment components against CNS leukemia are not known\n* Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation\n* Prior treatment with CPX-351 or venetoclax. Patients with prior treatment with venetoclax will be allowed in patients with relapsed\u002Frefractory (R\u002FR) disease including those in the lead-in phase as well as those in cohort A",{"count":573,"type":23},52,[103],"This phase II trial studies how well liposome-encapsulated daunorubicin-cytarabine and venetoclax work in treating participants with acute myeloid leukemia that has come back (relapsed), does not respond to treatment (refractory), or has not been treated (untreated). Drugs used in chemotherapy, such as liposome-encapsulated daunorubicin-cytarabine and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.",[61,31],{"date":559,"type":38},{"date":579,"type":38},"2018-10-29",{"date":581,"type":23},"2026-12-31",{"name":114,"class":91},{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":4,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":590,"enrollmentInfo":591,"targetDuration":4,"studyType":24,"phases":593,"briefSummary":594,"conditions":595,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":605,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":610,"locationsCount":92},"100218005","phase-2-cladribine-idarubicin-cytarabine-and-venetoclax-in-treating-patients-with-acute-myeloid-leukemia-high-risk-myelodysplastic-syndrome-or-blastic-phase-chronic-myeloid-leukemia-100218005","NCT02115295","Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia","Phase II Study of Cladribine Plus Idarubicin Plus Cytarabine (ARAC) in Patients With AML, HR MDS, or Myeloid Blast Phase of CML","Inclusion Criteria:\n\n1. Patients with a diagnosis of AML, Acute Biphenotypic Leukemia, or high risk MDS (\\>\u002F= 10% blasts or IPSS \\>\u002F= intermediate-2) will be eligible. Patients with CML in Myeloid Blast Phase are also eligible.\n2. For Frontline cohort (1 or 4): No prior potentially-curative therapy for leukemia. Prior therapy with hydroxyurea, hematopoietic growth factors, azacytidine, decitabine, ATRA, or a total dose of cytarabine up to 2g (for emergency use for stabilization) is allowed. Patients deemed able to receive venetoclax (ie. insurance clearance) will be assigned to Frontline cohort 4. Patients with secondary AMLwho have been treated for their antecedent myeloid neoplasm will be enrolled into the separate Secondary AML cohort.\n3. For Salvage cohort: Patients with previously treated, relapsed or refractory AML, Acute Biphenotypic Leukemia, or CML in Myeloid Blast Phase are eligible.\n4. Age \\\u003C\u002F= 65 years.\n5. Adequate organ function as defined below:\n\n   * liver function (bilirubin \\\u003C 2mg\u002FdL, AST and\u002For ALT \\\u003C3 x ULN - or \\\u003C5 x ULN if related to leukemic involvement)\n   * kidney function (creatinine \\\u003C 1.5 x ULN ).\n   * known cardiac ejection fraction of \\> or = 45% within the past 6 months\n6. ECOG performance status of ≤ 2.\n7. A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.\n8. Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient is required prior to their enrollment on the protocol.\n\nExclusion Criteria:\n\n1. Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided.\n2. Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (NYHA Class III or IV), unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n3. Patient with documented hypersensitivity to any of the components of the chemotherapy program.\n4. Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.","65 Years",{"count":592,"type":23},508,[103],"This phase II trial studies how well cladribine, idarubicin, cytarabine, and venetoclax work in patients with acute myeloid leukemia, high-risk myelodysplastic syndrome, or blastic phase chronic myeloid leukemia. Drugs used in chemotherapy, such as cladribine, idarubicin, cytarabine, and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.",[596,30,597,598,599,600,106,522,61,601,31,602,603,604],"Acute Biphenotypic Leukemia","Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Blasts 10 Percent or More of Bone Marrow Nucleated Cells","Blasts 10 Percent or More of Peripheral Blood White Cells","de Novo Myelodysplastic Syndrome","Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive","Secondary Acute Myeloid Leukemia","Untreated Adult Acute Myeloid Leukemia",{"date":559,"type":38},{"date":607,"type":38},"2014-05-19",{"date":609,"type":23},"2030-05-31",{"name":114,"class":91}]