[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-myeloid-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-myeloid-leukemia":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,354,0,25,[9,47,70,97,127,150,169,191,211,230,248,267,287,307,341,358,380,401,420,443,467,491,522,542,571],{"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":19,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":24,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100481851","phase-2-comparing-cytarabine--daunorubicin-therapy-versus-cytarabine--daunorubicin--venetoclax-versus-venetoclax--azacitidine-in-younger-patients-with-intermediate-risk-aml-a-myelomatch-treatment-trial-100481851","NCT05554393","Comparing Cytarabine + Daunorubicin Therapy Versus Cytarabine + Daunorubicin + Venetoclax Versus Venetoclax + Azacitidine in Younger Patients With Intermediate Risk AML (A MyeloMATCH Treatment Trial)","A Measurable Residual Disease (MRD) Focused, Phase II Study of Venetoclax Plus Chemotherapy for Newly Diagnosed Younger Patients With Intermediate Risk Acute Myeloid Leukemia: A Tier 1 MYELOMATCH SubStudy","Inclusion Criteria:\n\n* Participants must have been registered to master screening and re-assessment protocol (MYELOMATCH) prior to consenting to this study. Participants must have been assigned to this clinical trial, via MATCHBox Protocol Assignment Team, prior to registration to this study. Participants must have agreed to have specimens submitted for translational medicine and must be offered the opportunity to submit biosamples for banking for future research as per MYELOMATCH\n\n  * Note: Pre-enrollment\u002Fdiagnosis labs must have already been performed under MYELOMATCH\n* Previously untreated, de novo acute myeloid leukemia (AML) defined by \\>= 20% myeloblasts in the peripheral blood or bone marrow (as defined by the current World Health Organization \\[WHO\\] classification of myeloid neoplasms and acute leukemia) excluding all the following categories of AML:\n\n  * Favorable cytogenetics: (t(8;21)q22;q22.1); RUNX1-RUNX1T1, inversion 16(p13.1;q22), t(16;16)(p13.1;q22); CBFB-MYH11\n  * CEBPA biallelic mutations\n  * NPM1 mutation\n  * AML with PML-RARalpha\n  * AML with any adverse cytogenetics, TP53 mutation, RUNX1 mutation, ASXL1, 11q23\u002FKMT2 rearrangements\n  * AML with FLT3-ITD mutation\n  * Therapy related AML, or AML following a diagnosis of myelodysplasia or myeloproliferative neoplasm Participants with central nervous system (CNS) disease are eligible for this trial and will be treated according to institutional guidelines with intrathecal chemotherapy for this aspect of their disease\n* Age 18-59 years at time of induction therapy\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 3\n* Total bilirubin =\\\u003C 2 x institutional upper limit of normal (ULN) (must be done within 10 days of enrollment)\n* Aspartate aminotransferase (AST) (serum glutamate pyruvate transaminase \\[SGPT\\]) and\u002For alanine aminotransferase (ALT) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) =\\\u003C 3 × institutional ULN (must be done within 10 days of enrollment)\n* Cardiac ejection fraction \\>= 50% (echocardiography or MUGA) (if clinically indicated must be done within 14 days of enrollment)\n* Calculated creatinine clearance \\>= 30 mL\u002Fmin; Clearance to be calculated using Cockcroft formula (must be done within 10 days of enrollment)\n* White blood cells (WBC) must be =\\\u003C 25 x 10\\^9\u002FL. Hydroxyurea and leukapheresis are permitted to control the WBC prior to enrollment and initiation of protocol-defined therapy but must be stopped prior to the initiation of protocol therapy. Hydroxyurea +\u002F- no more than a total of 2500 mg cytarabine over a total of multiple days for urgent cytoreduction is also permitted\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* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* Males and females of reproductive potential must have agreed to use a highly effective contraceptive method while on treatment and for 6 months after stopping study drug. A woman is considered to be of \"childbearing potential\" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation, or vasectomy\u002Fvasectomized partner. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he\u002Fshe is responsible for beginning contraceptive measures.\n\nWomen of childbearing potential will have a pregnancy test to determine eligibility as part of the pre-study evaluation; this may include an ultrasound to rule-out pregnancy if a false-positive is suspected. Patient will be considered eligible if an ultrasound is negative for pregnancy\n\n* Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate\n* Patients must be accessible for treatment, response assessment and follow up. Patients enrolled on this trial must be treated and followed at the participating centre. Investigators must assure themselves the patients enrolled on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.\n\nPatients must agree to return to their primary care facility for any adverse events which may occur through the course of the trial\n\n* In accordance with Canadian Cancer Trials Group (CCTG) policy, protocol treatment is to begin within 7 working days of patient enrollment\n* Patients with known human immunodeficiency virus (HIV) infection who are on effective anti-retroviral therapy and have undetectable viral load within 6 months of enrollment are eligible for this trial\n* Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load within 28 days of enrollment. Patients need to be on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection who have been treated and cured are eligible. Patients who with active HCV infection who are currently being treated must have an undetectable HCV viral load within 28 days of enrollment to be eligible\n\nExclusion Criteria:\n\n* Prior therapy for AML except for hydroxyurea and leukapheresis to control blood counts. The use of all-trans retinoic acid (ATRA) is permitted until a diagnosis of acute promyelocytic leukemia, if suspected, is ruled out\n* Patients who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to cytarabine, daunorubicin, azacitidine, venetoclax\n* Pregnant women are excluded from this study because venetoclax, cytarabine and azacitidine have 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 venetoclax, cytarabine and azacitidine breastfeeding should be discontinued if the mother is treated with venetoclax, cytarabine and azacitidine. These potential risks may also apply to other agents used in this study\n* Patients with isolated myeloid sarcoma are not eligible\n* Any other serious intercurrent illness, life threatening condition, organ system dysfunction, or medical condition judged by the local investigator to compromise the subject's safety (for example):\n\n  * Active, uncontrolled bacterial, fungal, or viral infection","59 Years",{"count":56,"type":23},153,[58],"PHASE2","This phase II MyeloMATCH treatment trial compares cytarabine with daunorubicin versus cytarabine with daunorubicin and venetoclax versus venetoclax with azacitidine for the treatment of younger patients with intermediate risk acute myeloid leukemia (AML). Cytarabine is a drug that inhibits some of the enzymes needed for deoxyribonucleic acid (DNA) replication and repair and can slow or stop the growth of cancer cells. Daunorubicin is a drug that blocks a certain enzyme needed for cell division and DNA repair, and it may kill cancer cells. 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. Azacitidine is a drug that interacts with DNA to activate tumor-suppressing genes, resulting in an anti-tumor effect. Adding venetoclax to cytarabine and daunorubicin, and adding venetoclax to azacitidine, may work better than the usual treatment of cytarabine with daunorubicin alone. To decide if they are better, the study doctors are looking to see if venetoclax increases the rate of elimination of AML in participants by 20% or more compared to the usual approach.",[30],{"date":37,"type":38},{"date":63,"type":38},"2024-09-13",{"date":65,"type":23},"2027-12-31",{"name":67,"class":68},"National Cancer Institute (NCI)","NIH",180,{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":24,"phases":80,"briefSummary":82,"conditions":83,"keywords":84,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":96},"100637155","phase-2-a-study-to-assess-adverse-events-and-change-in-disease-activity-when-intravenous-iv-pivekimab-sunirine-is-given-in-combination-with-oral-venetoclax-and-iv-or-subcutaneous-azacitidine-in-adult-participants-with-acute-myeloid-leukemia-aml-100637155","NCT07581002","A Study to Assess Adverse Events and Change in Disease Activity When Intravenous (IV) Pivekimab Sunirine is Given in Combination With Oral Venetoclax and IV or Subcutaneous Azacitidine in Adult Participants With Acute Myeloid Leukemia (AML)","A Randomized Phase 2\u002F3 Study Evaluating the Safety and Efficacy of Pivekimab Sunirine (PVEK) in Combination With Venetoclax and Azacitidine in Adult Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) Ineligible to Receive Intensive Chemotherapy","REVIVAL","Inclusion Criteria:\n\n1. Participants must have newly diagnosed, untreated confirmed acute myeloid leukemia (AML) diagnosis as per the 5th edition of World Health Organization (WHO) criteria with a projected life expectancy of at least 12 weeks.\n2. CD123-positive\n3. Ineligible for intensive induction therapy (chemotherapy) defined by:\n\n   * ≥ 75 years of age OR\n   * ≥ 18 to 74 years of age with at least one of the following co-morbidities:\n\n     * Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3\n     * Cardiac history of congestive heart failure requiring treatment or ejection fraction ≤ 50% or chronic stable angina\n     * Diffusion capacity of the lung for carbon monoxide (DLCO) ≤ 65% or forced expiratory volume in 1 second (FEV1) ≤ 65%\n     * Creatinine clearance ≥ 30 mL\u002Fmin to \\\u003C 45 mL\u002Fmin\n     * Moderate hepatic impairment with total bilirubin \\> 1.5 to ≤ 3.0 × upper limit of normal (ULN)\n     * Any other comorbidity that the physician judges to be incompatible with intensive chemotherapy must be reviewed and approved by the medical monitor before study enrollment.\n4. ECOG performance status 0 to 2 for subjects ≥ 75 years of age or 0 to 3 for subjects ≥ 18 to 74 years of age.\n5. White blood cell (WBC) count \\\u003C 25 × 10\\^9\u002FL (hydroxyurea is permitted prior to beginning study treatment to reduce the WBC count to \\\u003C 25 × 10\\^9\u002FL).\n6. Subjects must have adequate organ function:\n\n   * Adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL\u002Fmin; calculated by the Cockcroft Gault formula or measured by 24-hour urine collection.\n   * Adequate liver function as demonstrated by:\n\n     * Aspartate aminotransferase (AST) ≤ 3.0 × ULN\\*,\n     * Alanine aminotransferase (ALT) ≤ 3.0 × ULN\\*,\n\n       ---\\*Unless considered due to leukemic organ involvement\n     * Subjects \\\u003C 75 years of age may have total bilirubin ≤ 3 x ULN\n     * Subjects ≥ 75 years of age total bilirubin ≤ 1.5 × ULN unless elevated level is considered to be due to Gilbert's syndrome or hemolysis, total bilirubin must be \\\u003C 3 x ULN and direct bilirubin \\\u003C 1 x ULN\n     * Activated partial thromboplastin time (aPTT) and prothrombin time (PT) not to exceed 1.5 × ULN International Normalized Ratio (INR) \\\u003C1.5\n\nExclusion Criteria:\n\n* Acute promyelocytic leukemia (APL), blast phase of CML or AML with t(9;22) or BCR:ABL1 fusion, transformation from myeloproliferative neoplasm (MPN), Chronic Myelomonocytic Leukemia (CMML), myelodysplastic\u002Fmyeloproliferative neoplasm unspecified, or myeloid sarcoma.\n* Known active central nervous system (CNS) involvement with AML. Participants may have non-CNS extramedullary disease (excludes participants with myeloid sarcoma as the only disease manifestation at screening).\n* Participants with history of any malignancies within 2 years prior to screening with exception of: adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of the breast, in situ - carcinomas of bladder and esophagus; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, and previous malignancy confined and surgically resected (or treated with other modalities) with curative intent and have no evidence of relapse within 2 years.\n* Participants must not have received a hypomethylating agent, any BCL-2 inhibitors including venetoclax, and\u002For chemotherapeutic agent for Myelodysplastic syndromes (MDS) or AML, CAR-T cell therapy, be currently participating in another clinical study, received any investigational treatment within 30 days prior to the first use of study combination product.\n* Female participant must not be pregnant or breastfeeding and is not considering becoming pregnant or donating eggs during the study and for approximately 7 months after the last dose of any study drug. Female participant of childbearing potential must agree to use at least 1 protocol specified method of birth control and male participant, if sexually active with female partner(s) of childbearing potential, must agree to practice the protocol-specified contraception.",{"count":79,"type":23},660,[58,81],"PHASE3","Cancer is a condition where cells in a specific part of the body grow and reproduce uncontrollably. Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow (the spongy tissue inside the bones) that affects white blood cells that helps to fight infections and also prevents normal blood cell production. This study will assess the adverse events and changes in the disease activity when Pivekimab Sunirine (PVEK) is given in combination with Venetoclax (VEN) and Azacitidene (AZA) in adult participants with AML ineligible to receive intensive chemotherapy.\n\nPivekimab sunirine is a drug being evaluated in the treatment of AML.This is a Phase 2\u002FPhase 3, study of PVEK. Phase 2 is open-label and randomized. Phase 3 is double-blind, randomized. Phase 2 and Phase 3 studies test potential new treatments in patients with a condition or disease. Open-label means that both patients and study doctors know which study treatment is given to patients in Phase 2 of the study. Double-blind means that neither the patients nor the study doctors know who is given which study treatment in Phase 3 of the study. Approximately 660 adult participants will be enrolled in 180 sites worldwide.\n\nIn Phase 2 of the study, patients will be randomized to receive PVEK + VEN + AZA or standard of care treatment with VEN + AZA. In Phase 3, patients will be randomized to receive PVEK + VEN + AZA or a matching-placebo for PVEK plus VEN + AZA. PVEK is given as an infusion into the vein, AZA is given as an injection under your skin (subcutaneous) or as an infusion into the vein (intravenous) (depending on country where patient enrolls), and VEN is a tablet given by mouth. The total study duration is approximately 71 months.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.",[30],[30,85,86,87],"Pivekimab Sunirine (PVEK)","Azacitidine","Venetoclax","2026-08-19",{"date":37,"type":38},{"date":91,"type":38},"2026-06-30",{"date":93,"type":23},"2032-06",{"name":95,"class":45},"AbbVie",15,{"id":98,"slug":99,"hasResults":12,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":24,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":126},"100516228","phase-1-safety-and-tolerability-of-ziftomenib-combinations-in-patients-with-relapsedrefractory-acute-myeloid-leukemia-100516228","NCT06001788","Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","Phase 1 Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-rearranged or NPM1-mutant Relapsed\u002FRefractory Acute Myeloid Leukemia","Key Inclusion Criteria:\n\n* Has been diagnosed with relapsed\u002Frefractory AML.\n* Has a documented NPM1 mutation or KMT2A rearrangement.\n* Has a documented FLT3 mutation (cA-3 only).\n* Has an Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2.\n* Has adequate hepatic and renal function as defined per protocol.\n* Has an ejection fraction above a protocol defined limit.\n* Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure.\n* Has agreed to use contraception as defined per protocol.\n\nKey Exclusion Criteria:\n\n* Has a diagnosis of acute promyelocytic leukemia or blast chronic myeloid leukemia.\n* Has clinically active central nervous system leukemia.\n* Has an active and uncontrolled infection.\n* Has a mean corrected QT interval (QTcF) \\> 480ms.\n* Has uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.\n* Has received radiation, chemotherapy, immunotherapy, or any other anticancer therapy including investigational therapy \\\u003C14 days or within 5 drug half-lives prior to the first dose of study intervention.\n* Has had major surgery within 4 weeks prior to the first dose of study intervention.\n* Has received a hematopoietic stem cell transplant (HSCT) and has not previously had adequate recovery per protocol defined criteria.\n* Has active graft-versus-host disease (GvHD) and or on immunosuppressive drugs for the treatment of GvHD\n* Participant is pregnant or lactating.",{"count":105,"type":23},171,[26],"The safety, tolerability, and antileukemic response of ziftomenib in combination with standard of care treatments for patients with relapsed\u002Frefractory acute myeloid leukemia will be examined with the following agents: FLAG-IDA, low-dose cytarabine, and gilteritinib.",[29,109,110,111,112,113,114,30,115,116,117,118],"AML With Mutated NPM1","Hematologic Malignancy","KMT2Ar","NPM1 Mutation","MLL Rearrangement","Leukemia","Leukemia, Myeloid","Leukemia, Myeloid, Acute","Acute Leukemia","Neoplasms by Histologic Type",{"date":35,"type":38},{"date":121,"type":38},"2024-02-22",{"date":123,"type":23},"2027-08",{"name":125,"class":45},"Kura Oncology, Inc.",45,{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":24,"phases":136,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":143,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},"100482619","phase-2-myelomatch-a-screening-study-to-assign-people-with-myeloid-cancer-to-a-treatment-study-or-standard-of-care-treatment-within-myelomatch-myelomatch-screening-trial-100482619","NCT05564390","MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)","Master Screening and Reassessment Protocol (MSRP) for the NCI MyeloMATCH Clinical Trials","Inclusion Criteria:\n\n* Participants must be suspected to have previously untreated acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Participants with AML cannot have a history of previously treated myeloproliferative neoplasms (MPN) or MDS.\n* Participants must be \\>= 18 years of age.\n* Participants must not have received prior anti-cancer therapy for AML or MDS.\n\n  * Note: Hydroxyurea to control the white blood cell count (WBC) is allowed.\n  * Note: Prior erythroid stimulating agent (ESA) is not considered prior therapy for the purposes of eligibility. Participants must not be currently receiving any cytarabine-containing therapy other than up to 1 g\u002Fm\\^2 of cytarabine, which is allowed for urgent cytoreduction.\n* Participants are allowed prior use of hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, erythropoiesis-stimulating agent, thrombopoietin receptor agonist and lenalidomide, with a maximum limit of 1 month of exposure.\n\n  * Note: Participants receiving hydroxyurea prior to treatment substudy or TAP assignment must agree to discontinue hydroxyurea within 24 hours before beginning substudy or TAP treatment.\n* Participants must not have a prior or concurrent malignancy that requires concurrent anti-cancer therapy\n\n  * Note: active hormonal therapy is allowed\n* Participants must have a Zubrod Performance Status evaluation within 28 days prior to registration.\n* Participants must agree to have translational medicine specimens submitted.\n* Participants must be offered the opportunity to participate in specimen banking.\n\n  * Note: Specimens must be collected and submitted following the initial paper-based process and subsequently via the Precision Medicine Specimen Tracking Forms in Medidata Rave instance for the MyeloMATCH MSRP.\n* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines.\n\n  * Note: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.\n* The master screening and reassessment protocol (MSRP) should only be used in sites where the relevant AML treatment substudies are open or if the site is willing to follow the MSRP Tier Advancement Pathway (TAP) for patients in the event that the site does not have the relevant study open and transfer to another site that does have the study open. For example, if a site does not have a myeloMATCH Tier 1 study for older AML open for enrollment, such older AML patients should only be consented for the MSRP if the site is willing to treat the patient with standard of care on TAP or is willing to transfer the patient to a center with a study open that the patient would otherwise match to.",{"count":135,"type":23},2000,[58],"This MyeloMATCH Master Screening and Reassessment Protocol (MSRP) evaluates the use of a screening tool and specific laboratory tests to help improve participants' ability to register to clinical trials throughout the course of their myeloid cancer (acute myeloid leukemia or myelodysplastic syndrome) treatment. This study involves testing patients' bone marrow and blood for certain biomarkers. A biomarker (sometimes called a marker) is any molecule in the body that can be measured. Doctors look at markers to learn what is happening in the body. Knowing about certain markers can give doctors more information about what is driving the cancer and how to treat it. Testing patients' bone marrow and blood will show doctors if patients have markers that specific drugs can target. The marker testing in this study will let doctors know if they can match patients with a treatment study (myeloMATCH clinical trial) that tests treatment for the type of cancer they have or continue standard of care treatment with their doctor on the Tier Advancement Pathway (TAP).",[30,139,140,141,142],"Acute Myeloid Leukemia Arising From Previous Myelodysplastic\u002FMyeloproliferative Neoplasm","Acute Myeloid Leukemia Post Cytotoxic Therapy","Acute Myeloid Leukemia, Myelodysplasia-Related","Myelodysplastic Syndrome",{"date":35,"type":38},{"date":145,"type":38},"2024-06-18",{"date":147,"type":23},"2029-05-15",{"name":67,"class":68},348,{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":54,"enrollmentInfo":157,"targetDuration":4,"studyType":24,"phases":159,"briefSummary":160,"conditions":161,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":162,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},"100481852","testing-new-therapies-for-patients-with-acute-myeloid-leukemia-who-are-newly-diagnosed-and-have-not-yet-started-treatment-a-myelomatch-treatment-trial-100481852","NCT05554406","Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)","A Randomized Phase II Study Comparing Cytarabine + Daunorubicin (7 + 3) vs (Daunorubicin and Cytarabine) Liposome, Cytarabine + Daunorubicin + Venetoclax, Azacitidine + Venetoclax, and (Daunorubicin and Cytarabine) Liposome + Venetoclax in Patients Aged 59 or Younger Who Are Considered High-Risk (Adverse) Acute Myeloid Leukemia As Determined by MYELOMATCH; A MYELOMATCH SubStudy","Inclusion Criteria:\n\n* STEP 1 REGISTRATION:\n* Participants must have been registered to Master Screening and Re-Assessment Protocol, MYELOMATCH, prior to consenting to this study. Participants must have been assigned to this clinical trial, via MATCHBox, prior to registration to this study.\n\n  * Note: Pre-enrollment\u002Fdiagnosis labs must have already been performed under MYELOMATCH\n* Participants must have newly diagnosed, untreated acute myeloid leukemia (AML) per World Health Organization (WHO) criteria\n* Participants must have high-risk (adverse) AML per European LeukemiaNet (ELN) 2017 criteria\n* Participants with therapy-related AML (t-AML), or with AML evolving from an antecedent hematologic disorder (such as myeloproliferative neoplasm), or AML with myelodysplasia-related changes (AML-MRC) are eligible-unless they were previously treated\n* Acute promyelocytic leukemia is excluded\n* Participants with favorable or intermediate risk disease per ELN 2017 criteria are excluded\n* Participants with FLT3 mutations (ITD or TKD) are excluded\n* Participants with t(9;22) translocation are excluded\n* A single dose of intrathecal chemotherapy for AML is allowed prior to study entry\n* Prior anthracycline therapy for any indication is allowed but must not exceed a cumulative lifetime dose of 200 mg\u002Fm\\^2 daunorubicin or equivalent\n* Participants must not have received or be currently receiving any prior therapy for acute myeloid leukemia. Hydroxyurea to control the white blood cells (WBC) is allowed prior to registration and initiation of protocol-defined therapy. All trans retinoic acid (ATRA) given until a diagnosis of acute promyelocytic leukemia is ruled out is also allowed. For urgent cytoreduction, cytarabine may be given either as a single dose or in multiple doses not to exceed 2500 mg\n* Participants must not be receiving or planning to receive any other investigational agents before completing protocol therapy\n* Participants must be between 18 and 59 years of age\n* Participants must have Zubrod performance status =\\\u003C 3 as determined by a complete medical history and physical exam (H\\&P) completed within 7 days prior to registration\n* Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications\n* Participants with a known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at time of registration and have undetectable HIV viral load on the most recent test results obtained within 6 months prior to registration\n* Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load within 28 days prior to registration and be on suppressive therapy, if indicated\n* Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with active HCV infection who are currently on treatment must have an undetectable HCV viral load within 28 days prior to registration\n* The following tests must be performed within 14 days prior to registration to establish baseline values:\n\n  * Complete blood count (CBC)\u002Fdifferential\u002Fplatelets\n  * Total bilirubin\n  * Lactate dehydrogenase (LDH)\n  * Albumin\n  * Glucose\n  * Fibrinogen\n* Participants must have adequate kidney function as evidenced by creatinine clearance \\>= 30mL\u002Fmin (by Cockcroft Gault) within 7 days prior to registration\n* Participants must have adequate liver function as evidenced by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x upper limit of normal (ULN) within 7 days prior to registration- unless elevations are considered due to leukemia in the opinion of the treating investigator\n* Total bilirubin =\\\u003C 2.0 x ULN (or 5.0 x ULN if the participant has a history of Gilbert's disease) within 28 days prior to registration\n* Participants must have adequate cardiac function as determined by echocardiography or MUGA scan with an ejection fraction \\>= 50% within 28 days prior to registration\n* Participants with a prior or concurrent malignancy whose natural history (in the opinion of the treating physician) does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. No concurrent therapies for such malignancy are allowed with the exception of hormonal therapy\n* Participants with central nervous system (CNS) disease are eligible for this trial and will be treated according to institutional guidelines with intrathecal chemotherapy for this aspect of their disease.\n* Participants with known history of Wilson's disease or other known copper-metabolism disorder are excluded\n* Participants must not be pregnant or nursing. Women\u002Fmen of reproductive potential must have agreed to use 2 contraception methods. A woman is considered to be of \"reproductive potential\" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods (e.g., hormonal contraceptives \\[examples include birth control pills, vaginal rings, or patches\\] associated with inhibition of ovulation for at least 1 month prior to taking study drug), \"effective contraception\" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate participant chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he\u002Fshe is responsible for beginning contraceptive measures. A barrier method should be used during this study along with hormonal contraceptives from initial study drug administration to 30 days after the last dose of study drug as drug-drug interaction with venetoclax is unknown\n* Participants must have agreed to have specimens submitted for translational medicine (MRD) under MYELOMATCH and specimens must be submitted\n* Participants must be offered the opportunity to participate in specimen banking\n\n  * Note: Specimens must be collected and submitted using the Southwest Oncology Group (SWOG) Specimen Tracking System\n* Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines\n\n  * For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations\n* As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system",{"count":158,"type":23},335,[58],"This phase II MyeloMATCH treatment trial tests whether the standard approach of cytarabine and daunorubicin in comparison to the following experimental regimens works to shrink cancer in patients with high risk acute myeloid leukemia (AML): 1) daunorubicin and cytarabine liposome alone; 2) cytarabine and daunorubicin with venetoclax; 3) azacitidine and venetoclax; 4) daunorubicin and cytarabine liposome and venetoclax. \"High-risk\" refers to traits that have been known to make the AML harder to treat. Cytarabine is in a class of medications called antimetabolites. It works by slowing or stopping the growth of cancer cells in the body. Daunorubicin is in a class of medications called anthracyclines. It also works by slowing or stopping the growth of cancer cells in the body. Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells. 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. There is evidence that these newer experimental treatment regimens may work better in getting rid of more AML compared to the standard approach of cytarabine and daunorubicin.",[30,139,140,141],{"date":35,"type":38},{"date":164,"type":38},"2024-09-25",{"date":166,"type":23},"2027-03-31",{"name":67,"class":68},225,{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":24,"phases":178,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":182,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":190},"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":177,"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.",[30,181,31],"Recurrent Acute Myeloid Leukemia",{"date":37,"type":38},{"date":184,"type":38},"2022-10-31",{"date":186,"type":23},"2029-01-25",{"name":188,"class":189},"City of Hope Medical Center","OTHER",1,{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":24,"phases":200,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":204,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":190},"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":199,"type":23},73,[26,58],"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.",[30,142,181,203,31],"Recurrent Myelodysplastic Syndrome",{"date":35,"type":38},{"date":206,"type":38},"2018-10-31",{"date":208,"type":23},"2028-01-01",{"name":210,"class":189},"M.D. Anderson Cancer Center",{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":24,"phases":219,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":229},"100563474","phase-1-a-phase-ib-study-of-rezatapopt-in-combination-with-azacitidine-in-patients-with-tp53y220c-mutant-myeloid-malignancies-acute-myeloid-leukemia-or-myelodysplastic-syndrome-100563474","NCT06616636","A Phase Ib Study of Rezatapopt in Combination With Azacitidine in Patients With TP53Y220C Mutant Myeloid Malignancies (Acute Myeloid Leukemia or Myelodysplastic Syndrome)","Inclusion Criteria:\n\n1. Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).\n2. Patient is willing and able to adhere to the study visit schedule and other protocol requirements.\n3. Patient has relapsed or primary refractory AML or MDS\n4. Any other comorbidity that per the investigator renders a patient inappropriate for intensive chemotherapy.\n5. Patients with MDS must be classified as MDS-IB1 or IB2 as per WHO 2022 criteria32\n6. TP53Y220C mutation confirmed by CLIA-approved local testing with a variant allele frequency \\>2%.\n7. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2\n8. Patient has adequate organ function defined as:\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 ≤ 1.5 x ULN. Higher levels are acceptable if these can be attributed to ineffective erythropoiesis, leukemia organ involvement or Gilbert\\'s syndrome.\n   * Serum creatinine \\< 2 x ULN or creatinine clearance \\> 40 mL\u002Fmin based on validated glomerular filtration rate (GFR) estimation (Cockcroft-Gault, CKD-epi, or MDRD equations).\n9. Females of childbearing potential may participate provided they have a negative serum or urine pregnancy test at screening and a negative serum OR urine pregnancy test within 72 hours of starting on treatment. They also must agree to either abstain from sexual intercourse or use two forms of a highly effective method of contraception while on study and up to 3 months after the last dose of the study drug.\n10. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) 14 days prior to study entry and for the duration of study participation. This includes all female patients between the onset of menses and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:\n\n    Postmenopausal (no menses in greater than or equal to 12 consecutive months). History of hysterectomy or bilateral salpingo-oophorectomy. Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n\n    History of bilateral tubal ligation or another surgical sterilization procedure.\n\n    • Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. 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    Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of investigational agent administration.\n11. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Patient has received prior chemotherapy, targeted therapy, immunotherapy, or treatment with an investigational anticancer agent within 14 days or 5 half-lives (if half-life is known), whichever is shorter, before receiving their first dose of study drug.\n2. Patient has received radiotherapy within 14 days.\n3. Patients with acute promyelocytic leukemia\n4. Subject has immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and\u002For disseminated intravascular coagulation.\n5. Patients with active, uncontrolled leukemia involvement of the CNS\n6. Subject has known active viral infection with human immunodeficiency virus (HIV), or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)\n7. Subject is known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.\n8. Subject 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).\n9. Patient has any unresolved toxicities from prior anti-cancer therapy greater than Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2 prior chemotherapy induced neuropathy.\n10. Patient has had major surgery within 2 weeks prior to the planned start of study treatment.\n11. Female subject who is pregnant or lactating.\n12. History of allergic reactions attributed to compounds of similar chemical or biologic composition to azacitidine, rezetapopt or other agents used in study.",{"count":218,"type":23},24,[26],"A non-randomized phase Ib study of PC14586 (PMV therapeutics) in patients diagnosed with TP53Y220C-mutant myeloid malignancies, including AML and MDS.",[142,30],"2026-08-18",{"date":35,"type":38},{"date":225,"type":38},"2025-01-30",{"date":227,"type":23},"2029-08-27",{"name":210,"class":189},2,{"id":231,"slug":232,"hasResults":12,"nctId":233,"briefTitle":234,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":24,"phases":239,"briefSummary":240,"conditions":241,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":242,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":246,"locationsCount":247},"100540500","venetoclax-and-hma-treatment-of-older-and-unfit-adults-with-flt3-mutated-acute-myeloid-leukemia-aml-a-myelomatch-treatment-trial-100540500","NCT06317649","Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)","A Randomized Phase II Study of Venetoclax and HMA-Based Therapies for the Treatment of Older and Unfit Adults With Newly Diagnosed FLT3-Mutated Acute Myeloid Leukemia (AML): A MyeloMATCH Substudy","Inclusion Criteria:\n\n* Patient must be ≥ 60 years of age or adults ˂ 60 who in the opinion of the treating physician are better served by azanucleoside-based therapy rather than intensive, cytarabine-based induction based on clinical status (i.e., performance status), organ dysfunction, or disease biology\n* Patient must have a morphologically confirmed diagnosis of AML as determined by the site and confirmed by the treatment verification team, excluding acute promyelocytic leukemia (APL) with PML-RARA, AML with RUNX1-RUNX1T1, or AML with CBFB-MYH11\n* Patient must have no prior therapy for AML with the exception of hydroxyurea, all-trans retinoic acid (ATRA), cytarabine-based emergency therapy or leukapheresis to ensure white blood cells (WBC) \\\u003C 25,000\u002Fmm\\^3 prior to starting venetoclax treatment\n* Patient must have no prior therapy with hypomethylating agents or FLT3 inhibitors\n* Patient must have the FLT3-ITD, D835, or I836del mutation based on MYELOMATCH Protocol\n* Patient must be assigned to this protocol by the MYELOMATCH Protocol\n* Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* Patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study. Contraception measures must continue for 30 days after the last dose of venetoclax for all patients who are able to conceive or father children and for 6 months after the last dose of gilteritinib for patients of childbearing potential and for 4 months after the last dose of gilteritinib for male patients with partners of childbearing potential. Patient must not breastfeed during treatment and for 2 months after treatment ends\n* Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible\n* Total bilirubin ≤ 2 X institutional upper limit of normal (ULN), unless thought to be elevated due to disease involvement or Gilbert's syndrome, in which case bilirubin ≤ 3 x ULN is allowed (must be obtained ≤ 14 days prior to randomization)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 3.0 x institutional ULN (must be obtained ≤ 14 days prior to randomization)\n* Creatinine clearance ≥ 30 mL\u002Fmin (must be obtained ≤ 14 days prior to randomization)\n\n  * Either measured or estimated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation (2021)\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial\n* Patients who meet the criteria below must have had an electrocardiogram (ECG) performed with a corrected QT interval using Fridericia's correction (QTcF) interval within normal limits:\n\n  * Patient \\\u003C 75 years old with a history of cardiac arrythmia, atrial fibrillation, or irregular QTcF interval OR\n  * Patient \\\u003C 75 years old with known genetic predisposition to long QT syndrome OR\n  * Any patient ≥ 75 years old OR\n  * Any patient at risk for electrolyte abnormalities, including tumor lysis syndrome\n\n    * Normal limits are QTcF ≤ 450 ms for males and QTcF ≤ 460 ms for females. Corrected QT interval method (QTcF) may follow institutional standards\n    * NOTE: Since older patients and patients with cardiac disease are at risk for prolonged QTcF and many will require supportive care with agents that affect the QTcF, an ECG is recommended if clinically indicated as noted above. If the QTcF is prolonged (\\> 450 ms for males and \\> 460 ms for females), they should be treated on the Tier Advancement Pathway (TAP) instead of MM1OA-EA02. In patients where ECG is not clinically indicated, QTcF does not need to be documented\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* Patient must not have the medical necessity for ongoing treatment with a strong CYP3A4 inducing drug\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* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2 or better\n* Patient must not have an uncontrolled infection",{"count":238,"type":23},147,[58],"This phase II MyeloMATCH treatment trial compares the usual treatment of azacitidine and venetoclax to the combination treatment of azacitidine, venetoclax and gilteritinib in treating older and unfit patients with acute myeloid leukemia and FLT3 mutations. Azacitidine is a drug that is absorbed into DNA and leads to the activation of cancer suppressor genes, which are genes that help control cell growth. 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. Gilteritinib is in a class of medications called kinase inhibitors. It works by blocking the action of a certain naturally occurring substance that may be needed to help cancer cells multiply. This study may help doctors find out if these different approaches are better than the usual approaches. To decide if they are better, the study doctors are looking to see if the study drugs lead to a higher percentage of patients achieving a deeper remission compared to the usual approach.",[30],{"date":88,"type":38},{"date":244,"type":38},"2024-09-27",{"date":147,"type":23},{"name":67,"class":68},227,{"id":249,"slug":250,"hasResults":12,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":255,"targetDuration":4,"studyType":257,"phases":4,"briefSummary":258,"conditions":259,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":260,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":190},"100538954","acute-myeloid-leukemia-and-markers-of-leukemia-stem-cells-cll1-and-cd45ra-100538954","NCT06297551","Acute Myeloid Leukemia and Markers of Leukemia Stem Cells (CLL1 and CD45RA)","Prospective Study of Leukemia Stem Cells Fractional Change in Peripheral Blood and Its Correlation With Therapeutic Outcome in Acute Myeloid Leukemia","Inclusion Criteria:\n\n* diagnosis of acute myeloid leukemia\n* ability to receive treatment for acute myeloid leukemia at the research center\n* elevated values of CLL1A and CD45RA positive cells at the time of diagnosis",{"count":256,"type":23},20,"OBSERVATIONAL","Acute myeloid leukemia (AML) is a malignant disorder of the bone marrow and the most common form of acute leukemia in adults. Patient with AML have the shortest survival compared to other forms of leukemia. In the past 6 years, several new therapies have been approved.\n\nBiomarkers are in urgent need to guide therapeutic regimen selection in order to maximize the benefit of available therapies and minimize treatment toxicity. Current standard practice is to perform bone marrow biopsy at end of treatment cycle (each cycle around 28 days), and based on bone marrow finding, to decide further treatment plan. It is invasive and time consuming.\n\nIn this study investigators will study whether tracking leukemia stem cells (LSC) in peripheral blood during early treatment cycle may provide a non-invasive method to predict therapeutic outcome at end of treatment cycle. A retrospective study found that LSC fractional change, defined by two LSC markers, named CLL1 and CD45RA, is highly correlated with therapeutic outcome. Further more, CLL1 and CD45RA positive LSC fraction demonstrates a high concordance between bone marrow and peripheral blood, offering the opportunity to track CLL1 and CD45RA positive LSC fraction non-invasively in peripheral blood during treatment.\n\nThis pilot study will allow the investigators to decide whether testing CLL1 and CD45RA positive LSC in peripheral blood during leukemia treatment is feasible in clinical practice. This result will lay the foundation for designing future trials using CLL1 and CD45RA positive LSC fractional change to optimize therapeutic strategy for patients with AML.",[30],{"date":35,"type":38},{"date":262,"type":38},"2024-05-17",{"date":264,"type":23},"2027-06-30",{"name":266,"class":189},"Suhu Liu",{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":274,"sex":18,"minAge":275,"maxAge":4,"enrollmentInfo":276,"targetDuration":4,"studyType":24,"phases":278,"briefSummary":279,"conditions":280,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":281,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":190},"100466931","phase-1-a-phase-i-ii-study-investigating-the-all-oral-combination-of-the-menin-inhibitor-sndx-5613-with-decitabinecedazuridine-astx727-and-venetoclax-in-acute-myeloid-leukemia-save-100466931","NCT05360160","A Phase I-II Study Investigating the All-Oral Combination of the Menin Inhibitor SNDX-5613 With Decitabine\u002FCedazuridine (ASTX727) and Venetoclax in Acute Myeloid Leukemia (SAVE)","A Phase I-II Study Investigating the All Oral Combination of the Menin Inhibitor SNDX-5613 With Decitabine\u002FCedazuridine (ASTX727) and Venetoclax in Acute Myeloid Leukemia (SAVE)","Inclusion Criteria:\n\n1. Age ≥ 12 years with weight ≥ 40Kg.\n2. ECOG performance status of ≤ 2.\n3. Newly diagnosed (frontline cohort), who are not eligible for high-intensity induction chemotherapy or relapsed\u002Frefractory (R\u002FR cohort) AML or myeloid phenotype MPAL with either KMT2Ar, or NUP98r, or NPM1c.\n4. WBC must be below 25,000\u002F μL at time of enrollment. Patients may receive cytoreduction prior to enrollment.\n5. Baseline ejection fraction must be \\> 40%.\n6. Adequate hepatic function (direct bilirubin \\\u003C 2x upper limit of normal (ULN) unless increase is due to Gilbert's disease or leukemic involvement, and AST and\u002For ALT \\\u003C 3x ULN unless considered due to leukemic involvement, in which case direct bilirubin or AST and\u002For ALT \\\u003C 5x ULN will be considered eligible).\n7. Adequate renal function (creatinine clearance ≥ 30 mL\u002Fmin) unless related to disease.\n8. Willing and able to provide informed consent.\n9. In the absence of rapidly proliferative disease, the interval from prior treatment to time of initiation will be at least 14 days for cytotoxic or non-cytotoxic (immunotherapy agent(s), or an interval of 5 half-lives of the prior therapy. Oral hydroxyurea and\u002For cytarabine (up to 2 g\u002Fm2) for patients with rapidly proliferative disease is allowed before the start of study therapy, as needed, for clinical benefit and after discussion with the PI. Concurrent therapy for central nervous system (CNS) prophylaxis or continuation of therapy for controlled CNS disease is permitted.\n10. Women of childbearing potential must agree to adequate methods of contraception during the study and at least 3 months after the last treatment. Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study and at least 3 months after the last treatment.\n\nExclusion Criteria:\n\n1. Prior treatment with a menin inhibitor.\n2. Patients with any concurrent uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the patient at unacceptable risk of study treatment.\n3. 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 for patients with rapidly proliferative disease or for control of counts during differentiation syndrome. (3) use of steroids for treatment of differentiation syndrome.\n4. Patients with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.\n5. Patients with a concurrent active malignancy under treatment.\n6. Known active hepatitis B (HBV) or Hepatitis C (HCV) infection or known HIV infection.\n7. Female subjects who are pregnant or breast-feeding.\n8. Patient has an active uncontrolled infection.\n9. Any of the following within the 6 months prior to study entry: myocardial infarction, uncontrolled\u002Funstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), life-threatening, uncontrolled arrhythmia, cerebrovascular accident, or transient ischemic attack.\n10. QTc \\>470 msec using the Fridericia Formula.\n11. History of a complete bundle branch block or high-degree atrioventricular block.\n12. History of or any concurrent condition, therapy, or laboratory abnormality that in the 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.\n13. Clinically active central nervous system (CNS) leukemia.\n14. Patients on immunosuppressive therapy post-HSCT at the time of screening with R\u002FR leukemia (must be off all systemic immunosuppression therapy for at least 2 weeks and calcineurin inhibitors for at least 4 weeks). The use of topical steroids for cutaneous graftversus- host disease (GVHD) or stable systemic steroid doses less than or equal to 20 mg of prednisone daily are permitted.\n15. Patients with Grade \\> 2 active acute GVHD, moderate or severe limited chronic GVHD, or extensive chronic GVHD of any severity.",true,"12 Years",{"count":277,"type":23},43,[26,58],"Part 1b of this clinical research study is to find the highest tolerable dose of SNDX-5613 that can be given in combination with ASTX727 (a combination of the drugs decitabine\u002Fcedazuridine) and venetoclax for patients with acute myeloid leukemia (AML) or those with a mixed phenotype acute leukemia with a myeloid phenotype (MPAL).\n\nPart 2 of this study is to learn if the dose of study drugs found in Part 1b can help to control AML\u002FMPAL",[30],{"date":35,"type":38},{"date":283,"type":38},"2022-10-14",{"date":285,"type":23},"2026-12-01",{"name":210,"class":189},{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":4,"eligibilityCriteria":293,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":294,"targetDuration":4,"studyType":24,"phases":296,"briefSummary":297,"conditions":298,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":301,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"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":295,"type":23},96,[26,58],"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.",[30,299,142,300,181,31],"Hematopoietic and Lymphoid System Neoplasm","Myeloproliferative Neoplasm",{"date":35,"type":38},{"date":303,"type":38},"2018-03-19",{"date":305,"type":23},"2027-09-30",{"name":210,"class":189},{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":18,"minAge":314,"maxAge":315,"enrollmentInfo":316,"targetDuration":4,"studyType":24,"phases":317,"briefSummary":318,"conditions":319,"keywords":329,"overallStatus":332,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"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":177,"type":23},[26,58],"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.",[33,31,320,321,322,323,324,30,325,326,327,328],"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",[328,327,326,325,30,324,323,322,321,33,31,330,331],"Sonrotoclax","Pediatric","NOT_YET_RECRUITING","2026-08-17",{"date":222,"type":38},{"date":336,"type":23},"2026-10",{"date":338,"type":23},"2031-09",{"name":340,"class":45},"BeOne Medicines",{"id":342,"slug":343,"hasResults":12,"nctId":344,"briefTitle":345,"officialTitle":345,"acronym":4,"eligibilityCriteria":346,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":347,"targetDuration":4,"studyType":24,"phases":349,"briefSummary":350,"conditions":351,"keywords":4,"overallStatus":332,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":352,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":190},"100635190","phase-1-phase-i-study-of-plm-102-in-patients-with-relapsed-and-refractory-acute-myeloid-leukemia-100635190","NCT07549464","Phase I Study Of PLM-102 In Patients With Relapsed And Refractory Acute Myeloid Leukemia","Inclusion Criteria:\n\nPatients need to be adults with R\u002FR AML or MDS\u002FAML per the ICC 2022 or the WHO 2022.4,5\n\n1. Relapsed or refractory disease following standard treatment:\n\n   1. Relapsed: Bone marrow blasts ≥5%, reappearance of blasts in the blood, or development of extramedullary disease following achievement of CR\u002FCRi\u002FMLFS\n   2. Refractory: Failure to achieve CR\u002FCRi\u002FMLFS following initial treatment, with evidence of persistent leukemia by blood and\u002For bone marrow evaluation with blasts ≥5%\n2. ECOG PS 0 to 2\n3. Patients with actionable mutations with available FDA-approved therapies, e.g., FLT3, IDH1\u002F2, menin inhibitors may be enrolled after they have exhausted or are ineligible for appropriate lines of FDA approved treatment options.\n4. Patients with antecedent hematological disorder (AHD), e.g., aplastic anemia, myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML) or myeloproliferative disorder or neoplasm (MPD or MPN) who have previously received a regimen appropriate for AML for the antecedent hematological disorder, and have progressed to AML, will be eligible due to recognized poor outcomes in such patients with \"treated secondary AML\".6,7\n5. Patients relapsing after allo-SCT may be eligible if they have recovered from all transplantrelated toxicities and are off all immunosuppression, with no more than grade 1 chronic GVHD. Physiologic (\"replacement\") dose of steroids (≤10 mg prednisone or equivalent) may be acceptable. Patients must be off all immunosuppression, including calcineurin inhibitors, for at least 2 weeks or 5 half-lives, whichever is longer, prior to enrollment on study.\n6. Adequate hepatic function (total bilirubin ≤ 1.5 x upper limit of normal (ULN) unless increase is due to Gilbert's disease or leukemic involvement, and AST and\u002For ALT ≤ 2.5 x ULN unless considered due to leukemic involvement, in which case total bilirubin or AST and\u002For ALT ≤ 3 x ULN will be considered eligible).\n7. Adequate renal function with creatinine clearance ≥ 45 mL\u002Fmin calculated by the CockcroftGault formula or MDRD equation.\n8. The effects of these agents on the developing human fetus are unknown. For this reason, and because other therapeutic agents used in this trial may be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for at least 90 days after last treatment.\n\n   a. This includes all female patients between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following: i. Postmenopausal (no menses in greater than or equal to 12 consecutive months). ii. History of hysterectomy or bilateral salpingo-oophorectomy. iii. Ovarian failure (follicle-stimulating hormone and estradiol in menopausal range, who have received whole pelvic radiation therapy). iv. History of bilateral tubal ligation or another surgical sterilization procedure.\n\n   b. Approved methods of birth control are as follows: Hormonal contraception (i.e., birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), tubal ligation or hysterectomy, subject\u002Fpartner post vasectomy, implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. 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. c. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of treatment.\n9. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\nPatient has a white blood cell count \\> 15 x 10⁹\u002FL. Hydroxyurea, and\u002For cytarabine (up to 2 g\u002Fm2 total) used as supportive care is permitted to meet this criterion.\n\n1. Prior use of any cytotoxic chemotherapy, targeted therapy, radiation therapy, immunotherapy, or other clinical trial therapies within 2 weeks, prior to first dose of study treatment. Patients should have recovered from all prior therapy related toxicities. Patients may receive hydroxyurea or cytarabine for control of WBC count during this washout period.\n2. Patient has uncontrolled systemic fungal, bacterial, viral or other infection with ongoing signs\u002Fsymptoms despite appropriate treatment.\n3. Patients with any severe gastrointestinal or metabolic condition or gastric bypass, which could interfere with absorption of oral drug.\n4. Active uncontrolled comorbidities including decompensated congestive heart failure NYHA class III\u002FIV, clinically significant, uncontrolled arrhythmia, acute respiratory failure, unstable or decompensated pulmonary disease, as judged by the treating physician.\n5. Decompensated congestive heart failure, hypokalemia, prolonged QT interval corrected for heart rate (QTc) (as calculated using Fridericia's formula) to greater than 450 msec for males, or to greater than 470 msec for females or long QT syndrome, or history of Torsades de pointes. Patients with bundle branch block or pacemaker and prolonged QTc interval are permitted after appropriate correction, (e.g., Bogossian formula, or others) or after discussion with the PI and\u002For cardiologist.\n6. Active hepatitis B (HBV) or Hepatitis C (HCV) infection with detectable viral DNA or RNA, respectively, or known HIV infection. Patients with history of hepatitis with undetectable viral load will be eligible.\n7. Any other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the investigator.\n8. Any previous malignancy, except when the patient has completed definitive curative-intent treatment with chemotherapy and\u002For surgery and\u002For radiotherapy at least 1 month prior to enrollment. Patients having completed definitive treatment for the following conditions may be eligible immediately after completion of definitive curative-intent therapy, after healing of wounds, and no evidence of residual disease by examination or imaging or cytology\u002Fpathology, e.g., non-melanoma skin cancers, or any carcinoma in-situ, e.g., ductal carcinoma in situ, urothelial cancer, cervical cancer, localized prostate cancer, pre-cancerous colon polyp, etc.\n9. Major surgery within 4 weeks prior to screening or a major wound that has not fully healed.\n10. Patients under legal protection measure (guardianship, trusteeship or safeguard of justice) and\u002For uncontrolled psychiatric comorbidities, ongoing illicit substance abuse, inability, any impairment or unwillingness to comply with the treatments, follow-up, requirements and procedures of this clinical trial.\n11. A known hypersensitivity or severe allergy to study drug components or diluents\n12. Nursing women, women of childbearing potential (WOCBP) with positive urine or serum pregnancy test, or WOCBP who are not willing to maintain adequate contraception.\n13. Pregnant women are excluded from this study because study agents may have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events (AEs) in nursing infants secondary to treatment of the mother with study agents, breastfeeding should be discontinued if the mother is treated on this study.",{"count":348,"type":23},12,[26],"The goal of this clinical research study is to find the highest tolerable dose of PLM-102 that can be given to patients who have AML\u002FMDS that is refractory and\u002For relapsed. The safety of PLM-102 will also be studied.",[30],{"date":222,"type":38},{"date":354,"type":23},"2026-10-01",{"date":356,"type":23},"2031-06-01",{"name":210,"class":189},{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":4,"eligibilityCriteria":364,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":365,"targetDuration":4,"studyType":24,"phases":367,"briefSummary":369,"conditions":370,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":374,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":378,"locationsCount":190},"100570682","evaluating-the-effects-of-hemoglobin-threshold-specific-packed-red-blood-cell-transfusions-on-quality-of-life-and-functional-outcomes-in-patients-with-high-grade-myeloid-neoplasms-acute-myeloid-leukemia-or-b-acute-lymphoblastic-lymphomaleukemia-100570682","NCT06710418","Evaluating the Effects of Hemoglobin Threshold-specific Packed Red Blood Cell Transfusions on Quality of Life and Functional Outcomes in Patients With High-grade Myeloid Neoplasms, Acute Myeloid Leukemia, or B Acute Lymphoblastic Lymphoma\u002FLeukemia","Red Blood Cell Transfusion Threshold-Specific Bleeding, Quality of Life and Functional Outcomes in Acute Leukemia Patients With Thrombocytopenia: a Randomized Feasibility Study","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of \"high-grade\" myeloid neoplasm (≥ 10% blasts in blood or bone marrow) or acute myeloid leukemia (AML) (other than acute promyelocytic leukemia \\[APL\\]) or B-cell acute lymphoblastic lymphoma\u002Fleukemia (ALL) according to the 2022 WHO classification. Outside diagnostic material is acceptable to establish diagnosis\n* Plan to undergo intensive chemotherapy induction or post-remission therapy for their diagnosis (defined as \"7+3,\" hyper-cyclophosphamide, vincristine, doxorubicin, and dexamethasone \\[CVAD\\], or regimen with cytarabine backbone ≥ 1,000mg\u002Fm\\^2), or allogeneic HSCT, expected to induce anemia requiring PRBC transfusion AND platelet counts of ≤ 30,000\u002FuL for ≥ 5 days following the therapy (as determined by principal investigator)\n* Plan to get all post-chemotherapy\u002Fpost-HSCT care at the University of Washington (UW)\u002FFred Hutchinson Cancer Center (FHCC)\n* Ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Patients requiring a prophylactic platelet transfusion at thresholds \\> 10,000\u002FuL\n* Patients requiring systemic anticoagulation, anti-platelet agent, or antifibrinolytic therapy that will not be held once platelets reach a level of \\\u003C 50,000\u002FuL\n* Patients with grade ≥ 2 bleeding (as determined by the WHO Bleeding Criteria) at the time of randomization\n* Arterial or venous thrombotic event, including myocardial infarction within 6 months prior to initiation of the chemotherapy\u002FHSCT\n* Patients requiring renal replacement therapy at the time of randomization\n* Patients who decline transfusion for personal or religious beliefs\n* Pregnancy or lactation",{"count":366,"type":23},50,[368],"NA","This clinical trial evaluates the effects of hemoglobin threshold-specific packed red blood cell (PRBC) transfusions on quality of life and functional outcomes in patients who have undergone chemotherapy or an allogeneic hematopoietic stem cell transplant for a high-grade myeloid neoplasm, acute myeloid leukemia, or B acute lymphoblastic lymphoma\u002Fleukemia. Some types of chemotherapy and stem cell transplants can induce low platelet counts and\u002For anemia that requires PRBC transfusions. Given critical shortages in blood supply, and risks associated with transfusion of PRBC, there has been much investigation into the \"minimum\" hemoglobin level that effectively balances safety and toxicity in patients. This clinical trial evaluates the effects of giving PRBC transfusions based on a more restrictive hemoglobin threshold (\\> 7 gm\u002FdL) compared to a more liberal hemoglobin threshold (\\> 9 gm\u002FdL) on quality of life and functional outcomes. A more restrictive threshold may be just as effective at maintaining patient quality of life and function while decreasing side effects from blood transfusions and helping to conserve blood supply resources.",[30,371,372,373],"B Acute Lymphoblastic Leukemia","B Lymphoblastic Lymphoma","Myeloid Neoplasm",{"date":88,"type":38},{"date":376,"type":38},"2025-10-15",{"date":65,"type":23},{"name":379,"class":189},"University of Washington",{"id":381,"slug":382,"hasResults":12,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":387,"targetDuration":4,"studyType":24,"phases":389,"briefSummary":390,"conditions":391,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":394,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":229},"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":388,"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.",[392,393,30,181,31],"Relapsed Myelodysplastic Syndrome","Refractory Myelodysplastic Syndrome",{"date":88,"type":38},{"date":396,"type":38},"2024-08-14",{"date":398,"type":23},"2027-10-01",{"name":400,"class":189},"Vanderbilt-Ingram Cancer Center",{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":408,"targetDuration":4,"studyType":24,"phases":410,"briefSummary":411,"conditions":412,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":413,"lastUpdatePostDateStruct":414,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":418,"locationsCount":419},"100567742","comparing-new-treatments-for-people-with-newly-diagnosed-acute-myeloid-leukemia-that-has-an-idh2-gene-change-a-myelomatch-treatment-trial-100567742","NCT06672146","Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMATCH Treatment Trial)","A Randomized Phase II Trial of ASTX727 and Venetoclax Compared With ASTX727, Venetoclax, and Enasidenib for Newly Diagnosed Older Adults With IDH2 Mutant Acute Myeloid Leukemia: A MyeloMATCH Substudy","Inclusion Criteria:\n\n* Participants must have been registered to the MYELOMATCH Master Screening and Reassessment Protocol prior to consenting to this study. Participants must have disease with a detectable IDH2 mutation based on central testing through the MYELOMATCH and be assigned to this clinical trial via MATCHBox prior to registration to this study\n\n  * Note: Pre-enrollment\u002Fdiagnosis labs must have already been performed under MYELOMATCH\n* Participants must have newly diagnosed, untreated acute myeloid leukemia (AML) defined by having ≥ 20% blasts in the bone marrow and\u002For peripheral blood, or with an AML defining genetic abnormality as described by the World Health Organization (WHO) classification of AML, excluding acute promyelocytic leukemia (APL) with PML-RARA\n* Participants must not be receiving or planning to receive any other investigational agents while on protocol therapy\n* Participants must not have received prior therapy for AML, myelodysplastic syndrome (MDS) or myeloproliferative neoplasm (MPN) with the exception of hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine kinase inhibitor, colony-stimulating factors, erythropoiesis-stimulating agents, thrombopoietin receptor agonist, lenalidomide, luspatercept, immunosuppressive therapy, intrathecal chemotherapy, cytarabine (up to 1 g\u002Fm\\^2 for the purpose of cytoreduction for hyperleukocytosis\u002Ftrial eligibility), and\u002For leukapheresis, with a maximum limit of 1 month of exposure.\n\n  * Note: White blood cell (WBC) must be \\\u003C 25 x 10\\^9\u002FL prior to start of treatment. Hydroxyurea, leukapheresis, and cytarabine ≤ 1g\u002Fm\\^2 are permitted to control the WBC prior to enrollment and initiation of protocol-defined therapy but must be stopped prior to initiation of protocol therapy.\n* Participants must be ≥ 60 years old; OR must be ≥ 18 years old and considered not eligible for cytarabine-based induction therapy\n* Participants must have Zubrod Performance Status of 0-3 as determined by a history and physical (H\\&P) exam completed within 14 days prior to registration\n* Participants must have a complete medical history and physical exam within 14 days prior to registration\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) unless history of Gilbert's syndrome. Participants with history of Gilbert's syndrome must have total bilirubin ≤ 3 x institutional ULN (within 14 days prior to registration)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 × institutional ULN, unless considered to be elevated due to disease involvement (within 14 days prior to registration)\n* Participants must have adequate kidney function as evidenced by creatinine clearance ≥ 30mL\u002Fmin (by Cockcroft Gault) within 14 days prior to registration\n* Participants must not have a baseline corrected QT interval ≥ 480 msec using Fridericia correction (QTcF).\n\n  * NOTE: Since older participants are at risk for prolonged QTc and may require supportive care with agents that affect QTc, an electrocardiogram (ECG) is recommended if clinically indicated. If the QTc is prolonged, they should be treated on MYELOMATCH TAP instead of MM1OA-S03\n* Participants must have adequate cardiac function in the assessment of their treating physician. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants must be class 2 or better\n* Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6 months prior to registration\n* Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration, if indicated\n* Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent test results obtained within 6 months prior to registration, if indicated\n* Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen\n* Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 12 consecutive months or who has semen likely to contain sperm is considered to be of \"reproductive potential.\" In addition to routine contraceptive methods, \"effective contraception\" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation\u002Focclusion, and vasectomy with testing showing no sperm in the semen\n* Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications\n* Participants with central nervous system (CNS) involvement are eligible if follow-up CNS evaluation shows no evidence of progression, or if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy\n* Participants must have agreed to have specimens submitted for translational medicine for MRD under MYELOMATCH and specimens must be submitted\n\n  * Enrollment to this treatment study requires prior enrollment into the myeloMATCH Master Protocol (MYELOMATCH). Participants enrolled in MYELOMATCH will submit bone marrow samples, peripheral blood samples, and buccal swabs to the Molecular Diagnostics Network (MDNet), the Clinical Laboratory Improvement Act (CLIA) laboratory network for myeloMATCH\n  * In addition to the MYELOMATCH specimens, there will be specimens obtained on treatment for this substudy. These specimens will be derived from procedures performed as part of standard assessments in the clinical care and management of AML with material being sent to the MDNet laboratories as specified. Therefore, participants must be asked for their consent for the biobanking of specimens for future unspecified research. Participants may refuse this, but it is mandatory for sites to ask participants\n* Participants must be offered the opportunity to participate in specimen banking\n* NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system\n\n  * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations",{"count":409,"type":23},93,[58],"This phase II MyeloMATCH treatment trial studies how well ASTX727 and venetoclax plus enasidenib works compared to ASTX727 and venetoclax alone for the treatment of older patients with newly diagnosed acute myeloid leukemia (AML) or younger patients who are considered unfit for standard treatment, and who have an abnormal change (mutation) in the IDH2 gene. This gene mutation can cause AML to grow and spread. This trial is being done to see if adding enasidenib to the usual treatment can help more patients with the IDH2 gene get rid of AML.\n\nASTX727 is a fixed-dose formulation of two drugs, cedazuridine and decitabine. 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. 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. 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. Enasidenib works by stopping the growth and spread of tumor cells that have the IDH2 mutation. Giving ASTX727 and venetoclax plus enasidenib may work better in treating AML patients with the IDH2 mutation.",[30],"2026-08-15",{"date":222,"type":38},{"date":416,"type":38},"2025-05-16",{"date":166,"type":23},{"name":67,"class":68},133,{"id":421,"slug":422,"hasResults":12,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":4,"eligibilityCriteria":426,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":427,"enrollmentInfo":428,"targetDuration":4,"studyType":24,"phases":430,"briefSummary":431,"conditions":432,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":436,"lastUpdatePostDateStruct":437,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":441,"locationsCount":442},"100507335","phase-1-a-phase-1b-study-of-menin-inhibitor-sndx--5613-in-combination-with-daunorubicin-and-cytarabine-in-newly-diagnosed-patients-with-acute-myeloid-leukemia-and-npm1-mutatedflt3-wildtype-or-mllkmt2a-rearranged-or-nup98-alterations-disease-100507335","NCT05886049","A Phase 1b Study of Menin Inhibitor SNDX- 5613 in Combination With Daunorubicin and Cytarabine in Newly Diagnosed Patients With Acute Myeloid Leukemia and NPM1 Mutated\u002FFLT3 Wildtype or MLL\u002FKMT2A Rearranged or NUP98 Alterations Disease","A Phase 1b Study of Menin Inhibitor SNDX-5613 in Combination With Daunorubicin and Cytarabine in Newly Diagnosed Patients With Acute Myeloid Leukemia and NPM1 Mutated\u002FFLT3 Wildtype or MLL\u002FKMT2A Rearranged or NUP98 Alterations Disease","Inclusion Criteria:\n\n* Dose escalation: Patients ages 18-75 years at time of diagnosis with NPM1-mutated\u002FFLT3-ITD wildtype and NPM1-mutated\u002FFLT3-TKD wildtype with high-risk features (adverse risk genetics per European LeukemiaNet \\[ELN\\] 2022 criteria, age ≥ 60 years, or secondary AML defined as either arising from a prior hematological malignancy or therapy-related), MLL (KMT2A) rearranged or NUP98 altered, untreated AML and who are candidates for intensive induction chemotherapy. Patients with CD33+ AML are eligible for this protocol.\n* Dose expansion: Patients ages 18-75 years at time of diagnosis with NPM1-mutated\u002FFLT3-ITD wildtype and NPM1-mutated\u002FFLT3-TKD wildtype (any patient-does not require high-risk features), MLL (KMT2A) rearranged, or NUP98 altered, untreated AML and who are candidates for intensive induction chemotherapy. Patients with CD33+ AML are eligible for this protocol\n* Because no dosing or adverse event data are currently available on the use of SNDX-5613 in combination with daunorubicin and cytarabine in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 (Karnofsky \\>= 60%). Patients over the age of 65 must have an ECOG performance status of 0-1\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN), except for patients with Gilbert's syndrome where required to be ≤ 3 x institutional ULN\n* Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT)(serum glutamic pyruvate transaminase \\[SGPT\\]) =\\\u003C 3 x institutional upper limit of normal (ULN)\n* Glomerular filtration rate (GFR) \\>= 60 mL\u002Fmin\u002F1.73 m\\^2 (via the Chronic Kidney Disease Epidemiology \\[CKD-EPI\\] glomerular filtration rate estimation)\n* Human immunodeficiency virus (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* 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* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* Ejection fraction \\>= 50% (or \\>= 45% if no evidence of congestive heart failure \\[CHF\\] or other cardiac symptoms) by transthoracic echocardiogram (TTE) or multi-gated acquisition (MUGA) scan\n* White blood cells (WBC) must be \\\u003C 25 x 10\\^9\u002FL. Hydroxyurea and leukapheresis are permitted to control the WBC prior to enrollment and initiation of protocol-defined therapy but must be stopped within 24 hours of initiation of protocol therapy. Must not have had any signs of leukostasis requiring cytoreduction\n* Female patients of childbearing potential must agree to use 2 forms of contraception from screening visit until 120 days following the last dose of study treatment. Male patients of childbearing potential having intercourse with females of childbearing potential must agree to abstain from heterosexual intercourse or have their partner use 2 forms of contraception from screening visit until 180 days until the last dose of study treatment. They must also refrain from sperm donation from screening visit until 180 days following the last dose of study treatment\n* Patients must have previously untreated AML with no prior treatment other than hydroxyurea or intrathecal chemotherapy for central nervous system (CNS) prophylaxis\u002Ftreatment. No chemotherapy for AML outside of hydroxyurea for treatment of leukostasis or all-trans retinoic acid (ATRA) for initially suspected acute promyelocytic leukemia (APL) (that is ruled out) is allowed\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* History of allergic reactions attributed to compounds of similar chemical or biologic composition to SNDX-5613, daunorubicin or cytarabine\n* Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n* Patient must not have received known strong or moderate CYP3A4 inhibitors, or strong CYP3A4 inducers (with the exception of antifungal prophylaxis with azoles) within 7 days of enrollment. 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* Pregnant women are excluded from this study because SNDX-5613 is a menin-KMT2A inhibitor agent 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 SNDX-5613, breastfeeding should be discontinued if the mother is treated with SNDX-5613. These potential risks may also apply to other agents used in this study\n* Isolated myeloid sarcoma (i.e., patients must have blood or marrow involvement with AML to enter the study)\n* Acute promyelocytic leukemia (French-American-British \\[FAB\\] M3)\n* Untreated, active central nervous system (CNS) involvement by AML. Patients are allowed to undergoing diagnostic lumbar puncture (LP) with intrathecal chemotherapy while on study\n* Uncontrolled symptomatic disseminated intravascular coagulopathy with active bleeding or signs of thrombosis\n* Patients with Fridericia's correction formula (QTcF) \\>= 450 ms at screening; patients with right, left, or partial bundle branch blocks or a pacemaker who are asymptomatic are eligible regardless of QTC if cleared by cardiology for enrollment in the trial. Any factors that increase the risk of QTc prolongation or risk of arrhythmic event such as congenital long QT syndrome or family history of long QT syndrome\n* Patients who will exceed a lifetime anthracycline exposure of \\> 550 mg\u002Fm\\^2 daunorubicin or equivalent (or \\> 400 mg\u002Fm\\^2 daunorubicin or equivalent in the event of prior mediastinal radiation) if they receive the maximum potential exposure to anthracyclines per protocol (including both induction and reinduction cycles)\n* Patients with any gastrointestinal issue of the upper gastrointestinal (GI) tract that might affect oral drug absorption or ingestion (eg, gastric bypass, gastroparesis, etc)\n* Patients who have cirrhosis with a Child-Pugh score of B or C\n* Patients with Down Syndrome due to higher rates of chemotherapy-associated toxicities, and may have different pharmacokinetics, as well. Toxicities that occur at higher frequencies include cardiotoxicity, a known risk of SNDX-5613 treatment (i.e., QTcF prolongation)\n* Patients with myelodysplastic syndromes (MDS) treated with previous intensive induction regimens similar to 7+3","75 Years",{"count":429,"type":23},38,[26],"This phase Ib trial tests the safety, side effects, and best dose of SNDX-5613 when given in combination with the standard chemotherapy treatment (daunorubicin and cytarabine) in treating patients with newly diagnosed acute myeloid leukemia that has changes in the NPM1 gene or MLL\u002FKMT2A gene. SNDX-5613 blocks signals passed from one molecule to another inside cancer cells that are needed for cancer cell survival. Drugs used in chemotherapy, such as daunorubicin 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. Adding SNDX-5613 to the standard chemotherapy treatment may be able to shrink or stabilize the cancer for longer than the standard chemotherapy treatment alone.",[30,433,434,435],"Acute Myeloid Leukemia With KMT2A Rearrangement","Acute Myeloid Leukemia With NPM1 Mutation","Secondary Acute Myeloid Leukemia","2026-08-14",{"date":333,"type":38},{"date":439,"type":38},"2024-06-20",{"date":65,"type":23},{"name":67,"class":68},23,{"id":444,"slug":445,"hasResults":12,"nctId":446,"briefTitle":447,"officialTitle":448,"acronym":4,"eligibilityCriteria":449,"healthyVolunteers":12,"sex":18,"minAge":314,"maxAge":315,"enrollmentInfo":450,"targetDuration":4,"studyType":24,"phases":451,"briefSummary":452,"conditions":453,"keywords":454,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":466},"100616532","phase-1-a-study-to-assess-adverse-events-and-how-intravenous-iv-pivekimab-sunirine-moves-through-the-body-in-pediatric-participants-with-relapsed-or-refractory-acute-myeloid-leukemia-aml-100616532","NCT07306832","A Study to Assess Adverse Events and How Intravenous (IV) Pivekimab Sunirine Moves Through the Body in Pediatric Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)","A Phase 1b Study of the Safety and Pharmacokinetics of Pivekimab Sunirine in Pediatric Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n* Must have histologically confirmed acute myeloid leukemia (AML) meeting one of the following disease criteria:\n\n  * Second or greater relapse. OR\n  * Disease refractory to second or subsequent line of therapy (defined as resistant disease after at least one cycle of each treatment regimen).\n* Must have myeloid leukemic blasts that are CD123-positive by flow cytometry as determined by the treating institution.\n* Has \\>= 5% myeloid leukemic blasts in bone marrow at time of relapse or refractory disease and prior to Screening for this study.\n* Performance status by Lansky (\\\u003C 16 years old at evaluation) or Karnofsky (\\>= 16 years old at evaluation) score \\>= 50 or ECOG score \\\u003C= 2.\n* May have status of central nervous system (CNS)1, CNS2, or CNS3 disease without clinical signs or neurologic symptoms suggestive of CNS leukemia, such as facial nerve palsy, brain\u002Feye involvement or hypothalamic syndrome. Participants receiving intrathecal therapy and no additional CNS-directed systemic therapy at study entry are eligible and may continue treatment as clinically indicated in accordance with institutional practice.\n* For those participants who have not reached the age of consent, parent or legal guardian with the willingness and ability to provide informed consent and participant willing and able to give assent, as appropriate for age and country.\n\nExclusion Criteria:\n\n* Known clinically significant cardiac disease.\n* Down syndrome.\n* Acute promyelocytic leukemia (APL) or juvenile myelomonocytic leukemia (JMML).\n* Symptomatic central nervous system (CNS3) disease\n* Prior history of any severity veno-occlusive disease\u002Fsinusoidal obstructive syndrome (VOD\u002FSOS) of the liver.\n* Prior history of hematopoietic stem cell transplant within 6 months prior to Screening without evidence of active GvHD at the time of screening and the participant is off medications to treat or prevent either post-transplant graft-versus-host disease (GvHD) or post-transplant rejection (except for a stable dose of corticosteroids).\n* Have received prior Chimeric Antigen Receptor T-cell (CAR-T) therapy.\n* Any other known current malignancy requiring therapy.\n* Currently receiving anticancer therapy with antineoplastic intent, including radiotherapy, systemic therapy small molecules, monoclonal antibodies, other investigational agents, or high-dose chemotherapy with the exception of intrathecal therapy.",{"count":22,"type":23},[26],"Acute myeloid leukemia (AML) is an aggressive blood cancer, withwith few options for participants who relapse after treatment or who don't respond to treatment. This study will assess the adverse events and how pivekimab sunirine moves through the body in pediatric participants with relapsed or refractory (R\u002FR) AML.\n\nPivekimab sunirine is a drug being evaluated in the treatment of AML. This is an open label, single arm study, participants will be enrolled in 1 of the 3 cohorts based on their age and will receive pivekimab sunirine at a dose based on their weight. Around 18 pediatric participants with a diagnosis of AML will be enrolled in the study at approximately 30 sites around the world.\n\nParticipants will receive intravenous (IV) pivekimab sunirine alone. The total study duration is approximately 28 months.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.",[30],[30,455,456,457,458,331],"Relapsed","Refractory","Pivekimab Sunirine","PVEK","2026-08-13",{"date":436,"type":38},{"date":462,"type":38},"2026-05-20",{"date":464,"type":23},"2030-03",{"name":95,"class":45},11,{"id":468,"slug":469,"hasResults":12,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":24,"phases":476,"briefSummary":478,"conditions":479,"keywords":480,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":484,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":490},"100596379","phase-4-study-to-assess-adverse-events-and-change-in-disease-activity-of-oral-venetoclax-in-combination-with-subcutaneous-sc-or-intravenous-iv-azacitidine-in-newly-diagnosed-adult-participants-with-acute-myeloid-leukemia-aml-who-are-ineligible-for-standard-induction-therapy-in-india-100596379","NCT07044687","Study to Assess Adverse Events and Change in Disease Activity of Oral Venetoclax in Combination With Subcutaneous (SC) or Intravenous (IV) Azacitidine in Newly Diagnosed Adult Participants With Acute Myeloid Leukemia (AML) Who Are Ineligible for Standard Induction Therapy in India","A Phase 4 Study of Venetoclax in Combination With Azacitidine in Indian Subjects With Newly Diagnosed Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy","Inclusion Criteria:\n\n* Confirmation of acute myeloid leukemia (AML) diagnosis by 2016 World Health Organization (WHO) criteria, previously untreated, and ineligible for treatment with intensive chemotherapy.\n* Eastern Cooperative Oncology Group (ECOG) performance status of:\n\n  * 0 to 2 for subject ≥ 75 years of age.\n  * 0 to 3 for subject ≥ 18 to 74 years of age.\n\nExclusion Criteria:\n\n* History of any malignancy within 2 years prior to study entry with exception to those noted in the protocol.\n* Have received any investigational drug 30 days prior to the first dose of study drug and have received strong CYP3A inducers within 7 days prior to the initiation of study treatment.",{"count":475,"type":23},100,[477],"PHASE4","Acute myeloid leukemia (AML) is one of the most aggressive blood cancers, with a very low survival rate and few options for participants who are unable to undergo standard induction therapy, the current standard of care. This study will assess the change in disease activity and adverse events in adult participants with acute myeloid leukemia (AML) being treated with of the combination of azacitidine and venetoclax, in India.\n\nThe combination of azacitidine and venetoclax is being evaluated in the treatment of acute myeloid leukemia (AML). Participants will receive azacitidine with increasing doses of venetoclax. Around 40 adult participants with a diagnosis of AML will be enrolled in the study at approximately 15 sites in India.\n\nParticipants will receive venetoclax oral tablets once daily in increasing doses until the study dose is achieved. Then ventoclax oral tablets will continue once daily thereafter. Azacitidine will be given by subcutaneous (SC) or intravenous (IV) injection on Days 1-7 of each cycle. The total study duration is approximately 29 months.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.",[30],[30,29,87,481,86,482,483],"Venclexta","Treatment Naïve AML","Untreated AML",{"date":436,"type":38},{"date":486,"type":38},"2025-07-24",{"date":488,"type":23},"2027-11",{"name":95,"class":45},13,{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":496,"acronym":497,"eligibilityCriteria":498,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":499,"targetDuration":4,"studyType":24,"phases":501,"briefSummary":502,"conditions":503,"keywords":505,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":514,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":521},"100570945","phase-3-impact-aml-a-randomized-pragmatic-clinical-trial-for-relapsed-or-refractory-acute-myeloid-leukemia-100570945","NCT06713837","IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia.","IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia. IMPACT-AML RPCT","IMPACT-AML","Inclusion Criteria:\n\n* Non-Acute promyelocytic leukemia (APL) AML defined according World Health Organization (WHO) 2022 (or International Consensus Classification (ICC) 2022) criteria\n* 1st or 2nd relapse or refractory according to European leukemia Network (ELN) 2022\n* Patient is clinically candidate to both low intensity therapy and high dose chemotherapy in the opinion of the physician\n* Both low intensity therapy and high dose chemotherapy to which patient is candidate are available and can be provided as per local practice\n* No specific treatment protocol can be rationally considered better suited to patient needs.This specifically include, but is not limited to:\n\n  i) the availability of a drug that is already demonstrated superior to comparator arm and can be considered the only standard of care ii) specific contraindications related to fitness or any medical conditions that deem to avoid one of the two arms of this randomization iii) patient willingness to avoid one of the two arm of this randomization iv) lack of social support that make unfeasible one of the two arm of this randomization\n* Male or Female, aged\\>18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status \\\u003C4\n* A female participant is eligible to participate if she is not pregnant and not breastfeeding. If Women of childbearing potential (WOCBP), negative serum pregnancy test within 14 days of starting treatment must be obtained. WOCBP must adopt highly effective birth control methods, according to guideline \"Recommendation related to contraception and pregnancy testing in clinical trials\". Male patient and his female partner who is of childbearing potential must use 2 methods of birth control (a condom as a barrier method of contraception and one of the highly effective birth control methods, according to guideline \"Recommendation related to contraception and pregnancy testing in clinical trials\". Use of- and compliance to- birth control methods are required beginning at the screening visit and continuing until 6 months following last treatment with study drug.\n* Participant is willing and able to give informed consent for participation in the study\n\nExclusion Criteria:\n\n* Known contraindication to the study drug that will be selected by the treating physician within the list of high or low intensity treatment, according to most update version of Summary of Product Characteristics (SmPC) (e.g. hypersensitivity, allergy, organ failure precluding treatment)\n* Participation in another clinical trial with any investigational agents within 14 days or 5 drug half-lives (whatever comes first) prior to randomization\n* Active infections or other clinical conditions that in the opinion of the investigator make the patient ineligible to receive study treatment.",{"count":500,"type":23},339,[81],"This is a multicenter, randomized, open-label, pragmatic low intervention clinical trial comparing high intensity reinduction chemotherapy with low intensity therapies in 1st or 2nd relapse Acute Myeloid Leukemia. The study is funded by European Commission (HORIZON-MISS-2022-CANCER-01-03, Project ID 101104421)",[30,504],"Relapse\u002FRecurrence",[506,30,507,508,509,510,511,512,513],"Relapsed\u002FRefractory","Low Intensity therapy","Pragmatic","Low intervention Clinical trial","Randomized controlled trial","Horizon Europe","Mission Cancer","Diagnosis and treatment",{"date":436,"type":38},{"date":516,"type":38},"2025-02-27",{"date":518,"type":23},"2028-01",{"name":520,"class":189},"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS",47,{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":4,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":529,"targetDuration":4,"studyType":24,"phases":531,"briefSummary":532,"conditions":533,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":535,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":190},"100642307","phase-1-fh-wt1-e50-tcr-t-cells-with-azacitidine-for-the-treatment-of-minimal-residual-disease-positive-acute-myeloid-leukemia-100642307","NCT07645469","FH-WT1-E50 TCR T Cells With Azacitidine for the Treatment of Minimal Residual Disease Positive Acute Myeloid Leukemia","Phase I Study of Autologous CD4+ and CD8+ T Cells That Have Been Transduced to Express a WT1-Specific T Cell Receptor for Treatment of MRD-Positive AML","Inclusion Criteria for Leukapheresis:\n\n* LEUKAPHERESIS: Age 18 years or older at the time of enrollment\n* LEUKAPHERESIS: Confirmed diagnosis of AML that is not M3 subtype (acute promyelocytic leukemia \\[APL\\])\n* LEUKAPHERESIS: Human leukocyte antigen (HLA) type HLA-A\\*02:01 confirmed through HLA typing\n* LEUKAPHERESIS: Tissue confirmation of WT1 expression by immunohistochemistry. Confirmation of diagnosis must be or have been performed by internal pathology review of archival biopsy material or other pathologic material at Fred Hutch\u002FUniversity of Washington Medical Center (UWMC)\n* LEUKAPHERESIS: Capable of understanding and willing to provide informed consent\n* LEUKAPHERESIS: Fertile male and female participants must be willing to use an effective contraceptive method before, during, and for at least 4 months after the last FH-WT1-E50 TCR T infusion\n* LEUKAPHERESIS: Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 or Karnofsky Performance Status (KPS) ≥ 60%\n* LEUKAPHERESIS: No immediate plan for allogeneic stem cell transplantation: patients must not have a planned allogeneic hematopoietic stem cell transplant (HCT) within 8 weeks of leukapheresis. Patients may still be considered for HCT in the future but must not have a scheduled transplant at the time of enrollment due to factors including, but not limited to, donor availability, performance status, comorbidities, or patient preference. Patients who subsequently become candidates for HCT (e.g., donor identified or improvement in performance status) may proceed to transplant at the discretion of the treating physician without a mandated waiting period related to study participation\n* LEUKAPHERESIS: Creatinine clearance ≥ 30 ml\u002Fmin by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) or 24-hour urine clearance\n* LEUKAPHERESIS: Total bilirubin \\\u003C 3.0 mg\u002FdL. Participants with suspected Gilbert syndrome may be included if total bilirubin (tBili) \\> 3mg\u002FdL but no other evidence of hepatic dysfunction\n* LEUKAPHERESIS: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C 5 x upper limit of normal (ULN)\n* LEUKAPHERESIS: Participants 60 years of age or older are required to have left ventricular ejection fraction (LVEF) evaluation performed within 60 days prior to enrollment. LVEF may be established with echocardiogram or MUGA scan, and left ejection fraction must be ≥ 35%. Cardiac evaluation for other participants is at the discretion of the treating physician\n\nInclusion Criteria at Start of Treatment:\n\n* START OF TREATMENT: Presence of Measurable Residual Disease (MRD) after induction therapy at the time of screening. Patients must have achieved a morphologic remission (marrow that is at least 10% cellular with \\\u003C 5% blasts on morphologic review) with detectable MRD, regardless of incomplete recovery of neutrophil counts\u002Fless than 1,000\u002Fmm3 (CRi) or platelet counts less than 100,000\u002Fmm3 (CRp). Eligible remission-induction regimens include, but are not limited to, conventional induction chemotherapy (e.g., 7+3 or similar anthracycline\u002Fcytarabine-based regimens) and hypomethylating agent-based combinations (e.g., azacitidine\u002Fvenetoclax).\n\n  * MRD definition:\n\n    * MRD by flow cytometry: defined by any abnormal myeloid blasts identified by flow cytometric analysis. In addition, for patients with NPM1-mutated disease, we will incorporate a clinically validated quantitative NPM1 MRD assay performed at Fred Hutch. For patients with FLT3-ITD-mutated disease, MRD assessment will include a clinically validated FLT3-ITD assay performed at Invivoscribe.\n* START OF TREATMENT: Participants must be willing to undergo serial tumor biopsies and\u002For aspirates for research purposes if safe and feasible at baseline (prior to first T cell infusion), 2-3 weeks after the first T cell infusion, and approximately 2 weeks +\u002F- 1 week after the second infusion (if applicable) (these windows may vary due to manufacturing or clinical reasons). Should there be no marrow tissue that is accessible, participants will still be considered for participation, at the discretion of the investigator. Similarly, should an investigator determine that a marrow assessment cannot be performed safely for clinical reasons, those may be cancelled or rescheduled. Participants must be at least two weeks or five half lives (for small molecules) from last systemic treatment: At least 2 weeks must have passed since any: immunotherapy (for example, T cell infusions, immunomodulatory agents, interleukins, vaccines), or chemotherapy cancer treatment. At least five half-lives must have passed from treatment with small molecules or other investigational agents\n* START OF TREATMENT: ECOG performance status of 0, 1, or 2 or Karnofsky Performance Status (KPS) ≥ 60%\n* START OF TREATMENT: Creatinine clearance ≥ 30 ml\u002Fmin by CKD-EPI or 24-hour urine clearance\n* START OF TREATMENT: Total bilirubin \\\u003C 3.0 mg\u002FdL. Participants with suspected Gilbert syndrome may be included if tBili \\> 3mg\u002FdL but no other evidence of hepatic dysfunction.\n* START OF TREATMENT: Participants 60 years of age or older are required to have left ventricular ejection fraction (LVEF) evaluation performed within 60 days prior to enrollment. LVEF may be established with echocardiogram or MUGA scan, and left ejection fraction must be ≥ 35%. Cardiac evaluation for other participants is at the discretion of the treating physician\n* START OF TREATMENT: Participants with a history of chronic obstructive pulmonary disease (COPD), emphysema, or greater than 30 pack year smoking history should undergo pulmonary function tests (PFTs) and meet the following criteria:\n\n  * Forced expiratory volume in 1 second (FEV1) ≥ 50% of predicted and carbon monoxide diffusing capacity (DLCO) (corrected) ≥ 40% of predicted will be eligible\n\nExclusion Criteria for Leukapheresis:\n\n* LEUKAPHERESIS: Prior solid organ transplant or allogeneic hematopoietic stem cell transplant. Kidney transplant participants will be considered on a case-by-case basis requiring discussion with principal investigator (PI). If the participant has had a kidney transplant, participant must have dialysis access, dialysis plan, supportive nephrologist, willingness to stop transplant immunosuppression, and express understanding that rejection is possible outcome. Dialysis or costs related to transplant kidney will not be supported by the study. Participants having had any other solid organ transplants will be excluded, as will those with any history of allogeneic hematopoietic stem cell transplant\n\nExclusion Criteria at Start of Treatment:\n\n* START OF TREATMENT: Evidence of TET2, ASXL1 or DNMT3a mutations as sole evidence of MRD\n* START OF TREATMENT: Pregnancy, breastfeeding, or expecting to conceive or father children for the duration of the trial through 4 months after last T cell infusion. Participants of childbearing potential must have a negative serum pregnancy test within the 2 weeks (14 days) preceding T cell infusion. Childbearing potential is defined as women who have not been surgically sterilized and who are not post-menopausal (free of menses for at least 1 year)\n* START OF TREATMENT: Active autoimmune disease: Participants with active autoimmune disease requiring immunosuppressive therapy are excluded. Case-by-case exemptions are possible with approval by PI\n* START OF TREATMENT: Unable to generate FH-WT1-E50 TCR T cells for infusions. However, if a lower than planned number of cells is available, the participant will have the option to receive the generated WT1-specific T cells\n* START OF TREATMENT: Corticosteroid therapy at a systemic dose equivalent of \\> 0.5 mg\u002Fkg of prednisone-equivalent per day. The following treatments are permitted: intranasal, inhaled, topical, or local steroid applications; systemic corticosteroids at physiologic doses equivalent to no more than 10 mg\u002Fday prednisone; steroids as premedication for contrast dye allergy\n* START OF TREATMENT: Concurrent use of other investigational anti-cancer agents\n* START OF TREATMENT: Active uncontrolled infection: HIV positive participants on highly active antiretroviral therapy (HAART) with a CD4 count \\> 500 cells\u002Fmm3 are considered controlled, as are individuals with a history of hepatitis C who have successfully completed antiviral therapy with an undetectable viral load, and those with hepatitis B who have, per standard practice, hepatitis well-controlled on medication\n* START OF TREATMENT: Uncontrolled concurrent illness: Participants may not have uncontrolled or concurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* START OF TREATMENT: Known allergic reactions to any of the components of study treatments\n* START OF TREATMENT: Other medical, social, or psychiatric factors that interfere with medical appropriateness and\u002For ability to comply with study, as determined by the PI",{"count":530,"type":23},9,[26],"This phase I trial tests the safety, side effects and best dose of FH-WT1-E50 TCR T cells with azacitidine for the treatment of minimal residual disease (MRD) positive acute myeloid leukemia (AML). T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize WT1, a protein on the surface of cancer cells. These WT1-specific T cells may help the body's immune system identify and kill WT1 cancer cells. Azacitidine is in a class of medications called antimetabolites. It works by stopping or slowing the growth of cancer cells. Giving FH-WT1-E50 TCR T Cells with azacitidine may be safe and\u002For effective for the treatment of MRD positive AML.",[30],"2026-08-11",{"date":459,"type":38},{"date":537,"type":23},"2026-09-01",{"date":539,"type":23},"2030-07-19",{"name":541,"class":189},"Fred Hutchinson Cancer Center",{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":548,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":550,"enrollmentInfo":551,"targetDuration":4,"studyType":257,"phases":4,"briefSummary":553,"conditions":554,"keywords":559,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":564,"startDateStruct":565,"completionDateStruct":567,"leadSponsor":569,"locationsCount":190},"100636801","quantification-of-peripheral-blood-inkts-after-allogeneic-stem-cell-transplantation-100636801","NCT07570407","Quantification of Peripheral Blood iNKTs After Allogeneic Stem Cell Transplantation","Standardised Quantification of Invariant NKT Cells Using DryTube Technology and Flow Cytometry in Patients Who Have Undergone Allogeneic Haematopoietic Stem Cell Transplantation.","QiNKT-HSCT","Inclusion Criteria:\n\n* Diagnosis: AML (exlusion of secondary disease)\n* Disease status at time of HSCT: complete remission\n* Karnofsky performance status: ≥80%\n* Source of HSC: PBSC\n\nExclusion Criteria:\n\n* Prior transplant\n* Uncontrolled Malignancy","70 Years",{"count":552,"type":23},75,"The transplantation of allogeneic haematopoietic stem cells (HSCs) can lead to serious complications after transplantation, such as graft-versus-host disease (GvHD), infections and relapse due to immunosuppression. Invariant NKT cells (iNKT cells) play a pivotal role in modulating the immune response and have been demonstrated to be instrumental in the pathogenesis of GvHD, cytomegalovirus (CMV) infection, and relapse. Their levels are associated with the development of these complications. This multicentre study aims to test the feasibility of standardising iNKT cell monitoring and to investigate the association between iNKT cell levels and post-transplant complications.",[555,556,557,558,30],"Allogeneic HSCT","Posttransplant Complications","GvHD","Relapse",[560,561,562,563],"iNKT cells","HSCT","Flow cytometry","Reconsitution",{"date":459,"type":38},{"date":566,"type":38},"2026-08-01",{"date":568,"type":23},"2029-01-31",{"name":570,"class":189},"University Hospital Pilsen",{"id":572,"slug":573,"hasResults":12,"nctId":574,"briefTitle":575,"officialTitle":576,"acronym":577,"eligibilityCriteria":578,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":579,"targetDuration":4,"studyType":24,"phases":581,"briefSummary":582,"conditions":583,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":595},"100473396","compassionate-communication-and-advance-care-planning-to-improve-end-of-life-care-in-treatment-of-hematological-disease-act-100473396","NCT05444348","Compassionate Communication and Advance Care Planning to Improve End of Life Care in Treatment of Hematological Disease (ACT)","Compassionate Communication and Advance Care Planning to Improve End of Life Care in Treatment of Hematological Disease (ACT)- a Cluster Randomized Controlled Study","ACT","Inclusion Criteria:\n\nPatients must:\n\n* Be at least 18 years of age\n* Have a diagnosis of one of the following:\n* High-risk myelodysplastic syndrome (MDS) or MDS with overlap of myeloproliferative neoplasms (high-risk MDS\u002FMPN),\n* Acute myeloid leukemia(AML): Age≥80 or in palliative treatment or relapse\n* Lymphoma: Age≥80 or relapse or refractory or palliative treatment\n* Multiple myeloma(MM): Age≥80 or relapsed or refractory\n\nHave limited treatment options. Provide informed consent. Have sufficient Danish skills to complete intervention sessions and data collection\n\nAn informal caregiver is identified by the patient as the primary provider of informal physical, practical or emotional support and must:\n\n* Be at least 18 years of age\n* Be able to accompany patients to intervention appointments\n* Provide informed consent\n* Have sufficient Danish skills to complete intervention sessions and data collection\n\nPhysicians:\n\n* specialized in hematology\n* treating patients with High risk myelodysplastic syndrome, acute myeloid leukemia, lymphoma, or multiple myeloma\n* work at the same department for the entire time of intervention.\n\nNurses:\n\n* treating patients with High-risk myelodysplastic syndrome, acute myeloid leukemia, lymphoma, or multiple myeloma\n* work at the same department for the entire time of intervention.\n\nExclusion Criteria:\n\nPatient and caregiver are excluded if one of them is:\n\n\\- Suffering from a severe psychiatric disorder\n\nPhysicians and nurses:\n\n\\- If they do not meet the inclusion criterion.",{"count":580,"type":23},920,[368],"Patients diagnosed with hematologic cancer are at substantial risk of dying, as 5-year survival among patients with acute myeloid leukemia is 20 % and only every second patient treated for incurable myeloma lives 5 years after date of diagnosis. Nevertheless, many overestimate their prognosis, and value of therapy. Patients with hematological cancers frequently have poor end of life outcomes, such as high treatment activity close to death, where clinical effects are doubtful, and low utilization of palliative care. Prognostic awareness and end of life (EOL) issues have urgency in the communication between patients, their caregiving relatives, and clinicians, in order to avoid futile treatments and suffering at EOL. Inspired by advanced care planning, the investigators developed the concept \"Advance Consultations Concerning participants Life and Treatment\" (ACT) in collaboration with a group consisting of hematologists, nurses, patients, and caregivers. The ACT concept consists of an 8-hour training day for clinicians, clinical tools, system changes, and preparation material for patients and caregivers prior to the consultation. ACT involves patients and caregivers earlier in preparation for life with chronic progressive disease and EOL-decisions, through an intervention based on compassionate communication and early planning of EOL-care. The aim of the study is to investigate the effect of the intervention on use of chemotherapy and quality of EOL-care in patients with hematological malignancy. Based on the results of the completed pilot study, the investigators are planning a nationwide 2-arm cluster randomized controlled trial where 40 physicians and 80 nurses across seven different hematological departments are randomized to either usual care or ACT training and completing ACT conversations. The investigators expect to include a total of 400 patients and their family caregivers. It is hypothesized that the ACT intervention will decrease use of futile chemotherapy, prepare patients and caregivers for difficult end-of-life-decisions, and improve quality of end-of-life care in hematology.",[584,585,586,30],"Multiple Myeloma","Myelodysplastic Syndromes","Lymphoma",{"date":588,"type":38},"2026-08-12",{"date":590,"type":38},"2022-08-01",{"date":592,"type":23},"2028-07-01",{"name":594,"class":189},"Christoffer Johansen",7]