[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"acute-myeloid-leukemia-aml\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:acute-myeloid-leukemia-aml":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,67,0,25,[9,42,64,104,132,151,181,205,226,247,275,297,322,351,376,403,423,450,481,509,535,555,580,601,623],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100652853","phase-1-study-of-monzosertib-in-patients-with-rr-aml-or-high-risk-myelodysplastic-syndrome-100652853",false,"NCT07780565","Study of Monzosertib In Patients With R\u002FR AML Or High-Risk Myelodysplastic Syndrome","Phase 1b Study of Monzosertib In Patients With Relapsed Or Refractory Acute Myeloid Leukemia Or High-Risk Myelodysplastic Syndrome","Inclusion Criteria:\n\n1. Patients need to be adults ≥18 years with R\u002FR AML, 'MDS\u002FAML', MDS, or CMML, per the ICC 2022 or the WHO 2022 with ≥5% blasts at screening. 6,7\n2. Relapsed or refractory disease is defined as: patient having received and have progressed or relapsed or intolerant to standard regimens, e.g., as listed in NCCN guidelines, or declined treatment with such therapies.\n\n   a. This may include at least one cycle of intensive chemotherapy for AML, or for AML\u002FMDS\u002FCMML at least 2 cycles of BCL2 inhibitor based lower intensity regimen or 4 cycles of HMA-based regimens without BCL2 inhibitor, or clear progression during such treatment.\n3. \"Treated secondary AML\" i.e., patients with antecedent hematological disorder, e.g., MDS, CMML, MPD\u002FMPN, who progress to AML despite receiving treatment adequate for AML (per NCCN) for the antecedent hematological disorder, will be eligible due to recognized poor outcomes similar to R\u002FR AML.\n\n   8,9\n4. Patients with actionable mutations with available FDA-approved therapies, e.g., FLT3, IDH1\u002F2, menin inhibitors may be enrolled after they have exhausted or ineligible for appropriate lines of FDA approved treatment options.\n5. ECOG PS 0 to 2\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 ≥ 30 mL\u002Fmin calculated by the CockcroftGault formula or MDRD equation.\n8. 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.\n9. 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.\n10. Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n1. Patient has a white blood cell count \\> 15 x 10⁹\u002FL. Hydroxyurea, and\u002For cytarabine use as supportive care is permitted to meet this criterion.10\n2. Prior use of any cytotoxic chemotherapy, targeted therapy, immunotherapy, or investigational therapies within 2 weeks or 5 half-lives (whichever is shorter), 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.\n3. Patient has uncontrolled systemic fungal, bacterial, viral or other infection with ongoing signs\u002Fsymptoms despite appropriate treatment.\n4. Decompensated congestive heart failure, clinically significant, uncontrolled arrhythmia prolonged QT interval corrected for heart rate (QTcF) to greater than 450 msec, 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. Acute respiratory failure, unstable or decompensated pulmonary disease\n5. Patients with any severe gastrointestinal or metabolic condition or gastric bypass, which could interfere with absorption of oral drug.\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. Nursing women, women of childbearing potential (WOCBP) with positive urine or serum pregnancy test, or WOCBP who are not willing to maintain adequate contraception.\n12. 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.","ALL","18 Years",{"count":20,"type":21},42,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The goal of this clinical research study is to find the recommended dose of monzosertib in patients with relapsed\u002Frefractory AML and high-risk MDS. The safety and effects of monzosertib will also be studied.",[27,28],"Acute Myeloid Leukemia (AML)","Myelodysplastic Syndrome","NOT_YET_RECRUITING","2026-08-19",{"date":32,"type":33},"2026-08-21","ACTUAL",{"date":35,"type":21},"2027-01-01",{"date":37,"type":21},"2031-08-30",{"name":39,"class":40},"M.D. Anderson Cancer Center","OTHER",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":41},"100652604","improving-delivery-of-aging-related-supportive-care-for-older-adults-with-acute-myeloid-leukemia-100652604","NCT07777471","Improving Delivery of Aging-Related Supportive Care for Older Adults With Acute Myeloid Leukemia","Active Default Pilot: Implementation of Geriatric Assessment-Driven Supportive Care for Older Adults With Acute Myeloid Leukemia Receiving Venetoclax-Based Therapy","ACTIVE DEFAULT","Inclusion Criteria:\n\nPatient participants:\n\n* Age 60 years or older\n* Newly diagnosed acute myeloid leukemia (AML), including de novo, secondary, or therapy-related AML, per current World Health Organization (WHO) or International Consensus Classification (ICC) classification\n* Planned for first-line venetoclax-based lower-intensity therapy\n* English-speaking\n* Able to provide informed consent personally or through a Legally Authorized Representative (LAR)\n\nProvider participants:\n\n-Participating leukemia attending physicians and supportive care service leads involved in the care of enrolled participants\n\nExclusion Criteria:\n\nPatient participants:\n\n* Acute promyelocytic leukemia\n* Planned intensive induction or non-venetoclax-based therapy\n* Life expectancy under 14 days or hospice enrollment at screening",true,{"count":52,"type":21},40,[54],"NA","The goal of this clinical trial is to test a way of delivering supportive care to adults 60 years and older who are starting venetoclax-based treatment for newly diagnosed acute myeloid leukemia (AML). Older adults with AML often have aging-related needs, such as problems with mobility, nutrition, mood, memory, or medications, that are not always addressed in a consistent way. In this study, a health questionnaire and short in-person checks (a geriatric assessment) are used to find these needs early, and matching supportive care orders are prepared in the electronic health record and sent to the treating doctor, who decides whether to place each one. This approach is called Active Default. The main questions the study aims to answer are:\n\n* How often are the prepared supportive care orders signed by treating doctors (implementation fidelity)?\n* Can each step of the process, from completing the assessment to receiving supportive care services, be carried out as planned?\n\nParticipants will:\n\n* Complete questionnaires and short in-person checks of walking, balance, strength, memory, mood, and medications at the start of treatment\n* Receive supportive care services (for example physical therapy, nutrition, or social work) if their doctor approves the prepared orders\n* Answer phone check-ins over 90 days and repeat two short checks at about two months\n* Be invited to one optional interview about their experience\n\nHealthcare providers involved in participants' care will be invited to complete a one-time survey and an optional interview about the approach.",[27],{"date":32,"type":33},{"date":59,"type":21},"2026-10-01",{"date":61,"type":21},"2028-09-30",{"name":63,"class":40},"University of Alabama at Birmingham",{"id":65,"slug":66,"hasResults":12,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":75,"conditions":76,"keywords":77,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":103},"100593505","phase-3-studies-to-assess-ziftomenib-in-combination-with-venaza-or-73-in-patients-with-untreated-npm1-m-or-kmt2a-r-aml-100593505","NCT07007312","Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML","Phase 3 Randomized, Double-blind, Placebo-controlled Studies Assessing Ziftomenib in Combination With Either Standard of Care Nonintensive (Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients With Untreated NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia","Key Inclusion Criteria:\n\nThe following criteria apply to both the Nonintensive Therapy Study and the Intensive Therapy Study unless otherwise noted:\n\n* Age ≥18 years at time of signing the informed consent form.\n* Diagnosis of AML per the 2022 WHO Classification of Hematolymphoid Tumors (5th Edition).\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.\n* Adequate liver and kidney function according to protocol requirements.\n* A female of childbearing potential must agree to use adequate contraception from the time of screening through 180 days following the last dose of study intervention. A male with a female partner of childbearing potential must agree to use abstinence or adequate contraception from the time of screening through 90 days following the last dose of study intervention.\n* NONINTENSIVE THERAPY STUDY ONLY (VEN+AZA):\n\n  1. Documented NPM1-m.\n  2. Patients considered ineligible for Intensive Therapy defined by the following:\n\n     * i. Age ≥75, OR\n     * ii. Age \\\u003C75 with an ECOG performance status of 2 or cardiac, renal, or hepatic impairment per protocol criteria.\n* INTENSIVE THERAPY STUDY ONLY (7+3):\n\n  1. Documented NPM1-m or KMT2A-r (KMT2A-r patients with a partial tandem duplication are not eligible).\n  2. Documented FLT3 wild-type or ITD ratio \\\u003C0.05 OR ineligible to receive FLT3-targeted therapy (medically ineligible or mutation in which FLT3 inhibition is not SOC). Lack of access to an FLT3 inhibitor is not considered \"ineligible\" for FLT3-targeted therapy.\n  3. Ejection fraction of ≥50%.\n  4. Fit for Intensive Therapy per Investigator opinion.\n\nKey Exclusion Criteria:\n\n* Prior therapy for AML (except hydroxyurea or leukapheresis for WBC control).\n* Diagnosis of acute promyelocytic leukemia (APL), blast phase chronic myeloid leukemia, or isolated myeloid sarcoma.\n* Known history of BCR-ABL mutation.\n* History of other active concurrent malignancies prior to study entry except:\n\n  1. Basal cell skin cancer or localized squamous cell cancer of the skin\n  2. Previous malignancy confined and locally resected (or treated with other modalities) with curative intent\n  3. Prostate or breast cancer receiving adjuvant hormonal therapy.\n* Active central nervous system (CNS) involvement by AML.\n* Clinical signs\u002Fsymptoms of leukostasis or white blood cells (WBC) \\>25×10\\^9\u002FL prior to start of ziftomenib\u002Fplacebo. Note: Hydroxyurea and\u002For leukapheresis are permitted to meet this criterion.\n* Known uncontrolled HIV infection or known active hepatitis B virus, hepatitis C virus infection, or other uncontrolled infection.\n* Uncontrolled intercurrent illness including but not limited to, cardiac illness as defined in the protocol.\n* Women who are pregnant or lactating.",{"count":72,"type":21},1300,[74],"PHASE3","Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with eligible genetic alterations. Ziftomenib is a type of therapy known to target the menin pathway in cancer cells.\n\nThis protocol has 2 separate studies that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) AML treatments in patients with certain genetic mutations who have not received any treatment for their AML. In the first study, the Nonintensive Therapy Study, older patients or those with serious medical problems will receive the SOC therapies venetoclax (ven) and azacitidine (aza), plus either ziftomenib or a placebo. In the second study, the Intensive Therapy Study, medically fit patients will receive (a) the SOC therapies cytarabine and daunorubicin, plus either ziftomenib or a placebo during a first treatment phase called induction, (b) cytarabine plus either ziftomenib or a placebo during a second treatment phase called consolidation, and (c) ziftomenib or a placebo during a third treatment phase called maintenance.\n\nThe physician will determine which study is the appropriate treatment for the patient, but neither the patient nor their physician will know whether the patient has been assigned to receive ziftomenib or a placebo. This design is called \"double-blinded\".",[27],[78,79,80,81,82,83,84,85,86,87,88,89,90,91,92],"AML","Hematological malignancy","KMT2A","NPM1","Menin","Acute Leukemia","Leukemia","Acute Myeloid Leukemia","Newly diagnosed AML","Newly diagnosed KMT2A-r AML","Newly diagnosed NPM1m AML","Untreated AML","Untreated NPM1m AML","Untreated KMT2A-r AML","MLL","RECRUITING",{"date":95,"type":33},"2026-08-20",{"date":97,"type":33},"2025-09-26",{"date":99,"type":21},"2031-11",{"name":101,"class":102},"Kura Oncology, Inc.","INDUSTRY",115,{"id":105,"slug":106,"hasResults":12,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":119,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":41},"100636402","phase-1-thiotepa-based-conditioning-regimen-with-de-escalated-post-graft-cyclophosphamide-for-allogeneic-stem-cell-transplantation-in-hematologic-malignancies-100636402","NCT07565220","Thiotepa-based Conditioning Regimen With De-escalated Post-graft Cyclophosphamide for Allogeneic Stem Cell Transplantation in Hematologic Malignancies","Phase 1 Trial of Thiotepa-based Conditioning Regimen With De-escalated Post-graft Cyclophosphamide for Allogeneic Stem Cell Transplantation in Hematologic Malignancies","Inclusion Criteria:\n\n1. Patients must be considered appropriate candidates for either the low- or high-intensity conditioning regimen for allogeneic hematopoietic stem cell transplantation based on the following age-related criteria:\n\n   1. Age 50-70 years old or\n   2. Age 18-49 and unfit for a conventional myeloablative conditioning regimen per the treating physician\n2. Patients have one of the following diagnoses:\n\n   1. Acute lymphocytic leukemia (ALL) in first or subsequent morphological remission (\\\u003C5% marrow blasts by morphology).\n   2. Acute myeloid leukemia (AML) in first or subsequent morphological remission (\\\u003C5% marrow blasts by morphology) with or without hematologic recovery.\n   3. Other acute leukemia or related neoplasm (including but not limited to 'mixed phenotype' 'biphenotypic', 'acute undifferentiated' or 'ambiguous lineage' acute leukemia, blastic plasmacytoid dendritic cell neoplasm, lymphoblastic lymphoma, Burkitt leukemia\u002Flymphoma, mast cell leukemia or chronic myeloid leukemia with blast crisis) in first or subsequent morphological remission (\\\u003C5% marrow blasts by morphology) with or without hematologic recovery.\n   4. Myelodysplastic syndrome (MDS) with a history of excess blasts, with \\>5% marrow blasts by morphology after receiving at least one cycle of treatment, including but not limited to hypomethylating agent, BCL-2 inhibitor, cytoreductive chemotherapy.\n   5. High-risk myeloproliferative neoplasm (MPN) with no evidence of high-grade bone marrow fibrosis or massive splenomegaly at the time of enrollment.\n3. Patients with an 8\u002F8 HLA-matched (HLA-A, B, C, DRB1) related or unrelated donor capable of donating peripheral blood stem cells (PBSC)\n4. Provision of signed and dated informed consent form\n5. Sexually active fertile subjects and their partners must agree to use highly effective methods of contraception prior to study entry, during the course of the study, and until tacrolimus or other immunosuppressive therapy for GVHD is discontinued (whichever is later). An additional contraceptive method, such as a barrier method (e.g., condom), is required. In addition, men must agree not to donate sperm and women must agree not to donate eggs (ova, oocyte) for the purpose of reproduction during these same periods.\n6. Female subjects of childbearing potential must not be pregnant or breastfeeding at screening. Female subjects are considered to be of childbearing potential unless one of the following criteria is met:\n\n   1. Permanent sterilization (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or documented postmenopausal status (defined as 12 months of amenorrhea in a woman \\> 45 years-of-age in the absence of other biological or physiological causes). Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff.\n\nExclusion Criteria:\n\nSubjects will be excluded from the study if they meet any of the following criteria.\n\nFor high-intensity regimen:\n\n1. Poor performance status with Karnofsky Score \\\u003C70%\n2. Center for International Blood and Marrow Transplant Research (CIBMTR) hematopoietic cell transplant co-morbidity index (HCT-CI) score \\>5\n3. Patients with active central nervous system (CNS) involvement refractory to intrathecal chemotherapy and\u002For standard craniospinal radiation.\n4. Patients who are positive for HIV-1, HIV-2, HTLV1 or HTLV2.\n5. Patients with uncontrolled infections for whom alloSCT is considered contraindicated by the consulting infectious disease physician.\n6. Patients with organ dysfunction, including:\n\n   1. Renal insufficiency creatinine clearance \\\u003C45 ml\u002Fmin\u002F1.72m2 measured by 24-hr urine specimen\n   2. Left ventricular ejection fraction \\\u003C45%\n   3. Diffusing capacity of the lung for carbon monoxide (DLCO) corrected \\\u003C50% or FEV1 \\\u003C50%\n   4. Liver function abnormality: total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) \\>5 times the upper limit of normal should be evaluated by a gastroenterologist. If a gastroenterologist considers that alloSCT is contraindicated, the patient will be excluded from the protocol.\n7. Patients who have received previous allogeneic transplantation.\n8. Patients with a life expectancy \\\u003C12 months due to co-existing diseases other than hematologic malignancies.\n9. Patients with any other significant medical conditions that would make them unsuitable for transplantation, as determined by the PI.\n10. Patients with a known hypersensitivity to cyclophosphamide, thiotepa, fludarabine, busulfan, tacrolimus, or mycophenolate mofetil (MMF).\n11. Patients who have received checkpoint inhibitors within three months of transplantation, unless an exception is made by the PI.\n\nFor low-intensity regimen\n\n1. Poor performance status with Karnofsky Score \\\u003C60%\n2. Patients with active CNS involvement refractory to intrathecal chemotherapy and\u002For standard craniospinal radiation.\n3. Patients who are positive for HIV-1, HIV-2, HTLV1 or HTLV2.\n4. Patients with uncontrolled infections for whom alloSCT is considered contraindicated by the consulting infectious disease physician.\n5. Patients with organ dysfunction, including:\n\n   1. Renal insufficiency creatinine clearance \\\u003C40 ml\u002Fmin\u002F1.72m2 measured by 24-hr urine specimen\n   2. Left ventricular ejection fraction \\\u003C40%\n   3. DLCO corrected\\\u003C 50% or FEV1\\\u003C50%\n   4. Liver function abnormality: total bilirubin, AST, ALT\\>5 times the upper limit of normal should be evaluated by a gastroenterologist. If a gastroenterologist considers that alloSCT is contraindicated, the patient will be excluded from the protocol.\n6. Patients who have received previous allogeneic transplantation.\n7. Patients with a life expectancy \\\u003C12 months from co-existing disease other than hematologic malignancies\n8. Patients with any other significant medical conditions that would make them unsuitable for transplantation, as determined by the PI.\n9. Patients with a known hypersensitivity to cyclophosphamide, thiotepa, fludarabine, busulfan, tacrolimus, or mycophenolate mofetil (MMF).\n10. Patients who have received checkpoint inhibitors within three months of transplantation, unless an exception is made by the PI.",{"count":112,"type":21},48,[24],"This phase 1 trial will investigate the safety and effectiveness of Thiotepa, Busulfan, and Fludarabine (TBF) conditioning regimen with post-transplant cyclophosphamide (PTCy) in HLA-matched related or unrelated donor allogeneic stem cell transplantation (alloSCT).",[116,27,83,117,118],"Acute Lymphocytic Leukemia (ALL)","Myelodysplastic Syndrome(MDS)","Myeloproliferative Neoplasm (MPN)",[120,121,122],"allogeneic hematopoietic stem cell transplantation","HLA","graft-versus-host disease (GVHD)","2026-08-17",{"date":125,"type":33},"2026-08-18",{"date":127,"type":33},"2026-07-27",{"date":129,"type":21},"2030-11-01",{"name":131,"class":40},"Sawa Ito, MD",{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":140,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":41},"100597017","phase-1-a-phase-1b2-open-label-dose-ranging-safety-and-efficacy-study-of-oral-cladribine-in-patients-with-acute-myeloid-leukemia-aml-100597017","NCT07053020","A Phase 1 Open-Label, Dose-Ranging Safety and Pharmacokinetics Study of Oral Cladribine in Patients With Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n1. Provision of written informed consent prior to any study related procedures.\n2. Disease characteristics, defined as:\n\n   Part 1:\n\n   Dose-escalation cohorts: Patients with relapsed and\u002For refractory AML.\n\n   Part 2:\n\n   Cohort A: Patients aged .18 years with newly diagnosed ts-AML, defined as patients with prior diagnosis of MDS, treated with hypomethylating agents who have then progressed to AML. Prior therapy with hydroxyurea, hematopoietic growth factors, HMA, ATRA, or a total dose of cytarabine up to 2g (for emergency use for stabilization) is allowed.\n\n   Cohort B: Patients aged . 60 years with newly diagnosed AML with monocytic phenotype, defined as AML-M5 by FAB or flow cytometry, and\u002For patients . 60 years with newly diagnosed AML with RAS mutations. Patients aged \\\u003C 60 years who are unsuitable for standard induction therapy may be eligible after discussion with primary investigator.\n3. Adequate renal and hepatic organ function as indicated by the following laboratory values:\n\n   * Serum creatinine . 2.0xupper limit of normal (ULN)\n   * Serum total bilirubin .2xULN (with the exception of patients with known Gilbert's syndrome: serum total bilirubin must be \\\u003C3xULN in these patients)\n   * Aspartate aminotransferase (serum glutamic oxaloacetic transaminase) and alanine aminotransferase (serum glutamic pyruvic transaminase) .2.5xULN or .5xULN if due to leukemic involvement)\n4. Adequate cardiac function with a left ventricular ejection fraction .50%\n5. Female participants are eligible to enter and participate in the study if they are of nonchildbearing potential. Female participants of childbearing age must use at least 2 forms of effective birth control during the study treatment period and for at least 90 days after the last dose of investigational product.\n6. Male participants are eligible to enter and participate in the study if they agree to use effective methods of contraception during the study treatment period and for at least 90 days after the last dose of investigational product.\n\nExclusion Criteria:\n\n1. Uncontrolled intercurrent illness including, but not limited to ongoing or active uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n2. History of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the compounds in the study.\n3. Legal incapacity or limited legal capacity.\n4. Inability to swallow oral medications (capsules and tablets) without chewing, breaking, crushing, opening or otherwise altering the product formulation.\n5. Patients unwilling to comply with protocol requirements related to the assigned part.\n6. Patients with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n7. Pregnant women are excluded from this study because the agents used in this study have the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with chemotherapy agents, breastfeeding should also be avoided.",{"count":139,"type":21},58,[24,141],"PHASE2","The goal of Part 1 of this clinical research study is to find the highest tolerable dose of cladribine that can be given in combination with low dose cytarabine (LDAC) and venetoclax to patients who have AML.\n\nThe goal of Part 2 of this clinical research study is to learn if the dose of cladribine found in Part 1, when combined with LDAC and venetoclax, can help to control the disease.",[27],"2026-08-14",{"date":123,"type":33},{"date":147,"type":21},"2027-12-01",{"date":149,"type":21},"2030-06-30",{"name":39,"class":40},{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":158,"enrollmentInfo":159,"targetDuration":4,"studyType":22,"phases":161,"briefSummary":162,"conditions":163,"keywords":170,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":41},"100616220","phase-1-tacrolimus-targeted-immunosuppression-cessation-in-allogeneic-hct-100616220","NCT07302776","TACrolimus Targeted Immunosuppression Cessation in ALlogeneic HCT","TACTICAL: TACrolimus Targeted Immunosuppression Cessation in ALlogeneic HCT","Inclusion Criteria:\n\n* Eligible diseases:\n\n  * Acute myeloid leukemia (AML) in complete remission (CR), CR with incomplete hematologic recovery (CRi), or MLFS.\n  * Myelodysplasic syndrome (MDS) myelodysplastic syndromes eligible for alloHSCT based on IPSS-M of intermediate or higher, or IPSS-R of intermediate or higher, or refractory disease to standard growth factor or hypomethylating agent-based therapy\n  * Myelofibrosis (MF)\n  * Chronic myeloid leukemia (CML) in chronic phase with a prior history of accelerated phase or blast crisis or CML in chronic phase refractory to standard TKI therapy\n  * Chronic myelomonocytic leukemia (CMML)\n* Age ≥ 18 and ≤ 80 years at the time of enrollment.\n* Planned for first myeloablative or reduced intensity allogenic transplant using a conditioning regimen listed in Appendix B.\n* Has a related or unrelated donor available who is 8\u002F8 HLA match at HLA-A, -B, -C, and -DRB1, all typed using DNA-based high-resolution methods.\n* Estimated glomerular filtration rate (eGFR) ≥ 50 mL\u002Fminute or creatinine \\\u003C 2 mg\u002FdL.\n\nCardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA).\n\n* Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50%.\n* Total bilirubin \\\u003C 2 times upper limit of normal (ULN) (patients with Gilbert's syndrome may be included once hemolysis has been excluded).\n* Karnofsky Performance Score ≥70%\n* Negative serum or urine beta-HCG test in females of childbearing potential (FCBP) within 3 weeks of enrollment.\n\nA female of childbearing potential (FCBP) is a female who: 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\n-Ability to understand and the willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Prior allogeneic HCT.\n* Planned donor lymphocyte infusion (DLI).\n* Recipient positive anti-donor HLA antibodies against a mismatched allele in the selected donor determined by either:\n\n  1. Positive crossmatch test of any titer (by complement-dependent cytotoxicity or flow cytometric testing), or\n  2. Presence of anti-donor HLA antibody to any of the following HLA loci: HLA-A, -B, -C, -DRB1, -DQB1, -DQA1, -DPB1, or -DPA1, with mean fluorescence intensity (MFI) \\>1000 by solid phase immunoassay.\n* Uncontrolled bacterial, viral, or fungal infections at time of enrollment including known, active tuberculosis infection.\n* Seropositive for HIV-1 or -2, HTLV-1 or -2, Hepatitis B sAg, and\u002For Hepatitis C antibody.\n\n  \\*History of hepatitis B or hepatitis C is permitted if viral load is undetectable per quantitative PCR and\u002For NAT.\n\nKnown allergy or hypersensitivity to planned GVHD prophylactic medications including PTCy, tacrolimus\n\n* Any uncontrolled autoimmune disease requiring active immunosuppressive treatment.\n* Concurrent malignancy diagnosed within 12 months of enrollment, except non-melanoma skin cancers or other early-stage solid tumors that have been curatively resected or treated to curative intent. Patients with history of low grade concurrent blood cancers that are controlled will be eligible.\n* Females of childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use effective forms of birth control or abstinence for one year after transplantation.\n\n(FCBP definition: A female of childbearing potential (FCBP) is a female who: 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\n-Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the recipient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results.\n\n\\* All subject files must include supporting documentation to confirm subject eligibility.","80 Years",{"count":160,"type":21},50,[24],"The purpose of this study is to test the feasibility and safety of early cessation of tacrolimus following allogeneic hematopoietic cell transplantation (HCT). Post-HCT tacrolimus is given to prevent graft-vs-host-disease (GVHD), but with the use of post-transplant cyclophosphamide (PTCy), the modern approach to GVHD prevention, GVHD rates have reduced markedly.",[164,165,27,166,167,168,169],"GVHD","Hematopoietic Cell Transplantation (HCT)","Myelodysplastic Syndromes","Myelofibrosis (MF)","Chronic Myeloid Leukemia (CML)","Chronic Myelomonocytic Leukemia (CMML)",[171,172],"Post-Hematopoietic Cell Transplant (HCT) tacrolimus","hematopoietic cell transplantation (HCT)","2026-08-13",{"date":123,"type":33},{"date":176,"type":33},"2026-07-21",{"date":178,"type":21},"2028-02",{"name":180,"class":40},"Stanford University",{"id":182,"slug":183,"hasResults":12,"nctId":184,"briefTitle":185,"officialTitle":186,"acronym":4,"eligibilityCriteria":187,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":188,"targetDuration":4,"studyType":22,"phases":190,"briefSummary":191,"conditions":192,"keywords":194,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":41},"100651391","phase-1-pbss1113-in-combination-with-azacitidine-to-treat-patients-with-amlmds-100651391","NCT07761533","PBSS1113 in Combination With Azacitidine to Treat Patients With AML\u002FMDS","A Phase Ib\u002FII, Open-Label, Dose-Escalation and Cohort Expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of PBSS1113 in Combination With Azacitidine in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome","Inclusion Criteria:\n\n* Age and Gender: Age ≥ 18 years at the time of signing the informed consent form, male or female.\n* Disease Status: Must meet one of the following diagnostic criteria:\n* Relapsed or refractory (R\u002FR) acute myeloid leukemia (AML).\n* Newly diagnosed AML in patients who are ineligible for intensive induction chemotherapy (including primary AML or secondary AML arising from myelodysplastic syndromes \\[MDS\\]).\n* Higher-risk MDS, defined per the Revised International Prognostic Scoring System (IPSS-R) as Intermediate risk (score \\> 3.5 points), High risk, or Very High risk. Prior therapy with hypomethylating agents (HMAs, e.g., decitabine or azacitidine) is permitted.\n* Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.\n* Life Expectancy: Expected survival period ≥ 3 months.\n* Organ Function: Baseline organ function meeting the following laboratory criteria:\n* Hepatic: Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN.\n* Renal: Serum creatinine ≤ 1.5 × ULN.\n* Coagulation: Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; prothrombin time (PT) ≤ 1.5 × ULN; International Normalized Ratio (INR) ≤ 1.5 × ULN.\n* Cardiac: Fridericia-corrected QT interval (QTcF) \\\u003C 450 ms for males and \\\u003C 470 ms for females.\n* Compliance: Able and willing to adhere to the study procedures, scheduling, and follow-up examinations outlined in the protocol.\n* Informed Consent: Capable of understanding and voluntarily providing written informed consent prior to the initiation of any trial-specific screening procedures.\n\nExclusion Criteria:\n\n* Leukemia Subtypes: Diagnosis of acute promyelocytic leukemia (APL), classified as AML-M3 per the French-American-British (FAB) criteria or APL with PML-RARA fusion gene per standard diagnostic classifications.\n* Concomitant Malignancies: Diagnosis of another active malignant tumor within the screening period, except for the target AML or MDS indications (as evaluated by the investigator).\n* Hyperleukocytosis: White blood cell (WBC) count \\> 25 × 10⁹\u002FL during screening. Note: Hydroxyurea use is permitted to stabilize the WBC count below this threshold prior to first dose.\n* Contraception: Female patients of childbearing potential, male patients, and their partners who are unwilling to practice a medically accepted, highly effective method of contraception during the treatment period and for at least 6 months following the final dose of the investigational drug. Note: Women are considered postmenopausal if they have experienced at least 12 consecutive months of amenorrhea with no alternative pathological cause.\n* Prior\u002FConcomitant Therapies:\n* Received radiotherapy, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, traditional Chinese medicine indicated for oncology, chemotherapy, or any other investigational agent within 14 days prior to the first dose of the study drug.\n* Prior allogeneic hematopoietic stem cell transplantation (HSCT) with evidence of active graft-versus-host disease (GVHD), or requiring systemic immunosuppressive therapy for GVHD.\n* Use of strong CYP3A inhibitors or inducers within 14 days prior to the first dose of the study drug (unless on a stable, clinically justified regimen approved by the investigator).\n* Residual Toxicity: Unresolved toxicities from prior anti-cancer therapies that have not recovered to ≤ Grade 1 per CTCAE v5.0 (excluding alopecia and stable Grade 2 peripheral neuropathy, if applicable).\n* Surgery: Major surgical procedures or significant traumatic injuries within 28 days prior to the first dose of the study drug, or an anticipated requirement for major surgery during the trial.\n* Gastrointestinal Disorders: Difficulty swallowing or any clinically significant gastrointestinal disease or malabsorption syndrome that would significantly impair the oral absorption of the investigational drug.\n* Infections and Comorbidities:\n* Active, clinically significant, or poorly controlled fungal, bacterial, or viral infections at baseline.\n* Known human immunodeficiency virus (HIV) infection (anti-HIV positive).\n* Active hepatitis B virus (HBV; HBsAg positive and HBV DNA ≥ 2000 copies\u002FmL or ≥ 500 IU\u002FmL) or active hepatitis C virus (HCV; HCV antibody positive and HCV RNA positive).\n* Active syphilis infection.\n* Any severe, poorly controlled systemic comorbidities (e.g., unstable psychiatric, neurological, cardiovascular, respiratory, hepatic, or renal diseases).\n* Hypersensitivity: Known hypersensitivity or allergy to the investigational drug (PBSS1113), azacitidine, or any of their excipients.\n* Investigator Discretion: Any other clinical condition or social circumstance that, in the opinion of the investigator, would compromise patient safety or interfere with the scientific integrity of the study data.",{"count":189,"type":21},29,[24,141],"Acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) are highly heterogeneous myeloid malignancies where few effective targeted therapies are available. While venetoclax has significantly advanced the treatment landscape, therapeutic resistance remains a critical challenge. Consequently, patients with relapsed or refractory (R\u002FR) AML\u002FMDS face a profound unmet medical need for novel therapeutic options. PBSS1113 has demonstrated robust anti-leukemic activity in both in vitro and in vivo models, alongside an acceptable safety profile in a Phase I study. This Phase Ib\u002FII trial will evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of PBSS1113 in combination with azacitidine for treatment-naive unfit AML, R\u002FR AML, and higher-risk MDS populations.",[27,193],"MDS (Myelodysplastic Syndrome)",[78,195,196],"MDS","PBSS1113","2026-08-12",{"date":144,"type":33},{"date":200,"type":33},"2025-09-08",{"date":202,"type":21},"2027-09",{"name":204,"class":102},"Chaser Therapeutics, Inc.",{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":12,"sex":17,"minAge":212,"maxAge":213,"enrollmentInfo":214,"targetDuration":4,"studyType":22,"phases":216,"briefSummary":217,"conditions":218,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":41},"100453717","phase-1-niclosamide-in-pediatric-patients-with-relapsed-and-refractory-aml-100453717","NCT05188170","Niclosamide in Pediatric Patients With Relapsed and Refractory AML","Phase 1 Study of Niclosamide (ANA001) in Pediatric Patients With Relapsed and Refractory AML","Inclusion Criteria:\n\n1\\. Prior morphologically-confirmed diagnosis of AML based on WHO Criteria 2. Has previously failed all available and suitable therapies for AML. Disease relapse or the presence of refractory disease after ≥ 2 cycles of intensive chemotherapy; or ≥ 4 cycles of non-intensive chemotherapy or hypomethylating agents (HMAs) must be documented by bone marrow (BM) examination demonstrating ≥ 5% blasts in the BM by morphology or ≥ 1% blasts by flow cytometry,\n\n* 5% blasts in the peripheral blood (confirmed by flow cytometry, cytogenetics or FISH), ≥ 1% MRD\n\n  \\+ by flow cytometry, FISH, PCR or NGS, and not attributable to another cause (EXCEPTION: subjects with frank disease progression in the face of treatment with HMA with or without venetoclax will be considered eligible regardless of treatment cycles administered if they meet the other eligibility criteria). No prior treatment with niclosamide. 3. Age ≥ 2 and ≤ 30 years 4. Body surface area (BSA) ≤ 2.10 m2\n\n  , calculated per the Mostellar formula 5. Must be able to tolerate po or ng medications. 6. Performance status: Subject ≤ 16 years old: Lansky ≥ 50 Subject \\> 16 years old: Karnofsky ≥ 50% 7. Life expectancy of greater than 4 weeks 8. Platelets ≥ 10,000\u002Fmm3 (for subjects with platelets \\\u003C 10,000\u002Fmm3 at baseline, platelet transfusion support is allowed) 9. Measured or calculated creatinine clearance\n* 60 mL\u002Fmin\u002F1.73 m2 (by the Cockcroft-Gault method) within 14 days prior to treatment initiation 10. Total bilirubin ≤ 2.0 x institutional upper limit of normal (ULN) within 14 days prior to treatment initiation (EXCEPTION: Subjects with Gilbert's syndrome may be included if the total bilirubin is\n\n  * 3.0 x ULN) 11. SGOT (AST) ≤ 3.0 x ULN and SGPT (ALT)\n  * 3.0 x ULN within 14 days prior to treatment initiation 12. Patients must have received their last dose of anti-cancer therapy (chemotherapy, immunotherapy, targeted agents, radiotherapy or investigational therapy) at least 2 weeks or 3 half-lives prior to the start of study treatment, whichever is longer. 13. For patients who have received prior hematopoietic stem cell transplants (HSCT), no evidence of GvHD and must be \\> 60 days since the HSCT. HSCT recipients must have completed their last course of tacrolimus, cyclosporine, or mycophenolate \\> 4 weeks before initiation of niclosamide 14. Females of reproductive potential (WOCBP) must have a negative pregnancy test within 14 days prior to study treatment. WOCBP must agree to use adequate contraception (eg, hormonal or barrier methods of birth control; abstinence; sterilized partner) from date of consent through the treatment period, and for 30 days after completion of niclosamide administration 15. Men only: Men must agree to use adequate contraception (eg, hormonal or barrier methods of birth control; abstinence; sterilized partner) from date of consent through the treatment period, and for 30 days after completion of niclosamide administration 16. Ability to understand the purpose and risks of the study and the willingness to sign a written informed consent document containing an authorization to use protected health information (in accordance with national and local subject privacy regulations\n\nExclusion Criteria:\n\n1. Received anticancer therapy (chemotherapy, immunotherapy, radiotherapy, or investigational therapy) within 2 weeks prior to starting study treatment. Administration of hydroxyurea 10 to 20 mg\u002Fkg\u002Fday PO (maximum 1000 mg PO BID) to control high WBC \\> 50 x 103\n\n   \u002Fmm3 is permitted at MD discretion (however, hydroxyurea should be stopped at least 24 hours prior to protocol therapy start).\n2. Receiving any other investigational agents, including niclosamide.\n3. Unresolved toxicities due to prior anticancer therapy, defined as not having resolved to Grade 0 or 1 (by CTCAE version 5 criteria), unless otherwise defined in the inclusion\u002Fexclusion criteria with the exception of alopecia\n4. Acute promyelocytic leukemia (French-American-British Class M3-AML)\n5. Known active central nervous system (CNS) leukemia; subjects can enroll on study if CNS disease can be cleared with intrathecal chemotherapy, in the judgement of the treating physician\n6. Known congenital bleeding disorders, including but not limited to hemophilia\n7. Known active uncontrolled systemic infection\n8. Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, uncontrolled symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction, at the time of study entry\n9. Inability to receive administration of niclosamide in the available formulation(s)\n10. Uncontrolled intercurrent illness including, but not limited to, uncontrolled active infection, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n11. Lactating or pregnant female\n12. Known active hepatitis C","2 Years","25 Years",{"count":215,"type":21},16,[24],"Protocol is designed to evaluate a niclosamide dose escalation scale in combination with cytarabine as a therapeutic modality for pediatric subjects with relapsed\u002Frefractory acute myeloid leukemia.",[27],"2026-08-10",{"date":197,"type":33},{"date":222,"type":33},"2022-11-21",{"date":224,"type":21},"2026-12",{"name":180,"class":40},{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":12,"sex":17,"minAge":233,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":22,"phases":236,"briefSummary":237,"conditions":238,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":240,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":4},"100650927","a-randomized-phase-ii-selection-trial-of-venetoclax-based-induction-intensity-in-newly-diagnosed-acute-myeloid-leukemia-100650927","NCT07754799","A Randomized Phase II Selection Trial of Venetoclax-Based Induction Intensity in Newly Diagnosed Acute Myeloid Leukemia","VISTA-AML- Venetoclax Intensity Selection Trial in AML: A Randomized Phase II Selection Trial of Venetoclax-Based Induction Intensity in Newly Diagnosed Acute Myeloid Leukemia","Inclusion Criteria:\n\n* Diagnosis of AML per WHO (2022) or ICC criteria, and MDS\u002FAML as defined by ICC (with bone marrow blast percentage of 10%-20%).\n* Age ≥14 years, male or female.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n* Judged by the investigator to be suitable for intensive induction chemotherapy and expected to tolerate the treatment intensity specified in the protocol.\n* Meet the following laboratory test requirements (assessed within 7 days prior to treatment):\n\n  1. Total bilirubin ≤1.5 × upper limit of normal (ULN) for the same age group;\n  2. AST and ALT ≤2.5 × ULN for the same age group;\n  3. Serum creatinine \\\u003C2 × ULN for the same age group;\n  4. Cardiac enzymes \\\u003C2 × ULN for the same age group;\n  5. Cardiac ejection fraction determined by echocardiography (ECHO) within the normal range.\n* Written informed consent must be signed before any study specific procedures are initiated, by the patient themselves or by their immediate family members. If, in consideration of the patient's medical condition, signing by the patient themselves would be detrimental to their treatment, the informed consent may be signed by the legally authorized representative or the patient's immediate family members.\n\nExclusion Criteria:\n\n* Acute promyelocytic leukemia with PML-RARA fusion gene.\n* Acute myeloid leukemia with RUNX1-RUNX1T1 or CBFB-MYH11 fusion gene.\n* Acute myeloid leukemia with BCR-ABL fusion gene.\n* Presence of FLT3 mutation (these patients are recommended to be enrolled in clinical trials of FLT3 inhibitors).\n* Patients who have previously received induction chemotherapy (however, cytoreductive therapy such as hydroxyurea is permitted).\n* Concurrent malignancy of other organs that requires treatment.\n* Active cardiac disease, defined as one or more of the following:\n\n  1. History of uncontrolled or symptomatic angina pectoris;\n  2. Myocardial infarction within 6 months prior to study enrollment;\n  3. History of arrhythmia requiring medication or with clinically significant symptoms;\n  4. Uncontrolled or symptomatic congestive heart failure (\\> NYHA class 2).\n* Serious infectious diseases (e.g., active tuberculosis, pulmonary aspergillosis).\n* Patients deemed unsuitable for enrollment by the investigator.","14 Years",{"count":235,"type":21},320,[141],"This randomized, open label, multi arm phase II trial will evaluate the efficacy and safety of venetoclax based induction regimens of varying intensity (VA, VAM, or 2+5+V) versus standard 3+7 in fit patients aged ≥14 years with newly diagnosed AML. The trial is designed to select the optimal regimen as the experimental arm for a subsequent phase III randomized controlled trial.\n\nA total of 320 patients will be enrolled in this study，and segregated into four groups with 80 in each group. Patients who achieve CR\u002FCRi\u002FCRh after using different induction regimens will receive the same consolidation. Allogeneic hematopoietic stem cell transplantation is recommended for patients in the high-risk group or those with persist MRD positivity. After completion of the treatment phase, patients entered the follow-up period.",[27],"2026-08-05",{"date":219,"type":33},{"date":242,"type":21},"2026-09-30",{"date":244,"type":21},"2029-09-30",{"name":246,"class":40},"Institute of Hematology & Blood Diseases Hospital, China",{"id":248,"slug":249,"hasResults":12,"nctId":250,"briefTitle":251,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":12,"sex":17,"minAge":253,"maxAge":158,"enrollmentInfo":254,"targetDuration":4,"studyType":22,"phases":256,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":239,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":41},"100446362","phase-1-phase-iii-study-of-car70--engineered-il15-transduced-cord-blood-derived-nk-cells-in-conjunction-with-lymphodepleting-chemotherapy-for-the-management-of-relapserefractory-hematological-malignances-100446362","NCT05092451","Phase I\u002FII Study of CAR.70- Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse\u002FRefractory Hematological Malignances","Inclusion criteria:\n\n1. Patients with hematological malignances with an expression of CD70 in the pre-enrollment tumor sample ≥ 10% measured by immunohistochemistry or flow cytometry.\n2. Patients must meet diseases specific eligibility criteria (see below)\n3. Patients at least 1 week from last cytotoxic chemotherapy at the time of starting lymphodepleting chemotherapy, except for Hydroxyurea which is allowed for peripheral blood count control in AML, CML, and MDS patients until the day prior to administration of lymphodepleting chemotherapy. Patients may continue tyrosine kinase inhibitors or other targeted therapies until up to three days prior to administration of lymphodepleting chemotherapy.\n4. Localized radiotherapy to one or more disease sites is allowed prior the infusion provided that there are additional disease sites that are not irradiated to assess response\n5. Karnofsky Performance Scale \\> 50% for patients who are \\>16 years old or Lansky score ≥50% for patients who are ≤16 years of age.\n6. Adequate organ function:\n\n   1. Renal: Serum creatinine \\\u003C\u002F= 2x ULN or estimated Glomerular Filtration Rate \\>\u002F= 30 ml\u002Fmin\u002F1.73 m2\n   2. Hepatic: ALT\u002FAST \\\u003C\u002F= 3 x ULN or \\\u003C\u002F= 5 x ULN if documented liver metastases, Total bilirubin \\\u003C\u002F2xULN, except in subjects with Gilbert's Syndrome in whom total bilirubin must be \\\u003C\u002F= 3 x.ULN. No history of liver cirrhosis. No ascites.\n   3. Cardiac: Cardiac ejection fraction \\>\u002F= 40%, no clinically significant pericardial effusion as determined by an ECHO, and no uncontrolled arrhythmias or symptomatic cardiac disease.\n   4. Pulmonary: No clinically significant pleural effusion (per PI discretion), baseline oxygen saturation \\> 92% on room air and adequate pulmonary function with FEV1, FVC and DLCO (corrected for Hgb) \\>50%.\n7. Able to provide written informed consent.\n8. 12-80 years of age.\n9. Weight ≥40 kg\n10. All participants who are able to have children must practice effective birth control while on study and up to 3 months post completion of study therapy. Acceptable forms of birth control for female patients include: hormonal birth control, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence, for the length of the study. If the participant is a female and becomes pregnant or suspects pregnancy, she must immediately notify her doctor. If the participant becomes pregnant during this study, she will be taken off this study. Men who are able to have children must use effective birth control while on the study. If the male participant fathers a child or suspects that he has fathered a child while on the study, he must immediately notify his doctor.\n11. Signed consent to long-term follow-up protocol PA17-0483 to fulfill the institutional responsibilities to various regulatory agencies.\n12. Are willing and able to provide informed consent, as appropriate (either directly or through a legally authorized representative \\[LAR\\])\n\nExclusion criteria:\n\n1. Positive beta HCG in female of child-bearing potential defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females.\n2. Presence of clinically significant Grade 3 or greater toxicity from the previous treatment, as determined by PI.\n3. Presence of uncontrolled fungal, bacterial, viral, or other infection not responding to appropriate therapy.\n4. HIV with detectable viral load\n5. Presence of active neurological disorder(s).\n6. Active autoimmune disease within 12 months of enrollment\n7. Amyloidosis or POEMS syndrome\n8. Active cerebral or meningeal involvement by the malignancy\n9. Active (defined as requiring therapy) acute or chronic GVHD\n10. Any other malignancy known to be active, except for treated cervical intra-epithelial neoplasia and non-melanoma skin cancer.\n11. Presence of any other serious medical condition that may endanger the patient at investigator discretion.\n12. Major surgery \\\u003C4 weeks prior to first dose of the preparatory chemotherapy\n13. Allogeneic SCT or DLI \\\u003C12 weeks prior to first dose of preparatory chemotherapy\n14. Concomitant use of other investigational agents.\n15. Concomitant use of other anti-cancer agents.\n16. Patients receiving systemic steroid therapy at time of NK cell infusion (physiological substitutive doses are allowed), or have received antithymocyte globulin or lymphocyte immune globulin within 14 days of enrollment or alemtuzumab within 28 days of enrollment.\n17. Patients receiving immunosuppressive therapy","12 Years",{"count":255,"type":21},80,[24,141],"The goal of this clinical research study is to learn about the safety of giving immune cells called natural killer (NK) cells with chemotherapy to patients with leukemia, lymphoma, or multiple myeloma.\n\nImmune system cells (such as NK cells) are made by the body to attack foreign or cancerous cells. Researchers think that NK cells you receive from a donor may react against cancer cells in your body, which may help to control the disease.",[259,260,27,261,262,263,264,265,266,267],"B-Cell Lymphoma","Myelodysplastic Syndromes (MDS)","Multiple Myeloma","Plasma Cell Leukemia","Hodgkin Lymphoma","T-cell Non-Hodgkin's Lymphoma\u002F T-cell Acute Lymphoblastic Leukmeia","Myelodysplastic Syndrome \u002F Chronic Myelomonocytic Leukemia","Blastic Transformation of Chronic Myeloid Leukemia","Germ Cell Tumors",{"date":269,"type":33},"2026-08-07",{"date":271,"type":33},"2022-11-01",{"date":273,"type":21},"2030-08-31",{"name":39,"class":40},{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":281,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":17,"minAge":283,"maxAge":4,"enrollmentInfo":284,"targetDuration":4,"studyType":285,"phases":4,"briefSummary":286,"conditions":287,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":41},"100644594","venetoclax-tdm-in-newly-diagnosed-aml-exposure-response-and-prognosis-100644594","NCT07670130","Venetoclax TDM in Newly Diagnosed AML: Exposure-Response and Prognosis","Exposure-Response and Prognostic Analysis of Venetoclax Therapeutic Drug Monitoring in Newly Diagnosed AML","ND-AML","Inclusion Criteria:\n\n1. Diagnosis: Newly diagnosed acute myeloid leukemia (AML) confirmed according to the WHO 2022 or International Consensus Classification (ICC) criteria, based on bone marrow morphology, flow cytometry, and molecular genetics. Acute promyelocytic leukemia (APL) is excluded.\n2. Treatment regimen: Planned or already initiated first-line therapy with venetoclax plus azacitidine (VEN-AZA), with dosing determined by the treating physician according to routine clinical practice (no protocol-mandated dose restrictions).\n3. Age: ≥ 16 years.\n4. Informed consent: Willingness and ability to provide written informed consent for participation in this observational study.\n5. Follow-up: Agreement to attend scheduled follow-up visits and to permit clinical data collection at the time points specified in the study protocol.\n\nExclusion Criteria:\n\n1. Prior AML therapy: Prior treatment for AML, with the exception of leukapheresis, hydroxyurea, low-dose cytarabine, or corticosteroids.\n2. Concurrent interventional trials: Current participation in any interventional clinical trial, including those involving investigational agents.\n3. Extremely short life expectancy: Judged by the investigator to be unable to complete at least one full cycle of therapy and the associated follow-up.","16 Years",{"count":160,"type":21},"OBSERVATIONAL","Venetoclax combined with azacitidine (VEN-AZA) is the current first-line standard of care for newly diagnosed acute myeloid leukemia (AML) patients unfit for intensive chemotherapy. Although this regimen substantially improves remission rates, marked inter-individual variability is observed in clinical practice-ranging from severe myelosuppression or tumor lysis syndrome in some patients to poor response or early relapse in others. Venetoclax is primarily metabolized by CYP3A4, and its systemic exposure is modulated by multiple factors, including hepatic and renal function, concomitant medications (particularly azole antifungals), and UGT1A1 polymorphisms, leading to a 50%-70% inter-individual variability in blood drug concentrations.\n\nDespite this variability, the current VEN-AZA regimen employs a fixed-dose strategy (400 mg\u002Fday) without incorporating therapeutic drug monitoring (TDM) to guide individual dosing. Critical knowledge gaps remain: (1) whether a clear exposure-response relationship exists between venetoclax exposure and composite remission rate (CR+CRi); (2) what blood concentration range optimizes efficacy while minimizing toxicity; (3) which covariates significantly influence venetoclax clearance; and (4) whether early concentration sampling can reliably predict subsequent exposure and clinical outcomes.\\*\n\nTo address these questions, investigators designed a prospective study enrolling newly diagnosed AML patients receiving VEN-AZA therapy. Investigators aim to systematically characterize the exposure-response relationship, establish an optimal therapeutic concentration window, identify key covariates contributing to inter-individual pharmacokinetic variability, and evaluate early-sampling prediction strategies. The findings are expected to provide direct evidence for TDM-guided individualized dosing and to support a paradigm shift from a \"fixed-dose\" to a \"concentration-guided\" approach in precision AML therapy.",[27],"2026-08-04",{"date":290,"type":33},"2026-08-06",{"date":292,"type":33},"2026-06-01",{"date":294,"type":21},"2027-06-01",{"name":296,"class":40},"The First Affiliated Hospital of Soochow University",{"id":298,"slug":299,"hasResults":12,"nctId":300,"briefTitle":301,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":303,"targetDuration":4,"studyType":22,"phases":305,"briefSummary":306,"conditions":307,"keywords":310,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":41},"100565397","phase-1-a-phase-i-single-arm-clinical-study-of-donor-nk-cells-infusion-combined-with-low-dose-interleukin-2-in-the-treatment-of-acute-myeloid-leukemia-relapse-after-allogeneic-hematopoietic-stem-cell-transplantation-100565397","NCT06641648","A Phase I Single-arm Clinical Study of Donor NK Cells Infusion Combined With Low-dose Interleukin-2 in the Treatment of Acute Myeloid Leukemia Relapse After Allogeneic Hematopoietic Stem Cell Transplantation.","Inclusion Criteria:\n\n* Age ≥ 18 years old,;\n* Expected survival period ≥ 3 months;\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;\n* The diagnosis of AML who received allo-HSCT, and met the following criteria:\n\nA. Diagnostic criteria for relapsed AML: after complete remission (CR), leukemia cells reappeared in peripheral blood or blast cells in bone marrow ≥ 5% (except for other reasons such as bone marrow regeneration after consolidation chemotherapy) or extramedullary leukemia cell infiltration; B. Minimal Residual Disease (MRD) positive only or relapse: Patient is minimal residual disease (MRD) positive, as assessed on bone marrow aspirate (BMA) by Multiparameter Flow Cytometry (MFC) at time of Treatment Eligibility assessment; C. Degree II and above acute graft-versus-host disease did not occur after transplantation; D. Available allogeneic hematopoietic stem cell transplant donors.\n\n-Adequate organ function: A. Liver function: ALT≤3×ULN, AST≤3×ULN, total bilirubin≤2×ULN; B. Coagulation function: international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤ 1.5×ULN; C. Renal function: serum creatinine≤1.5×ULN or creatinine clearance rate ≥30mL\u002Fmin; D. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 45%;\n\n* Women of child-bearing potential and all male participants must use effective methods of contraception for at least 12 months after infusion.;\n* Informed Consent\u002FAssent: All subjects must have the ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* Central nervous system involved;\n* Patients who received the following anti-tumor therapies prior to infusion:\n\nA. Systemic use of hormones within 3 days prior to infusion (except for patients with inhaled corticosteroids); B. Systemic anti-tumor therapy within 2 weeks or within 5 drug half-lives (whichever is shorter); C. Radiotherapy within 4 weeks; D. DLI within 6 weeks; E. Intrathecal injection within 1 week; F. Received CAR-T, CAR-NK or other modified cell therapy within 6 months;\n\n* Any active infection requiring systemic therapy by intravenous infusion within 14 days prior to the first dose of study drug, including: HBV, HCV, HIV, syphilis infection, or active pulmonary tuberculosis.\n* History of hypersensitivity reactions to murine protein-containing products, or macromolecular biopharmaceuticals such as antibodies or cytokines;\n* Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment;\n* Women who are pregnant (urine\u002Fblood pregnancy test positive) or lactating;\n* Suffering from a serious autoimmune disease or immunodeficiency disease;\n* Known alcohol dependence or drug dependence;\n* According to the investigator\\'s judgment, the patient has other unsuitable grouping conditions.",{"count":304,"type":21},12,[24],"This is a single-centre, single-arm, open-label, early clinical study to evaluate the safety, tolerability and preliminary efficacy of donor NK cells injection combined with low-dose interleukin-2 in the treatment of acute myeloid leukemia (AML) relapse after allogeneic hematopoietic stem cell transplantation (allo-HSCT).",[27,308,309],"Acute Myeloid Leukemia (AML) Relapse","NK Cell",[78,311,312,313],"relapse","allogeneic hematopoietic stem cell transplantation.","NK cell","2026-08-03",{"date":239,"type":33},{"date":317,"type":33},"2025-11-01",{"date":319,"type":21},"2027-06-30",{"name":321,"class":40},"Peking University First Hospital",{"id":323,"slug":324,"hasResults":12,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":4,"eligibilityCriteria":328,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":329,"enrollmentInfo":330,"targetDuration":4,"studyType":22,"phases":332,"briefSummary":333,"conditions":334,"keywords":335,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":4},"100649359","phase-3-mitoxantrone-hydrochloride-liposome-cytarabine-g-csf-plus-venetoclax-vs-azacitidine-plus-venetoclax-for-mds-ib2-and-secondaryelderly-aml-100649359","NCT07735117","Mitoxantrone Hydrochloride Liposome, Cytarabine, G-CSF Plus Venetoclax vs. Azacitidine Plus Venetoclax for MDS-IB2 and Secondary\u002FElderly AML","A Prospective, Multicenter, Randomized Controlled Clinical Study of Mitoxantrone Hydrochloride Liposome, Subcutaneous Cytarabine and G-CSF Combined With Venetoclax Versus Azacitidine Combined With Venetoclax in the Treatment of MDS-IB2 and Newly Diagnosed Adult Secondary or Elderly AML","Inclusion Criteria:\n\n* 1\\. The patient fully understands the study, voluntarily participates, and signs the Informed Consent Form (ICF).\n\n  2\\. Age: 18-75 years inclusive. 3. Patients with clinically confirmed adult AML or MDS-IB2 (according to WHO 2022 criteria or ICC 2022 criteria). AML patients must meet any of the following:\n  1. Therapy-related AML\n  2. Prior history of MDS\n  3. Presence of MDS-related genetic\u002Fchromosomal abnormalities\n  4. Prior history of CMML\n  5. Age ≥ 60 years\n  6. Prior history of antecedent MPN (including ET, PV, and MF) with bone marrow fibrosis ≤ grade 2 (on a 0-3 grade scale) 4. For elderly AML patients, comprehensive assessment must show they belong to the Fit population: ECOG \\\u003C 3, CCI ≤ 0, and MMSE and SPPB assessment results meeting the Fit population criteria.\n\n     5\\. Liver and kidney function: ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver infiltration); total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for patients with liver infiltration); serum creatinine ≤ 1.5 × ULN.\n\n     6\\. Expected survival ≥ 3 months. 7. Prior MDS-related therapy (excluding blood transfusions) must be completed at least 2 weeks before the start of study treatment. In cases of rapidly proliferative disease, hydroxyurea is permitted up to 24 hours before the start of study treatment. Toxicities from prior MDS therapy must have recovered to Grade 2 or lower before the start of study treatment.\n\n     Exclusion Criteria:\n* Patients who meet any of the following criteria will be excluded from the study:\n\n  1. Prior anti-cancer treatment history meeting any of the following:\n\n     1. Prior treatment with mitoxantrone or mitoxantrone liposome.\n     2. Prior treatment with venetoclax or hypomethylating agents.\n     3. Prior treatment with doxorubicin or other anthracyclines, with a cumulative doxorubicin dose \\> 360 mg\u002Fm\\^2 (for other anthracyclines, 1 mg doxorubicin is equivalent to 2 mg daunorubicin or 0.5 mg idarubicin).\n     4. Received anti-cancer treatment including surgery, chemotherapy, targeted therapy, etc., or participated in another clinical trial with investigational drug within 4 weeks or 5 half-lives before the first dose of study drug.\n  2. Cardiac function or disease meeting any of the following:\n\n     1. Long QTc syndrome or QTc interval \\> 480 ms.\n     2. Complete left bundle branch block, second-degree or third-degree atrioventricular block.\n     3. Severe, uncontrolled arrhythmia requiring medication.\n     4. New York Heart Association (NYHA) Class ≥ II.\n     5. Left ventricular ejection fraction (LVEF) \\\u003C 50%.\n     6. History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, clinically significant pericardial disease within 6 months before enrollment, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.\n  3. Concurrent uncontrolled malignancy other than adequately controlled non-melanoma skin basal cell carcinoma, carcinoma in situ of breast\u002Fcervix, or other malignancies that have been effectively controlled without treatment for \\> 6 months and patients receiving long-term non-chemotherapy treatment (e.g., hormone therapy).\n  4. Uncontrolled systemic disease (e.g., progressive infection, uncontrolled hypertension, diabetes mellitus).\n  5. Central nervous system (CNS) leukemia.\n  6. Secondary AML with bone marrow fibrosis ≥ grade 3.\n  7. Blast crisis of chronic myeloid leukemia (CML).\n  8. AML with favorable-risk karyotypes: t(8;21)(q22;q22.1) RUNX1::RUNX1T1, inv(16)(p13.1q22) CBFB::MYH11, or acute promyelocytic leukemia (APL).\n  9. Human immunodeficiency virus (HIV) infection (HIV antibody positive).\n  10. Active hepatitis B or hepatitis C infection (HBsAg or HBcAb positive with HBV-DNA \\> 1×10\\^3 copies\u002FmL; HCV antibody positive with HCV-RNA \\> 1×10\\^3 copies\u002FmL).\n  11. Known immediate or delayed hypersensitivity reaction to the study drug's class or excipients.","75 Years",{"count":331,"type":21},168,[74],"This study aims to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome, subcutaneous cytarabine and G-CSF combined with venetoclax (CMG+Ven) versus azacitidine combined with venetoclax (VA) in the treatment of adult myelodysplastic syndrome IB2 (MDS-IB2) and newly diagnosed secondary or elderly AML.",[27,260],[336,166,337,338,339,340,341],"Acute myeloid leukemia","mitoxantrone hydrochloride liposome","Cytarabine","Granulocyte Colony-Stimulating Factor","Venetoclax","Randomized Controlled Trial","2026-07-26",{"date":344,"type":33},"2026-07-29",{"date":346,"type":21},"2026-07-30",{"date":348,"type":21},"2029-07-31",{"name":350,"class":40},"Ruijin Hospital",{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":357,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":359,"enrollmentInfo":360,"targetDuration":4,"studyType":22,"phases":362,"briefSummary":363,"conditions":364,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":375},"100241068","phase-2-study-to-improve-os-in-18-to-60-year-old-patients-comparing-daunorubicin-versus-high-dose-idarubicin-induction-regimens-high-dose-versus-intermediate-dose-cytarabine-consolidation-regimens-and-standard-versus-mmf-prophylaxis-of-gvhd-in-allografted-patients-in-first-cr-100241068","NCT02416388","Study to Improve OS in 18 to 60 Year-old Patients, Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens, High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens, and Standard Versus MMF Prophylaxis of GvHD in Allografted Patients in First CR","Phase II\u002FIII Randomized Study to Improve Overall Survival in 18 to 60 Year-old Patients, Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens, High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens, and Standard Versus Mycophenolate Mofetil Prophylaxis of Graft Versus Host Disease in Allografted Patients in First CR : a Backbone InterGroup-1 Trial","BIG-1","Inclusion Criteria (at diagnosis) :\n\n1. Age ≥ 18 years and \\\u003C 61 years\n2. With a newly diagnosed de novo or secondary type AML (post myelodysplastic syndrome MDS or therapy-related AML)\n3. No prior treatment for neither AML (with the exception of hydroxyurea), nor MDS (with the exception of EPO)\n4. ECOG performance status ≤ 3\n5. Absence of severe uncontrolled infection\n6. No cardiac contraindications for the use of anthracyclines : decompensated or uncontrolled heart failure, recent myocardial infarction, current signs of cardiac impairment, uncontrolled arrhythmias, LVEF (left ventricular ejection fraction) \\\u003C 50%\n7. Total bilirubin ≤ 2 x upper limit of normal (UNL), ASAT(SGOT) and ALAT (SGPT) ≤ 2.5 X UNL, creatinine \\\u003C 150 µmol\u002Fl, unless AML-related out of range values\n8. Genetic mutation testing of the FLT3 (FLT3-ITD ou FLT3-TKD) gene, performed in local or central laboratory\n9. Use of appropriate methods of contraception:\n\n   * for patients treated with Midostaurin:\n\n     * women of childbearing potential should use appropriate methods of contaception throughout treatment, and for 5 months post cessation of treatment\n     * men will need to use condoms during intercourse throughout treatment, and for 5 months post cessation of treatment with Midostaurin\n10. Patients who are covered by or beneficiaries of a social security system (Social Security or Universal Medical Coverage)\n11. Patients who have read and understood the information sheet and signed the informed consent form\n\nExclusion criteria (at diagnosis) :\n\n1.Patients with acute promyelocytic leukemia (APL), as confirmed either by t(15;17) or by the presence of PML-RARA fusion transcripts 2.Patients with core binding factor (CBF) AML, as confirmed either by t(8;21), t(16,16) or inv(16), or by fusion transcripts resulting from these cytogenetic abnormalities (RUNX1-RUNX1T1, CBFB-MYH11).\n\n3.Patients with secondary AML arising from myeloproliferative disorders previously known according to the 2008 WHO classification 4.Patients with Ph1+ AML or previous Ph1+ disorder (chronic myelogenous leukemia) 5.Severe psychiatric or organic disorder, supposed to be independent from AML, that would contraindicate treatment, including allogeneic HSCT 6.No psychological, familial, social, or geographic reason that would compromise clinical follow up 7.History of uncontrolled cancer for the last 2 years, with the exception of basal cell carcinoma or carcinoma in situ of the cervix 8.Uncontrolled severe infection 9.Patients with positive serology for HIV-1 and -2, or HTLV -1 and -2, or active hepatitis virus B or C infection 10.Pregnant or lactating women 11.Legal incapacity (patients under tutorship, curatorship or judicial protection)\n\n\\------------------------------------------\n\nFor randomization R4-VOS (post-induction\u002Fsalvage) :\n\nInclusion criteria\n\n1. Patients enrolled in the BIG-1 trial at diagnosis\n2. Patient presenting with AML in first CR or CRp\u002FCRi after induction or one cycle of salvage therapy (confirmed in the 15 days preceding R4-VOS)\n3. Favorable or intermediate risk AML patients, as stratified with BIG-1 prognostic classification\n4. Patients randomized to R2-IDAC arm (intermediate dose cytarabine)\n5. ECOG performance status ≤ 2\n6. Left ventricular ejection fraction (LVEF) at least 40% by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO)\n7. Local clinical laboratory values as follows:\n\n   o Serum creatinine ≤ 2.0 mg\u002FdL\n\n   o Total bilirubin ≤ 1.5 X the upper limit of normal (ULN)\n   * Aspartate aminotransferase (AST) ≤ 2.5 X ULN\n   * Alanine aminotransferase (ALT) ≤ 2.5 X ULN\n8. Signed written informed consent for vosaroxin study (R4-VOS)\n9. Women of childbearing potential must have a negative pregnancy test within 8 days before randomization R4-VOS and commit to the use of effective contraception during the period of treatment and up to 36 days after vosaroxin has been stopped. Men must use effective contraception during the treatment period and up to 96 days after vosaroxin has been stopped.\n\nExclusion criteria\n\n1.Patients classified in the unfavorable risk group according to the BIG-1 protocol classification 2.Complete remission is not attained (CR, CRp\u002FCRi) after induction and\u002For salvage therapy 3.Positive pregnancy test 4.Severe uncontrolled infection such as sepsis, or multiple organ dysfunction syndrome, uncontrolled fever 5.Documented uncontrolled fungal infection (positive blood test and cultures) 6.History of myocardial infarction, unstable angina, cerebrovascular accident (CVA) or transient ischemic attack (TIA) in the 3 months before randomization 7.Patient under hemodialysis (HD) or peritoneal dialysis (PD)\n\n\\------------------------------------------\n\nFor randomization R4-DEX (post-induction\u002Fsalvage) :\n\nInclusion criteria\n\n1. Patients enrolled in the BIG-1 trial at diagnosis\n2. Patient presenting with AML in first CR or CRp\u002FCRi after induction or one cycle of salvage therapy (confirmed in the 15 days preceding R4-DEX)\n3. Favorable or intermediate risk AML patients, as stratified with BIG-1 prognostic classification\n4. ECOG performance status ≤ 2\n5. Local clinical laboratory values as follows:\n\n   * Serum creatinine ≤ 150 µmol\u002FL\n   * Total bilirubin ≤ 1.5 X the upper limit of normal (ULN)\n   * Aspartate aminotransferase (AST) ≤ 2.5 X ULN\n   * Alanine aminotransferase (ALT) ≤ 2.5 X ULN\n6. Signed written informed consent for dexamethasone study (R4-DEX)\n\nExclusion criteria\n\n1.Severe uncontrolled infection such as sepsis, or multiple organ dysfunction syndrome, uncontrolled fever 2.Documented uncontrolled fungal infection (positive blood test and cultures 3.History of myocardial infarction, unstable angina, cerebrovascular accident (CVA) or transient ischemic attack (TIA) in the 3 months before randomization 4.Patient under hemodialysis (HD) or peritoneal dialysis (PD)\n\n\\--------------------------------------\n\nFor randomization R4-VEN (post-induction\u002Fsalvage) :\n\nInclusion criteria\n\n1. Age 18 - 60 years at inclusion in BIG-1 protocol\n2. diagnosis of AML according to WHO classification de novo or secondary to myelodysplastic syndrome (myelodysplastic syndrome must not have been treated except by ESA, Lenalidomide or non-chemotherapy) or therapy-related AML\n3. Patients included in the BIG-1 protocol\n4. Patients in first CR or CRp\u002FCRi following 1 or 2 courses of induction chemotherapy according to BIG-1 protocol and who are planned to receive consolidation.\n5. Patients stratified within the favorable and intermediate risk groups as defined by BIG-1 protocol\n6. ECOG performance status ≤ 2\n7. Left ventricular ejection fraction (LVEF) at least 40% by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO)\n8. Creatinine clearance ≥ 30 ml\u002Fmin (calculated by the usual method of each institution), total bilirubin ≤ 1.5 times the ULN; ASAT and ALAT ≤ times the upper limit of normal (ULN)\n9. Absence of uncontrolled infection\n10. Women of childbearing potential must agree to use effective contraception without interruption throughout the study and for a further 3 months after the end of treatment\n11. Written signed informed consent\n\nExclusion criteria\n\n1.AML stratified in the unfavorable BIG-1 risk-group. 2.Diagnosis of Acute Promyelocytic Leukemia or CBF AML (ie. AML with t(8;21), t(16,16) or inv(16), or their molecular equivalents RUNX1-RUNX1T1 and CBFB-MYH11) 3.AML secondary to prior myeloproliferative disorder according to WHO classification (2008) and Philadelphia chromosome-positive AML (Ph1+) 4.Absence of CR\u002FCRp\u002FCRi after a maximum of two chemotherapy cycles 5.Severe medical or mental condition precluding the administration of protocol treatments 6.Prior history of cancer unless controlled for at least 2 years and except for basocellular cutaneous cancers and in situ cervix cancers 7.Positive pregnancy test 8.Breast feeding 9.Uncontrolled infection such as sepsis, or multiple organ dysfunction syndrome, uncontrolled fever 10.Documented uncontrolled fungal infection (positive blood test and cultures) 11.Prior venetoclax exposure 12.Known HBV with detectable viral load 13.Known HIV positive patients 14.Known hypersensitivity to any of the study medication 15.History of myocardial infarction, unstable angina, cerebrovascular accident (CVA) or transient ischemic attack (TIA) in the 3 months before randomization 16.Patient under hemodialysis (HD) or peritoneal dialysis (PD) 17.Concomitant treatment with cytochrome CYP3A4 inhibitor which cannot be stopped during venetoclax administration ONLY FOR PHASE 1 18.During the phase 2, for patients randomized in the IDAC + Venetoclax arm, if concomitant treatment with cytochrome CYP3A4 inhibitor cannot be stopped, a dose reduction of 70% of venetoclax must be apply\n\n\\--------------------------------------\n\nFor randomization R3 (before AlloHSCT):\n\nInclusion criteria\n\n1. Patients enrolled in the BIG-1 trial at diagnosis\n2. Patient presenting with AML in first CR or CRp\u002FCRi treated in the BIG-1 trial and classified in the intermediate risk group, namely:\n\n   * either initially favorable but poor molecular responders for NPM1 MRD: NPM1 mutation, without FLT3-ITD mutation or with an FLT3-ITD ratio \\\u003C 0.50 and MRD2 positive blood (decrease of less than 4 log from baseline at diagnosis)).\n   * Or initially favorable but requiring two cycles of chemotherapy (a salvage therapy) to obtain the first CR\u002FCRp\u002FCRi\n   * Or other immediate intermediaries\n3. No metastatic or progressive cancer, with the exception of basal cell skin carcinoma and cervical carcinoma in situ\n4. Patients with general condition preserved (ECOG ≤ 3) and with no uncontrolled severe infection\n5. Women of childbearing age must make use of effective contraception\n6. Patients who are covered by or beneficiaries of a social security system (Social Security or Universal Medical Coverage).\n7. Patients who have read and understood the information sheet and signed the informed consent form\n\nExclusion criteria\n\n1. Complete remission is not obtained (CR, CRp\u002FCRi) after induction and\u002For salvage therapy\n2. Patient presenting with AML in first CR or CRp\u002FCRi treated in the BIG-1 trial and classified either in the favorable risk group or the unfavorable risk group\n3. Patients with a severe organ or psychiatric pathology, presumed to be independent of AML and contraindicating the allograft\n4. Patients who, for family, social or geographic reasons, do not wish to be regularly monitored via consultation\n5. Uncontrolled severe infection at the time of inclusion\n6. Serology positive for HIV 1 or 2 or HTLV 1 or 2, or active HBV or HCV viral infection\n7. Pregnant women (beta-HCG positive) or currently breastfeeding\n8. Adult patient who is incapacitated, under wardship, legal guardianship, or under the protection of the courts\n9. Patients under State Medical Assistance (AME)","61 Years",{"count":361,"type":21},3100,[141,74],"This open label, multicenter phase II\u002FIII study with multiple randomization phases at differents stages of AML treatment (induction, consolidation and HSCT where applicable) is designed to improve OS in younger (18 to 60 year-old) patients, with AML risk-adapted patient strategies. Within the intermediate risk AML group, optimal GvHD prophylaxis following allogeneic SCT in first CR, after either myeloablative (MAC) or reduced intensity (RIC) conditioning, will also be evaluated. With an adaptative design, this clinical trial could test up to 3 novel AML agents of interest.",[27],"2026-07-16",{"date":367,"type":33},"2026-07-17",{"date":369,"type":4},"2015-01",{"date":371,"type":21},"2032-01",{"name":373,"class":374},"University Hospital, Angers","OTHER_GOV",56,{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":382,"eligibilityCriteria":383,"healthyVolunteers":12,"sex":17,"minAge":384,"maxAge":385,"enrollmentInfo":386,"targetDuration":4,"studyType":22,"phases":388,"briefSummary":389,"conditions":390,"keywords":391,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":41},"100628692","phase-1-cart123-cells-with-or-without-ruxolitinib-in-relapsedrefractory-acute-myeloid-leukemia-100628692","NCT07464951","CART123 Cells With or Without Ruxolitinib in Relapsed\u002FRefractory Acute Myeloid Leukemia","Phase 1 Trial of Autologous CD123-Directed CAR T-Cells (CART123) as Monotherapy or in Combination With Ruxolitinib in Relapsed\u002FRefractory Acute Myeloid Leukemia","CART123","Inclusion Criteria:\n\n* 1\\. Age at time of consent: Cohort A: 0-29 years. Cohort B: 1-29 years (Note: the first subject at each dose level of Cohort B must be ≥12 years old)\n* 2\\. Subjects with AML in second or greater relapse, post-transplant relapse, or with chemotherapy-refractory disease. Specifically:\n\n  1. Second or greater relapse defined as bone marrow flow cytometric confirmation of myeloid leukemia of at least 0.1% or development of extramedullary disease by imaging or biopsy after second documented complete remission; OR\n  2. Any detectable disease post-allogeneic transplant with bone marrow flow cytometric confirmation of myeloid leukemia of at least 0.1% or development of extramedullary disease by imaging or biopsy; OR\n  3. Refractory disease, defined as: Persistent bone marrow involvement with ≥0.1% disease by flow cytometry or persistent extramedullary disease by imaging or biopsy after two courses of induction chemotherapy for patients at initial presentation, ≥ 0.1% bone marrow disease by flow cytometry or persistent extramedullary disease by imaging or biopsy after one course of induction chemotherapy for patients who have relapsed after previously achieving a CR , and ≥ 0.1% bone marrow disease by flow cytometry or persistent extramedullary disease by imaging or biopsy after one course of AML-directed chemotherapy for those with myeloid lineage switch.\n* 3\\. Subjects must have an identified stem cell donor with the ability to proceed rapidly to transplant following CART123 treatment if indicated.\n* 4\\. Adequate organ function defined as:\n\n  1. Serum creatinine based on age\u002Fgender.\n  2. Adequate liver function: ALT ≤ 500 U\u002FL, Bilirubin ≤3x the upper limit of normal, and ALT and\u002For bilirubin results that exceed this range are acceptable if, in the opinion of the physician-investigator (or as confirmed by liver biopsy), the abnormalities are directly related to AML infiltration of the liver.\n  3. Must have a minimum level of pulmonary reserve defined as ≤Grade 1 dyspnea and \\\u003CGrade 3 hypoxia; DLCO ≥ 40% (corrected for anemia if necessary) if PFTs are clinically appropriate as determined by the treating investigator.\n  4. Left Ventricular Shortening Fraction (LVSF) ≥ 28% or Ejection Fraction (LVEF) ≥ 45% confirmed by echocardiogram or another scan.\n* 5\\. Adequate performance status defined as Lansky or Karnofsky performance score ≥ 50.\n* 6\\. Subjects of reproductive potential must agree to use acceptable birth control methods.\n\nExclusion Criteria:\n\n* 1\\. Active hepatitis B or active hepatitis C\n* 2\\. HIV infection\n* 3\\. Active acute or chronic GVHD requiring systemic therapy\n* 4\\. Concurrent use of systemic steroids or immunosuppression at the time of cell infusion or cell collection, or a condition, in the treating physician's opinion, that is likely to require steroid therapy or immunosuppression during collection or after infusion. Steroids for disease treatment at times other than cell collection or at the time of infusion are permitted. Use of physiologic replacement hydrocortisone or inhaled steroids is permitted as well.\n* 5\\. CNS disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity.\n* 6\\. Pregnant or nursing (lactating) subjects.\n* 7\\. Uncontrolled active infection","0 Years","29 Years",{"count":387,"type":21},30,[24],"This study is designed to evaluate the safety and effectiveness of CART123 cells either alone or when combined with ruxolitinib in pediatric and young adult subjects with relapsed or refractory AML. Subjects will be enrolled into one of two treatment cohorts: subjects who will receive CART123 alone (Cohort A) or subjects who will receive CART123 in combination with ruxolitinib (Cohort B).",[27],[392,78,382,84,393],"CART","Ruxolitinib","2026-07-03",{"date":396,"type":33},"2026-07-07",{"date":398,"type":33},"2026-05-14",{"date":400,"type":21},"2030-05-14",{"name":402,"class":40},"Stephan Grupp MD PhD",{"id":404,"slug":405,"hasResults":12,"nctId":406,"briefTitle":407,"officialTitle":408,"acronym":4,"eligibilityCriteria":409,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":329,"enrollmentInfo":410,"targetDuration":4,"studyType":22,"phases":412,"briefSummary":413,"conditions":414,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":419,"completionDateStruct":420,"leadSponsor":422,"locationsCount":4},"100646675","phase-3-lisaftoclax-plus-azacitidine-maintenance-after-allogeneic-hematopoietic-stem-cell-transplantation-in-acute-myeloid-leukemia-patients-at-high-risk-of-relapse-100646675","NCT07686965","Lisaftoclax Plus Azacitidine Maintenance After Allogeneic Hematopoietic Stem Cell Transplantation in Acute Myeloid Leukemia Patients at High Risk of Relapse","Maintenance Therapy With Lisaftoclax Plus Azacitidine After Allogeneic Hematopoietic Stem Cell Transplantation in Acute Myeloid Leukemia Patients at High Risk of Relapse: A Multicenter, Open-Label, Randomized Controlled Trial","Inclusion Criteria:\n\nParticipants must meet all of the following criteria to be eligible for enrollment in this study:\n\n1. Diagnosed with acute myeloid leukemia (AML), excluding acute promyelocytic leukemia, according to the WHO 2022 classification, and without FLT3-ITD or FLT3-TKD mutations.\n2. Presence of at least one of the following high-risk features:\n\n1\\) Adverse-risk AML according to the ELN 2022 risk classification; 2) Refractory AML; 3) Relapsed AML; 4) Persistent measurable residual disease positivity prior to transplantation; 5) Secondary AML transformed from myelodysplastic syndrome or myeloproliferative neoplasm.\n\n3\\. Undergoing first allogeneic hematopoietic stem cell transplantation (allo-HSCT).\n\n4\\. Stable hematologic recovery, defined as: Absolute neutrophil count ≥ 1.0 × 10⁹\u002FL without G-CSF support; and Platelet count ≥ 50 × 10⁹\u002FL without platelet transfusion within 7 days prior to randomization.\n\n5\\. Age ≥18 years and ≤75 years. 6. Eastern Cooperative Oncology Group performance status of 0-2. 7. Ability to provide written informed consent before initiation of any study procedures.\n\n8\\. Written informed consent may be provided by the participant or an authorized immediate family member in accordance with local regulations.\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded from the study:\n\n1. Evidence of disease relapse or impending relapse prior to randomization after transplantation, as determined by morphologic assessment or flow cytometry.\n2. Active or uncontrolled acute graft-versus-host disease (aGVHD) requiring systemic immunosuppressive therapy.\n3. Uncontrolled active infection requiring systemic antibacterial, antifungal, or antiviral therapy within 7 days prior to enrollment.\n4. Moderate or severe hepatic impairment, as defined by the Child-Pugh classification.\n5. Severe renal impairment, defined as creatinine clearance \\\u003C30 mL\u002Fmin (calculated using the Cockcroft-Gault formula) or requirement for dialysis.\n6. Pregnancy, or unwillingness\u002Finability to use adequate contraception during the study treatment period.\n7. Psychiatric disorders or other medical conditions that, in the investigator's judgment, would interfere with compliance with study treatment, monitoring, or study procedures.",{"count":411,"type":21},191,[74],"This study evaluates the efficacy and safety of maintenance therapy with lisaftoclax plus azacitidine after allogeneic hematopoietic stem cell transplantation (allo-HSCT) in adults with acute myeloid leukemia (AML) at high risk of relapse.\n\nThe main questions this study aims to answer are:\n\n* Does maintenance therapy with lisaftoclax plus azacitidine improve disease-free survival compared with observation alone after allo-HSCT?\n* Does maintenance therapy reduce relapse and improve overall survival?\n* What adverse events and safety outcomes are associated with this treatment strategy?\n\nResearchers will compare maintenance therapy with lisaftoclax plus azacitidine with observation or best supportive care in patients with AML at high risk of relapse following allo-HSCT.\n\nParticipants will:\n\n* Be randomly assigned in a 2:1 ratio to receive either maintenance therapy with lisaftoclax plus azacitidine or observation.\n* Receive study treatment for up to 12 cycles or undergo observation according to the study assignment.\n* Undergo regular follow-up assessments, disease monitoring, and safety evaluations after transplantation.",[27,415,416],"Maintenance Treatment","Hematopoetic Stem Cell Transplantation","2026-06-30",{"date":396,"type":33},{"date":219,"type":21},{"date":421,"type":21},"2030-08-10",{"name":246,"class":40},{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":430,"targetDuration":4,"studyType":285,"phases":4,"briefSummary":432,"conditions":433,"keywords":437,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":41},"100645293","caris-chromoseq-data-collection-100645293","NCT07680868","Caris Chromoseq Data Collection","An Observational Study to Describe the Performance of Caris Chromoseq as Compared to Conventional Cytogenetics, FISH, and NGS Testing Among Patients Receiving the Caris Chromoseq Assay for Hematologic Malignancies","Inclusion Criteria:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study and has signed consent form\n2. Subject must be 18 or older\n3. Subject be diagnosed with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or myeloproliferative neoplasms (MPN)\n4. Physician must order or plan to order Caris Chromoseq for their patient\n5. Physicians must order or have ordered conventional cytogenetics, FISH, and NGS testing for AML, MDS, or MPN within the same timeframe of Caris Chromoseq without intervening line of therapy.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Patient for whom Caris Chromoseq is not being ordered\n2. Patient is pregnant or lactating\n3. Patient is not able or willing to provide consent to data collection for this protocol",{"count":431,"type":21},300,"The study will collect clinical data on patients who receive the Caris Chromoseq assay for an underlying hematologic malignancy. The assay provides risk stratification for patients with acute myeloid leukemia (AML) myelodysplastic syndrome (MDS), or myeloproliferative neoplasms (MPN). The hypothesis of the study is that Caris Chromoseq compares favorably to conventional cytogenetics, FISH, and NGS analysis in terms of risk stratification capabilities, ease of use, and turnaround time.",[27,434,435,436],"Myelodysplastic (MDS) \u002F Myeloproliferative (MPN) Diseases","Myelodysplatic Syndromes","Myeloproliferative Neoplasm",[438,439,78,195,440],"Chromoseq","Caris","MPN","2026-06-26",{"date":443,"type":33},"2026-07-02",{"date":445,"type":21},"2026-07",{"date":447,"type":21},"2029-07",{"name":449,"class":102},"Caris Science, Inc.",{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":456,"eligibilityCriteria":457,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":458,"enrollmentInfo":459,"targetDuration":4,"studyType":22,"phases":461,"briefSummary":462,"conditions":463,"keywords":464,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":480},"100643991","phase-1-anti-cd33-cll1-car-t-cells-icg415-for-the-treatment-of-relapsedrefractory-acute-myeloid-leukemia-100643991","NCT07668557","Anti-CD33-CLL1 CAR-T Cells (ICG415) for the Treatment of Relapsed\u002FRefractory Acute Myeloid Leukemia","A Clinical Study to Evaluate the Safety and Efficacy of ICG415 CAR-T Cells in Adult Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","ICG415-AML-01","Inclusion Criteria:\n\n1. Written informed consent approved by IRB\u002FIEC obtained from subject or legally authorized representative prior to any screening procedures.\n2. Age ≥ 18 years and ≤ 70 years at the time of informed consent signing.\n3. Diagnosis of acute myeloid leukemia (AML) per 2022 WHO Classification, meeting criteria for relapsed\u002Frefractory (R\u002FR) AML as defined in the Chinese Guidelines for the Diagnosis and Management of Relapsed\u002FRefractory Acute Myeloid Leukemia (2023 Edition): Relapsed AML: Reappearance of leukemic blasts in peripheral blood, bone marrow blasts ≥5%, or extramedullary leukemic infiltration after complete remission (CR). Refractory AML: failure to achieve CR after two cycles of standard induction chemotherapy; early relapse within 12 months post-CR; late relapse with salvage chemotherapy resistance; ≥2 disease relapses or persistent extramedullary disease.\n4. Bone marrow leukemic blasts positive for both CLL-1 and CD33 by flow cytometry.\n5. If circulating blasts are detectable at screening, tumor cell surface immunophenotype must be CD4 and CD8 double-negative by flow cytometry.\n6. ECOG performance status 0-2.\n7. Expected overall survival \\> 3 months.\n8. Females of childbearing potential: negative serum pregnancy test and effective contraception for 1 year post-infusion. Males of reproductive potential: effective barrier contraception for 1 year post-infusion and no sperm donation within 1 year after infusion.\n\nExclusion Criteria:\n\n1. Prior receipt of CAR-T cell therapy or other genetically modified cell therapy prior to informed consent.\n2. Severe major organ dysfunction: Renal: eGFR \\\u003C 50 mL\u002Fmin (Cockcroft-Gault); Hepatic: ALT\u002FAST \\> 3 × ULN (\\>5×ULN if disease-related), total bilirubin \\> 2 × ULN (\\>3×ULN for Gilbert syndrome); Cardiac: LVEF \\\u003C 50%, room air SpO₂ \\\u003C94%, uncontrolled severe cardiac disease.\n3. Active uncontrolled infection: positive HBsAg\u002FHBV-DNA, active HCV-RNA positivity, HIV positive, positive syphilis antibody, active uncontrolled EBV or CMV viremia.\n4. Unstable severe systemic disease requiring continuous medication.\n5. Grade \\>2 bleeding within 30 days before screening or chronic long-term anticoagulant treatment.\n6. Uncontrolled life-threatening bacterial, fungal or viral infection.\n7. Non-leukemic central nervous system organic disease or active CNS-2\u002FCNS-3 leukemia; previously treated and resolved CNS leukemia is permitted.\n8. Concurrent other malignant tumor except cured in-situ carcinoma or malignancies with ≥5 years continuous complete remission.\n9. Live-attenuated vaccines within 30 days before screening or planned within 3 months after CAR-T infusion.\n10. Received any other investigational medicinal product within 3 months prior to ICF signature.\n11. Allogeneic hematopoietic stem cell transplantation within 6 months before screening.\n12. Pregnant or breastfeeding women.\n13. Suicidal tendency, ongoing alcohol or illicit drug dependence.\n14. Known hypersensitivity to investigational product, excipients or concomitant drugs.\n15. Any other condition judged inappropriate for trial entry by investigator.","70 Years",{"count":460,"type":21},18,[24],"This single-arm, open-label phase I trial evaluates the safety and tolerability of ICG415, autologous CAR-T cells targeting CD33 and CLL1, in patients with relapsed or refractory acute myeloid leukemia (AML). Subjects receive lymphodepleting chemotherapy followed by autologous CAR-T infusion. The primary goal is to assess safety and preliminary anti-leukemic efficacy in patients failing standard AML therapies.",[27],[85,78,84,83,465,466,467,468,469,470],"Myeloid Leukemia","CAR-T","Cellular Therapy","CD33-CLL1 CAR-T","Relapsed or Refractory","R\u002FR AML","2026-06-19",{"date":473,"type":33},"2026-06-25",{"date":475,"type":33},"2026-06-10",{"date":477,"type":21},"2029-07-04",{"name":479,"class":102},"iCell Gene Therapeutics",2,{"id":482,"slug":483,"hasResults":12,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":4,"eligibilityCriteria":487,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":488,"targetDuration":4,"studyType":22,"phases":489,"briefSummary":490,"conditions":491,"keywords":492,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":499,"lastUpdatePostDateStruct":500,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":508},"100497402","phase-1-a-study-of-gilteritinib-in-combination-with-ivosidenib-or-enasidenib-in-people-with-acute-myeloid-leukemia-aml-100497402","NCT05756777","A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)","A Phase 1b Multi-center Study of the FLT3 Inhibitor Gilteritinib in Combination With the IDH1 Inhibitor Ivosidenib or the IDH2 Inhibitor Enasidenib for Patients With Relapsed or Refractory Acute Myeloid Leukemia Who Have Co-occurring FLT3\u002FIDH1 or FLT3\u002FIDH2 Mutations","Inclusion Criteria:\n\n* Adult patient is ≥18 years of age at the time of signing the informed consent form (ICF)\n* Patient is willing and able to adhere to the study visit schedule and other protocol requirements.\n* Patient has a confirmed diagnosis of relapsed AML as per World Health Organization (2016) guidelines. Patients in morphologic remission with the reappearance of MRD are also eligible to participate OR the patient has refractory AML as defined below:\n\n  1. For patients who received intensive induction chemotherapy they must have persistent AML (defined as overt disease with over 5% myeloblasts) after at least one cycle of intensive induction OR\n  2. For patients treated with low intensity therapy, the patient must be refractory to treatment with a single agent hypomethylating agent (HMA) or low dose cytarabine (LDAC) (at least two cycles) or an HMA\u002FLDAC in combination with venetoclax (at least one cycle) or another standard of care therapy (e.g. gemtuzumab ozogamicin, glasdegib\u002FLDAC).\n* Patient has relapsed or refractory AML with dually mutant IDH2\u002FFLT3, IDH1\u002FFLT3 (ITD or TKD) , or other FLT3 mutation sensitive to gilteritinib.\n\n  a. A Patient receiving enasidenib or ivosidenib as a single agent who acquires a FLT3 mutation during treatment or a patient on single agent gilteritinib who acquires an IDH2 or IDH1 mutation during treatment is eligible to participate in this study\n* Patient has documentation of FLT3 and IDH1 or IDH2 mutation in bone marrow or blood at time of relapsed\u002Frefractory status confirmed by next-generation sequencing (NGS) and\u002For polymerase chain reaction (PCR) or fragment length analysis within the previous 30 days by a local CLIA approved test.\n* Patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.\n* Patient should have adequate renal function, defined as creatine clearance ≥30mL\u002Fmin calculated using the Cockcroft-Gault equation or a serum creatinine less than 2.0.\n* Patient should have adequate hepatic function, defined as aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3x the upper limit of normal (ULN) and serum direct bilirubin ≤ 2.0 x ULN. Patient with leukemic organ involvement as assessed by the study investigator, must have a serum direct bilirubin ≤ 5.0 x ULN.\n* Patient who has previously had an autologous or allogeneic stem cell transplant for AML is allowed on study.\n* Female patient of childbearing potential must have had a negative pregnancy test within 7 days of initiation of dosing and must agree to use two acceptable methods of birth control while on treatment. A woman must agree to remain on a highly effective method throughout the study and for at least 6 months after the last dose of study drug. A female is considered fertile following menarche and until becoming postmenopausal unless permanently sterile.\n* Male participants with female partners of childbearing potential are eligible for participation in the study if they agree to the following during treatment and until the end of relevant systemic exposure defined as 6 months after final drug administration.\n\nExclusion Criteria:\n\n* Patient has a diagnosis of acute promyelocytic leukemia (APL).\n* Patient on any other investigational anti-cancer agents.\n* Patient has active uncontrolled systemic fungal, bacterial, or viral infection.\n* Patient has presence of any other condition that may increase the risk associated with study participation, and in the opinion of the investigator, would make the patient inappropriate for entry into the study.\n* Patient has immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and\u002For severe disseminated intravascular coagulation.\n* Patient has significant active cardiac disease within 6 months prior to the start of study treatment, including New York Heart Association (NYHA) class III or IV congestive heart failure; acute coronary syndrome (ACS); and\u002For ischemic stroke.\n* Patient has left ventricular ejection fraction (LVEF) \\\u003C 40% by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan obtained within 28 days prior to the start of study treatment.\n* Patient is known to have dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.\n* Patient has a medical history of progressive multifocal leukoencephalopathy.\n* Patient has QTc interval (i.e., Fridericia's correction \\[QTcF\\]) ≥ 450 ms (mean of triplicate ECG) or other factors that increase the risk of QT prolongation or ventricular arrhythmic events (e.g. family history of long QT interval syndrome). Patients with a QTcF over 450 ms due to a bundle branch block or a pacemaker may participate in the study with approval of the study principal investigator.\n* Patient has active graft-versus-host disease. However patients with isolated skin GVH controlled with topical steroids are eligible to participate\n* Female patient who is pregnant or lactating.",{"count":460,"type":21},[24],"The researchers are doing this study to see if the combination of gilteritinib with ivosidenib or enasidenib is a safe and effective treatment for people with relapsed\u002Frefractory AML with FLT3\u002FIDH1 or FLT3\u002FIDH2 gene mutations. The researchers will also look for the highest dose of the combination of gilteritinib with ivosidenib or enasidenib that causes few or mild side effects. When the highest safe dose is found, they will test that dose in new groups of participants.",[27],[493,494,495,496,497,498],"Gilteritinib","Ivosidenib","Enasidenib","FLT3\u002FIDH1 Mutations","FLT3\u002FIDH2 Mutations","21-174","2026-06-18",{"date":501,"type":33},"2026-06-22",{"date":503,"type":33},"2023-10-25",{"date":505,"type":21},"2027-04-21",{"name":507,"class":40},"Memorial Sloan Kettering Cancer Center",7,{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":4,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":329,"enrollmentInfo":516,"targetDuration":4,"studyType":22,"phases":518,"briefSummary":519,"conditions":520,"keywords":523,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":527,"startDateStruct":528,"completionDateStruct":530,"leadSponsor":532,"locationsCount":534},"100570457","phase-2-ivosidenib-as-post-hsct-maintenance-for-aml-100570457","NCT06707493","Ivosidenib as Post-HSCT Maintenance for AML","A Randomized, Placebo-Controlled Phase 2 Study of IDH1 Inhibition Using Ivosidenib as Maintenance Therapy for IDH1-mutant Acute Myeloid Leukemia Following Allogeneic Stem Cell Transplantation","Inclusion Criteria:\n\n* Pathologically confirmed diagnosis of IDH1(R132)-mutant acute myeloid leukemia (AML). IDH1 mutations could have been detected by any mutational technique at any prior point including at diagnosis or remission.\n* Between the ages of 18 and 75 years\n* Will undergo allogeneic hematopoietic stem cell transplantation (HSCT) for their malignancy. Conditioning may be either conventional myeloablative (MAC) or reduced intensity conditioning (RIC). There will be no restrictions on type of graft source.\n* ECOG performance status ≤ 2\n* Participants must have normal organ and marrow function as defined below:\n\n  * Absolute neutrophil count ≥ 1000\u002FµL without growth factor support (e.g. GCSF) in the previous 7 days.\n  * Platelet count ≥ 50,000\u002FµL without transfusional support in the previous 7 days.\n  * AST (SGOT), ALT (SGPT) and Alkaline phosphatase \\\u003C 3x institutional upper limit of normal (ULN)\n  * Direct bilirubin \\\u003C 2.0 mg\u002FdL\n  * Calculated creatinine clearance ≥ 40 mL\u002Fmin (Cockcroft-Gault formula)\n* LVEF must be equal to or greater than 40%, as measured by MUGA scan or echocardiogram\n* Female patients of childbearing potential must have a negative pregnancy test\n* The effects of ivosidenib on the developing human fetus are unknown. For this reason female participants of child-bearing potential and male participants must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) during the entire study treatment period and through 90 days after the last dose of treatment\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Prior allogeneic hematopoietic stem cell transplants.\n* Morphologically relapsed or refractory disease, as assessed by bone marrow aspirate and biopsy performed within 42 days prior to study entry\n* History of other malignancy(ies) unless\n\n  * the participant has been disease-free for at least 5 years and is deemed by the investigator to be at low risk of recurrence of that malignancy, or\n  * the only prior malignancy was cervical cancer in situ and\u002For basal cell or squamous cell carcinoma of the skin\n* Known diagnosis of active hepatitis B or hepatitis C\n* Current or history of congestive heart failure New York Heart Association (NHYA) class 3 or 4, or any history of documented diastolic or systolic dysfunction (LVEF \\\u003C 40%, as measured by MUGA scan or echocardiogram)\n* Current or history of ventricular or life-threatening arrhythmias or diagnosis of long-QT syndrome\n* QTc interval (i.e., Friderica's correction \\[QTcF\\]) ≥ 450 ms or other factors that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome) at screening\n* Uncontrolled intercurrent illness that would limit compliance with study requirements.\n\nPost-transplantation Pre-Treatment Criteria Treatment may begin at any time between day 45 and day 90 following stem cell transplantation.\n\nHowever, at time of treatment start, it must be ensured that:\n\n* The patient has continued willingness and interest in participating in the study.\n* There is no systemic infection requiring IV antibiotic therapy within 7 days preceding the first dose of study drug, or other severe infection\n* Chimerism studies reveal that ≥ 70% of blood or bone marrow cells, or of the CD33 expressing fraction, are of donor origin,\n* There is no acute graft versus host disease (GVHD), requiring an equivalent dose of ≥ 0.5mg\u002Fkg\u002Fday of prednisone within one week of starting ivosidenib \u002F placebo, or have escalation of systemic immunosuppression in terms of increase of corticosteroids or addition of new agent\u002Fmodality within two weeks of starting ivosidenib \u002F placebo.\n* For prophylaxis for GVHD, agents that are permitted for administration on study:\n\n  * Tacrolimus\n  * Cyclosporine\n  * Sirolimus\n  * Cyclophosphamide\n  * Mycophenolate Mofetil\n  * Methotrexate\n  * ATG\n  * Ruxolitinib\n  * Vedolizumab\n  * As standards of care may change, any other prophylactic agents used should be discussed with the PI.\n* Investigational agents, defined as not approved for any indication, are forbidden unless the participant comes off study.\n\n  * Agents used to treat GVHD that are permitted for administration on study:\n  * Any agent used in prophylaxis may be continued (see list above)\n\n    * Ruxolitinib\n    * Etanarcept\n    * ATG\n    * Belumosidil\n    * Axatilimab\n    * Rituximab\n    * Fecal microbiota transplantation\n    * Alpha1-Antitrypsin\n    * Pregnyl\n    * Extracorporal photopheresis (ECP)\n  * As standards of care may change, any other treatment agents used should be discussed with the PI.\n  * Investigational agents, defined as not approved for any indication, are forbidden unless the participant comes off study.\n* There is no evidence of relapsed\u002Frecurrent\u002Fresidual disease.\n* Prior to the start of ivosidenib \u002F placebo administration, the participant must have adequate hematological function, defined as:\n\n  * ANC ≥ 1000\u002FµL\n  * Platelets ≥ 50,000\u002FµL\n\nand adequate organ function defined as\n\n* Direct bilirubin level \\\u003C 2.0 mg\u002FdL\n* AST (SGOT), ALT (SGPT) and Alkaline phosphatase \\\u003C 3x institutional upper limit of normal (ULN)\n* No presence of congestive heart failure, defined by New York Heart Association (NHYA) criteria as class 3 or 4\n* Calculated creatinine clearance ≥ 40 mL\u002Fmin (Cockcroft-Gault formula)",{"count":517,"type":21},75,[141],"This is a Phase 2 study of the study drug, ivosidenib (a mutant IDH1 inhibitor), compared to placebo, given to patients with IDH1-mutant acute myeloid leukemia (AML) after hematopoietic stem cell transplantation (HCT).",[521,27,522],"IDH1 Mutation","Hematopoietic Stem Cell Transplant (HSCT)",[524,525],"hematopoietic stem cell transplantation (HCT)","IDH1-mutant acute myeloid leukemia (AML)","2026-06-17",{"date":499,"type":33},{"date":529,"type":33},"2026-01-16",{"date":531,"type":21},"2030-01-01",{"name":533,"class":40},"Massachusetts General Hospital",6,{"id":536,"slug":537,"hasResults":12,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":4,"eligibilityCriteria":541,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":329,"enrollmentInfo":542,"targetDuration":4,"studyType":22,"phases":544,"briefSummary":545,"conditions":546,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":548,"startDateStruct":550,"completionDateStruct":551,"leadSponsor":553,"locationsCount":4},"100643248","phase-2-va-cag-two-week-vs-three-week-regimen-for-induction-remission-in-newly-diagnosed-acute-myeloid-leukemia-100643248","NCT07642453","VA-CAG Two-Week vs. Three-Week Regimen for Induction Remission in Newly Diagnosed Acute Myeloid Leukemia.","VA-CAG Two-Week vs. Three-Week Regimen for Induction Remission in Newly Diagnosed Acute Myeloid Leukemia: A Prospective, Multicenter, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Diagnosis of acute myeloid leukemia confirmed according to NCCN guidelines;\n2. Age 18-75 years;\n3. Body weight 30-100 kg;\n4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3;\n5. No significant organ dysfunction (echocardiographic ejection fraction \\>45%; bilirubin \\\u003C2 times the upper limit of normal; AST and ALT \\\u003C3 times the upper limit of normal; serum creatinine \\\u003C2 times the upper limit of normal);\n6. No severe infections;\n7. Study participants voluntarily agree to participate in this clinical trial and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Patients with other types of diseases;\n2. Patients with a projected survival of less than 1 month;\n3. History of prior treatment;\n4. Severe psychiatric or neurological disorders that impair the ability to provide informed consent and\u002For report or observe adverse events;\n5. Other circumstances deemed unsuitable for enrollment by the investigator.",{"count":543,"type":21},110,[141],"Objective: This clinical trial aims to compare the efficacy and safety of the VA-CAG regimen administered as a two-week schedule versus a three-week schedule for induction remission in acute myeloid leukemia (AML).\n\nKey Research Questions:\n\n1. Is the efficacy of the two-week VA-CAG regimen equivalent to that of the three-week regimen in inducing remission in AML?\n2. Does the two-week VA-CAG regimen reduce treatment-related adverse events compared to the three-week regimen? Methods: Researchers will compare the efficacy and safety of the two-week VA-CAG regimen with the three-week regimen for induction remission in AML. Study participants will be randomly assigned to receive standard treatment with either the two-week or three-week VA-CAG regimen. Patients are required to attend monthly follow-up visits for a total of one year. At each follow-up, the following assessments will be performed: complete blood count, liver and kidney function tests, bone marrow aspiration, flow cytometric measurement of minimal residual disease (MRD), and\u002For fusion gene analysis, along with monitoring of other efficacy endpoints and adverse reactions.",[27],"2026-06-07",{"date":549,"type":33},"2026-06-11",{"date":292,"type":21},{"date":552,"type":21},"2028-06-01",{"name":554,"class":40},"Hematology department of the 920th hospital",{"id":556,"slug":557,"hasResults":12,"nctId":558,"briefTitle":559,"officialTitle":560,"acronym":4,"eligibilityCriteria":561,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":562,"targetDuration":4,"studyType":22,"phases":564,"briefSummary":565,"conditions":566,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":577,"locationsCount":579},"100544732","phase-1-a-study-to-investigate-apl-4098-alone-and-in-combination-in-adults-with-aml-or-mds-100544732","NCT06372717","A Study to Investigate APL-4098 Alone and in Combination in Adults With AML or MDS","A Phase 1 Study to Assess the Safety and Antitumor Activity of APL-4098 Alone and in Combination With Azacitidine and in Combination With Azacitidine Plus Venetoclax in Adults With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome\u002FAML (MDS\u002FAML) or Myelodysplastic Syndrome With Excess Blasts (MDS-EB)","Inclusion Criteria:\n\n* 18 years or older\n* Confirmed diagnosis of relapsed refractory acute myeloid leukemia (R\u002FR AML), myelodysplastic syndrome (MDS)\u002F AML, or MDS-excess blasts (MDS-EB) with the following characteristics: - R\u002FR AML (primary or secondary, including treatment-related), participant is intolerant to, or considered ineligible for available therapies known to provide clinical benefit.\n* WBC count ≤ 25,000\u002Fmicroliter\n* ECOG Performance Status of ≤ 2\n* Weight ≥ 40kg\n* Female participants of childbearing potential must have negative serum pregnancy test at screening; must not plan to become pregnant or have ova harvested or breastfeed while on study; must be willing to use specific contraception or avoid intercourse\n* Male participants must be willing to use specific contraception and not plan to impregnant a female partner or donate sperm while on study\n* Participant must be willing and able to provide written informed consent and to comply with the requirements of the trial\n\nExclusion Criteria:\n\n* Certain prior therapies such as: received an allogeneic stem cell transplant within 6 months of screening, received an autologous stem cell transplant within 3 months of screening, received any anti-cancer treatments within 2 weeks of Cycle 1 Day 1, prior radiation therapy within 4 weeks of screening\n* Certain medical conditions such as: other malignancies, myocardial infarction within 6 months of screening, symptomatic congestive heart failure, uncontrolled active infection, history of arterial thrombosis within 6 months of screening\n* Diagnostic assessments: Left ventricular ejection fraction \\\u003C 45%, Fridericia's corrected QT interval \\> 470msec, Aspartate aminotransferase and\u002For alanine aminotransferase \\> 3 x upper limit of normal (ULN), total bilirubin \\> 1.5 x ULN, calculated or measured creatinine clearance \\\u003C 45 mL\u002Fminute (multiply by 0.85 if female)\n* Infectious disease: HIV positive, active hepatitis B and\u002For C",{"count":563,"type":21},100,[24],"This is an open-label, Phase 1 study to determine the safety, tolerability, and efficacy of APL-4098 alone, and in combination with azacitidine, and in combination with azacitidine plus venetoclax for the treatment of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS)\u002FAML and MDS-excess blasts (EB).",[567,568,569,570,27],"Acute Myeloid Leukemia Refractory","Myelodysplastic Syndrome Acute Myeloid Leukemia","Myelodysplastic Syndrome With Excess Blasts","Acute Myeloid Leukemia, in Relapse","2026-05-29",{"date":292,"type":33},{"date":574,"type":33},"2024-06-04",{"date":576,"type":21},"2027-05-01",{"name":578,"class":102},"Apollo Therapeutics Ltd",9,{"id":581,"slug":582,"hasResults":12,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":4,"eligibilityCriteria":586,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":587,"targetDuration":4,"studyType":22,"phases":588,"briefSummary":589,"conditions":590,"keywords":4,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":598,"locationsCount":600},"100637951","phase-2-a-phase-2-clinical-study-of-ziftomenib-in-patients-with-relapsed-or-refractory-npm1-mutated-acute-myeloid-leukemia-100637951","NCT07623616","A Phase 2 Clinical Study of Ziftomenib in Patients With Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia","A Phase 2, Multicenter, Open-Label Study of Ziftomenib Monotherapy in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia With NPM1 Mutation","Inclusion Criteria:\n\n* Voluntary written informed consent and willingness to comply with all study procedures\n* Age ≥ 18 years\n* Confirmed diagnosis of acute myeloid leukemia (AML)\n* Patients with R\u002FR AML with NPM1-m\n* No available standard of care expected to provide clinical benefit, ineligible for or declined standard therapy.\n* ECOG performance status 0-2.\n* White blood cell count ≤ 30,000\u002Fmm³ at screening (hydroxyurea permitted for cytoreduction).\n* Adequate organ function according to protocol requirements.\n* Women of childbearing potential must be willing to use a highly effective method of contraception throughout the study and for at least 187 days after the last dose of study treatment.\n* Males with female partners of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 97 days after the last dose of study treatment.\n\nExclusion Criteria:\n\n* Diagnosis of acute promyelocytic leukemia.\n* Donor lymphocyte infusion \\\u003C 30 days prior to study entry.\n* Clinically active central nervous system (CNS) leukemia.\n* Prior hematopoietic stem cell transplantation (HSCT) without adequate hematologic recovery.\n* Active Grade ≥ 2 acute graft-versus-host disease or moderate\u002Fsevere chronic graft-versus-host disease.\n* Prior treatment with a menin inhibitor.\n* Receipt of chemotherapy, immunotherapy, radiotherapy, or investigational therapy within 14 days or 5 half-lives prior to first dose.\n* Unresolved toxicities from prior therapy \\> Grade 1.\n* Requirement for strong CYP3A4 inducers.\n* Active or uncontrolled infection, including hepatitis B, hepatitis C, or HIV.\n* Conditions predisposing to serious or life-threatening infection or significant immunodeficiency.\n* Cardiovascular disease or QTcF \\> 480 ms.\n* Interstitial lung disease.\n* Major surgery within 4 weeks prior to first dose.\n* Women who are pregnant or lactating\n* Any medical, psychiatric, or social condition that may interfere with study participation or safety, or that makes the patient unsuitable in the investigator's judgment.",{"count":534,"type":21},[141],"This is the first study to administer ziftomenib to Japanese patients. In this study, the efficacy, safety, and pharmacokinetics of ziftomenib will be evaluated in patients with relapsed or refractory NPM1-mutated acute myeloid leukemia",[27],"2026-05-28",{"date":593,"type":33},"2026-06-03",{"date":595,"type":33},"2026-04-23",{"date":597,"type":21},"2028-12",{"name":599,"class":102},"Kyowa Kirin Co., Ltd.",20,{"id":602,"slug":603,"hasResults":12,"nctId":604,"briefTitle":605,"officialTitle":606,"acronym":4,"eligibilityCriteria":607,"healthyVolunteers":12,"sex":17,"minAge":608,"maxAge":4,"enrollmentInfo":609,"targetDuration":4,"studyType":22,"phases":610,"briefSummary":611,"conditions":612,"keywords":614,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":616,"lastUpdatePostDateStruct":617,"startDateStruct":618,"completionDateStruct":620,"leadSponsor":622,"locationsCount":41},"100640492","phase-2-vabu-conditioning-in-elderly-aml-hsct-100640492","NCT07583888","VABu Conditioning in Elderly AML HSCT","Efficacy and Safety of the VABu Conditioning Regimen in Elderly Patients With Acute Myeloid Leukemia Undergoing Hematopoietic Stem Cell Transplantation: An Open-Label, Multicenter, Single-Arm Clinical Study","Inclusion Criteria:\n\n1. Age ≥ 60 years.\n2. Confirmed diagnosis of acute myeloid leukemia (AML) according to WHO classification, with intermediate or high-risk prognosis.\n3. Previous response to Venetoclax-based therapy.\n4. Planned to undergo allogeneic hematopoietic stem cell transplantation (HSCT).\n5. Donor availability: Related donor matched at least 5\u002F10 at HLA-A, -B, -C, -DQB1, and -DRB1; OR unrelated donor matched at least 8\u002F10 at the same loci.\n6. Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI) score ≤ 4.\n7. ECOG performance status 0-2.\n8. Adequate organ function as defined by: Creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 45 mL\u002Fmin (Cockcroft-Gault formula or 24-hour urine collection)； AST ≤ 3.0 × ULN and ALT ≤ 3.0 × ULN； Total bilirubin ≤ 1.5 × ULN； Left ventricular ejection fraction (LVEF) \\> 50%； Baseline oxygen saturation \\> 92%； DLCO ≥ 40% and FEV1 ≥ 50%；\n9. Ability to understand and provide written informed consent.\n\nExclusion Criteria:\n\n1. Age \\\u003C 60 years.\n2. Poor response to prior Venetoclax-based therapy.\n3. Unstable systemic disease (unstable angina, myocardial infarction, cerebrovascular accident within 3 months; NYHA Class III-IV heart failure; severe arrhythmia; pulmonary hypertension).\n4. Active uncontrolled infection or active bleeding in vital organs.\n5. CNS symptoms grade ≥ 2 requiring treatment.\n6. Major organ surgery within 6 weeks.\n7. History of malignant disease other than AML within 5 years.\n8. History of thrombosis, embolism, or cerebral hemorrhage within 1 year.\n9. ECOG performance status \\> 2.\n10. HCT-CI score \\> 4.\n11. Organ failure meeting specified criteria.\n12. Known HIV, active HBV, or active HCV infection.\n13. History of autoimmune disease requiring systemic immunosuppressive therapy.\n14. Pregnancy, breastfeeding, or unwillingness to use effective contraception in patients of childbearing potential.\n15. Drug abuse or chronic alcoholism.\n16. Psychiatric disorder or other condition compromising informed consent or compliance.\n17. Any other condition making the patient unsuitable for study participation in the investigator's judgment.","60 Years",{"count":600,"type":21},[141,74],"This is an open-label, multi-center, single-arm clinical study evaluating the efficacy and safety of the VABu conditioning regimen in elderly patients (≥60 years) with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic stem cell transplantation (HSCT).\n\nThe VABu regimen consists of Venetoclax, Azacitidine, Semustine, Cytarabine, and Busulfan. All enrolled participants will receive the VABu regimen as conditioning therapy prior to HSCT.\n\nThe study aims to enroll 20 participants from multiple centers in China. The primary objectives are to evaluate the overall response rate, cumulative relapse rate, overall survival, graft-versus-host disease (GVHD)-free relapse-free survival (GRFS), non-relapse mortality (NRM), incidence of acute and chronic GVHD, and reactivation rates of cytomegalovirus (CMV) and Epstein-Barr virus (EBV). Safety outcomes include treatment-related toxicities, such as bone marrow suppression, infection, and organ dysfunction.",[613,27],"Allogeneic Hematopoietic Stem Cell Transplantation Recipient",[615],"Acute Myeloid Leukemia; Elderly; Hematopoietic Stem Cell Transplantation; Venetoclax; Busulfan; Preconditioning","2026-05-12",{"date":398,"type":33},{"date":619,"type":21},"2026-05-07",{"date":621,"type":21},"2027-08-15",{"name":296,"class":40},{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":628,"acronym":4,"eligibilityCriteria":629,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":630,"targetDuration":4,"studyType":22,"phases":632,"briefSummary":633,"conditions":634,"keywords":635,"overallStatus":93,"whyStopped":4,"lastUpdateSubmitDate":637,"lastUpdatePostDateStruct":638,"startDateStruct":640,"completionDateStruct":642,"leadSponsor":644,"locationsCount":646},"100508948","phase-3-an-open-label-phase-3b-study-of-ivosidenib-in-combination-with-azacitidine-in-adult-patients-newly-diagnosed-with-idh1m-acute-myeloid-leukemia-aml-ineligible-for-intensive-induction-chemotherapy-100508948","NCT05907057","An Open-label Phase 3b Study of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy.","A Single Arm, Open-label Phase 3b Study to Describe the Safety and Tolerability of Ivosidenib in Combination With Azacitidine in Adult Patients Newly Diagnosed With IDH1m Acute Myeloid Leukemia (AML) Ineligible for Intensive Induction Chemotherapy","Inclusion Criteria:\n\n* Has untreated Acute Myeloid Leukemia (AML)\n* Have a documented IDH1 R132 gene-mutated disease\n* Have at least one of the following making yourself ineligible for intensive chemotherapy (IC): 75 years or older, Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 2, or any comorbidity that the investigator judges to be incompatible with IC including but not limited to severe cardiac or pulmonary disorder, creatinine clearance less than 45 mL\u002Fminute, or bilirubin greater than 1.5 times the upper limit of normal\n* Has adequate hepatic (liver) and renal (kidney) function\n* Female participants of reproductive potential must have a negative blood pregnancy test and must use effective contraception during treatment and for at least 6 months following treatment\n* Fertile male participants with female partners of reproductive potential must use effective contraception during treatment and for at least 3 months following treatment\n\nExclusion Criteria:\n\n* Has received any prior treatment for AML, with the exception of hydroxyurea or leukapheresis for white blood cell count control\n* Has received prior treatment with an IDH1 inhibitor\n* Is a woman who is pregnant or breastfeeding\n* Has an active, uncontrolled, systemic fungal, bacterial, or viral infection (including human immunodeficiency virus \\[HIV\\], active hepatitis B (HBV), or hepatitis C virus \\[HCV\\]) without improvement despite appropriate antibiotics, antiviral therapy, and\u002For other treatment\n* Has had significant active cardiac disease within 6 months prior to the start of study treatment, including Class III or IV congestive heart failure, myocardial infarction (heart attack), unstable angina (chest pain), and\u002For stroke\n* Has dysphagia (difficulty swallowing), short-gut syndrome, gastroparesis (stomach paralysis), or any other condition that limits the ingestion or gastrointestinal absorption of orally administered drugs\n* Has uncontrolled hypertension (high blood pressure)",{"count":631,"type":21},245,[74],"The purpose of this study is to learn more about the safety and efficacy of ivosidenib taken with azacitidine to treat adult patients with acute myeloid leukemia (AML) who are presenting a gene mutation called IDH1 (isocitrate dehydrogenase1 mutation-positive \\[IDH1m\\]) and cannot receive treatment with intensive chemotherapy (IC).",[27],[636],"IDH1 Mutation AML","2026-05-06",{"date":639,"type":33},"2026-05-08",{"date":641,"type":33},"2023-06-14",{"date":643,"type":21},"2027-10-15",{"name":645,"class":102},"Servier Affaires Médicales",15]