[{"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":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,61,0,25,[9,49,71,101,136,167,195,223,244,275,300,321,348,370,394,412,433,462,487,520,543,569,590,612,641],{"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":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100636402","phase-1-thiotepa-based-conditioning-regimen-with-de-escalated-post-graft-cyclophosphamide-for-allogeneic-stem-cell-transplantation-in-hematologic-malignancies-100636402",false,"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.","ALL","18 Years",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","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).",[27,28,29,30,31],"Acute Lymphocytic Leukemia (ALL)","Acute Myeloid Leukemia (AML)","Acute Leukemia","Myelodysplastic Syndrome(MDS)","Myeloproliferative Neoplasm (MPN)",[33,34,35],"allogeneic hematopoietic stem cell transplantation","HLA","graft-versus-host disease (GVHD)","RECRUITING","2026-06-29",{"date":39,"type":40},"2026-07-01","ACTUAL",{"date":42,"type":21},"2026-08-01",{"date":44,"type":21},"2030-11-01",{"name":46,"class":47},"Sawa Ito, MD","OTHER",1,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":12,"sex":17,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":48},"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":59,"type":21},50,"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.",[28],"2026-06-27",{"date":39,"type":40},{"date":66,"type":21},"2026-06-01",{"date":68,"type":21},"2027-06-01",{"name":70,"class":47},"The First Affiliated Hospital of Soochow University",{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":48},"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":79,"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.",[28,82,83,84],"Myelodysplastic (MDS) \u002F Myeloproliferative (MPN) Diseases","Myelodysplatic Syndromes","Myeloproliferative Neoplasm",[86,87,88,89,90],"Chromoseq","Caris","AML","MDS","MPN","2026-06-26",{"date":93,"type":40},"2026-07-02",{"date":95,"type":21},"2026-07",{"date":97,"type":21},"2029-07",{"name":99,"class":100},"Caris Science, Inc.","INDUSTRY",{"id":102,"slug":103,"hasResults":12,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":112,"conditions":113,"keywords":114,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":128,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},"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":109,"type":21},1300,[111],"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\".",[28],[88,115,116,117,118,29,119,120,121,122,123,124,125,126,127],"Hematological malignancy","KMT2A","NPM1","Menin","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",{"date":37,"type":40},{"date":130,"type":40},"2025-09-26",{"date":132,"type":21},"2031-11",{"name":134,"class":100},"Kura Oncology, Inc.",82,{"id":137,"slug":138,"hasResults":12,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":144,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":147,"briefSummary":148,"conditions":149,"keywords":150,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":166},"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":146,"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.",[28],[120,88,119,29,151,152,153,154,155,156],"Myeloid Leukemia","CAR-T","Cellular Therapy","CD33-CLL1 CAR-T","Relapsed or Refractory","R\u002FR AML","2026-06-19",{"date":159,"type":40},"2026-06-25",{"date":161,"type":40},"2026-06-10",{"date":163,"type":21},"2029-07-04",{"name":165,"class":100},"iCell Gene Therapeutics",2,{"id":168,"slug":169,"hasResults":12,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":22,"phases":175,"briefSummary":176,"conditions":177,"keywords":178,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":194},"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":146,"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.",[28],[179,180,181,182,183,184],"Gilteritinib","Ivosidenib","Enasidenib","FLT3\u002FIDH1 Mutations","FLT3\u002FIDH2 Mutations","21-174","2026-06-18",{"date":187,"type":40},"2026-06-22",{"date":189,"type":40},"2023-10-25",{"date":191,"type":21},"2027-04-21",{"name":193,"class":47},"Memorial Sloan Kettering Cancer Center",7,{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":202,"enrollmentInfo":203,"targetDuration":4,"studyType":22,"phases":205,"briefSummary":207,"conditions":208,"keywords":211,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":222},"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)","75 Years",{"count":204,"type":21},75,[206],"PHASE2","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).",[209,28,210],"IDH1 Mutation","Hematopoietic Stem Cell Transplant (HSCT)",[212,213],"hematopoietic stem cell transplantation (HCT)","IDH1-mutant acute myeloid leukemia (AML)","2026-06-17",{"date":185,"type":40},{"date":217,"type":40},"2026-01-16",{"date":219,"type":21},"2030-01-01",{"name":221,"class":47},"Massachusetts General Hospital",6,{"id":224,"slug":225,"hasResults":12,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":202,"enrollmentInfo":230,"targetDuration":4,"studyType":22,"phases":232,"briefSummary":233,"conditions":234,"keywords":4,"overallStatus":235,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":240,"leadSponsor":242,"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":231,"type":21},110,[206],"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.",[28],"NOT_YET_RECRUITING","2026-06-07",{"date":238,"type":40},"2026-06-11",{"date":66,"type":21},{"date":241,"type":21},"2028-06-01",{"name":243,"class":47},"Hematology department of the 920th hospital",{"id":245,"slug":246,"hasResults":12,"nctId":247,"briefTitle":248,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":12,"sex":17,"minAge":250,"maxAge":251,"enrollmentInfo":252,"targetDuration":4,"studyType":22,"phases":254,"briefSummary":255,"conditions":256,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":48},"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","80 Years",{"count":253,"type":21},80,[24,206],"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.",[257,258,28,259,260,261,262,263,264,265],"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","2026-06-04",{"date":268,"type":40},"2026-06-08",{"date":270,"type":40},"2022-11-01",{"date":272,"type":21},"2026-08-31",{"name":274,"class":47},"M.D. Anderson Cancer Center",{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":22,"phases":284,"briefSummary":285,"conditions":286,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":299},"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":283,"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).",[287,288,289,290,28],"Acute Myeloid Leukemia Refractory","Myelodysplastic Syndrome Acute Myeloid Leukemia","Myelodysplastic Syndrome With Excess Blasts","Acute Myeloid Leukemia, in Relapse","2026-05-29",{"date":66,"type":40},{"date":294,"type":40},"2024-06-04",{"date":296,"type":21},"2027-05-01",{"name":298,"class":100},"Apollo Therapeutics Ltd",9,{"id":301,"slug":302,"hasResults":12,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":4,"eligibilityCriteria":306,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":307,"targetDuration":4,"studyType":22,"phases":308,"briefSummary":309,"conditions":310,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":320},"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":222,"type":21},[206],"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",[28],"2026-05-28",{"date":313,"type":40},"2026-06-03",{"date":315,"type":40},"2026-04-23",{"date":317,"type":21},"2028-12",{"name":319,"class":100},"Kyowa Kirin Co., Ltd.",20,{"id":322,"slug":323,"hasResults":12,"nctId":324,"briefTitle":325,"officialTitle":326,"acronym":327,"eligibilityCriteria":328,"healthyVolunteers":12,"sex":17,"minAge":329,"maxAge":330,"enrollmentInfo":331,"targetDuration":4,"studyType":22,"phases":333,"briefSummary":334,"conditions":335,"keywords":336,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":48},"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 flow cytometric confirmation of myeloid leukemia of at least 0.1% after second documented complete remission; OR\n  2. Any detectable disease post-allogeneic transplant with flow cytometric confirmation of myeloid leukemia of at least 0.1%; OR\n  3. Refractory disease, defined as: Persistent bone marrow involvement with \\>5% blasts after two courses of induction chemotherapy for patients at initial presentation, \\>5% bone marrow blasts after one course of induction chemotherapy for patients who have relapsed after previously achieving a CR, and \\>5% bone marrow blasts 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":332,"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).",[28],[337,88,327,119,338],"CART","Ruxolitinib","2026-05-22",{"date":341,"type":40},"2026-05-27",{"date":343,"type":40},"2026-05-14",{"date":345,"type":21},"2030-05-14",{"name":347,"class":47},"Stephan Grupp MD PhD",{"id":349,"slug":350,"hasResults":12,"nctId":351,"briefTitle":352,"officialTitle":353,"acronym":4,"eligibilityCriteria":354,"healthyVolunteers":12,"sex":17,"minAge":355,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":22,"phases":357,"briefSummary":358,"conditions":359,"keywords":361,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":48},"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":320,"type":21},[206,111],"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.",[360,28],"Allogeneic Hematopoietic Stem Cell Transplantation Recipient",[362],"Acute Myeloid Leukemia; Elderly; Hematopoietic Stem Cell Transplantation; Venetoclax; Busulfan; Preconditioning","2026-05-12",{"date":343,"type":40},{"date":366,"type":21},"2026-05-07",{"date":368,"type":21},"2027-08-15",{"name":70,"class":47},{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":377,"targetDuration":4,"studyType":22,"phases":379,"briefSummary":380,"conditions":381,"keywords":382,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":393},"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":378,"type":21},245,[111],"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).",[28],[383],"IDH1 Mutation AML","2026-05-06",{"date":386,"type":40},"2026-05-08",{"date":388,"type":40},"2023-06-14",{"date":390,"type":21},"2027-10-15",{"name":392,"class":100},"Servier Affaires Médicales",15,{"id":395,"slug":396,"hasResults":12,"nctId":397,"briefTitle":398,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":400,"targetDuration":4,"studyType":22,"phases":402,"briefSummary":403,"conditions":404,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":48},"100578433","phase-2-monitoring-detoxifying-and-rebalancing-metals-during-acute-myeloid-leukemia-aml-therapy-a-phase-2-randomized-study-100578433","NCT06811233","Monitoring, Detoxifying, and Rebalancing Metals During Acute Myeloid Leukemia (AML) Therapy, a Phase 2 Randomized Study","Inclusion Criteria:\n\n1. Understand and voluntarily sign an informed consent form for participants 18 years or older, unless LAR signs where applicable along with any required verbal assents if patients can provide assent.\n2. Age 18 years or older at the time of signing the informed consent form.\n3. Diagnosis of Any of the Following:\n\n   * Newly diagnosed (or untreated) AML or Newly diagnosed Myeloproliferative Neoplasm in Myeloid Blast Phase (MPN-BP) \\[including Chronic Myeloid Leukemia in Blast Phase (CML-BP)\\], Ph+AML with intermediate-risk or high-risk (by ELN), or any other intermediate or high-risk AML by ELN\n   * Secondary AML regardless of ELN risk status, however, may not have CBF \\[t(8;21) or inv(16)\\]\n\n   Secondary AML types include:\n   * Secondary AML evolved from prior untreated MDS, myeloproliferative neoplasm (MPN), or Aplastic Anemia\n   * Therapy-related AML (t-AML)\n   * AML evolved after prior MDS, MPN, or Aplastic Anemia after prior therapy for those myeloid bone marrow disorders\n   * Secondary AML, including blast phase of MPN (MPN-BP) \\[also, including CML in blast phase (BP of CML) after prior hematologic myeloid bone marrow disease (MDS, MPN, Aplastic Anemia, CML) (patients may have received treatment for their prior hematologic disorder for their previous bone marrow disorder) . Newly diagnosed (or untreated) myeloid blast phase of MPN (including myeloid blast phase of CML)\u002FPh+AML.150\n4. Patients can enroll on this study after start of non-investigational induction therapy but must be within first 2 cycles of front-line therapy, as long as not in a complete remission.\n5. Transformed and untreated AML transformed from previously treated MDS, myeloproliferative neoplasm (MPN) or other types of secondary AML are allowed. Myeloid-Blast Phase of MPN and Myeloid Blast Phase of Chronic Myeloid Leukemia (CML) are allowed\u002FPh+ AML are allowed.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of . 2\n7. Laboratory test results within these ranges (unless due to leukemia or other hematologic malignancy):\n\n   * Serum creatinine.2.0 mg\u002FdL\n   * Total Bilirubin . 2.0 x Upper limit of normal (ULN) unless the patient has Gilbert fs.\n   * AST (SGOT) and\u002For ALT (SGPT) . 2.0 x ULN\n8. Women of childbearing potential (WCBP) must have a negative urine or serum pregnancy test within 14 days and must either commit to continued abstinence from heterosexual intercourse or adopting at least one highly effective method of contraception. These methods include intra-uterine device, tubal ligation, partners vasectomy, and hormonal birth control pills. Men must agree not to father a child and agree to use a condom if his partner is of childbearing potential.\n9. Extramedullary disease is allowed if it can be measured and followed for response.\n\nExclusion Criteria:\n\n1. Nursing and pregnant individuals. Should a study participant become pregnant or suspect pregnancy while participating in this study, the study participant should inform their treating physician immediately.\n2. Uncontrolled inter-current illness including, but not limited to, uncontrolled active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements or which judged by the investigator, places the patient at unacceptable risk.\n3. Acute Promyelocytic leukemia (APL)\n4. Prior venetoclax failure",{"count":401,"type":21},140,[206],"The goal of this clinical research study is to learn if metal detoxification (with calcium disodium edetate \\[Ca-EDTA\\] and dimercaptosuccinic acid \\[DMSA\\]) during standard therapy can help improve outcomes in patients with intermediate-risk, high-risk, or secondary AML compared to standard therapy alone. Researchers think lowering the level of metals found in the blood\u002Fbone marrow may help to control the disease and\u002For improve the response to chemotherapy.",[28],"2026-04-20",{"date":315,"type":40},{"date":408,"type":40},"2025-05-08",{"date":410,"type":21},"2031-08-31",{"name":274,"class":47},{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":416,"acronym":4,"eligibilityCriteria":417,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":418,"targetDuration":420,"studyType":60,"phases":4,"briefSummary":421,"conditions":422,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":432},"100300270","clinical-aml-registry-and-biomaterial-database-of-the-study-alliance-leukemia-sal-100300270","NCT03188874","Clinical AML Registry and Biomaterial Database of the Study Alliance Leukemia (SAL)","Inclusion Criteria:\n\n* AML according to the WHO (World Health Organization) diagnostic criteria, including acute promyelocytic leukemia\n* Age ≥ 18 years. There is no upper age limit.\n* Signed written informed consent\n\nExclusion Criteria:\n\n* there are no exclusion criteria",{"count":419,"type":21},15000,"10 Years","This is a registry study in adult patients with newly diagnosed or refractory\u002Frelapsed acute myeloid leukemia.\n\nInvestigator's sites: 60 sites in Germany.\n\nPrimary objectives:\n\n* Identification of epidemiological data on AML: age, prognostic factors and subgroup distributions. Incidence and age distribution are compared with the data of population-related tumor registry.\n* Evaluation of the most important patient-relevant clinical endpoints (outcomes): relapse-free survival (RFS) \u002F time to relapse (TTR), calculation of cumulative incidence of relapse (CIR) and overall survival (OS)\n* Documentation of treatment strategy",[28],"2026-04-16",{"date":425,"type":40},"2026-04-21",{"date":427,"type":4},"2010-09",{"date":429,"type":21},"2030-09-30",{"name":431,"class":47},"Technische Universität Dresden",60,{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":4,"eligibilityCriteria":439,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":251,"enrollmentInfo":440,"targetDuration":4,"studyType":22,"phases":441,"briefSummary":442,"conditions":443,"keywords":450,"overallStatus":235,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":48},"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.",{"count":59,"type":21},[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.",[444,445,28,446,447,448,449],"GVHD","Hematopoietic Cell Transplantation (HCT)","Myelodysplastic Syndromes","Myelofibrosis (MF)","Chronic Myeloid Leukemia (CML)","Chronic Myelomonocytic Leukemia (CMML)",[451,452],"Post-Hematopoietic Cell Transplant (HCT) tacrolimus","hematopoietic cell transplantation (HCT)","2026-04-14",{"date":455,"type":40},"2026-04-17",{"date":457,"type":21},"2026-06",{"date":459,"type":21},"2028-02",{"name":461,"class":47},"Stanford University",{"id":463,"slug":464,"hasResults":12,"nctId":465,"briefTitle":466,"officialTitle":466,"acronym":467,"eligibilityCriteria":468,"healthyVolunteers":12,"sex":17,"minAge":469,"maxAge":355,"enrollmentInfo":470,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":472,"conditions":473,"keywords":475,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":481,"completionDateStruct":483,"leadSponsor":485,"locationsCount":48},"100634288","leukemia-stem-cell-based-assay-to-predict-relapse-and-survival-in-patients-with-acute-myeloid-leukemia-100634288","NCT07537738","Leukemia Stem Cell-based Assay to Predict Relapse and Survival in Patients With Acute Myeloid Leukemia","MLL-LSC","Inclusion Criteria:\n\nAcute myeloiud leukemia patients with MLL arrangement aging 6-60 years recieving chemoterapy or allo-geneic hematopoietic stem cell transplantation.\n\nExclusion Criteria:\n\n1. Patients who cannot recieve chemoterapy or allo-geneic hematopoietic stem cell transplantation.\n2. Patients who cannot comply with the study.","6 Years",{"count":471,"type":21},210,"The goal of this observational study is to learn about the predict value of leukemia stem cell for acute myeloid leukemia patients with MLL-rearrangement. The main question it aims to answer is:\n\n• Could be leukemia stem cell used for relapse prediction in acute myeloid leukemia patients with MLL-rearrangement? Leukemia stem cell will be detected at the same time for participants who detected minimal residual disease using bone marrow as part of their regular medical care to answer the question.",[28,474],"MLL Rearrangement",[476,477,478],"acute myeloid leukemia","leukemia stem cell","allo-SCT","2026-04-13",{"date":455,"type":40},{"date":482,"type":40},"2025-06-01",{"date":484,"type":21},"2026-04-07",{"name":486,"class":47},"Peking University People's Hospital",{"id":488,"slug":489,"hasResults":12,"nctId":490,"briefTitle":491,"officialTitle":492,"acronym":493,"eligibilityCriteria":494,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":495,"enrollmentInfo":496,"targetDuration":4,"studyType":22,"phases":498,"briefSummary":499,"conditions":500,"keywords":505,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":166},"100633910","phase-1-proton-based-total-marrow-irradiation-for-allogeneic-transplantation-in-high-risk-amlmds-100633910","NCT07532824","Proton-Based Total Marrow Irradiation for Allogeneic Transplantation in High-Risk AML\u002FMDS","Proton Total Marrow Irradiation-Based Conditioning for Allogeneic Hematopoietic Stem Cell Transplantation in High-Risk Acute Myeloid Leukemia and Myelodysplastic Syndrome","UHKT-PTC-TMI-1","Inclusion Criteria:\n\n1. Underlying diagnosis of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS),\n\n   A) Acute Myeloid Leukemia (AML), meeting at least one of the following criteria:\n\n   i. Relapsed disease after a prior complete remission (CR) or\n\n   ii. Disease refractory to at least two cycles of intensive chemotherapy or\n\n   iii. High-risk AML in complete remission (CR), defined by at least one of the following:\n\n   iii a) Adverse molecular or cytogenetic risk according to ELN 2022 classification or\n\n   iii b) Presence of measurable\u002Fminimal residual disease (MRD).\n\n   B) Myelodysplastic Syndrome (MDS), meeting at least one of the following criteria:\n\n   i. Relapsed MDS with increased blasts (MDS-IB) or\n\n   ii. MDS-IB2 without reduction of bone marrow blasts below 10% after induction chemotherapy or after at least two cycles of azacitidine or\n\n   iii. IPSS-M score \\> 0.5 (high-risk or very high-risk disease).\n2. Eligibility confirmed by the institutionalal Transplant Indication Committee according to standard criteria.\n3. Age ≥ 18 years and ≤ 65 years\n4. Ability to understand and voluntarily sign written informed consent\n\nExclusion Criteria:\n\nSevere comorbidity, defined as the presence of one or more of the following conditions:\n\n1. Left ventricular ejection fraction (LVEF) \\\u003C 40%\n2. Creatinine clearance \\\u003C 0.5 mL\u002Fs\n3. Total bilirubin \\> 40 µmol\u002FL (unless attributable to Gilbert's syndrome or hemolysis) and alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 5 × upper limit of normal (ULN)\n4. Pulmonary function impairment defined as forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) \\\u003C 50% of predicted value, or diffusing capacity of the lung for carbon monoxide (DLCO) \\\u003C 50% of predicted value after correction for anemia\n5. Karnofsky Performance Status \\\u003C 70%\n6. Active viral hepatitis or human immunodeficiency virus (HIV) infection\n7. Presence of liver cirrhosis\n8. Pregnancy","65 Years",{"count":497,"type":21},16,[24,206],"This is an open-label, single-center, non-randomized phase I\u002FII pilot study evaluating proton-based Total Marrow Irradiation (TMI) as part of the conditioning regimen prior to allogeneic hematopoietic stem cell transplantation (allo-HSCT) in adult patients with high-risk or relapsed\u002Frefractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). These patients have an unfavorable prognosis with standard conditioning approaches.\n\nParticipants will receive a standard conditioning regimen consisting of either myeloablative or reduced-intensity chemotherapy, selected according to age and comorbidities, combined with proton TMI delivered at a total dose of 12 Gy in three fractions. Graft-versus-host disease (GvHD) prophylaxis will be administered according to institutional standards, preferentially using post-transplant cyclophosphamide. Patients will subsequently undergo standard allo-HSCT and will be followed for at least 24 months after transplantation.\n\nThe primary objective of the study is to assess the safety and tolerability of proton TMI added to standard conditioning, as measured by non-relapse mortality and treatment-related toxicity within the first 100 days after transplantation. Secondary objectives include evaluation of engraftment kinetics, incidence of relapse, overall and relapse-free survival, GvHD outcomes, and quality of life. Study outcomes will be analyzed descriptively and compared with a matched historical cohort.",[28,501,502,503,504],"Myelodysplastic Syndrome (MDS)\u002FAML","Proton Therapy","MDS and AML Prior to Allogeneic SCT","Myelodysplastic Neoplasm",[506,507,508,502,509,510,511],"High-Risk Hematologic Malignancy","Total Marrow Irradiation","TMI","Conditioning Regimen","Targeted Radiotherapy","HSCT","2026-04-09",{"date":423,"type":40},{"date":515,"type":40},"2025-11-21",{"date":517,"type":21},"2029-11",{"name":519,"class":47},"Institute of Hematology and Blood Transfusion, Czech Republic",{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":4,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":17,"minAge":355,"maxAge":202,"enrollmentInfo":527,"targetDuration":4,"studyType":22,"phases":529,"briefSummary":530,"conditions":531,"keywords":533,"overallStatus":235,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":541,"locationsCount":48},"100629007","phase-3-vah-vs-va-in-newly-diagnosed-elderly-aml-100629007","NCT07469046","VAH vs VA in Newly Diagnosed Elderly AML","Venetoclax, Azacitidine Combined With Homoharringtonine Versus Venetoclax and Azacitidine in Newly Diagnosed Elderly (60-75 Years) Acute Myeloid Leukemia: A Multicenter, Open-label, Randomized, Controlled Clinical Trial","Inclusion Criteria:\n\n* Diagnosis of acute myeloid leukemia (AML), non-APL, according to the 2022 International Consensus Classification (ICC) criteria.\n* Age 60 to 75 years, inclusive.\n* Life expectancy of at least 12 weeks.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3.\n* Adequate organ function unless abnormalities are considered due to leukemic organ involvement:\n\nSerum creatinine ≤ 1.5 × upper limit of normal (ULN). Oxygen saturation \\> 92% on room air. Total bilirubin ≤ 3.0 × ULN. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN.\n\nIf laboratory abnormalities are considered due to leukemic organ involvement, total bilirubin ≤ 5.0 × ULN and ALT\u002FAST ≤ 5.0 × ULN are permitted.\n\n* Female subjects of childbearing potential must be postmenopausal or surgically sterile. Male subjects must agree to use effective contraception or abstain from sperm donation from study start through 90 days after the last dose of study treatment.\n* Ability to understand and voluntarily sign an informed consent form prior to any study-related procedures.\n\nExclusion Criteria:\n\n* Prior treatment with hypomethylating agents for myelodysplastic syndrome (MDS). Prior chemotherapy for AML, except hydroxyurea. Prior CAR-T cell therapy.\n* Prior investigational therapy for AML.\n* Documented history of myeloproliferative neoplasm (MPN).\n* Favorable-risk AML according to 2022 European LeukemiaNet (ELN) criteria.\n* Known active central nervous system (CNS) involvement of AML.\n* Known human immunodeficiency virus (HIV) infection.\n* Active hepatitis B or hepatitis C requiring antiviral therapy. Risk of hepatitis B reactivation (hepatitis B surface antigen positive or hepatitis B core antibody positive without antiviral prophylaxis).\n* History of another malignancy within 5 years prior to screening, except adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer treated with curative intent, or ductal carcinoma in situ treated with curative intent.\n* Unstable systemic disease including unstable angina, cerebrovascular accident, or transient ischemic attack within 3 months prior to screening. Myocardial infarction within 3 months prior to screening. Congestive heart failure New York Heart Association class III or IV. Recent pacemaker implantation. Severe liver, kidney, or metabolic disease requiring ongoing treatment. Pulmonary arterial hypertension. Clinically significant or uncontrolled arrhythmias including persistent atrial fibrillation or flutter, symptomatic ventricular arrhythmias, QTc ≥ 470 ms in males or ≥ 480 ms in females, second- or third-degree atrioventricular block without pacemaker, or arrhythmias requiring continuous antiarrhythmic therapy.\n* Malabsorption syndrome or any condition preventing enteral drug administration. Active systemic infection requiring treatment.\n* Significant neurological or psychiatric disorders requiring treatment including epilepsy grade 2 or higher, paralysis, aphasia, recent cerebral infarction, severe traumatic brain injury, dementia, Parkinson's disease, or schizophrenia.\n* Fertile males or females of childbearing potential unwilling to use effective contraception during treatment and for 12 months after completion of treatment.\n* White blood cell count \\> 25 × 10⁹\u002FL at screening (hydroxyurea permitted to reduce count to meet eligibility).",{"count":528,"type":21},308,[111],"This is a multicenter, open-label, randomized, controlled phase III clinical trial designed to evaluate the efficacy and safety of the combination of Venetoclax, Azacitidine, and Homoharringtonine (VAH) compared to Venetoclax and Azacitidine (VA) alone in newly diagnosed elderly patients with Acute Myeloid Leukemia (AML).\n\nA total of 308 treatment-naïve patients aged 60-75 years with AML (non-APL) will be enrolled and randomly assigned in a 1:1 ratio to either the control arm (VA) or the experimental arm (VAH). The study aims to determine if the addition of Homoharringtonine to the standard VA regimen can improve response rates. To mitigate bias in this open-label study, the primary and key secondary efficacy endpoints will be assessed by an Independent Review Committee or central laboratory blinded to treatment allocation.",[28,532],"Elderly Patients (60-75 Years)",[28,534],"Elderly Patients","2026-04-06",{"date":479,"type":40},{"date":538,"type":21},"2026-04-10",{"date":540,"type":21},"2029-03-31",{"name":542,"class":47},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",{"id":544,"slug":545,"hasResults":12,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":549,"eligibilityCriteria":550,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":551,"targetDuration":4,"studyType":22,"phases":552,"briefSummary":553,"conditions":554,"keywords":555,"overallStatus":235,"whyStopped":4,"lastUpdateSubmitDate":561,"lastUpdatePostDateStruct":562,"startDateStruct":564,"completionDateStruct":566,"leadSponsor":567,"locationsCount":48},"100631987","phase-2-exploratory-study-of-venetoclax-homoharringtonine-azacitidine-plus-g-csf-for-newly-diagnosed-aml-vhag-100631987","NCT07507825","Exploratory Study of Venetoclax, Homoharringtonine, Azacitidine Plus G-CSF for Newly Diagnosed AML (VHAG)","A Prospective, Multicenter, Exploratory Study of Venetoclax, Homoharringtonine, and Azacitidine Combined With G-CSF in Elderly or Unfit Patients With Newly Diagnosed Acute Myeloid Leukemia","VHAG","Inclusion Criteria:\n\n* The patient has fully understood the study, voluntarily participated, and signed the informed consent form (ICF).\n* Newly diagnosed acute myeloid leukemia (AML) confirmed by bone marrow morphology, immunophenotyping, cytogenetics, and\u002For molecular biology testing, in accordance with the WHO Classification of Tumours of Haematopoietic and Lymphoid Tissues (2022 edition).\n* No prior systemic therapy for AML (including induction, consolidation, or maintenance therapy).\n* Patients judged unfit for standard cytarabine plus anthracycline induction chemotherapy due to age or comorbidities.\n* Short-term use of hydroxyurea or low-dose cytarabine before enrollment to control hyperleukocytosis is permitted.\n* Age ≥ 75 years, or age 18-74 years with any of the following comorbidities:\n* ECOG performance status 2-3\n* History of congestive heart failure, left ventricular ejection fraction (LVEF) ≤ 50%, or chronic stable angina\n* Diffusing capacity of the lung for carbon monoxide (DLCO) ≤ 65% predicted, or forced expiratory volume in 1 second (FEV1) ≤ 65% predicted\n* Creatinine clearance 30-45 mL\u002Fmin (≥ 30 and \\\u003C 45)\n* Moderate hepatic impairment: total bilirubin \\> 1.5 × ULN and ≤ 3 × ULN\n* Other comorbidities deemed unfit for standard chemotherapy by the investigator\n* Estimated survival time ≥ 12 weeks.\n* For patients aged ≥ 75 years: ECOG performance status 0-2.\n* For patients aged 18-74 years: ECOG performance status 0-3.\n* Creatinine clearance ≥ 30 mL\u002Fmin (calculated by the Cockcroft-Gault formula).\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN).\n* Total bilirubin ≤ 1.5 × ULN; may be relaxed to ≤ 3 × ULN in patients with leukemic hepatic infiltration.\n* For patients \\\u003C 75 years old, total bilirubin ≤ 3 × ULN.\n\nExclusion Criteria:\n\n* Acute promyelocytic leukemia (APL).\n* History of prior myeloproliferative neoplasms, including polycythemia vera, essential thrombocythemia, myelofibrosis, etc.\n* Prior receipt of hypomethylating agents, venetoclax (VEN), or systemic chemotherapy for myelodysplastic syndromes (MDS).\n* Prior receipt of any investigational drug or device therapy for MDS\u002FAML.\n* Concurrent participation in another clinical trial.\n* AML with central nervous system (CNS) involvement confirmed by imaging or cerebrospinal fluid examination.\n* Positive HIV antibody during the screening period.\n* Positive HBsAg or HCV antibody with a high-sensitivity viral load above the lower limit of detection within 3 months (excluding those who are cured or with persistent low-level replication).\n* Ingestion of grapefruit, grapefruit juice, Seville oranges, star fruit, or their products within 72 hours prior to the first dose.\n* Chronic respiratory failure requiring long-term oxygen therapy.\n* Presence of severe cardiac, hepatic, renal, endocrine, metabolic, immune, neurological, or psychiatric disorders.\n* History of hypersensitivity to the study drug (including azacitidine excipients).\n* Impaired drug absorption due to malabsorption syndrome, short bowel syndrome, or other conditions affecting oral drug absorption.\n* Active tuberculosis or other severe infections requiring intravenous anti-infective therapy for ≥7 days.\n* Presence of a second malignancy within 2 years prior to enrollment, excluding cured carcinoma in situ of the cervix or breast, completely resected basal cell carcinoma or localized squamous cell carcinoma of the skin, or localized malignancies cured by surgery and requiring no further follow-up.\n* The investigator judges that the patient is otherwise ineligible to participate in this study.",{"count":5,"type":21},[206],"This study is a single-arm, prospective, multi-center exploratory clinical trial. A total of 61 patients with newly diagnosed acute myeloid leukemia (AML) who are not suitable for intensive chemotherapy will be enrolled. The Simon two-stage design will be adopted to control the type I and type II errors, with the minimum acceptable composite remission rate of 65% and a power of 80%.\n\nPrior to treatment, subjects will undergo screening within 28 days, including bone marrow aspiration, genetic testing, ECOG performance status assessment, and organ function evaluation. Data will be recorded in Excel and subject to unified quality control. During the treatment period, G-CSF (granulocyte colony-stimulating factor) will be administered subcutaneously as appropriate, and supportive care such as antiemetic and hydration therapy will be provided routinely.\n\nFor patients who achieve remission, individualized consolidation therapy will be given: those eligible for transplantation will undergo allogeneic hematopoietic stem cell transplantation; those who can tolerate moderate-intensity treatment will receive consolidation with medium-dose cytarabine first, followed by 4 cycles of VHAG regimen consolidation. Patients with FLT3 mutations will receive additional targeted therapy during consolidation.\n\nSafety assessment will be conducted in accordance with the NCI-CTCAE Version 5.0. For grade 4 hematological toxicity or severe non-hematological toxicity, the treatment dose will be adjusted or the treatment will be suspended. Severe adverse events will be reported in a timely manner, and all research-related data will be retained for at least 10 years in accordance with relevant regulations.",[28],[556,557,558,559,560],"Acute myeloid leukemia (AML)","Venetoclax","Homoharringtonine","Azacitidine","Elderly\u002Funfit patients","2026-03-30",{"date":563,"type":40},"2026-04-02",{"date":565,"type":21},"2026-03-31",{"date":540,"type":21},{"name":568,"class":47},"First People's Hospital of Hangzhou",{"id":570,"slug":571,"hasResults":12,"nctId":572,"briefTitle":573,"officialTitle":574,"acronym":4,"eligibilityCriteria":575,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":202,"enrollmentInfo":576,"targetDuration":4,"studyType":22,"phases":578,"briefSummary":579,"conditions":580,"keywords":4,"overallStatus":235,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":582,"startDateStruct":584,"completionDateStruct":586,"leadSponsor":588,"locationsCount":48},"100631782","phase-2-efficacy-and-safety-of-lisafotoclax-plus-decitabine-and-homoharringtonine-in-venetoclaxazacitidine-pretreated-aml-patients-100631782","NCT07505160","Efficacy and Safety of Lisafotoclax Plus Decitabine and Homoharringtonine in Venetoclax\u002FAzacitidine Pretreated AML Patients","A Multi-Center, Prospective, Single-Arm, Phase 2 Clinical Study on the Efficacy and Safety of Lisafotoclax Combined With Decitabine and Homoharringtonine in Patients With Acute Myeloid Leukemia Previously Treated With Venetoclax Combined With Azacitidine Regimen","Inclusion Criteria\n\n* Age ≥18 years old.\n* Diagnosis of acute myeloid leukemia (AML), not otherwise specified (non-acute promyelocytic leukemia \\[APL\\]), confirmed by WHO 2022 5th edition criteria.\n* Evidence of treatment failure after prior venetoclax + azacitidine (VA) regimen, defined as either:\n\n  1. VA intolerance: Treatment discontinuation due to ≥Grade 3 non-hematologic toxicity or persistent ≥Grade 4 hematologic toxicity;\n  2. VA treatment failure:\n* Primary resistance: No partial remission (PR) after 1-2 cycles of VA induction therapy;\n* Molecular persistence\u002Fprogression: ≥1 log increase or persistent positivity of driver gene mutations (e.g., FLT3-ITD, IDH1\u002F2, NPM1) by quantitative PCR or NGS compared to best response;\n* Hematologic relapse: ≥5% bone marrow blasts or extramedullary leukemia after prior CR\u002FCRi.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.\n* Adequate organ function within 7 days prior to study initiation:\n* Liver: Total bilirubin ≤1.5×ULN; AST\u002FALT ≤2.5×ULN;\n* Kidney: Serum creatinine ≤1.5×ULN or CrCl ≥50 mL\u002Fmin;\n* Heart: Left ventricular ejection fraction (LVEF) ≥50%.\n* Ability to provide written informed consent and comply with study procedures. Exclusion Criteria\n* Diagnosis of acute promyelocytic leukemia (APL) or Philadelphia chromosome-positive AML.\n* Prior treatment with any BCL-2 inhibitor other than venetoclax as part of VA regimen.\n* Active central nervous system (CNS) leukemia involvement.\n* Uncontrolled systemic active infection.\n* Known HIV infection, or active hepatitis B or C.\n* New York Heart Association (NYHA) Class III-IV heart failure, unstable angina, myocardial infarction within 6 months, or severe arrhythmia.\n* Other active uncontrolled malignancy.\n* Severe gastrointestinal disease affecting drug absorption.\n* Pregnant or breastfeeding individuals; fertile patients refusing effective contraception during study and 6 months after last dose.\n* Known hypersensitivity to any component of LDH or LD regimens.\n* Any other condition judged by investigator to interfere with study conduct or patient safety.",{"count":577,"type":21},35,[206],"This is a multi-center, prospective, single-arm, phase 2 clinical study conducted in China to evaluate the efficacy and safety of Lisafotoclax combined with Decitabine and Homoharringtonine in patients with acute myeloid leukemia (AML) who have failed or are intolerant to prior treatment with Venetoclax plus Azacitidine.\n\nEligible participants must be at least 18 years old, have a confirmed diagnosis of AML according to WHO 2016 criteria, and have an ECOG performance status of 0-2. Participants will receive oral Lisafotoclax in combination with intravenous Decitabine and Homoharringtonine according to the study protocol.\n\nThe primary objective is to assess the overall response rate (ORR) after induction treatment. Secondary objectives include evaluating complete remission (CR) rate, event-free survival (EFS), overall survival (OS), and the incidence of adverse events (AEs) and serious adverse events (SAEs). Participants will be followed for up to 12 months after the last patient is enrolled to collect long-term efficacy and safety data.\n\nThis study has been approved by the Ethics Committee of the Second Affiliated Hospital of Zhejiang University School of Medicine and will be conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice (GCP).",[28],"2026-03-26",{"date":583,"type":40},"2026-04-01",{"date":585,"type":21},"2026-03",{"date":587,"type":21},"2029-03",{"name":589,"class":47},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":591,"slug":592,"hasResults":12,"nctId":593,"briefTitle":594,"officialTitle":595,"acronym":4,"eligibilityCriteria":596,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":597,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":598,"conditions":599,"keywords":600,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":605,"lastUpdatePostDateStruct":606,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":611,"locationsCount":48},"100631420","digital-pcr-of-chip-and-mr-for-mrd-monitoring-after-allo-hsct-in-aml-100631420","NCT07500441","Digital PCR of CHIP and MR for MRD Monitoring After Allo-HSCT in AML","Digital PCR-Based Detection of CHIP and MR Mutations for Minimal Residual Disease Monitoring After Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Acute Myeloid Leukemia","Inclusion Criteria:\n\n1. Diagnosis of acute myeloid leukemia (AML).\n2. Undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT) at the investigating center.\n3. Negative for recurrent fusion genes routinely monitored in the clinical laboratory, including but not limited to AML1::ETO, CBFB::MYH11, KMT2A (MLL) rearrangements, NUP98::NSD1, NUP98::HOXA9, FUS::ERG, DEK::NUP214, SET::NUP214, PICALM::AF10, and BCR::ABL1.\n4. Availability of next-generation sequencing (NGS) results at initial diagnosis with accessible original reports.\n5. Negative for NPM1 mutations at initial diagnosis.\n6. Presence of clonal hematopoiesis (CH) and\u002For myelodysplasia-related (MR) gene mutations at initial diagnosis, including but not limited to DNMT3A, TET2, ASXL1, SRSF2, SF3B1, U2AF1, JAK2, IDH2, BCOR, EZH2, RUNX1, STAG2, and ZRSR2.\n\nExclusion Criteria:\n\n1. Patients with mutation profiles unsuitable for the design of patient-specific digital PCR (dPCR) assays achieving a sensitivity of ≤0.1%.\n2. Absence of evaluable molecular targets for longitudinal MRD monitoring.",{"count":283,"type":21},"This prospective observational study aims to evaluate the clinical significance of measurable residual disease (MRD) monitoring using digital PCR (dPCR) in patients with acute myeloid leukemia (AML) following allogeneic hematopoietic stem cell transplantation (allo-HSCT). The study will specifically enroll patients harboring clonal hematopoiesis (CH) and\u002For myelodysplasia-related (MR) gene mutations.\n\nPatient-specific dPCR assays will be established to enable highly sensitive, longitudinal quantification of mutation burden. Serial assessments will be performed at predefined time points within the first 12 months after transplantation. The study will investigate the prognostic value of dPCR-based MRD dynamics for predicting relapse, relapse-free survival, and overall survival, and will further explore its potential to enable earlier detection of molecular relapse compared with conventional methods.",[28],[601,602,603,604],"Measurable Residual Disease (MRD)","Digital PCR (DPCR)","Allogeneic Hematopoietic Stem Cell Transplantation","Clonal Hematopoiesis","2026-03-24",{"date":561,"type":40},{"date":608,"type":40},"2026-03-20",{"date":610,"type":21},"2029-12-31",{"name":486,"class":47},{"id":613,"slug":614,"hasResults":12,"nctId":615,"briefTitle":616,"officialTitle":617,"acronym":618,"eligibilityCriteria":619,"healthyVolunteers":12,"sex":17,"minAge":620,"maxAge":144,"enrollmentInfo":621,"targetDuration":4,"studyType":22,"phases":623,"briefSummary":624,"conditions":625,"keywords":630,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":635,"startDateStruct":636,"completionDateStruct":638,"leadSponsor":640,"locationsCount":166},"100628593","phase-3-mrd-guided-maintenance-post-hct-gilteritini-vs-sorafenib-100628593","NCT07463651","MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib","Post-transplant Optimization Based on Ultra-high Sensitivity MRD Detection: A Prospective, Randomized Controlled Study Comparing Gilteritinib Versus Sorafenib as Post-transplant Maintenance Therapy in FLT3-ITD Mutation-positive Acute Myeloid Leukemia Patients","TROPHY-15","Inclusion Criteria:\n\n* Informed consent and willingness to participate in this clinical study;\n\n  * Gender is not limited, age range is 14-70 years old (including threshold);\n\n    * ECOG score 0-2 points;\n\n      * Diagnosed with AML through bone marrow morphology, immunology, cytogenetics, and molecular biology (MICM) typing, and confirmed to have FLT3-ITD mutation;\n\n        * Successfully accepted allo HSCT, with no restrictions on the pre-treatment protocol, allowing any donor source \\[fully matched cell, unrelated donor (URD), incompatible unrelated donor, haploidentical relative donor or umbilical cord blood\\], allowing any graft source \\[umbilical cord blood, bone marrow (BM), peripheral blood (PB)\\]; ⑥ Patients with complete morphological remission (CR) prior to allo HSCT, and FLT3-ITD MRD positivity detected by PCR-NGS within 30 days prior to allo HSCT (defined as FLT3-ITD transcript level ≥ 10 - 6);\n\n          ⑦ After transplantation: hematopoietic function implantation (ANC ≥ 500\u002Fμ L, platelet count ≥ 20000\u002Fμ L and not dependent on infusion), oral administration of investigational drugs, exclusion of overlap syndrome, complete donor chimerism (FDC) status, no activity requiring daily prednisone dose\\>0.5 mg\u002Fkg, acute GVHD;\n\n          ⑧ Clinical laboratory tests meet the following criteria: a. Serum creatinine ≤ 2.0 times the upper limit of normal value; b. Total bilirubin ≤ 2.5 mg\u002FdL (excluding Gilbert syndrome patients); c. Serum AST and\u002For ALT\\\u003C3 times the upper limit of normal values;\n\n          ⑨ Maintenance treatment should be started 60 to 90 days after transplantation;\n\n          ⑩ Female participants must meet the following criteria: have undergone menopause (at least 1 year without menstruation) or surgical sterilization (at least 1 month ago) before screening for infertility; Or have the ability to conceive but agree not to plan pregnancy during the study period and within 6 months after the last dose; Conduct pregnancy tests during the screening period; If there is heterosexual behavior, agree to continue using local standard high-efficiency contraceptive measures plus barrier method from the beginning of screening to 6 months after the last administration; Agree not to breastfeed or donate eggs during the study period and for 6 months after the last administration Male participants must meet the following requirements: male participants (even if sterilized) and their reproductive partners must use efficient contraception plus barrier method during the study period and within 127 days after the last dose; Male participants are not allowed to donate sperm during the study period and for 127 days after the last dose;\n\nExclusion Criteria:\n\n* Allergies to Girotinib or Sorafenib, as well as any components of the therapeutic drugs used during the study period;\n\n  * Any serious comorbidities that make patients unsuitable for participation in this study or may affect protocol compliance;\n\n    * FLT3-ITD molecular MRD positivity before maintenance therapy;\n\n      * Severe organ dysfunction such as organ failure occurs after allogeneic hematopoietic stem cell transplantation;\n\n        * Subjects who are positive for hepatitis B B surface antigen (HBsAg) and whose hepatitis B virus (HBV) DNA titer is higher than the upper limit of the normal value range of the research center, and who are judged by the researchers not suitable for this study; Individuals with positive hepatitis C virus (HCV) antibodies and positive peripheral blood HCV RNA; Individuals who are HIV antibody positive; Positive syphilis test results;\n\n          ⑥ There is evidence within the first 6 months of enrollment that the patient has other diseases or physiological conditions that may interfere with the evaluation results of this trial, or complications that seriously endanger life, including but not limited to uncontrolled infections, pulmonary arterial hypertension, severe heart failure (NYHA grades III and IV), unstable angina or acute myocardial infarction, poorly controlled refractory hypertension (based on hospitalization medical records diagnosis), etc;\n\n          ⑦ Individuals with mental or neurological disorders who are unable to express their wishes correctly;\n\n          ⑧ Individuals who have had active malignant solid tumors within the past 5 years prior to participating in this study, except for cervical cancer, localized prostate cancer in situ, and non melanoma skin cancer that have been cured;\n\n          ⑨ Have participated in or are currently participating in other clinical trials within one month prior to enrollment;\n\n          ⑩ Researchers have determined that individuals are not suitable to participate in this clinical trial.","14 Years",{"count":622,"type":21},594,[111],"The study population consisted of FLT3-ITD-mutated AML patients who were FLT3-ITD-positive before allogeneic hematopoietic stem cell transplantation. This open-label, randomized, controlled trial enrolled participants and randomly assigned them in a 1:1 ratio to either the experimental group or the control group. The experimental group received maintenance therapy with gilteritinib, while the control group received maintenance therapy with sorafenib, with 297 cases in each group, totaling 594 enrolled subjects.\n\nAll patients' minimal residual disease (MRD) testing was sent to the designated central laboratory and uniformly performed using the PCR-NGS method to ensure consistency and comparability of the test results.\n\nStudy Visits: This study includes a screening period (within 30 days prior to HCT) and a 2-year treatment phase, with efficacy and safety follow-up until death, withdrawal of informed consent, or 2 years after the first administration of treatment, whichever occurs first.",[28,626,627,628,179,629],"FLT3-ITD Mutation","Allogeneic Hematopoietic Cell Transplantation (HCT)","Maintenance Therapy","Sorafenib",[120,626,631,632,179,633],"Allogeneic Hematopoietic Cell Transplantatio","Maintenance therapy","sorafeni","2026-03-18",{"date":608,"type":40},{"date":637,"type":21},"2026-05-01",{"date":639,"type":21},"2030-03-31",{"name":70,"class":47},{"id":642,"slug":643,"hasResults":12,"nctId":644,"briefTitle":645,"officialTitle":646,"acronym":4,"eligibilityCriteria":647,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":495,"enrollmentInfo":648,"targetDuration":4,"studyType":22,"phases":650,"briefSummary":651,"conditions":652,"keywords":653,"overallStatus":235,"whyStopped":4,"lastUpdateSubmitDate":659,"lastUpdatePostDateStruct":660,"startDateStruct":661,"completionDateStruct":663,"leadSponsor":665,"locationsCount":666},"100630346","phase-3-venetoclax-azacitidine-and-mitoxantrone-hydrochloride-liposome-versus-idarubicin-and-cytarabine-in-newly-diagnosed-aml-100630346","NCT07486479","Venetoclax, Azacitidine, and Mitoxantrone Hydrochloride Liposome Versus Idarubicin and Cytarabine in Newly Diagnosed AML","A Prospective, Multicenter, Randomized Controlled Clinical Study of Venetoclax Combined With Azacitidine and Mitoxantrone Hydrochloride Liposome Versus Idarubicin Combined With Cytarabine \"3+7\" in the Treatment of Newly Diagnosed AML","Inclusion Criteria:\n\n* 1\\. The patient fully understands the study, voluntarily participates, and has signed the informed consent form (ICF).\n\n  2\\. Aged 18 to 65 years, any gender. 3. Newly diagnosed with AML according to the 2022 WHO classification. 4. Eligible for intensive chemotherapy as determined by the investigator. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 6. Life expectancy ≥ 3 months. 7. Adequate liver and renal function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN) (≤ 5 × ULN for patients with hepatic involvement); total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for patients with hepatic involvement); serum creatinine ≤ 1.5 × ULN.\n\nExclusion Criteria:\n\n* Patients who meet any of the following criteria will be excluded from the study:\n\n  1. Any of the following conditions:\n\n     1. Acute promyelocytic leukemia (APL);\n     2. Central nervous system leukemia (CNSL);\n     3. AML secondary to chemotherapy\u002Fradiotherapy for other malignancies or antecedent hematological disorders (e.g., MDS, MPN, CML);\n  2. Prior treatment with hypomethylating agents (HMA) or venetoclax;\n  3. Prior anti-AML therapy (except for leukocytosis management such as hydroxyurea or leukapheresis);\n  4. History of other malignancies within the past 5 years (except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, or other malignancies that have been effectively controlled without treatment in the past five years);\n  5. Inability to take oral medication or malabsorption syndrome;\n  6. Cardiac function or disease meeting any of the following criteria:\n\n     1. Long QTc syndrome or QTc interval \\> 480 ms;\n     2. Complete left bundle branch block, second- or third-degree atrioventricular block;\n     3. Severe, uncontrolled arrhythmias 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 significant arrhythmia requiring treatment, clinically significant pericardial disease within 6 months prior to enrollment, or ECG evidence of acute ischemia or active conduction system abnormalities.\n  7. Uncontrolled systemic illnesses (e.g., active infection, uncontrolled hypertension, diabetes);\n  8. Human Immunodeficiency Virus (HIV) infection (HIV antibody positive);\n  9. Active Hepatitis B or C infection (Hepatitis B: HBsAg or HBcAb positive, with HBV-DNA \\> 1×10³ copies\u002FmL; Hepatitis C: HCV-Ab positive, with HCV-RNA \\> 1×10³ copies\u002FmL);\n  10. Known history of immediate or delayed hypersensitivity reaction to drugs of the same class or excipients of the investigational product;\n  11. Significant neurological or psychiatric history;\n  12. Pregnant or lactating women;\n  13. Patients considered by the investigator to be unsuitable for participation in this study.",{"count":649,"type":21},204,[111],"This study aims to evaluate the efficacy and safety of venetoclax combined with azacitidine and mitoxantrone hydrochloride liposome (MVA) versus idarubicin combined with cytarabine (IA) in the treatment of newly diagnosed AML.",[28],[654,655,557,559,656,657,658],"Acute myeloid leukemia","mitoxantrone hydrochloride liposome","Idarubicin","Cytarabine","Randomized Controlled Trial","2026-03-17",{"date":608,"type":40},{"date":662,"type":21},"2026-03-10",{"date":664,"type":21},"2027-12-31",{"name":70,"class":47},21]