[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aml-acute-myelogenous-leukemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aml-acute-myelogenous-leukemia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,41,70,94,130,160,182,202,231,252,282,308,332,353,382],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100642409","efficacy-and-safety-of-the-clob2m-clofarabine-combined-with-busulfan-and-melphalan-conditioning-regimen-in-allogeneic-hematopoietic-stem-cell-transplantation-for-adult-patients-with-acute-myeloid-leukemia-in-first-complete-remission-100642409",false,"NCT07644481","Efficacy and Safety of the CloB2M (Clofarabine Combined With Busulfan and Melphalan) Conditioning Regimen in Allogeneic Hematopoietic Stem Cell Transplantation for Adult Patients With Acute Myeloid Leukemia in First Complete Remission","Efficacy and Safety of the CloB2M (Clofarabine Combined With Busulfan and Melphalan) Conditioning Regimen in Allogeneic Hematopoietic Stem Cell Transplantation for Adult Patients With Acute Myeloid Leukemia in First Complete Remission: An Open-Label, Prospective, Single-Arm Clinical Trial","Inclusion Criteria:\n\n* 1.Aged from 18 to 60 years inclusive, with no restriction on gender;\n* 2.Patients diagnosed with acute myeloid leukemia (AML, excluding acute promyelocytic leukemia, APL) by bone marrow morphological, immunological and genetic examinations according to the 2022 World Health Organization (WHO) classification, who have achieved first complete remission (CR1) after induction therapy;\n* 3.Meeting any of the following criteria upon clinical evaluation:\n\n  1. AML classified as intermediate or adverse genetic risk according to the 2022 ELN genetic risk stratification;\n  2. AML with positive measurable residual disease (MRD) before transplantation;\n* 4.Eastern Cooperative Oncology Group Performance Status (ECOG PS): 0-2;\n* 5.Estimated survival time more than 6 months;\n* 6.Meeting the indications for allogeneic hematopoietic stem cell transplantation (allo-HSCT), and having an eligible hematopoietic stem cell donor with qualified physical examination, including HLA-matched sibling donor, unrelated donor (high-resolution HLA 9-10\u002F10 matched) or haploidentical related donor;\n* 7.Adequate major organ function meeting the following criteria:\n\n  1. Total bilirubin (TBIL) ≤ 2 times the upper limit of normal (ULN); Alanine transaminase (ALT) and Aspartate transaminase (AST) ≤ 3 × ULN;\n  2. Serum creatinine (Cr) ≤ 1.5 × ULN, or estimated creatinine clearance ≥ 50 mL\u002Fmin calculated by the Cockcroft-Gault glomerular filtration formula;\n  3. Coagulation function meeting the following standards: Prothrombin time (PT), activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤ 1.5 × ULN (without anticoagulant therapy);\n  4. Electrocardiogram showing no acute myocardial infarction or severe arrhythmia; Echocardiography with left ventricular ejection fraction (LVEF) ≥ 50%, without significant cardiomegaly, valvular heart disease or congenital heart disease;\n  5. Pulmonary function tests: FEV1, FVC and DLCO ≥ 60% of predicted value;\n* 8.Willing to provide available diagnostic evidence or undergo bone marrow aspiration and biopsy prior to study treatment, and agree to receive regular bone marrow aspiration and biopsy after study treatment;\n* 9.Must sign the informed consent form prior to study enrollment, signed by the patient personally or immediate family members. If signature by the patient is deemed detrimental to disease treatment based on clinical condition assessment, the informed consent shall be signed by the legal guardian or immediate family member of the patient.\n\nExclusion Criteria:\n\n* 1.Refractory\u002Frelapsed AML;\n* 2.Known hypersensitivity to any drugs in the conditioning regimen or their excipients;\n* 3.Major surgery within the past 4 weeks (excluding diagnostic surgical procedures);\n* 4.History of or concurrent other malignant tumors (excluding well-controlled non-melanoma basal cell carcinoma of the skin, breast\u002Fcervical carcinoma in situ, and other malignancies well controlled without treatment for more than five years);\n* 5\\. Uncontrolled systemic diseases (such as uncontrolled hypertension, diabetes mellitus, etc.);\n* 6.Active hepatitis B or hepatitis C infection:（Hepatitis B virus surface antigen positive, hepatitis B core antibody positive with HBV-DNA level exceeding 1×103 copies\u002FmL;Hepatitis C virus RNA level exceeding 1×10 3 copies\u002FmL）;\n* 7.Uncontrolled ongoing infection, or patients requiring mechanical ventilation or with hemodynamic instability;\n* 8.Patients with psychiatric disorders or other medical conditions who are unable to comply with study treatment and monitoring requirements;\n* 9.Participation in another ongoing clinical trial, or enrollment in any other drug clinical trial within the past 1 month;\n* 10.Pregnant or lactating females, and patients who refuse to use effective contraception during the study period;\n* 11.Patients who are unable to understand the trial protocol, adhere to medication instructions, or refuse to sign the informed consent form;\n* 12.Patients deemed ineligible for enrollment by the investigator.","ALL","18 Years","60 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a single-center, prospective, exploratory clinical study. It plans to enroll 30 adult patients with acute myeloid leukemia (AML) who have achieved first complete remission (CR1) after induction therapy and meet the indications for allogeneic hematopoietic stem cell transplantation (allo-HSCT). The aim is to evaluate the efficacy and safety of allo-HSCT following conditioning regimens with clofarabine, busulfan and melphalan.",[27,28],"AML (Acute Myelogenous Leukemia)","Allogeneic Hematopoietic Stem Cell Transplantation Recipient","NOT_YET_RECRUITING","2026-06-08",{"date":32,"type":33},"2026-06-12","ACTUAL",{"date":35,"type":21},"2026-07-20",{"date":37,"type":21},"2029-12-31",{"name":39,"class":40},"Institute of Hematology & Blood Diseases Hospital, China","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100638161","forecasting-relapse-outcomes-with-alloheme-based-risk-detection-in-post-allo-hct-amlmds-patients-forward-100638161","NCT07607327","Forecasting Relapse Outcomes With AlloHeme-based Risk Detection in Post-Allo-HCT AML\u002FMDS Patients (FORWARD)","Forecasting Relapse Outcomes With AlloHeme-based Risk Detection in Post-Allo-HCT AML\u002FMDS Patients (FORWARD): A Multicenter, Prospective Observational Cohort Study in US Transplant Centers","FORWARD","Inclusion Criteria:\n\n1. Adults aged 18 years or above.\n2. The participant must have one of the following diseases: AML or MDS (including CMML) and be eligible for allogeneic hematopoietic stem cell transplant. For participants with active disease (\\> 5% blasts) before HCT, the treating physician must have the intent to perform a bone marrow examination at day 30 post-HCT as SOC patient management to confirm complete remission (\\\u003C5% blasts).\n3. Participant must receive an allo-HCT from an HLA-matched related or unrelated donor, an HLA-mismatched donor, or a haploidentical donor.\n4. Participant can be enrolled before, at, or up to 1-month post-allo-HCT as long as the participant is in complete remission (CR) at Day 30 and that a recipient pre-transplant or donor sample is available for baseline genotyping (reference). If the reference sample is unavailable or fails testing, the buccal swab collected at Day 30 may be used as the reference sample.\n5. Myeloablative or reduced intensity\u002Fnon-myeloablative conditioning except T-cell depleting therapies (Ex-vivo T cell depletion, CD34 selected graft, use of anti-thymocyte globulin or alemtuzumab).\n6. Any graft versus host disease (GVHD) prophylaxis regimen.\n7. Willing and able to provide written informed consent.\n8. Willing and able to comply with study visits and procedures, including scheduled sample collections and clinical assessments\n\nExclusion Criteria:\n\n1. History of prior allo-HCT or any prior solid organ transplant.\n2. Syngeneic donor (identical twin).\n3. T cell depleted transplant (Ex-vivo T cell depletion, CD34 selected graft, use of antithymocyte globulin or alemtuzumab in the conditioning regimen)\n4. Cord blood graft.\n5. Pregnancy\n6. Any condition that, in the investigator's opinion, would interfere with the participant's ability to comply with study procedures or jeopardize their safety.\n7. Concurrent participation in an interventional or maintenance clinical trial for post allo-HCT relapse prevention; co-enrollment with other trials, such as those intended for GVHD \u002F infection prevention or improving supportive care, is allowed.",{"count":50,"type":21},400,"OBSERVATIONAL","AlloHeme is a blood-based monitoring test developed by the CareDx laboratory that utilizes NGS technology coupled with a proprietary algorithm to predict the likelihood of a relapse in post-allo-HCT AML\u002FMDS patients. The technology analyzes 405 single nucleotide polymorphisms (SNPs) selected from across all somatic chromosomes between the donor and the recipient. Pre-transplant DNA is obtained from donor and\u002For recipient to identify specific donor and recipient SNPs (baseline samples). Post-transplant blood samples are obtained and compared to the baseline sample profiles to precisely calculate the percentage chimerism of recipient cells in the blood samples using a proprietary quantitative method and unique dual indexing that optimizes recipient DNA at trace levels. This approach enables highly accurate and reproducible chimerism measurement with a limit of detection down to 0.02%. The AlloHeme test leverages a proprietary algorithm that integrates this multi-analyte longitudinal chimerism data with post-transplant time points to predict the likelihood of a clinical relapse for AML\u002FMDS patients following an allo-HCT.",[27,54,55],"MDS (Myelodysplastic Syndrome)","CMML",[57,58],"Chimerism","Relapse","2026-05-19",{"date":61,"type":33},"2026-05-26",{"date":63,"type":21},"2026-08-31",{"date":65,"type":21},"2030-08-31",{"name":67,"class":68},"CareDx","INDUSTRY",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":18,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":69},"100564938","phase-2-efficacy-of-venetoclax-combined-with-intensive-chemotherapy-in-different-subgroups-of-aml-100564938","NCT06635681","Efficacy of Venetoclax Combined With Intensive Chemotherapy in Different Subgroups of AML","Efficacy of Venetoclax Combined With Intensive Chemotherapy in Different Subgroups of Acute Myeloid Leukemia : a Multi-center, Single-arm Clinical Trial","DAV-AML-2024","Inclusion Criteria:\n\n1. Patients who meet AML according to WHO (2022) or AML and MDS\u002FAML defined by ICC standards.\n2. Age ≥14 years old, ≤ 60 years old, male or female.\n3. The physical status assessment (ECOG-PS) of the Eastern Oncology Collaboration group was 0-2 points.\n4. Fulfill the requirements of the following laboratory tests (performed within 7 days prior to treatment) :\n\n   1. Total bilirubin ≤ 1.5 times the upper limit of normal value (same age);\n   2. AST and ALT≤ 2.5 times the upper limit of normal value (same age);\n   3. Blood creatinine \\\u003C 2 times the upper limit of normal (same age);\n   4. Myocardial enzymes \\\u003C 2 times the upper limit of normal (same age);\n   5. Left ventricular ejection fraction \\>50% by measure of echocardiogram (ECHO). Informed consent must be signed before the commencement of all specific study procedures, and signed by the patient himself or his immediate family. Considering the patient\\'s condition, if the patient\\'s signature is not conducive to the treatment of the condition, the informed consent shall be signed by the legal guardian or the patient\\'s immediate family.\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria are excluded from the study:\n\n1. Acute promyelocytic leukemia with PML-RARA fusion gene\n2. Acute myeloid leukemia with BCR-ABL fusion gene\n3. Treated patients (but can receive hydroxyurea or cytarabine to the lower tumor burden).\n4. Concurrent malignant tumors of other organs (those requiring treatment).\n5. Active heart disease, defined as one or more of the following:\n\n   1. A history of uncontrolled or symptomatic angina;\n   2. Myocardial infarction less than 6 months after enrollment;\n   3. Have a history of arrhythmia requiring drug treatment or severe clinical symptoms;\n   4. Uncontrolled or symptomatic congestive heart failure (\\> NYHA level 2);\n6. Serious infectious diseases (uncured tuberculosis, pulmonary aspergillosis).\n7. Those who were not considered suitable for inclusion by the researchers.","14 Years",{"count":80,"type":21},380,[82],"PHASE2","Acute myeloid leukemia (AML) is a common hematological malignancy. Intensive chemotherapy is the main treatment in fit patients.\n\nRetrospective studies have shown that Venetoclax is highly effective in elder AML patients with IDH2 and NPM1 mutations while in those with TP53 and FLT3 mutations, the combination of azacitidine with Venetoclax showed an increased remission rate without improved survival.\n\nSince AML is a highly heterogeneous disease, it is not clear which genetic type of adult AML patients would benefit from Venetoclax combined with intensive chemotherapy.\n\nTherefore, this study intends to conduct a phase II clinical trial to investigate the efficacy of intensive chemotherapy combined with Venetoclax in adult AML patients, and reveal the efficacy of Venetoclax added to chemotherapy regimens for AML with different cytogenetic and molecular subgroups.",[27],"RECRUITING","2026-05-10",{"date":88,"type":33},"2026-05-13",{"date":90,"type":33},"2024-09-29",{"date":92,"type":21},"2028-10-01",{"name":39,"class":40},{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":105,"conditions":106,"keywords":116,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":129},"100582139","phase-2-a-platform-protocol-to-investigate-post-transplant-cyclophosphamide-based-graft-versus-host-disease-prophylaxis-in-patients-with-hematologic-malignancies-undergoing-mismatched-unrelated-donor-peripheral-blood-stem-cell-transplantation-100582139","NCT06859424","A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation","ACCELERATE","Inclusion Criteria, MAC RECIPIENTS:\n\n1. Age 18 to \\\u003C 66 years (chemotherapy-based conditioning) or \\\u003C 61 years (TBI-based conditioning) at the time of signing informed consent\n2. Patient or legally authorized representative has the ability to provide informed consent according to the applicable regulatory and institutional requirements\n3. Stated willingness to comply with all study procedures and availability for the duration of the study\n4. Planned MAC regimen (see Table 8 in Section 7.4 for allowed MAC regimens)\n5. Available partially HLA-MMUD (4\u002F8-7\u002F8 at HLA-A, -B, -C, and -DRB1 is required) with age 16-35\n6. Product planned for infusion is MMUD T-cell replete PBSC as allograft\n7. HCT-CI \\\u003C 5 (Appendix H - Hematopoietic Cell Transplant Comorbidity Index Scoring). The presence of prior malignancy will not be used to calculate HCT-CI for this trial, to allow for the inclusion of patients with secondary or therapy-related AML or MDS.\n8. One of the following diagnoses:\n\n   1. AML, ALL, or other acute leukemia in first remission or beyond with ≤ 5% marrow blasts and no circulating blasts or evidence of extramedullary disease. Documentation of bone marrow assessment will be accepted within 45 days prior to the anticipated start of conditioning.\n   2. Patients with MDS with no circulating blasts and with \\\u003C 10% blasts in the bone marrow (higher blast percentage allowed in MDS due to lack of differences in outcomes with \\\u003C 5% vs 5-10% blasts in MDS). Documentation of bone marrow assessment will be accepted within 45 days prior to the anticipated start of conditioning.\n9. Cardiac function: Left ventricular ejection fraction ≥ 45% based on most recent echocardiogram or multi-gated acquisition scan (MUGA) results\n10. Estimated creatinine clearance ≥ 45mL\u002Fmin calculated by equation\n11. Pulmonary function: diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin ≥ 50% and forced expiratory volume in first second (FEV1) predicted ≥ 50% based on most recent PFT results\n12. Liver function acceptable per local institutional guidelines\n13. KPS of ≥ 70% (Appendix I - Performance Status)\n\nInclusion Criteria, RIC\u002FNMA RECIPIENTS:\n\n1. Age ≥ 18 years at the time of signing informed consent\n2. Patient or legally authorized representative has the ability to provide informed consent according to the applicable regulatory and local institutional requirements\n3. Stated willingness to comply with all study procedures and availability for the duration of the study\n4. Planned NMA\u002FRIC regimen (see\n5. Table 9 in Section 7.4 for allowed NMA\u002FRIC regimens)\n6. Available partially HLA-MMUD (4\u002F8-7\u002F8 at HLA-A, -B, -C, and -DRB1 is required) with age 16-35\n7. Product planned for infusion is MMUD T-cell replete PBSC allograft\n8. One of the following diagnoses:\n\n   1. Patients with acute leukemia or chronic myeloid leukemia (CML) with no circulating blasts, no evidence of extramedullary disease, and with \\\u003C 5% blasts in the bone marrow. Documentation of bone marrow assessment will be accepted within 45 days prior to the anticipated start of conditioning.\n   2. Patients with MDS with no circulating blasts and with \\\u003C 10% blasts in the bone marrow (higher blast percentage allowed in MDS due to lack of differences in outcomes with \\\u003C 5% vs 5-10% blasts in MDS.) Documentation of bone marrow assessment will be accepted within 45 days prior to the anticipated start of conditioning.\n   3. Patients with chronic lymphocytic leukemia (CLL) or other leukemias (including prolymphocytic leukemia) with chemosensitive disease at time of transplantation.\n   4. Higher-risk chronic myelomonocytic leukemia (CMML) according to CMML-specific prognostic scoring system or high-risk MDS\u002Fmyeloproliferative neoplasms (MPN) not otherwise specified are eligible, provided there is no evidence of high-grade bone marrow fibrosis or massive splenomegaly at the time of enrollment.\n   5. Patients with lymphoma with chemosensitive disease at the time of transplantation.\n   6. Patients with primary myelofibrosis or myelofibrosis secondary to essential thrombocythemia, polycythemia vera or MDS with grade 4 fibrosis.\n9. Cardiac function: Left ventricular ejection fraction ≥ 40% based on most recent echocardiogram or MUGA results with no clinical evidence of heart failure\n10. Estimated creatinine clearance ≥ 45mL\u002Fmin calculated by equation\n11. Pulmonary function: DLCO corrected for hemoglobin ≥ 50% and FEV1 predicted ≥ 50% based on most recent PFT results\n12. Liver function acceptable per local institutional guidelines\n13. KPS of ≥ 60% (Appendix I - Performance Status)\n\nExclusion Criteria:\n\n1. Suitable HLA-matched related or 8\u002F8 high-resolution matched unrelated donor available\n2. Subject unwilling or unable to give informed consent, or unable to comply with the protocol including required follow-up and testing\n3. Subjects with a prior allogeneic transplant\n4. Subjects with an autologous transplant within the past 3 months\n5. Subjects who are breastfeeding or pregnant\n6. Uncontrolled bacterial, viral or fungal infection at the time of the transplant preparative regimen\n7. Concurrent enrollment on a GVHD prevention clinical trial\n8. Subjects who undergo desensitization to reduce anti-donor HLA antibody levels prior to transplant\n9. Patients who are HIV-positive with persistently positive viral load. HIV-infected patients on effective anti-retroviral therapy (ART) with undetectable viral load within 6 months are eligible for this trial. Patients with well-controlled HIV are eligible provided resistance panels are negative, the patient is compliant with ART, and their disease remains well controlled.","66 Years",{"count":103,"type":21},358,[82],"The purpose of this clinical trial is to compare drug combinations to learn which drugs work best to prevent graft-versus-host-disease (GVHD) in people who have received a stem cell transplant. The source of stem cells is from someone who is not related and has a different blood cell type than the study participant. The researchers will compare the new drug combination to a standard drug combination. They will also learn about the safety of each drug combination.\n\nParticipants will:\n\n* Receive the standard or new drug combination after transplant\n* Visit the doctor's office for check-ups and tests after transplant that are routine for most transplant patients\n* Take surveys about physical and emotional well-being\n* Give blood and stool samples.",[27,107,108,54,109,110,111,112,113,114,115],"Acute Lymphoid Leukemia (ALL)","Acute Leukemia (Category)","CML (Chronic Myelogenous Leukemia)","CLL (Chronic Lymphocytic Leukemia)","Prolymphocyctic Leukemia","Chronic Myelomonocytic Leukemia (CMML)","Myeloproliferative Neoplasm (MPN)","Lymphoma","Myelofibrosis",[99,117,118],"ACCEL-001","ACCEL-002","2026-03-16",{"date":121,"type":33},"2026-03-17",{"date":123,"type":33},"2025-07-25",{"date":125,"type":21},"2028-06",{"name":127,"class":128},"Center for International Blood and Marrow Transplant Research","NETWORK",13,{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":140,"briefSummary":142,"conditions":143,"keywords":147,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":159},"100619634","phase-1-a-phase-1-study-of-cg009301-for-injection-in-adult-subjects-with-recurrent-or-refractory-haematological-malignancies-100619634","NCT07347171","A Phase 1 Study of CG009301 for Injection in Adult Subjects With Recurrent or Refractory Haematological Malignancies","A Phase 1, Open-label, Multicentre Study Evaluating the Safety, Tolerability, Pharmacokinetic\u002FPharmacodynamic Characteristics, and Preliminary Efficacy of CG009301 for Injection in Adult Subjects With Relapsed or Refractory Haematological Malignancies","Inclusion Criteria:\n\n1. Age ≥18 years and \\\u003C75 years at the time of signing the informed consent form; no gender restrictions;\n2. Patients with relapsed\u002Frefractory haematological malignancies who have received a definitive diagnosis by pathology and\u002For cytology, confirmed histologically, and who have failed prior standard treatment regimens. The investigator must deem that no standard treatment is available or that the patient cannot tolerate existing therapies. Dose-escalation phase: unrestricted haematological tumour types. Dose-expansion phase: must meet one of the following criteria: a. Subjects meeting AML diagnostic criteria based on WHO 2022 5th edition classification, confirmed by bone marrow cytomorphology, including AML evolving from early-stage MDS or MPN. Criteria for recurrent AML: Leukaemic cells reappearing in peripheral blood after CR, or \\>5% blast\u002Fimmature cells in bone marrow, or extramedullary leukaemic infiltration. Criteria for refractory AML: - Treatment-naïve cases unresponsive to two standard-regimen cycles; - Relapse within 12 months after consolidation\u002Fintensification therapy following CR; - Relapse after 12 months unresponsive to conventional chemotherapy; Patients with two or more relapses; Persistent extramedullary leukaemia; b. Patients diagnosed with high-risk or very high-risk MDS according to the WHO 2022 5th edition classification, with a percentage of blasts in bone marrow smear or biopsy pathology \\\u003C 20%, and deemed by the investigator to have no other appropriate treatment options. Diagnostic criteria for recurrent MDS: Following achievement of complete remission, partial remission, or haematological improvement, at least one of the following must occur: - Bone marrow blastic count returns to pre-treatment levels; - ANC or PLT decreases by ≥50% from best response; - HGB decreases by ≥15 g\u002FL or becomes transfusion-dependent. Diagnostic criteria for refractory MDS: Following adequate treatment (at least four cycles of demethylating agent therapy), meeting the IWG 2023 response criteria for \"stable disease\", \"failure\", or \"disease progression\"; progression after demethylating agent or other drug therapy, or patient intolerance to toxicity (e.g., treatment-related grade 3 or higher hepatic or renal toxicity during therapy leading to permanent discontinuation); c. Subjects meeting ALL diagnostic criteria based on WHO 2022 5th edition classification, with ≥20% primitive\u002Fimmature lymphocytes in bone marrow. Relapsed ALL diagnostic criteria: Patients who, after achieving CR following induction therapy, exhibit recurrence of leukaemic cells in peripheral blood, \\>5% primitive\u002Fimmature lymphocytes in bone marrow, or development of extramedullary disease; Criteria for refractory ALL: Patients failing to achieve CR following standard induction therapy;\n3. ECOG performance status score of 0-1;\n4. Investigator-assessed expected survival ≥3 months;\n5. Recovery of toxicities from prior treatment to ≤Grade 1 according to NCI-CTCAE v5.0 (excluding alopecia and long-term stable chronic conditions);\n6. No prior autologous haematopoietic stem cell transplantation, or transplantation more than 2 months prior with toxicities resolved to ≤ Grade 1;\n7. Adequate organ function support, with screening laboratory tests meeting all criteria: a. Coagulation function prior to study drug administration: INR ≤ 1.5 × ULN or aPTT ≤ 1.5 × ULN; b. Hepatic function: serum total bilirubin ≤ 2× ULN; AST and\u002For ALT ≤ 2.5× ULN; c. Cr ≤ 2× ULN or CrCL \\> 30 mL\u002Fmin (calculated using Cockcroft-Gault formula); d. LVEF ≥ 40%; and QTc ≤ 480 milliseconds; e. White blood cell count may decrease below 50.0 × 10⁹\u002FL at baseline or following hydroxyurea administration\n8. Non-pregnant and non-lactating: Infertile subjects; or subjects with potential for conception who agree to use effective contraception (hormonal, barrier, or abstinence). Male subjects must also abstain from sperm donation during study participation and for 90 days after the last dose of CG009301 injection. Women of childbearing potential must have a negative serum pregnancy test (serum-β-hCG) during the screening period;\n9. Understand the study's purpose, process, nature, significance, potential benefits, and risks, and voluntarily sign the written informed consent form. Be able to comply with scheduled visits, treatment plans, laboratory tests, and other study instructions or procedures.\n\nExclusion Criteria:\n\n1. Central nervous system leukaemia presenting with neurological and\u002For psychiatric symptoms;\n2. Receipt of antitumour therapy (excluding hydroxyurea and prophylactic intrathecal injections) such as chemotherapy, immunotherapy, targeted therapy, or biological therapy within 4 weeks or 5 half-lives (whichever is shorter) prior to the first study drug administration; receipt of radiotherapy within 2 weeks; receipt of traditional Chinese herbal medicine within 2 weeks;\n3. Major surgery within 4 weeks prior to the first study dose, or anticipated need for major surgery during the study period;\n4. Active infection deemed uncontrolled by the investigator following treatment with antibiotics, antiviral agents, or antifungal medications;\n5. Severe or uncontrolled underlying medical conditions deemed ineligible for inclusion by the investigator, including but not limited to respiratory disorders (e.g., chronic obstructive pulmonary disease requiring oxygen therapy, moderate or higher asthma, moderate or higher pulmonary fibrosis, recurrent pulmonary oedema), cardiovascular disorders (e.g., prior coronary artery bypass grafting or coronary stent implantation, myocardial infarction within the past 6 months, NYHA Class III-IV heart failure), unstable angina within the past 6 months, uncontrolled hypertension (systolic \\>160 mmHg or diastolic \\>100 mmHg), arrhythmias requiring ongoing medical or interventional management), endocrine disorders (severe hyperthyroidism\u002Fhypothyroidism, uncontrolled diabetes mellitus), and neurological\u002Fpsychiatric conditions affecting cognition, compliance, or personal safety (e.g., unstable epilepsy, dementia, schizophrenia, depression); psychiatric disorders (e.g., unstable epilepsy, dementia, schizophrenia, depression);\n6. Active autoimmune diseases (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune haemolytic anaemia, scleroderma, severe psoriasis, rheumatoid arthritis), or allergy to the study drug or excipients;\n7. Significant non-leukaemia-related bleeding risk (e.g., anticoagulant or antiplatelet therapy, arteriovenous malformation), or recent history of major bleeding (e.g., gastrointestinal haemorrhage, intracranial haemorrhage, disseminated intravascular coagulation);\n8. Grade 2 or higher central nervous system or peripheral neuropathy (excluding stable Grade 3 conditions lasting over 6 months that do not impair daily functioning);\n9. Allogeneic haematopoietic stem cell transplantation within 12 months prior to initial administration;\n10. History of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolic event within 6 months prior to initial administration (thrombosis originating from implanted venous access ports or catheters, superficial vein thrombosis, or lacunar cerebral infarction are not considered \"severe\" thromboembolic events); Known familial and\u002For acquired thrombotic predisposition, such as hereditary or acquired defects in anticoagulant proteins, coagulation factors, fibrinolytic proteins, or presence of acquired risk factors conferring high thrombotic propensity;\n11. HIV, HBV, and HCV infection: positive HIV antibody and PCR tests; HBsAg positive or viral DNA ≥100 IU\u002FmL; positive HCV antibody with HCV-RNA quantification exceeding the upper limit of normal;\n12. Individuals who received (attenuated) live virus vaccination within 4 weeks prior to first dosing;\n13. Individuals with a documented history of alcohol or substance abuse;\n14. Any past or current medical condition, treatment, or laboratory abnormality that may interfere with study results or affect the subject's ability to complete the study, or if the investigator deems the subject unsuitable for participation in this study.","75 Years",{"count":139,"type":21},45,[141],"PHASE1","The goal of this clinical trial is to learn about the safety of drug CG009301. It also learns if drug CG009301 works to treat in Participants with relapsed or refractory adult haematological malignancies.\n\nThe main question\\[s\\] it aims to answer are:\n\n1. To determine the maximum tolerated dose (MTD) and\u002For objective best dose (OBD) of CG009301 for injection in subjects with relapsed or refractory adult haematological malignancies.\n2. To establish subsequent dosing regimens for CG009301 for injection.\n3. To characterise the safety profile and tolerability of CG009301 for injection. Participants will Receive treatment with CG009301 until disease progression.",[144,145,146,27,54],"Leukemia","AML","MDS",[144,148,149,145,146],"GSPT1","CG009301","2026-01-08",{"date":152,"type":33},"2026-01-16",{"date":154,"type":33},"2025-04-17",{"date":156,"type":21},"2027-12-30",{"name":158,"class":40},"Cullgen (Shanghai),Inc",3,{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":22,"phases":169,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":69},"100615820","safety-and-feasibility-of-sulforaphane-to-promote-early-haematopoietic-recovery-after-cord-blood-transplantation-100615820","NCT07297576","Safety and Feasibility of Sulforaphane to Promote Early Haematopoietic Recovery After Cord Blood Transplantation","Safety and Feasibility of Sulforaphane to Promote Early Haematopoietic Recovery After Cord Blood Transplantation A Single-arm, Open, Single-centre Clinical Study","Inclusion criteria：\n\n1. Patients with high-risk haematological malignancies: including AML, ALL, high-risk MDS\n2. Age: ≥18 years\n3. Karnofsky score ≥70%, Eastern Cooperative Oncology Group (ECOG) physical status ≤2 points\n4. Selection of non-haematopoietic cord blood: donor-recipient HLA high-resolution compatibility ≥4\u002F6, 7\u002F10 and CD34 cells ≥0.83×105\u002Fkg (recipient's body weight), meeting the above criteria, only cord blood with a freezing time of ≥10 years can be found in China's public umbilical cord blood stem cell banks.\n\nExclusion criteria：\n\n1. Patients who test positive for the following pathogens: HIV (HIV-1\u002F2), human cytomegalovirus (HCMV-DNA), EBV (EBV-DNA), Hepatitis B (positive for Hepatitis B Surface Antigen (HBsAg) or Hepatitis B DNA (HBV-DNA)), Hepatitis C Antibody (HCV-Ab), Treponema pallidum Antibody (TP-Ab).\n2. Active bacterial, viral, fungal or parasitic infections of clinical significance as judged by the investigator at the time of screening\n3. Willing donors with full HLA compatibility and eligible for allogeneic haematopoietic stem cell transplantation\n4. Previous gene therapy or allogeneic haematopoietic stem cell transplant recipients\n5. Immediate family members with known or suspected familial cancer syndromes (including but not limited to hereditary breast and ovarian cancer syndromes, hereditary non-polyposis colorectal cancer syndromes, familial adenomatous polyposis, etc.)\n6. Confirmed diagnosis of a major mental illness or predisposition to mental illness that would seriously affect the ability to participate in clinical research\n7. History of major organ injury, including: Liver lesions: liver function tests suggesting AST or ALT \\> 3 × ULN; total serum bilirubin \\> 2.5 × ULN; total bilirubin \\> 3 × ULN and direct bilirubin \\> 2.5 × ULN if consistent with Gilbert's syndrome; history of hepatic pontine fibrosis, cirrhosis, and the presence of active hepatitis; Cardiac lesions: left ventricular ejection fraction (\"LVEF\") \\\u003C 45%; New York Heart Association (NYHA) class III or IV congestive heart failure (see Appendix 1 for classifications of heart failure); severe heart failure requiring treatment. Cardiac pathology: left ventricular ejection fraction (LVEF) \\\u003C45%; New York Heart Association (NYHA) class III or IV congestive heart failure (see Appendix 1 for NYHA heart failure classification); severe arrhythmia requiring treatment; uncontrolled hypertension or unstable angina; myocardial infarction or bypass or stent surgery within 12 months prior to enrolment; clinically significant valvular disease; calculated eGFR \\\u003C60mL\u002Fmin\u002F1.73m2 and direct bilirubin \\>1.73m2; history of hepatic bridging fibrosis and cirrhosis; and presence of active hepatitis. Lung function: FEV1\u002FFVC \\\u003C60% and\u002For diffusion function \\\u003C60% of predicted value; clinically significant evidence of pulmonary hypertension requiring medical intervention.\n8. Uncorrectable coagulation disorders or history of severe bleeding disorders\n9. Any other condition that, in the opinion of the doctor, makes the subject unsuitable for haematopoietic stem cell transplantation\n10. Known allergy to the test drug or ingredients\n11. Have participated or are participating in other interventional clinical studies within 3 months prior to screening\n12. Live vaccination within 6 weeks prior to screening\n13. Pregnant or breastfeeding women\n14. Subjects did not follow the study protocol well\n15. Any other condition deemed by the investigator to be unsuitable for participation in this clinical trial",{"count":168,"type":21},36,[24],"Umbilical cord blood (UCB) is rich in haematopoietic stem progenitor cells and immune cells, and is used for transplantation for a variety of haematological disorders with the advantages of low mating requirements and fewer transplant complications. By March 2025 China's seven (eight) public cord blood stem cell banks had frozen more than 280,000 public umbilical cord blood, while the percentage of those frozen for ≥10 years was 26%, making clinical application a concern. The previous study showed that long-term freezing impairs cellular mitochondrial function leading to decreased reconstruction of cord blood haematopoietic stem progenitor cells and impaired differentiation into the megakaryotic lineage, and that intervention with the antioxidant radicicol thiols (SFN) can partially rescue the cellular functional damage caused by freezing. The findings were based on immunodeficient animals, and clinical studies are urgently needed to determine whether SFN intervention can promote post-transplant haematopoietic reconstitution in patients with long term cryopreserved (≥10 years) UCB. In this project, the investigators propose to conduct a single-arm, open, single-centre phase I-II clinical study on the safety and feasibility of dietary supplement SFN to promote early haematopoietic restoration after cord blood transplantation to evaluate the safety and feasibility of the use of long-frozen UCB for peri-infusion SFN use in adult transplant recipients, and to reveal the effect of peri-infusion SFN use on neutrophil implantation. This project will provide scientific guidance to promote the clinical application of long-term cryopreserved UCB, as well as key data to optimise the clinical transplantation strategy of UCB and expand its application.",[172,173,54],"ALL (Acute B-Lymphoblastic Leukemia)","AML (Acute Myelogenous Leukemia","2025-12-23",{"date":176,"type":33},"2025-12-30",{"date":178,"type":33},"2025-10-22",{"date":180,"type":21},"2027-06",{"name":39,"class":40},{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":69},"100612494","correlation-of-venetoclax-plasma-concentrations-with-toxicity-of-hypometilating-agents-and-venetoclax-combination-for-acute-myeloid-leukemia-patients-in-remission-100612494","NCT07254312","Correlation of Venetoclax Plasma Concentrations With Toxicity of Hypometilating Agents and Venetoclax Combination for Acute Myeloid Leukemia Patients in Remission.","VEN-AML","Inclusion Criteria:\n\n* patients with newly diagnosed Acute Myeloid Leukemia treated with HMA-VEN in disease remission (from the first post-remission cycle).\n\nExclusion Criteria:\n\n* undergoing treatment with moderate or strong Cytochrome 3A4 inhibitors or inducers,\n* unwilling to receive treatment as previously specified and to be tested for VEN plasma levels at the previously specified timepoint.",{"count":190,"type":21},14,"Venetoclax (VEN) is a potent and selective oral inhibitor of the BCL-2 gene and has shown anti-leukemic activity when used in combination with hypomethylating agents (HMA) in patients with Acute Myeloid Leukemia (AML), both newly diagnosed and in relapse or refractory (R\u002FR) stages. A daily dose of 400 mg has shown the best results in terms of efficacy, toxicity, and low early mortality rates (DiNardo et al., Blood 2019). The HMA-VEN combination has been approved for the treatment of newly diagnosed AML patients who are not candidates for intensive therapy. However, although this treatment is considered low-intensity, it causes a non-negligible toxicity profile, especially hematological toxicity, even in patients who have already achieved remission. As a result, treatment often needs to be interrupted, and VEN dosage adjusted in subsequent cycles.\n\nAn analysis by Pratz et al. (Pratz et al., Am J Hematol 2022) following the publication of the pivotal trial reported grade IV cytopenias lasting at least 7 days in the cycles following remission in 161 (87%) patients in the VEN+Azacitidine arm. Furthermore, plasma concentrations of VEN were analyzed in patients who developed grade IV cytopenias for at least 7 days, and no correlation was found between VEN plasma levels and the number of observed cytopenias.\n\nIn the routine management of these patients, when hematologic toxicity occurs, the approach varies greatly from center to center and is based on the individual experience and assessment of the referring clinician. As a result, there is no standardized approach. Plasma concentrations of VEN are not routinely measured during treatment.\n\nA better understanding of the factors determining the variable toxicity observed in patients in remission could optimize treatment to improve patient tolerability and allow for the regular administration of therapy, which is essential for maintaining leukemia remission status.",[173],"2025-11-26",{"date":195,"type":33},"2025-11-28",{"date":197,"type":33},"2024-10-21",{"date":199,"type":21},"2026-04",{"name":201,"class":40},"Fondazione IRCCS Policlinico San Matteo di Pavia",{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":16,"minAge":210,"maxAge":17,"enrollmentInfo":211,"targetDuration":4,"studyType":22,"phases":213,"briefSummary":215,"conditions":216,"keywords":218,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":69},"100610788","phase-3-the-efficacy-of-therapy-in-patients-with-acute-myeloid-leukemia-and-down-syndrome-in-russia-100610788","NCT07232134","The Efficacy of Therapy in Patients With Acute Myeloid Leukemia and Down Syndrome in Russia","Prospective Non-randomized Multicenter Trial: the Efficacy of Therapy in Patients With Acute Myeloid Leukemia and Down Syndrome in Russia","AML-DS-2025","Inclusion Criteria:\n\n* Age 0-18 years\n* Diagnosis of AML, MDS and presence of Down syndrome (constitutional trisomy 21 and mutation in the GATA1 gene)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Children with Down syndrome and acute lymphoblastic leukemia (ALL)\n* Severe comorbidities with contraindications to the treatment according to the protocol\n* Pre-treatment \\>14 days with intensive induction therapy\n* Refusal of all therapy or important elements of therapy","1 Day",{"count":212,"type":21},100,[214],"PHASE3","This prospective non-randomized multicenter trial created based on protocol ML DS 2006 and aimed at standardization of current therapy approaches and creating a national network for diagnostic, treatment and monitoring of children (0-18 years) with AML and Down syndrome in Russia. Based on the results the investigators expect to increase long-term overall and event-free survival in children with AML and DS and reduce the immediate and remote toxicity of chemotherapy by reducing the dose load of chemotherapeutic drugs.\n\nThe study protocol therapy for all patients includes four chemotherapy blocks:\n\nCourse 1 AIE (cytarabine\u002Fidarubicin\u002Fetoposide) Course 2 AI (cytarabine\u002Fidarubicin) Course 3 HAD (high -dose cytarabine (1g)\u002Fdaunorubicin) Course 4 HA (high-dose cytarabine) Safety to be monitored based on CTCAE v5.0",[27,217],"Down Syndrome (DS)",[145,219,220,221],"Acute Myelogenous Leukemia","Down Syndrome","DS","2025-11-17",{"date":224,"type":33},"2025-11-20",{"date":226,"type":33},"2025-07-24",{"date":228,"type":21},"2032-12-30",{"name":230,"class":40},"Federal Research Institute of Pediatric Hematology, Oncology and Immunology",{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":22,"phases":240,"briefSummary":242,"conditions":243,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":69},"100602689","early-phase-1-the-efficacy-and-safety-assessment-of-allogeneic--t-cells-in-patients-with-mrd-positive-aml-after-allo-hsct-100602689","NCT07126782","The Efficacy and Safety Assessment of Allogeneic γδ T Cells in Patients With MRD-positive AML After Allo-HSCT","Clinical Study on the Efficacy and Safety of Allogeneic γδ T Cells in the Treatment of Patients With MRD-positive Acute Myeloid Leukemia (AML) After Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)","Inclusion Criteria:\n\n1. Patients should sign informed consent form voluntarily before the trail and comply with the requirements of this study.\n2. Age≥18 years old, gender unlimited.\n3. All the subjects met the 2016 WHO classification and were diagnosed with AML via MICM (Morphology,Immunophenotyping, Cytogenetics, and Molecular genetics).\n4. AML patients receiving allo-HSCT.\n5. Subjects classified into the favorable -to-intermediate risk group according to the 2022 European Leukemia Net (ELN) risk stratification guidelines.\n6. All subjects were detected positive for MRD, and MRD was positive by flow cytometry (MFC) or\u002Fand positive for fusion genes\u002Fgene mutations by RQ-PCR.\n7. ECOG performance status score: 0-2.\n8. Inactive GVHD (acute GVHD grade II-IV or moderate to severe chronic GVHD).\n9. Adequate bone marrow reserve, defined as: absolute neutrophil count (ANC) \\> 0.5E9\u002FL and platelet count ≥20E9\u002FL.\n10. Adequate organ function as per protocol.\n11. Male and female patients of reproductive potential must agree to use birth control during the study and for at least 28 days post study.\n\nExclusion Criteria:\n\n1. Post-transplant relapse or extramedullary disease: AML patients post-allo-HSCT with ≥5% blasts in peripheral blood or bone marrow (excluding causes such as bone marrow regeneration after consolidation chemotherapy) or extramedullary leukemia infiltration.\n2. Active GVHD: Subjects with active GVHD within 30 days before screening.\n3. Active infections: HBV, HCV, HIV, syphilis (TP), active CMV, or EBV infection.\n4. Neurological disorders: active autoimmune or inflammatory neurological diseases, clinically significant active cerebrovascular disease.\n5. Unstable systemic diseases, including: unstable angina, cerebrovascular accident or transient ischemic attack (within 6 months before screening), myocardial infarction (within 6 months before screening), NYHA Class III\u002FIV heart failure, refractory hypertension (defined as failure to control blood pressure despite lifestyle modifications and treatment with ≥4 antihypertensive drugs, including diuretics, for \\>1 month), clinically significant arrhythmias requiring medication, severe hepatic, renal, or metabolic disorders.\n6. Major surgery: Subjects who underwent major surgery within 4 weeks before screening, as deemed ineligible by the investigator.\n7. Concurrent non-hematologic malignancies.\n8. Cardiac abnormalities, meeting any of the following: Left ventricular ejection fraction (LVEF) ≤45%. NYHA Class III\u002FIV congestive heart failure. QTc interval \\>480 msec. Other cardiac conditions considered unsuitable by the investigator.\n9. History of epilepsy or other active CNS disorders.\n10. Uncontrolled infections: active systemic infections requiring treatment (e.g., sepsis, bacteremia, fungemia, tuberculosis, opportunistic infections).\n11. Recent participation in other interventional trials: Subjects who participated in another interventional clinical study within 30 days prior to enrollment.\n12. Other conditions: Any other circumstances deemed by the investigator to compromise subject safety or trial integrity.",{"count":239,"type":21},10,[241],"EARLY_PHASE1","The purpose of this study is to evaluate the efficacy and safety of allogeneic γδ T cells in patients with MRD-positive AML after allo-HSCT.",[27,145],"2025-08-11",{"date":246,"type":33},"2025-08-17",{"date":248,"type":33},"2025-07-20",{"date":250,"type":21},"2028-07-20",{"name":39,"class":40},{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":22,"phases":261,"briefSummary":262,"conditions":263,"keywords":269,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":69},"100594054","phase-1-clinical-trial-of-wbc100-capsule-in-relapsedrefractory-acute-myeloid-leukemia-100594054","NCT07014449","Clinical Trial of WBC100 Capsule in Relapsed\u002FRefractory Acute Myeloid Leukemia","An Open-Label, Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetic, and Preliminary Efficacy of WBC100 Capsules in Patients With Relapsed or Refractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n* 1\\. Signed informed consent and compliance with study procedures;\n* 2\\. Male or female participants aged ≥18 years at the time of consent;\n* 3\\. Diagnosis of relapsed or refractory acute myeloid leukemia (R\u002FR AML) according to the 2016 World Health Organization (WHO) classification;\n* 4\\. ECOG PS 0-2;\n* 5\\. Life expectancy ≥3 months;\n* 6\\. Adequate bone marrow reserve and organ function as defined below:\n\n  1. Bone marrow reserve: Peripheral WBC \\\u003C 25 × 10⁹\u002FL (leukocyte-reducing agents are allowed, with a washout period of at least 5 half-lives prior to study drug administration);\n  2. Coagulation: International normalized ratio (INR) ≤ 2;\n  3. Hepatic function: Total bilirubin (TBIL) ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN. In cases of hepatic involvement: ALT or AST ≤ 5 × ULN, and TBIL ≤ 3 × ULN;\n  4. Renal function: Creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault), or serum creatinine ≤1.5 × ULN;\n  5. Cardiac function: Left ventricular ejection fraction (LVEF) ≥50%; QTcF ≤450 ms for males, ≤470 ms for females.\n* 7\\. Female participants of childbearing potential and fertile male participants with partners of childbearing potential must use medically approved contraception during treatment and for 6 months after the final dose.\n\nExclusion Criteria:\n\n* 1\\. Known hypersensitivity to WBC100 capsules or any of their excipients;\n* 2\\. Diagnosis of acute promyelocytic leukemia (APL);\n* 3\\. Diagnosis of mixed phenotype acute leukemia, chronic myeloid leukemia in blast crisis, or AML transformed from myelodysplastic syndromes (MDS) or myeloproliferative neoplasms (MPN);\n* 4\\. Subjects with relapse after allogeneic HSCT, grade ≥ 2 acute GVHD, extensive chronic GVHD requiring immunosuppressive therapy, or autologous HSCT within the past 90 days;\n* 5\\. Subjects who have undergone major surgery, have active ulcers, or have unhealed wounds within 28 days prior to the first dose;\n* 6\\. Received other investigational drugs or treatments within 28 days prior to the first administration, or are still within the safety follow-up period of another clinical trial;\n* 7\\. Subjects with a history of severe cardiovascular or cerebrovascular conditions, including but not limited to:\n\n  1. Significant arrhythmias or conduction disorders (e.g., ventricular arrhythmias, Grade II-III AV block);\n  2. Thromboembolic events requiring anticoagulation or presence of vena cava filter;\n  3. NYHA Class III-IV heart failure;\n  4. Poorly controlled hypertension (SBP ≥140 mmHg or DBP ≥90 mmHg despite treatment).\n* 8\\. Evidence of severe or uncontrolled systemic diseases, such as refractory effusions, poorly controlled diabetes, or significant disorders of the psychiatric, neurological, cardiovascular, respiratory, endocrine, gastrointestinal, hepatic, or renal systems;\n* 9\\. History or presence of immunodeficiency, autoimmune disease requiring systemic immunosuppressants, or organ transplantation;\n* 10\\. Congestive heart failure, aortic dissection, stroke (excluding lacunar infarct), unstable angina, myocardial infarction, bypass surgery, or pulmonary embolism within 180 days prior to first dosing;\n* 11\\. Known risk factors for QT prolongation, including congenital long QT syndrome or drug-induced arrhythmia history;\n* 12\\. Positive for syphilis antibodies, HIV, active HBV infection (HBsAg+ or HBcAb+ with HBV DNA ≥1000 IU\u002FmL), or active HCV infection (HCV Ab+ with detectable HCV RNA);\n* 13\\. Active infection requiring systemic treatment, including uncontrolled bacterial, viral, or fungal infections;\n* 14\\. Gastrointestinal conditions preventing oral drug intake or absorption, such as severe vomiting, chronic diarrhea, intestinal stoma, malabsorption, or inability to swallow;\n* 15\\. Use of strong CYP450 inhibitors\u002Finducers that cannot be stopped ≥7 days before dosing;\n* 16\\. Receipt of monoclonal antibodies, ADCs, radiotherapy within 28 days (14 days for localized radiotherapy), cytotoxic chemotherapy, targeted small molecules within 14 days or 5 half-lives, or CAR-T therapy within 100 days;\n* 17\\. Receipt of any live or attenuated vaccines (e.g., influenza, varicella) within 28 days;\n* 18\\. History of other malignancies within 2 years, except adequately treated basal cell carcinoma, carcinoma in situ of cervix or breast, or squamous cell carcinoma of the skin;\n* 19\\. History of psychiatric or neurological disorders that may interfere with protocol compliance;\n* 20\\. Inability to tolerate venous blood draws;\n* 21\\. Pregnant or breastfeeding women, or women with positive serum hCG during screening;\n* 22\\. Any condition deemed by the investigator to make the subject unsuitable for study participation.",{"count":260,"type":21},18,[141],"The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of WBC100 capsules in patients with relapsed or refractory acute myeloid leukemia (R\u002FR AML). The main questions it aims to answer are:\n\n* What is the safety and tolerability profile of WBC100 in R\u002FR AML patients?\n* Can WBC100 effectively induce remission in R\u002FR AML patients?\n\nParticipants will:\n\n* Take WBC100 capsules orally once daily in 28-day treatment cycles;\n* Undergo regular safety assessments, including adverse event monitoring and laboratory tests;\n* Provide blood samples for pharmacokinetic (PK) analysis;\n* Have their remission status and efficacy evaluated according to the ELN2022 criteria.",[173,264,265,266,267,268],"Relapsed Acute Myelogenous Leukemia","Refractory Acute Myeloid Leukemia","Hematologic Malignancy","C-Myc","Adult Acute Myeloid Leukemia",[270,271,219,272],"c-Myc","Molecular glue","Relapsed and Refractory Acute Myelogenous Leukemia","2025-06-02",{"date":275,"type":33},"2025-06-11",{"date":277,"type":33},"2024-11-03",{"date":279,"type":21},"2026-06",{"name":281,"class":68},"Hangzhou Weben Pharma Co., Ltd",{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":289,"targetDuration":4,"studyType":22,"phases":291,"briefSummary":292,"conditions":293,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":299,"lastUpdatePostDateStruct":300,"startDateStruct":302,"completionDateStruct":304,"leadSponsor":306,"locationsCount":69},"100586156","phase-1-the-application-of-car-t-cell-therapy-in-relapsed-and-refractory-malignant-hematologic-tumors-100586156","NCT06911710","The Application of CAR-T Cell Therapy in Relapsed and Refractory Malignant Hematologic Tumors","CAR-T","Inclusion Criteria:\n\nWith their own consent and have signed an informed consent form, willing and able to comply with the planned visits, study treatment, laboratory tests and other experimental procedures; Patients with recurrent\u002Frefractory malignant hematologic tumors as determined by clinical diagnosis; Age 18 years and above, both male and female; Subjects with a physical status of 0\\~2 on the Eastern Cooperative Oncology Group (ECOG) score; Expected survival \\>3 months from the date of informed consent; HGB ≥ 60g\u002FL (transfusion is allowed); Liver and kidney function, cardiopulmonary function meet the following requirements: a) creatinine ≤1.5×ULN;b) Left ventricular ejection fraction ≥50%; c) Blood oxygen saturation \\>90%;d) Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; Subjects with pregnancy plans must agree to use contraception prior to enrollment in the study and after the study has lasted for six months; subjects should notify the investigator immediately if they become pregnant or suspect pregnancy.\n\nSubjects in the different cohorts will still be required to fulfill the following conditions:\n\nLymphoma Cohort:\n\nB-cell lymphoma Diagnosis of CD19+ and\u002For CD20+ and\u002For CD22+ and\u002For BAFF+ B-cell lymphoma confirmed by pathology and histology; Inert B-cell lymphoma (CLL, FL, MZL, LPL, HCL); Aggressive B-cell lymphoma (DLBCL, BL, MCL).\n\nMeet the following criteria for relapsed or refractory B-cell lymphoma (meet 1 of the first 2 plus 3 below):\n\nLess than 50% tumor shrinkage or disease progression after 4 courses of standard regimen regulated chemotherapy; relapse after achieving CR after standard regimen chemotherapy; subjects must have received adequate prior therapy, including at least: Anti-CD20 monoclonal antibody; Anthracycline-containing combination chemotherapy. T-cell lymphoma\n\nDiagnosis of CD7+ refractory\u002Frelapsed T-lymphocyte lymphoma confirmed by pathology and histology, meeting any of the following criteria:\n\nRelapsed: Disease relapse determined after having previously received at least two standardized treatment regimens to achieve complete remission, or disease relapse after having undergone stem cell transplantation to achieve complete remission; Refractory: previous treatment with at least two regimens and failure to achieve complete remission after the last treatment, or failure to achieve remission or disease progression after stem cell transplantation.\n\nII Acute lymphoblastic leukemia cohort:\n\nAcute B-lymphoblastic leukemia Refractory\u002Frelapsed B-lymphoblastic leukemia diagnosed as CD19+ and\u002For CD20+ and\u002For CD22+ and\u002For BAFF+ confirmed by immunohistochemistry or flow cytometry.\n\nRefractory\u002Frelapsed B-lymphoblastic leukemia (meeting 1 of the following 4 criteria is sufficient):\n\nRelapse within 6 months of first remission; first refractory without achieving complete remission with 2 cycles of standard chemotherapy regimen; failure to achieve complete remission or relapse after first or multiple lines of salvage chemotherapy; those who are not suitable for HSCT, or who have abandoned HSCT due to medical constraints, or those who have relapsed after HSCT.\n\nAcute T-lymphoblastic leukemia\n\nDiagnosis of CD7+ refractory\u002Frelapsed T-ALL\u002FLBL confirmed by immunohistochemistry or flow cytometry, meeting any of the following criteria:\n\nNo CR after standard chemotherapy; CR after first treatment, but CR lasted less than 12 months; No CR after first or more remedial therapy; Relapse two or more times.\n\nIII. multiple myeloma cohort:\n\nPositive expression of BCMA and\u002For CD19 and\u002For GPRC5D in myeloma cells by flow or immunohistochemistry; Patients with relapsed\u002Frefractory multiple myeloma who have received at least 1 prior therapy (including proteasome inhibitors (PIs) and immunomodulatory drugs (IMiDs)) or are resistant to proteasome inhibitors and\u002For immunomodulatory agents.\n\nIV. myeloid tumor cohort:\n\nPositive tumor cell antigen test results (CD7 and\u002For CD19 and\u002For CD47) confirmed by immunohistochemistry or flow cytometry; Diagnosis of myeloid tumors, including but not limited to AML and MDS, confirmed by pathology and the patient meets the following\n\nRelapse or refractory requirements:\n\nRelapse: reappearance of leukemic cells in the peripheral blood, or \\>5% of primitive cells found in the bone marrow, or extramedullary relapse after second-line or higher salvage therapy to achieve CR\u002FCRi; Refractory: failure to achieve CR\u002FCRi after at least 2 cycles of standard chemotherapy.\n\nExclusion Criteria:\n\na history of severe cardiac insufficiency with a left ventricular ejection fraction \\\u003C50%; A history of severe lung function-impairing disease; Combination of other malignant tumors in progressive stages; Combination of severe infections that cannot be effectively controlled; Combination of severe autoimmune disease or congenital immunodeficiency; Active hepatitis (Hepatitis B virus deoxyribonucleic acid \\[HBV-DNA\\] or Hepatitis C virus ribonucleic acid \\[HCV-RNA\\] test results above the lower limit of detection); Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection; History of severe allergy to biological products (including antibiotics); Allogeneic hematopoietic stem cell transplantation patients who still have acute graft-versus-host reaction (GvHD) one month after stopping immunosuppressive drugs; Presence of other serious physical or mental illnesses or abnormal laboratory tests that may increase the risk of participation in the study or interfere with the results of the study, as well as patients who, in the opinion of the investigator, are not suitable for participation in this study.",{"count":290,"type":21},90,[141,82],"This study is an open, single-arm, prospective, Phase I\u002FII clinical study using \"3+3\" dose escalation and dose expansion to investigate the safety, maximum tolerated dose, in vivo pharmacokinetic profile, and preliminary efficacy of CAR-T cell injections for the treatment of relapsed\u002Frefractory malignant hematological neoplasms in subjects.",[294,27,295,296,297,298],"Lymphoma, B-cell, Aggressive Non-Hodgkin (B-NHL)","Myeloma Multiple","B-ALL","T-ALL\u002FLymphoma","T-lymphocyte Lymphoma","2025-04-03",{"date":301,"type":33},"2025-04-04",{"date":303,"type":33},"2024-11-09",{"date":305,"type":21},"2027-02-28",{"name":307,"class":40},"Tianjin Medical University General Hospital",{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":11,"sex":16,"minAge":315,"maxAge":316,"enrollmentInfo":317,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":319,"conditions":320,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":69},"100585224","gut-health-in-children-with-cancer-100585224","NCT06899581","Gut Health in Children With Cancer","Monitor Gut Health in Children Undergoing Treatment for Acute Myeloid Leukaemia Treatment: Case-control Study","Inclusion Criteria:\n\n* \\- Consented to partake in the study\n* Aged 0-16 years old\n* Diagnosed with AML\u002FHLH\u002F Burkits\n\nExclusion Criteria:\n\n* 17 years old + (treated at UCL adolescent unit)\n* Inflammatory bowel disease: ulcerative colitis or Crohn's disease\n* Children who had previously been treated with chemotherapy in another institution age","1 Month","16 Years",{"count":318,"type":21},40,"The purpose of this study is to observe the impact leukaemia treatment has on gut health (microbiomes) and how quickly the gut health recovers after leukamia treatment. The gut microbiome has a number of important functions not only in the gut but within the whole body. Changes to your child's nutritional status throughout treatment may affect how well they recover from treatment. This study will monitor the impact of feeding and nutrition on nutritional status and gut health in young people undergoing treatment for leukaemia. The measurements needed to observe nutritional and gut microbiomes will occur when your child attends their routine medical appointments at Great Ormond Street Hospital.\n\nMedical treatment uses chemicals to kill leukaemia cells. The type of medications used in the treatment of leukaemia can damage the gut resulting in inflammation call mucositis. This stops the gut from working and sometimes nutrition has to be provided via a feeding tube or intravenous. Chemotherapy, mucositis and intravenous nutrition all have an impact on the gut. Little is know how the gut health recovers after treatment for leukaemia. This will be the first study to specifically monitor the impact of feeding and nutritional on gut health in children undergoing treatment for leukaemia.\n\nBy understanding what changes are occurring to your child's nutritional status and gut halth during treatment and during recovery will help to develop guidelines for healthcare professionals to support optimal gut health recovery.",[173,321,322],"HLH","Burkitt Lymphoma\u002FLeukemia","2025-03-21",{"date":325,"type":33},"2025-03-28",{"date":327,"type":33},"2025-01-30",{"date":329,"type":21},"2026-10-30",{"name":331,"class":40},"Great Ormond Street Hospital for Children NHS Foundation Trust",{"id":333,"slug":334,"hasResults":11,"nctId":335,"briefTitle":336,"officialTitle":336,"acronym":4,"eligibilityCriteria":337,"healthyVolunteers":338,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":339,"targetDuration":341,"studyType":51,"phases":4,"briefSummary":342,"conditions":343,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":344,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":69},"100583279","targeting-acute-myeloid-leukemia-immunosuppressive-microenvironment-by-combinedido1-inhibition-and-pd-1-blockade-100583279","NCT06874257","Targeting Acute Myeloid Leukemia Immunosuppressive Microenvironment by combinedIDO1 Inhibition and PD-1 Blockade","Inclusion Criteria:\n\n* Subject is ≥ 18 years of age\n* Subject has a new diagnosis of AML according to World Health Organization 2022 criteria\n* Subject is ineligible for intensive induction chemotherapy according to investigator assessment\n* Subject will undergo front-line treatment with azacitidine and venetoclax according to normal clinical practice\n* Subject providing signed written informed consent according to ICH\u002FEU\u002FGCP and national local laws\n\nFor healthy donors:\n\n* Age ≥ 18 years\n* Subject providing signed written informed consent according to ICH\u002FEU\u002FGCP and national local laws\n\nExclusion Criteria:\n\nFor patients:\n\n* Subject has acute promyelocytic leukemia\n* Subject has known AML with central nervous system involvement\n* Subject has not initiated treatment with azacitidine and venetoclax\n\nFor healthy donors:\n\nNone",true,{"count":340,"type":21},20,"12 Months","The combination of azacitidine and venetoclax is currently considered a therapeutic strategy innovative in AML through the addition of new compounds (triplet therapies), including inhibitors of the immune checkpoint inhibitors. Despite strong motivation, the clinical results of these approaches have been disappointing overall. The mechanisms leading to treatment failure of immunotherapies in AML are poorly elucidated as the effects on the AML microenvironment induced by basic azactidine and venetoclax therapy are largely unknown. In particular, the activity of the IDO1 enzyme as a potential mechanism of microenvironment resistance has been scarcely studied. The products of the IDO1-catalysed pathway activate the signalling of the AHR in mesenchymal stem cells and enhance their immunosuppressive effects, including the ability to reprogram the phenotype of M1\u002FM2 macrophages. Furthermore, activation of the AHR by by products of the IDO1 pathway kinurenine-promotes tolerogenic dendritic cells and the generation of regulatory T cells. Based on this rationale, TALETE-2023 will aim to analyse the leukaemia immune microenvironment through multiomics (epigenomics transcriptomics, proteomics, metabolomics) and assess its contribution to the effect of the combination of azacitidine and venetoclax.",[27],"2025-03-07",{"date":346,"type":33},"2025-03-13",{"date":348,"type":33},"2024-04-17",{"date":350,"type":21},"2026-10-31",{"name":352,"class":40},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",{"id":354,"slug":355,"hasResults":11,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":359,"eligibilityCriteria":360,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":361,"enrollmentInfo":362,"targetDuration":4,"studyType":22,"phases":364,"briefSummary":365,"conditions":366,"keywords":369,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":69},"100580272","phase-1-cd123-cd16-nk-cells-immunotherapy-for-aml-100580272","NCT06835140","CD123-CD16-NK Cells Immunotherapy for AML","CD123-Targeted CD16 Antibody-Modified NK Cell Immunotherapy for Refractory\u002FRelapsed Acute Myeloid Leukemia (R\u002FR AML)","CD123-CD16-NK","Inclusion Criteria:\n\n1. Age: Between18 years and 70 years.\n2. Diagnosis and Treatment History:\n\n   Diagnosed with Acute Myeloid Leukemia (AML) in the hospital. Has undergone multiple first-line clinical treatments and has developed resistance to current treatments. Relapse after original induction therapy failure with a predicted survival of more than three months.\n3. CD123 Expression:\n\n   Flow cytometry detection shows CD123-positive AML cells.CD123 expression level is not less than 20%.\n4. Hospital Examination Criteria:\n5. Performance Status:\n\n   ECOG Performance Status score of 0-2 or Karnofsky Performance Status (KPS) score greater than 80.\n6. Donor Availability:\n7. Have a suitable healthy donor and agree to peripheral blood collection.\n\nExclusion Criteria:\n\n1. Specific AML Subtype:\n\n   Diagnosed with Acute Promyelocytic Leukemia(APL).\n2. CD123 Expression:\n\n   Flow cytometry shows CD123 negative or CD123 expression level less than 20%.\n3. Prior Treatment Toxicity:\n\n   Persistent non-hematologic toxicity of grade 2 or higher related to previous treatments.\n4. GVHD Requiring Immunosuppression:\n\n   Patients requiring immunosuppressants for grade II-IV acute Graft-Versus-Host Disease (GVHD).\n5. Recent Steroid Treatment:\n\n   Systemic steroid treatment within 7 days prior to first study drug treatment (excluding topical and inhaled corticosteroids or short-term prophylactic steroid treatment).\n6. Severe Cardiovascular and Cerebrovascular Diseases:\n\n   Certain cardiovascular and cerebrovascular diseases within 6 months prior to first dose.\n\n   New York Heart Association (NYHA) classification ≥3 or uncontrolled malignant arrhythmias.Other cardiovascular and cerebrovascular diseases deemed unsuitable by the investigator.\n7. Pregnancy and Lactation:\n\n   Pregnant or breastfeeding women (the safety of this treatment for unborn babies is unknown).\n\n   For female participants, pregnancy must be confirmed negative by serum or urine pregnancy test within 48 hours before infusion.\n8. Infections:\n\n   Active Hepatitis B,Hepatitis C virus infection, Peripheral blood CMV-DNA ≥500 copies\u002FmL, HIV\u002FAIDS infection and any uncontrolled active infection.\n9. Allergic Reactions:\n\n   Allergic to immunotherapy and related drugs.\n10. Neurological Diseases:\n\nNeurological diseases such as neurodegenerative diseases, primary central nervous system tumors\u002Finfections, multiple sclerosis, epilepsy, severe peripheral neuropathy, etc.","70 Years",{"count":363,"type":21},9,[141],"The goal of this clinical trial is to evaluate the effectiveness of CD123-CD16 bispecific antibody-modified NK cells in treating patients with CD123-positive relapsed or refractory Acute Myeloid Leukemia (RR AML). It will also assess the safety of this modified NK cell therapy.\n\nThe main questions： Does the infusion of CD123-CD16 bispecific antibody-modified NK cells induce remission in RR AML patients? What are the safety and potential adverse effects associated with the administration of these modified NK cells? Researchers will administer CD123-CD16 bispecific antibody-modified NK cells to RR AML patients and compare the outcomes to existing treatment options to determine efficacy and safety.\n\nParticipants will:\n\nUndergo lymphocyte-depleting chemotherapy Fludarabine\\&Cyclophosphamide from day -5 to day -3 before NK cell infusion.\n\nReceive intravenous infusions of modified NK cells at escalating doses:\n\nThe first three patients will receive 1×10⁷ cells\u002Fkg. The next three patients will receive 2×10⁷ cells\u002Fkg. The final three patients will receive 4×10⁷ cells\u002Fkg. Have NK cell infusions administered every 96-120 hours for a total of three infusions, with each infusion completed within 10 to 15 minutes.\n\nUndergo dose escalation with subsequent groups only after confirming the safety of the previous dose group.\n\nHave their vital signs (temperature, heart rate, respiratory rate, blood pressure, etc.) monitored before and after each infusion.\n\nKeep baseline data records during NK cell infusions. Participate in follow-up assessments to monitor disease remission and detect any adverse events.\n\nThis trial aims to provide new treatment options for RR AML patients by leveraging the targeted cytotoxic effects of CD123-CD16 bispecific antibody-modified NK cells to achieve disease remission.",[27,367,368],"NK Cell","CD123+ Acute Myeloid Leukemia",[370,371,372],"CD123-CD16 bispecific antibody","NK cell","Refractory\u002Frelapsed AML","2025-02-23",{"date":375,"type":33},"2025-02-25",{"date":377,"type":21},"2025-02-21",{"date":379,"type":21},"2025-12-31",{"name":381,"class":40},"Chunji Gao",{"id":383,"slug":384,"hasResults":11,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":389,"targetDuration":4,"studyType":22,"phases":390,"briefSummary":391,"conditions":392,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":397,"leadSponsor":399,"locationsCount":69},"100576322","phase-2-avapritinib-combined-with-azacitidine-and-venetoclax-in-the-treatment-of-relapsed-aml-after-allo-hsct-100576322","NCT06783790","Avapritinib Combined With Azacitidine and Venetoclax in the Treatment of Relapsed AML After Allo-HSCT","An Exploratory Clinical Study of the Safety and Efficacy of Avapritinib Combined With Azacitidine and Venetoclax in the Treatment of Relapsed Acute Myeloid Leukemia After Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n1. Subjects met the criteria for recurrence after allogeneic transplantation: re-emergence of leukemia cells or bone marrow original cells in peripheral blood \\>5% (except for other causes such as bone marrow recovery period) or extramedullary leukemia cell infiltration or molecular or cytogenetic recurrence.\n2. Bone marrow molecular biology detected C-KIT D816 or C-KIT N822 mutations\n3. Patients with CBFB::MYH11 gene or RUNX1::RUNX1T1 fusion gene detected.\n4. Eastern Cancer Collaboration Group (ECOG) physical status score 0-2 points.\n5. Liver, kidney and cardiopulmonary functions met the following requirements: Within 2 weeks before enrollment ① creatinine ≤1.5 upper limit of normal value; ② Left ventricular ejection fraction ≥50%; ③ Blood oxygen saturation \\>91%; ④ Total bilirubin ≤2×ULN; ALT and AST≤2.5 x ULN; Myocardial enzymes \\\u003C 2 times the upper limit of normal (for the same age)\n6. Volunteer to participate in clinical studies and sign informed consent, willing to follow and able to complete all trial procedures.\n\nExclusion Criteria:\n\n1. Known allergy to KIT inhibitor drug analogues.\n2. Patients who have received previous treatment with Midostaurin.\n3. Patients who have previously been treated with mutation-specific C-KIT inhibitors and have developed disease progression during treatment.\n4. FLT3-ITD mutation in patients with recurrent\u002Frefractory disease (except low gene ratio).\n5. HIV infected persons, HBV, HCV active infected persons.\n6. Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulation disorders, connective tissue diseases, serious infectious diseases and other diseases.\n7. With uncontrolled active GVHD (NIH for GVHD diagnosis and classification standards, aGVHD classification refer to the improved Glucksberg standard).\n8. Central nervous system leukemia.",{"count":340,"type":21},[82],"This is a single-center, prospective, single-arm, exploratory clinical study. To explore the efficacy and safety of avapritinib in patients with recurrent acute myeloid leukemia after allogeneic hematopoietic stem cell transplantation with C-KIT mutation RUNX1::RUNX1T1 or CBFB::MYH11.",[27],"2025-01-14",{"date":395,"type":33},"2025-01-20",{"date":395,"type":21},{"date":398,"type":21},"2027-12",{"name":39,"class":40}]