[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"leukemia-myeloid-acuteaml\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:leukemia-myeloid-acuteaml":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,55],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100651580","a-prospective-single-arm-study-of-vabu-conditioning-regimen-in-allo-hsct-for-low-performance-or-high-comorbidity-aml-patients-in-cr1-100651580",false,"NCT07762508","A Study of VABu Conditioning Regimen in Allo-HSCT for AML Patients","A Single-Arm, Prospective Clinical Study of the Efficacy and Safety of VABu Conditioning Regimen in Allogeneic Hematopoietic Stem Cell Transplantation for Non-High-Risk AML Patients in CR1 With Low Performance Status (ECOG ≥ 2) or High Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI ≥ 2)","VABu","Inclusion Criteria:\n\n1. Age 18 to 70 years.\n2. Diagnosis of acute myeloid leukemia (AML) other than acute promyelocytic leukemia (APL), with first complete remission (CR1) achieved after induction chemotherapy.\n3. Classified as non-high-risk per ELN 2022 risk stratification guidelines.\n4. ECOG performance status ≥ 2 (not due to leukemia) OR Hematopoietic Cell Transplantation-Specific Comorbidity Index (HCT-CI) ≥ 2.\n5. Willing to undergo allogeneic hematopoietic stem cell transplantation and has a suitable donor.\n6. Voluntarily signs informed consent form after full understanding of the study.\n\nExclusion Criteria:\n\n1. Allergy to any component of the study drugs.\n2. Psychiatric or psychological disorders that prevent cooperation with treatment.\n3. Uncontrolled systemic or local severe infection.\n4. Severe dysfunction of major organs (heart, lung, liver, kidney) that, in the investigator's opinion, makes the patient unsuitable for enrollment.\n5. Currently participating in or planning to participate in any other clinical study.\n6. Any other conditions that, in the investigator's opinion, make the patient unsuitable for enrollment.","ALL","18 Years","70 Years",{"count":21,"type":22},42,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study evaluates the effectiveness and safety of a new conditioning regimen called VABu before stem cell transplantation in patients with acute myeloid leukemia (AML) who are in their first complete remission (CR1), classified as non-high-risk per ELN 2022 guidelines, but have poor physical condition (ECOG performance status ≥ 2) or high comorbidity burden (HCT-CI ≥ 2). VABu combines venetoclax, azacitidine (or decitabine as an alternative), and busulfan. This is a single-arm, prospective study with 42 participants. All participants will receive the VABu regimen followed by stem cell transplantation. The primary outcome measure is 2-year overall survival (OS). Secondary outcomes include 2-year relapse-free survival (RFS), transplant-related mortality (TRM), engraftment failure rate, bloodstream infection (BSI), and 2-year all-cause mortality and non-relapse mortality (NRM). The study is conducted at the First Affiliated Hospital of Soochow University.",[28,29],"Leukemia, Myeloid, Acute(AML)","Hematopoietic Stem Cell Transplantation (HSCT)",[31,32,33,34,35,15,36,37,38,39,40,41],"Acute Myeloid Leukemia","Allogeneic Hematopoietic Stem Cell Transplantation","Conditioning Regimen","Venetoclax","Azacitidine","Low Performance Status","High Comorbidity Index","Single-Arm Study","Prospective Study","AML","Allo-HSCT","NOT_YET_RECRUITING","2026-08-16",{"date":45,"type":46},"2026-08-19","ACTUAL",{"date":48,"type":22},"2026-08",{"date":50,"type":22},"2029-07",{"name":52,"class":53},"The First Affiliated Hospital of Soochow University","OTHER",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":63,"targetDuration":4,"studyType":23,"phases":65,"briefSummary":67,"conditions":68,"keywords":72,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":54},"100574945","early-phase-1-cart123-t-cells-in-relapsed-or-refractory-cd123-hematologic-malignancies-a-dose-escalation-phase-i-trial-100574945","NCT06765876","CART123 T Cells in Relapsed or Refractory CD123+ Hematologic Malignancies: A Dose Escalation Phase I Trial","Safety and Efficacy of Anti-CD123 Chimeric Antigen Receptor-Modified Autologous T Cells (CART123) in Patients With Relapsed\u002FRefractory CD123+ Hematologic Malignancies: A Dose Escalation, Open-Label, Phase I Study","UHKT-CAR123-01","Inclusion Criteria:\n\n1. Patients with AML, MDS-IB2, BPDCN or ALL positive for CD123 antigen, who meet one of disease specific criteria below:\n\n   a) Patients with AML will be eligible if they meet one of the following criteria:\n\n   i) Patient with refractory AML defined as failure to achieve CR or CRi after at least 2 cycles of induction chemotherapy or 1 cycle of high dose salvage regimen or 4 cycles of venetoclax with azacytidine OR\n\n   ii) Second or subsequent relapse of AML OR\n\n   iii) Relapse after allogeneic HSCT.\n\n   b) Patients with ALL will be eligible if they meet one of following criteria:\n\n   i) disease refractory to or relapsed after CAR-19 cell therapy OR\n\n   ii) CD19 negative relapse ineligible for treatment with TKI inhibitors and inotuzumab ozogamicin.\n\n   c) Patients with BPDCN will be eligible if they meet following criteria:\n\n   i) Refractory or relapsing after chemotherapy with or without allogeneic stem cell transplantation.\n\n   d) Patients with MDS-IB2 will be eligible if they meet one of following criteria:\n\n   i) Disease refractory to at least four cycles of azacytidine or progression on azacytidine-based therapy OR\n\n   ii) Disease refractory to induction chemotherapy OR\n\n   iii) Relapse after haematopoietic stem cell transplantation.\n2. CD123 expression on malignant cells confirmed by flow cytometry or by immunohistochemistry.\n3. Age between 18 and 70 years.\n4. Patient has a suitable donor for allogeneic hematopoietic stem cell transplantation. Workup and clearance of the donor must be completed before IMP administration.\n5. Patient able to understand and sign informed consent.\n6. Women of child-bearing potential: negative pregnancy test at enrolment (PSV) and at Visit 1.\n7. Patient for whom there are no standard-of-care treatments available or such treatment options have been exhausted.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to any component of the IMP.\n2. Allogeneic HSCT within 3 months prior to IMP administration.\n3. Severe, uncontrolled active infection.\n4. Life expectancy \\\u003C 8 weeks.\n5. Respiratory insufficiency (need for oxygen therapy).\n6. Significant liver impairment: bilirubin \\> 50 µmol\u002FL, AST or ALT \\> 4 times normal upper limit.\n7. Acute kidney injury with serum creatinine \\> 180 µmol\u002FL, oliguria or need for acute dialysis.\n8. Heart failure with LVEF \\\u003C 50% by echocardiography.\n9. Presence of active grade 3 - 4 acute GvHD or severe chronic GvHD.\n10. Serious uncontrolled neurological comorbidity.\n11. Vaccination with live virus vaccines in the 4 weeks before IMP administration and within 90 days after the IMP dose.\n12. Women: pregnancy or breast-feeding.\n13. Subjects of fertile age, unless permanent sexual abstinence is their lifestyle choice:\n\n    1. female patients of childbearing potential not willing to use a highly effective method of contraception during the study,\n    2. male patients whose sexual partner(s) are women of childbearing potential who are not willing to use a highly effective method of contraception during the study.",{"count":64,"type":22},18,[66],"EARLY_PHASE1","Adult patients with refractory or relapsed CD123+ hematologic malignancies, including acute myeloid leukemia, myelodysplastic syndrome, acute lymphoblastic leukemia, or blastic plasmocytoid dentritic cell neoplasm will be recruited in the trial. CART123 cells will be manufatured from blood of each patient. During the production of CAR123 cells, patients may receive appropriate bridging therapy. After cells are produced, participants will undergo a single course of lymphodepleting chemotherapy and receive a single dose of CAR123 T cells. The trial will establish the recommended dose for further studies, either the Maximum Tolerated Dose (MTD) or Maximum Feasible Dose (MFD). Patients must be eligible for hematopoietic stem cell transplantation in order to participate in the trial.",[28,69,70,71],"Precursor Cell Lymphoblastic Leukemia-Lymphoma","Myelodysplastic Syndromes (MDS)","Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)",[73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88],"CAR123 T lymphocytes","CART123","CD123+ Hematologic Malignancies","Anti-CD123","Chimeric Antigen Receptor (CAR) T Cells","Autologous T Cells","Hematopoietic Malignancies","Immunotherapy","Personalized Medicine","Biological Therapy","Phase I Clinical Trial","Acute Lymphoblastic Leukemia, in Relapse","Acute Lymphoblastic Leukemia, Refractory","Relapsed Myelodysplastic syndrome","Relapsed Blastic Plasmacytoid Dendritic Cell Neoplasm","Acute Myeloid Leukaemia Recurrent","RECRUITING","2026-01-08",{"date":92,"type":46},"2026-01-12",{"date":94,"type":46},"2024-10-23",{"date":96,"type":22},"2028-12-31",{"name":98,"class":53},"Institute of Hematology and Blood Transfusion, Czech Republic"]