[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"transplantation-stem-cell\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:transplantation-stem-cell":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,67,88],{"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":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100642605","phase-2-shr2554aza--overlapped-modified-bucy-for-high-riskrelapsed-leukemiamds-100642605",false,"NCT07575412","SHR2554\u002FAZA + Overlapped Modified BUCY for High-risk\u002FRelapsed Leukemia\u002FMDS","A Prospective, Multicenter, Open-label, Randomized Controlled Trial of SHR2554 Plus Azacitidine in Overlapped Sequential Combination With Modified BUCY Conditioning Regimen in Patients With High-risk or Relapsed\u002FRefractory Acute Leukemia and Myelodysplastic Neoplasms Secondary IDs","Inclusion Criteria:\n\n1. Age 15-60 years, of either sex.\n2. Diagnosis of AML or ALL according to the WHO 2022 criteria, with an indication for allogeneic hematopoietic stem cell transplantation:\n\n   AML with high-risk genetics at diagnosis (risk stratification per ELN 2022) or relapsed\u002Frefractory AML (meeting any of the following: refractory-failure to achieve complete remission (CR) after two cycles of induction chemotherapy; relapse-reappearance of blasts in peripheral blood or bone marrow (≥5%) after first CR, or extramedullary relapse (EMR)).\n\n   High-risk B-ALL at diagnosis (risk stratification per ELN 2022) or pre-transplant MRD-positive B-ALL.\n\n   Confirmed T-ALL. History of central nervous system leukemia (CNSL) or pathologically confirmed extramedullary disease (EMD) during AML or ALL.\n\n   Myelodysplastic neoplasms (MDS): IPSS score intermediate-2 or high; IPSS-R score high or very high; IPSS-M score high or very high.\n3. Availability of an appropriate HLA-matched donor.4: ECOG performance status 0-2.5: Adequate major organ function, defined as: Left ventricular ejection fraction ≥50%. Pulmonary function: DLCO ≥50% of predicted value. Liver function: ALT\u002FAST ≤3×ULN, total bilirubin ≤2×ULN. Renal function: estimated creatinine clearance (CrCl) ≥60 mL\u002Fmin.6: Ability to understand the study and voluntary signed informed consent.\n\nExclusion Criteria:\n\n1: Acute promyelocytic leukemia (APL);2: Active central nervous system leukemia;3: Prior allogeneic hematopoietic stem cell transplantation;4: Prior treatment with any EZH2 inhibitor;5: Uncontrolled active infection as assessed by the investigator;6: Myocardial infarction or unstable angina within the previous 6 months;7: Known hypersensitivity to SHR2554, azacitidine, or any excipient of the mBuCy regimen;8: Pregnant or breastfeeding women;9: Any other medical condition that, in the investigator's judgment, would preclude study enrollment.","ALL","18 Years","65 Years",{"count":20,"type":21},180,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study was designed as a prospective, multicenter, open-label, randomized controlled trial. Eligible participants were patients aged 15-65 years with high risk or relapsed\u002Frefractory acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or myelodysplastic neoplasms (MDS), diagnosed based on bone marrow morphology, immunophenotyping, genetic testing, and treatment response assessment. The experimental group received SHR2554 combined with azacitidine as an overlapped sequential combination with the mBuCy conditioning regimen, whereas the control group received the mBuCy conditioning regimen, both followed by allogeneic hematopoietic stem cell transplantation (allo-HSCT). The primary endpoint is 1-year event-free survival (EFS). Secondary endpoints include 2-year overall survival, 2-year cumulative incidence of relapse, transplant-related mortality, incidence of acute\u002Fchronic GVHD, and safety profiles.",[27,28,29,30,31,32,33],"Acute Myeloid Leukemia","Acute Lymphoblastic Leukemia","MDS","Transplantation, Stem Cell","Conditioning Therapy","SHR2554","Azacytidine","NOT_YET_RECRUITING","2026-06-08",{"date":37,"type":38},"2026-06-10","ACTUAL",{"date":40,"type":21},"2026-06",{"date":42,"type":21},"2030-06",{"name":44,"class":45},"The First Affiliated Hospital of Soochow University","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":65,"leadSponsor":66,"locationsCount":46},"100636198","phase-2-shr2554aza--overlapped-tbf-for-high-riskrelapsed-leukemiamds-100636198","NCT07562568","SHR2554\u002FAZA + Overlapped TBF for High-risk\u002FRelapsed Leukemia\u002FMDS","A Prospective, Multicenter, Open-label, Randomized Controlled Trial of SHR2554 Plus Azacitidine in Overlapped Sequential Combination With TBF Conditioning Regimen in Patients With High-risk or Relapsed\u002FRefractory Acute Leukemia and Myelodysplastic Neoplasms","Inclusion Criteria:\n\n1. Age 15-60 years, of either sex.\n2. Diagnosis of AML or ALL according to the WHO 2022 criteria, with an indication for allogeneic hematopoietic stem cell transplantation: AML with high-risk genetics at diagnosis (risk stratification per ELN 2022) or relapsed\u002Frefractory AML (meeting any of the following: refractory-failure to achieve complete remission (CR) after two cycles of induction chemotherapy; relapse-reappearance of blasts in peripheral blood or bone marrow (≥5%) after first CR, or extramedullary relapse (EMR)). High-risk B-ALL at diagnosis (risk stratification per ELN 2022) or pre-transplant MRD-positive B-ALL. Confirmed T-ALL. History of central nervous system leukemia (CNSL) or pathologically confirmed extramedullary disease (EMD) during AML or ALL. Myelodysplastic neoplasms (MDS): IPSS score intermediate-2 or high; IPSS-R score high or very high; IPSS-M score high or very high.\n3. Availability of an appropriate HLA-matched donor.\n4. ECOG performance status 0-2.\n5. Adequate major organ function, defined as: Left ventricular ejection fraction ≥50%. Pulmonary function: DLCO ≥50% of predicted value. Liver function: ALT\u002FAST ≤3×ULN, total bilirubin ≤2×ULN. Renal function: estimated creatinine clearance (CrCl) ≥60 mL\u002Fmin.\n6. Ability to understand the study and voluntary signed informed consent.\n\nExclusion Criteria:\n\n1. Acute promyelocytic leukemia (APL);\n2. Active central nervous system leukemia;\n3. Prior allogeneic hematopoietic stem cell transplantation;\n4. Prior treatment with any EZH2 inhibitor;\n5. Uncontrolled active infection as assessed by the investigator;\n6. Myocardial infarction or unstable angina within the previous 6 months;\n7. Known hypersensitivity to Zeprumetostat, azacitidine, or any excipient of the mBuCy regimen;\n8. Pregnant or breastfeeding women;\n9. Any other medical condition that, in the investigator's judgment, would preclude study enrollment.","15 Years","60 Years",{"count":57,"type":21},160,[24],"This study was designed as a prospective, multicenter, open-label, randomized controlled trial. Eligible participants were patients aged 15-60 years with high-risk or relapsed\u002Frefractory acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or myelodysplastic neoplasms (MDS), diagnosed based on bone marrow morphology, immunophenotyping, genetic testing, and treatment response assessment. The experimental group received SHR2554 combined with azacitidine as an overlapped sequential combination with the TBF conditioning regimen, whereas the control group received the mBuCy conditioning regimen, both followed by allogeneic hematopoietic stem cell transplantation (allo-HSCT). The primary endpoint was the 2-year cumulative incidence of relapse (CIR) after allo-HSCT. Secondary endpoints included 2-year overall survival (OS), 2-year disease-free survival (DFS), transplant-related mortality (TRM), the incidence of acute and chronic graft-versus-host disease (GVHD), and safety profiles.",[27,28,29,30,31,32,33],"2026-04-26",{"date":63,"type":38},"2026-05-01",{"date":40,"type":21},{"date":42,"type":21},{"name":44,"class":45},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":18,"enrollmentInfo":74,"targetDuration":4,"studyType":22,"phases":76,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":46},"100578810","phase-2-study-on-the-efficacy-and-safety-of-the-tmbu-conditioning-regimen-in-high-risk-or-relapsedrefractory-acute-leukemia-100578810","NCT06816134","Study on the Efficacy and Safety of the TmBU Conditioning Regimen in High-risk or Relapsed\u002FRefractory Acute Leukemia","A Prospective, Randomized Controlled Clinical Study on the Efficacy and Safety of the TmBU Regimen Versus mBUCY Regimen for Conditioning Before Allo-HSCT in High-risk or Relapsed\u002FRefractory Acute Leukemia","Inclusion Criteria:\n\n* Confirmed diagnosis of AML or ALL according to WHO 2022 guideline criteria, with indications for allo-HSCT list below:\n\n  1. Relapsed\u002Fprimary refractory (definitions refer to NCCN 2025) or genetic high-risk group AML at diagnosis (risk stratification refers to ELN 2022)\n  2. High-risk at diagnosis (risk stratification refers to ELN 2022) or MRD positive before transplantation B-ALL\n  3. Confirmed diagnosis of T-ALL\n  4. History of central nervous system leukemia (CNSL) or histopathologically confirmed extramedullary manifestation (EMD) during the course of the AML or ALL\n* Age 15-65 years old (≤ 65 years old)\n* HCT-CI score \\\u003C 2 points ECOG 0-2 points\n* Adequate organ function:\n\n  1. Cardiac NYHA grade ≤ 2, left ventricular ejection fraction ≥55%\n  2. Creatinine clearance ≥ 50ml\u002Fmin\n  3. ALT and AST ≤ 2.5 times the upper limit of the normal range, and total bilirubin ≤ 1.5 times the upper limit of the normal range\n  4. Oxygen saturation \\> 92% without oxygen\n* Expected survival time ≥ 3 months\n* Ability to understand and voluntarily sign the informed consent form\n\nExclusion Criteria:\n\n* With other malignant tumors and have received any treatment for this tumor within the past 3 years\n* Previous or current other CNS disease (such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis) or any CNS-related autoimmune disease\n* HIV\u002FSyphilis infection or uncontrolled active other infections (bacteria or fungus or virus is included)\n* With active hepatitis B or hepatitis C infection\n* Patients received cardiac angioplasty or stent implantation within 12 months before signing the informed consent form, or have symptoms requiring medical treatment for coronary heart disease\n* With primary immunodeficiency or active autoimmune disease\n* Previous history of severe immediate hypersensitivity reactions to any of the drugs to be used in this study\n* Received a live vaccine within 6 weeks prior to screening\n* Pregnant, lactating females and patients of childbearing potential who are unwilling to use contraception\n* Inability to cooperate with the requirements of study, treatment and monitoring due to psychiatric illness or other conditions\n* Patients not suitable for the study according to the investigator's assessment",{"count":75,"type":21},48,[24],"This project is a prospective, single-center, randomized controlled clinical study. The subjects were high-risk or relapsed\u002Frefractory AML or ALL patients aged ≤ 65 years diagnosed by bone marrow cell morphology, immunology, genetics and therapeutic efficacy evaluation. The TmBU scheme or modified Bu\u002FCy (mBuCy) scheme was used for pretreatment in allo-HSCT. The primary endpoint of the study was the 2-year cumulative incidence of relapse (CIR) after allo-HSCT, and the secondary endpoints were 2-year overall survival rate (OS), progressing-free survival rate (PFS), non-relapse mortality rate (NRM), graft-versus-host disease (GVHD)-free relapse-free survival (GRFS) rate.",[27,28,30,31],"RECRUITING","2026-04-19",{"date":82,"type":38},"2026-04-23",{"date":84,"type":38},"2025-01-30",{"date":86,"type":21},"2030-01-30",{"name":44,"class":45},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":100,"conditions":101,"keywords":105,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":120},"100596903","early-versus-late-stopping-of-antibiotics-in-adults-with-high-risk-hematological-malignanciesreceiving-cellular-therapies-and-fever-100596903","NCT07051525","Early Versus Late Stopping of Antibiotics in Adults With High-risk Hematological Malignancies\u002FReceiving Cellular Therapies and Fever","Early Versus Late Stopping of Antibiotics in Adults With High Risk Haematological Malignancies\u002FReceiving Cellular Therapies and Fever (ELSA- Adult)","ELSA-Adult","Inclusion Criteria:\n\nAdult patients ( ≥18 years) who are receiving either:\n\n* Conditioning chemotherapy for an autologous or allogeneic haematopoietic cell transplant or CAR T cell therapy, OR\n* Induction remission chemotherapy for acute leukaemia,\n\nAND develop fever ( ≥38degC) between time of initiation of chemotherapy\u002Fconditioning administration and ANC recovery to ≥500 cells\u002Fmm3 post the ANC nadir,\n\nAND fever subsequently has settled (\\\u003C38degC) for ≥48 and \\\u003C96h hours.\n\n\\[participants will be stratified into pre-neutropenic (ANC ≥500 cells\u002Fmm3) and neutropenic (ANC\\\u003C500 cells\u002Fmm3) strata based on ANC level at 48 hours post fever onset, as per international consensus definition of neutropenic fever\\]\n\nExclusion Criteria:\n\n* \\- Prolonged fever prior to defervescence (documented daily temperature ≥38.0°C for ≥ 5 days)\n* Documented positive blood culture for bacteria since onset of fever episode and prior to randomisation\n* Documented other infection (clinically or microbiologically defined) requiring antibacterial treatment\n* Grade 2 or higher mucositis (WHO) or neutropenic enterocolitis\n* Clinically unstable and\u002For admission to ICU at time of potential randomization\n* Within 28 days of last randomization\n* Prior randomization during current chemotherapy\u002Fconditioning cycle\n* Pregnant or breastfeeding\n* Currently being treated for CRS Grade 3 or 4, and\u002For ICANS Grade 3 or 4 (defined as per ASTCT Consensus Guidelines, Lee et al)",{"count":97,"type":21},214,[99],"NA","Pre-neutropenic fever (PNF) (fever following chemotherapy but before developing low white cells) and neutropenic fever (NF) (fever in the setting of low white cells) are very common after chemotherapy for acute leukemia, bone marrow transplantation or Chimeric Antigen Receptor T-cell (CAR T) therapy. Often, there is no bacterial cause for fever found, and in the setting of a well patient with resolved fever, some studies have shown it to be safe to cease antibiotic therapy which was commenced at the onset of fever. This reduces the overall exposure to antibiotics, which can be beneficial to the patient (reduced risk of resistant bugs emerging, reduced serious side effects). However, some subgroups of high-risk patients have been underrepresented in these studies (in particular, those who have received a bone marrow transplant from a donor, those with longer duration of low white cells) and none have been performed in Australia, hence applying this data to our setting and patient groups is indirect and further data are needed. This study plans to recruit participants who have received chemotherapy for acute leukemia or a stem cell transplant (either their own cells or a donor's cells) or CAR T-cell therapy and perform a trial to compare early stopping of antibiotics (STOP arm) to the standard of care, which traditionally involves continuing antibiotics until the white cell count reaches above a specific threshold. The primary study outcome is duration of days free of antibiotics within 28 days of study allocation. The investigators will also observe for important clinical outcomes including rates of fever recurrence, bloodstream and other infections, intensive care admission and mortality. Patients will stay in hospital during this period, even in the setting of stopping antibiotics, and these antibiotics can be recommenced urgently according to the sepsis protocol if there is concern for infection.",[102,103,30,104],"Leukemia","CART Therapy","Infections, Bacterial",[106,107,108,109,110],"EPIC","ELSA","Febrile neutropaenia","Febrile neutropenia","antibitoics","2025-12-07",{"date":113,"type":38},"2025-12-15",{"date":115,"type":38},"2025-12-03",{"date":117,"type":21},"2028-02-05",{"name":119,"class":45},"Peter MacCallum Cancer Centre, Australia",2]