Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-27 @ 11:31 PM
Study NCT ID:
NCT06816134
Status:
RECRUITING
Last Update Posted:
2025-02-19
First Post:
2025-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study on the Efficacy and Safety of the TmBU Conditioning Regimen in High-risk or Relapsed/Refractory Acute Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2030-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-16', 'studyFirstSubmitDate': '2025-02-04', 'studyFirstSubmitQcDate': '2025-02-04', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative incidence of relapse（CIR）', 'timeFrame': '2 years', 'description': 'It is measured the date from complete remission after transplantation to hematological relapse or molecular relapse was recorded. Patients who had no relapse at the last follow-up were considered as censored data, and non-relapse death was regarded as a competing risk event.'}], 'secondaryOutcomes': [{'measure': 'Time period for hematopoietic reconstruction', 'timeFrame': '24 weeks', 'description': 'Granulogenetic hematopoietic reconstitution: The absolute neutrophil count in peripheral blood needs to reach or exceed 0.5×10\\^9 cells/L for 3 consecutive days. Megakaryotic hematopoietic reconstitution: platelet count needs to be more than 20×10\\^9/L and does not rely on platelet transfusion for 7 consecutive days.'}, {'measure': 'Incidence of acute graft-versus-host disease (aGVHD)', 'timeFrame': '100 days'}, {'measure': 'Progressing-free survival（PFS）', 'timeFrame': '2 years', 'description': 'It is measured from the date of achievement of a remission until the date of relapse from CR, or CRi, or death from any cause; patients not known to have any of these events are censored on the date they were last examined.'}, {'measure': 'Overall survival（OS）', 'timeFrame': '2 years', 'description': 'It is measured from the date of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.'}, {'measure': 'Non-relapse mortality（NRM）', 'timeFrame': '2 years', 'description': 'It is described as proportion of deaths due to non-primary recurrence from enrollment start date to 2 years post-transplant.'}, {'measure': 'Graft-versus-host disease (GVHD)-free relapse-free survival (GRFS)', 'timeFrame': '2 years', 'description': 'It is defined as a composite end point of death from any cause, relapse of malignancy, grade 3 to 4 acute GVHD, or chronic GVHD requiring systemic immune suppression therapy.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Myeloid Leukemia', 'Acute Lymphoblastic Leukemia', 'Transplantation, Stem Cell', 'Conditioning Therapy']}, 'descriptionModule': {'briefSummary': 'This project is a prospective, single-center, randomized controlled clinical study. The subjects were high-risk or relapsed/refractory 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/Cy (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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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/primary 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 \\< 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/min\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/Syphilis 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"}, 'identificationModule': {'nctId': 'NCT06816134', 'briefTitle': 'Study on the Efficacy and Safety of the TmBU Conditioning Regimen in High-risk or Relapsed/Refractory Acute Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Soochow University'}, 'officialTitle': '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/Refractory Acute Leukemia', 'orgStudyIdInfo': {'id': 'SZConditioning01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TmBu conditioning Regimen Group', 'description': 'TmBU conditioning regimen（TT 9mg/kg -8\\~-7d; Ara-C 2g/m2/d -6d; CDA 5 mg/m2/d -6d; Bu 3.2 mg/kg/d from -5 to -3 days）', 'interventionNames': ['Drug: TmBU conditioning Regimen']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'mBUCY conditioning Regimen Group', 'description': 'mBuCy conditioning regimen（CCNU/BCNU -9d, Ara-C 2g/m2/d -8d; CDA 5 mg/m2/d -8d; Busulfan 3.2 mg/kg/d from -7 to -5 days; Cyclophosphamide 1.8 mg/m2/d from -4 to -3 days）', 'interventionNames': ['Drug: mBUCY conditioning regimen']}], 'interventions': [{'name': 'TmBU conditioning Regimen', 'type': 'DRUG', 'otherNames': ['Experimental Group'], 'description': "TmBU conditioning Regimen and GVHD Prophylaxis of Haploid transplantation (Haplo-HSCT) and unrelated donor transplantation (UDT) : Cyclosporine A (CsA) + Mycophenolate mofetil dispersible tablets (MMF) + short-term low-dose methotrexate (MTX) + rabbit anti-human antithymocyte globulin (ATG) or GVHD Prophylaxis of Matched Sibling Donor Hematopoietic Stem Cell Transplantation (MSD-HSCT)：Cyclosporine A (CsA) + short-term low-dose methotrexate (MTX), then stem cells are infused into patient's blood.", 'armGroupLabels': ['TmBu conditioning Regimen Group']}, {'name': 'mBUCY conditioning regimen', 'type': 'DRUG', 'otherNames': ['Control Group'], 'description': "mBUCY conditioning Regimen and GVHD Prophylaxis of Haploid transplantation (Haplo-HSCT) and unrelated donor transplantation (UDT): Cyclosporine A (CsA) + Mycophenolate mofetil dispersible tablets (MMF) + short-term low-dose methotrexate (MTX) + rabbit anti-human antithymocyte globulin (ATG) or GVHD Prophylaxis of Matched Sibling Donor Hematopoietic Stem Cell Transplantation (MSD-HSCT)：Cyclosporine A (CsA) + short-term low-dose methotrexate (MTX), then stem cells are infused into patient's blood.", 'armGroupLabels': ['mBUCY conditioning Regimen Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '215006', 'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Sheng-Li Xue, M.D.', 'role': 'CONTACT', 'email': 'slxue@suda.edu.cn', 'phone': '+8651267781139'}], 'facility': 'The First Affiliated Hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'centralContacts': [{'name': 'Sheng-Li Xue, M.D.', 'role': 'CONTACT', 'email': 'slxue@suda.edu.cn', 'phone': '008651267781139'}], 'overallOfficials': [{'name': 'Sheng-Li Xue, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Soochow University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Soochow University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Sheng-Li Xue, MD', 'investigatorAffiliation': 'The First Affiliated Hospital of Soochow University'}}}}