Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2025-12-25 @ 10:50 PM
Study NCT ID:
NCT06673459
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-05
First Post:
2024-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BuCy Vs. TBICy for Allo-HSCT in T-ALL Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015458', 'term': 'Leukemia, T-Cell'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'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': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 430}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2029-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-02', 'studyFirstSubmitDate': '2024-11-02', 'studyFirstSubmitQcDate': '2024-11-02', 'lastUpdatePostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '2 years after randomization', 'description': 'estimated progression-free survival at 2 year'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '2 years after randomization', 'description': 'estimated overall survival at 2 year'}, {'measure': 'Cumulative incidence of relapse', 'timeFrame': '2 years after randomization', 'description': 'estimated cumulative incidence of relapse at 2 year'}, {'measure': 'Non-relapse mortality', 'timeFrame': '2 years after randomization', 'description': 'estimated non-relapse mortality at 2 year'}, {'measure': 'Adverse events', 'timeFrame': '2 years after randomization', 'description': 'Number of participants with adverse events. Frequencies of toxicities based on Common Terminology Criteria for Adverse Events (CTCAE) will be tabulated.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['T-Cell Lymphocytic Leukemia', 'ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION', 'Total Body Irradiation', 'Chemotherapy']}, 'descriptionModule': {'briefSummary': 'T-cell acute lymphoblastic leukemia (T-ALL), a hematological malignant neoplasm of immature T cells, accounting for a morbidity of 10-15% among pediatric and 20-25% among adult patients of ALL. Despite the application of improved intensive therapies, the overall survival (OS) of T-ALL patients is still unsatisfactory, with a 5-year OS rate of less than 60% in adults and 85% in children. Over the past few decades, allogeneic hematopoietic stem-cell transplantation (allo-HSCT) has emerged as a potential and the most likely curative treatment for patients with high-risk hematological malignant neoplasms, and it has been proven that allo-HSCT could hold the potential to improve the prognosis of T-ALL patients and may even cure T-ALL.\n\nThe two most common myeloablative conditioning regimens for T-ALL patients with allo-HSCT were total body irradiation (TBI) plus cyclophosphamide (TBI-Cy) and busulfan (Bu) plus cyclophosphamide (BuCy). The most common use conditioning regimen for ALL patients is the TBI-Cy conditioning regimen over other hematological malignancy patients because TBI possess potent and distinct anti-leukemic effects, particularly in organs not easily affected by systemic chemotherapy and intense immunosuppressive effects. However, TBI-based conditioning regimens may cause a high risk of cataracts, interstitial pneumonitis (IP), engraftment failure and even subsequent malignant neoplasms (SMNs). To avoid these disadvantages, intravenous Bu replaced TBI as a part of conditioning.\n\nExtensive studies have shown that allo-HSCT with conditioning regimens based on TBI could benefit survival compared with conditioning regimens based on chemotheraphy in treating ALL. We retrospectively analyzed post-10-year data from T-ALL patients from two transplant centers, and all the databases were used to eliminate confounding factors via PSM. We demonstrated that the TBI-Cy conditioning regimen had inferior efficacy to the BuCy conditioning regimen, especially for T-ALL patients who were children, refractory, had extramedullary disease before transplantation, had active disease or an MRD-positive status at allo-HSCT, or who received haplo-HSCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '55 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. T-ALL patients aged \\> 2 years and ≤55 years;\n2. For the first time accept allo-HSCT;\n3. With Eastern Cooperative Oncology Group (ECOG) performance status of 0-3; 4. Signing an informed consent form, having the ability to comply with study and follow-up procedures.\n\nExclusion Criteria:\n\n1. With other malignancies;\n2. With a previous history of autologous hematopoietic cell transplantation, allogeneic hematopoietic cell transplantation or chimeric antigen receptor T cell therapy;\n3. With uncontrolled infection intolerant to haploidentical hematopoietic cell transplantation;\n4. With severe organ dysfunction;\n5. In pregnancy or lactation period;\n6. With any conditions not suitable for the trial (investigators' decision)."}, 'identificationModule': {'nctId': 'NCT06673459', 'briefTitle': 'BuCy Vs. TBICy for Allo-HSCT in T-ALL Patients', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Soochow University'}, 'officialTitle': 'Busulfan Plus Cyclophosphamide Vs. Total Body Irradiation Plus Cyclophosphamide for Allogeneic Hematopoietic Stem Cell Transplantation in Patients with Acute T Lymphoblastic Leukemia: a Randomized Controlled, Open-label, Multi-center Clinical Trial', 'orgStudyIdInfo': {'id': 'TREAL1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TBICy', 'description': 'Patients enrolled in this arm will receive total body irradiation plus cyclophosphamide as conditioning regimen.', 'interventionNames': ['Biological: TBICy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BuCy', 'description': 'Patients enrolled in this arm will receive busulfan plus cyclophosphamide as conditioning regimen.', 'interventionNames': ['Biological: BuCy']}], 'interventions': [{'name': 'TBICy', 'type': 'BIOLOGICAL', 'description': 'The TBI-Cy group was administered 250 mg/m2/d oral Me-CCNU on day -8. A total of 12 Gy TBI was for each patient and fractionated dose was 2 Gy twice daily or 4Gy once daily on days -8 to -6. Occluding of the lung fields during TBI, the corresponding irradiation dose reduced to a total of 8 Gy. On day -5, the schedule was intravenous 2 g/m2 Ara-C every 12 hours. Then intravenous 1.8 g/m2 CTX once per day from days -4 to -3.', 'armGroupLabels': ['TBICy']}, {'name': 'BuCy', 'type': 'BIOLOGICAL', 'description': 'The BuCy group received oral Me-CCNU 250 mg/m2/d twice daily on day -8, intravenous cytosine arabinoside (Ara-C) 2 g/m2 twice daily on day -7, intravenous Bu 3.2 mg/kg/d from days -6 to -4, and intravenous cyclophosphamide (CTX) 1.8 g/m2/d from days -3 to -2. There were no patients accepted oral Bu.', 'armGroupLabels': ['BuCy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '215000', 'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Yang Xu', 'role': 'CONTACT', 'email': 'xuyang1020@126.com', 'phone': '86+051267781850'}], 'facility': 'The First Affiliated Hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'centralContacts': [{'name': 'Yang Xu', 'role': 'CONTACT', 'email': 'xuyang1020@126.com', 'phone': '86+051267781850'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Soochow University', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Hospital of Soochow University", 'class': 'OTHER'}, {'name': 'Ruijin Hospital', 'class': 'OTHER'}, {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, {'name': 'Fujian Medical University Union Hospital', 'class': 'OTHER'}, {'name': "First Affiliated Hospital Xi'an Jiaotong University", 'class': 'OTHER'}, {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}, {'name': 'Zhejiang University', 'class': 'OTHER'}, {'name': 'Anhui Provincial Hospital', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'The First Affiliated Hospital of Soochow University', 'investigatorFullName': 'Yang Xu', 'investigatorAffiliation': 'The First Affiliated Hospital of Soochow University'}}}}