BuCY vs TBICY Conditioning Regimen for Standard-risk ALL Undergoing Allo-HSCT
Study Details
Study Description
Brief Summary
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) appears to be an efficient tool to cure standard-risk acute lymphocytic leukemia (ALL) in first CR (CR1) but the choice between BU-based or TBI-based conditioning regimens still remains controversial. In this study, the safety and efficacy of BUCY and TBICY myeloablative conditioning regimens in patients undergoing allo-HSCT for ALL in CR1 are evaluated.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Detailed Description
Allo-HSCT appears to be an efficient tool to cure standard-risk ALL in CR1. The conditioning regimen with BUCY or TBICY is considered as the standard myeloablative regimen for ALL in CR1, but the choice between BU-based or TBI-based conditioning regimen still remains controversial.In order to analyze the impact of conditioning regimen on long-term survival and relapse, in this study, the safety and efficacy of BUCY and TBICY myeloablative conditioning regimens in patients undergoing allo-HSCT for ALL in CR1 are evaluated.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: BUCY For standard-risk ALL undergoing HLA-matched allo-HSCT,BUCY conditioning regimen was BU 3.2 mg/kg/day on days -7 and -4;CY 60 mg/kg/day on days -3 and -2. |
Drug: Busulfan (BU)
Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.
Drug: Cyclophosphamide (CY)
Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.
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Active Comparator: TBICY For standard-risk ALL undergoing HLA-matched allo-HSCT,TBICY conditioning regimen was 4.5 Gy TBI/day on days -5 and -4;CY 60 mg/kg/day on days -3 and -2. |
Drug: Cyclophosphamide (CY)
Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.
Radiation: Total Body Irradiation (TBI)
Total Body Irradiation was given 4.5 Gy TBI/day on days -5 and -4.
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Outcome Measures
Primary Outcome Measures
- overall survival (OS) [2 year]
Secondary Outcome Measures
- leukemia relapse rate [2 year]
- disease-free survival (DFS) [2 year]
- transplant-related mortality (TRM) [2 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Standard-risk ALL
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Achieving CR1
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Undergoing HLA-matched allo-HSCT (related or unrelated)
Exclusion Criteria:
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Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
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Patients with any conditions not suitable for the trial (investigators' decision)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Department of Hematology,Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong | China | 510515 |
Sponsors and Collaborators
- Nanfang Hospital of Southern Medical University
- Guangzhou First People's Hospital
- Zhujiang Hospital
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Third Affiliated Hospital, Sun Yat-Sen University
- The First Affiliated Hospital of Zhengzhou University
- Xiangya Hospital of Central South University
- The Seventh Affiliated Hospital of Sun Yat-sen University
- The First Affiliated Hospital of Guangzhou Medical University
- Guangdong Second Provincial General Hospital
- The Affiliated Hospital of Qingdao University
- First People's Hospital of Chenzhou
- Guangzhou Panyu Central Hospital
Investigators
- Principal Investigator: Qifa Liu, Nanfang Hospital of Southern Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
- BUCY vs TBICY-ALL-2016