BuCY vs TBICY Conditioning Regimen for Standard-risk ALL Undergoing Allo-HSCT
NCT ID: NCT02670252
Last Updated: 2022-04-08
Study Results
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Basic Information
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COMPLETED
PHASE3
550 participants
INTERVENTIONAL
2016-01-31
2022-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Busulfan (BU)
Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.
Cyclophosphamide (CY)
Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.
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.
Cyclophosphamide (CY)
Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.
Total Body Irradiation (TBI)
Total Body Irradiation was given 4.5 Gy TBI/day on days -5 and -4.
Interventions
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Busulfan (BU)
Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.
Cyclophosphamide (CY)
Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.
Total Body Irradiation (TBI)
Total Body Irradiation was given 4.5 Gy TBI/day on days -5 and -4.
Eligibility Criteria
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Inclusion Criteria
* Achieving CR1
* Undergoing HLA-matched allo-HSCT (related or unrelated)
Exclusion Criteria
* Patients with any conditions not suitable for the trial (investigators' decision)
14 Years
65 Years
ALL
No
Sponsors
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Guangzhou First People's Hospital
OTHER
Zhujiang Hospital
OTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Third Affiliated Hospital, Sun Yat-Sen University
OTHER
The First Affiliated Hospital of Zhengzhou University
OTHER
Xiangya Hospital of Central South University
OTHER
The Seventh Affiliated Hospital of Sun Yat-sen University
OTHER
The First Affiliated Hospital of Guangzhou Medical University
OTHER
Guangdong Second Provincial General Hospital
OTHER
The Affiliated Hospital of Qingdao University
OTHER
First People's Hospital of Chenzhou
OTHER
Guangzhou Panyu Central Hospital
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Qifa Liu
Professor
Principal Investigators
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Qifa Liu
Role: PRINCIPAL_INVESTIGATOR
Nanfang Hospital, Southern Medical University
Locations
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Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Countries
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References
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de Berranger E, Cousien A, Petit A, Peffault de Latour R, Galambrun C, Bertrand Y, Salmon A, Rialland F, Rohrlich PS, Vannier JP, Lutz P, Yakouben K, Duhamel A, Bruno B, Michel G, Dalle JH. Impact on long-term OS of conditioning regimen in allogeneic BMT for children with AML in first CR: TBI+CY versus BU+CY: a report from the Societe Francaise de Greffe de Moelle et de Therapie Cellulaire. Bone Marrow Transplant. 2014 Mar;49(3):382-8. doi: 10.1038/bmt.2013.185. Epub 2013 Dec 9.
Zhang H, Fan Z, Huang F, Han L, Xu Y, Xu N, Deng L, Wang S, Lin D, Luo X, Zhang Q, Liu X, Li X, Liang X, Xie S, Qu H, Yu S, Zhou H, Shi P, Xuan L, Lin R, Liu H, Jin H, Sun J, Liu Q. Busulfan Plus Cyclophosphamide Versus Total Body Irradiation Plus Cyclophosphamide for Adults Acute B Lymphoblastic Leukemia: An Open-Label, Multicenter, Phase III Trial. J Clin Oncol. 2023 Jan 10;41(2):343-353. doi: 10.1200/JCO.22.00767. Epub 2022 Sep 9.
Other Identifiers
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BUCY vs TBICY-ALL-2016
Identifier Type: -
Identifier Source: org_study_id
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