drugset / Trial / NCT02670252
BuCY vs TBICY Conditioning Regimen for Standard-risk ALL Undergoing Allo-HSCT
Phase 3
Completed
550 enrolled
Nanfang Hospital, Southern Medical University
First People's Hospital of Chenzhou · collabGuangdong Second Provincial General Hospital · collabGuangzhou First People's Hospital · collabGuangzhou Panyu Central Hospital · collabSun Yat-Sen Memorial Hospital of Sun Yat-Sen University · collabThe Affiliated Hospital of Qingdao University · collabThe First Affiliated Hospital of Guangzhou Medical University · collabThe First Affiliated Hospital of Zhengzhou University · collabThe Seventh Affiliated Hospital of Sun Yat-sen University · collabThird Affiliated Hospital, Sun Yat-Sen University · collabXiangya Hospital of Central South University · collabZhujiang Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2016-01
- Primary completion
- 2020-02
- Completion
- 2022-02
Publications
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Busulfan | Small molecule | 3.2 mg/kg | — |
| Subject | Cyclophosphamide | Other / unclassified | 60 mg/kg | — |