BuCY vs TBICY Conditioning Regimen for Standard-risk ALL Undergoing Allo-HSCT

NCT02670252 — Phase 3, Completed, 550 participants, Nanfang Hospital, Southern Medical University

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Busulfan Plus Cyclophosphamide vs Total Body Irradiation Plus Cyclophosphamide Conditioning Regimen for Standard-risk Acute Lymphocytic Leukemia Undergoing HLA-matched Allogeneic Hematopoietic Stem Cell Transplantation

Registry	NCT02670252
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	550 (Actual)
Sponsor	Nanfang Hospital, Southern Medical University (Other); collaborators: 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
Conditions	Allogeneic Hematopoietic Stem Cell Transplantation, Busulfan, Total Body Irradiation, Acute Lymphocytic Leukemia
Interventions	Busulfan (BU), Cyclophosphamide (CY), Total Body Irradiation (TBI) (Drug, radiation)
Dates	start 2016-01-01, primary completion 2020-02-01, completion 2022-02-01, first posted 2016-02-01, last updated 2022-04-08
Locations	1 site in China

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
BUCY	Experimental	Drug: Busulfan (BU); Drug: Cyclophosphamide (CY)	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.
TBICY	Active comparator	Drug: Cyclophosphamide (CY); Radiation: Total Body Irradiation (TBI)	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.

Busulfan (BU) (Drug): Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.
Cyclophosphamide (CY) (Drug): Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.
Total Body Irradiation (TBI) (Radiation): Total Body Irradiation was given 4.5 Gy TBI/day on days -5 and -4.

+Outcome measures

Primary outcomes

overall survival (OS) [2 year]

Secondary outcomes

leukemia relapse rate [2 year]
disease-free survival (DFS) [2 year]
transplant-related mortality (TRM) [2 year]

+Eligibility

Sex: All, ages: 14 Years to 65 Years

Inclusion Criteria:

* Standard-risk ALL
* Achieving CR1
* Undergoing HLA-matched allo-HSCT (related or unrelated)

Exclusion Criteria:

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision)

+Locations (1)

Facility	City	Country	Status
Department of Hematology,Nanfang Hospital, Southern Medical University	Guangzhou, Guangdong	China

+Publications

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. PMID 24317131
Results publication: 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. PMID 36084276

+Investigators

Qifa Liu, Principal investigator, Nanfang Hospital, Southern Medical University