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

Acute Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02670252
• Other study ID #: BUCY vs TBICY-ALL-2016
• Status: Completed
• Phase: Phase 3
• Start date: January 2016
• Est. completion date: February 2022

Study information

• Verified date: March 2022
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: February 2022
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Lymphocytic Leukemia
• Allogeneic Hematopoietic Stem Cell Transplantation
• Busulfan
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Total Body Irradiation

Intervention

Drug:
• 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.

Radiation:
• Total Body Irradiation (TBI)
Total Body Irradiation was given 4.5 Gy TBI/day on days -5 and -4.

Locations

Country	Name	City	State
China	Department of Hematology,Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (13)

Lead Sponsor

Collaborator

Nanfang Hospital of Southern Medical University

First People's Hospital of Chenzhou, Guangdong Second Provincial General Hospital, Guangzhou First People's Hospital, Guangzhou Panyu Central Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The Affiliated Hospital of Qingdao University, The First Affiliated Hospital of Guangzhou Medical University, The First Affiliated Hospital of Zhengzhou University, The Seventh Affiliated Hospital of Sun Yat-sen University, Third Affiliated Hospital, Sun Yat-Sen University, Xiangya Hospital of Central South University, Zhujiang Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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 Société Française de Greffe de Moelle et de Thérapie Cellulaire. Bone Marrow Transplant. 2014 Mar;49(3):382-8. doi: 10.1038/bmt.2013.185. Epub 2013 Dec 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival (OS)		2 year
Secondary	leukemia relapse rate		2 year
Secondary	disease-free survival (DFS)		2 year
Secondary	transplant-related mortality (TRM)		2 year