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

Sponsor
Nanfang Hospital of Southern Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT02670252
Collaborator
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)
550
1
2
73
7.5

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
  • Drug: Busulfan (BU)
  • Drug: Cyclophosphamide (CY)
  • Radiation: Total Body Irradiation (TBI)
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

Study Type:
Interventional
Actual Enrollment :
550 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Feb 1, 2020
Actual Study Completion Date :
Feb 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

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.

Outcome Measures

Primary Outcome Measures

  1. overall survival (OS) [2 year]

Secondary Outcome Measures

  1. leukemia relapse rate [2 year]

  2. disease-free survival (DFS) [2 year]

  3. transplant-related mortality (TRM) [2 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
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

Responsible Party:
Qifa Liu, Professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT02670252
Other Study ID Numbers:
  • BUCY vs TBICY-ALL-2016
First Posted:
Feb 1, 2016
Last Update Posted:
Apr 8, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 8, 2022