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

Primary Purpose

Allogeneic Hematopoietic Stem Cell Transplantation, Busulfan, Total Body Irradiation

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Busulfan (BU)

Cyclophosphamide (CY)

Total Body Irradiation (TBI)

About this trial

This is an interventional treatment trial for Allogeneic Hematopoietic Stem Cell Transplantation

Eligibility Criteria

14 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Department of Hematology,Nanfang Hospital, Southern Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BUCY

TBICY

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

overall survival (OS)

Secondary Outcome Measures

leukemia relapse rate

disease-free survival (DFS)

transplant-related mortality (TRM)

Full Information

NCT ID

NCT02670252

First Posted

January 28, 2016

Last Updated

March 30, 2022

Sponsor

Nanfang Hospital, Southern Medical University

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

1. Study Identification

Unique Protocol Identification Number

NCT02670252

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

January 2016 (Actual)

Primary Completion Date

February 2020 (Actual)

Study Completion Date

February 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nanfang Hospital, Southern Medical University

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allogeneic Hematopoietic Stem Cell Transplantation, Busulfan, Total Body Irradiation, Acute Lymphocytic Leukemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

550 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BUCY

Arm Type

Experimental

Arm Description

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.

Arm Title

TBICY

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Busulfan (BU)

Intervention Description

Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide (CY)

Intervention Description

Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.

Intervention Type

Radiation

Intervention Name(s)

Total Body Irradiation (TBI)

Intervention Description

Total Body Irradiation was given 4.5 Gy TBI/day on days -5 and -4.

Primary Outcome Measure Information:

Title

overall survival (OS)

Time Frame

2 year

Secondary Outcome Measure Information:

Title

leukemia relapse rate

Time Frame

2 year

Title

disease-free survival (DFS)

Time Frame

2 year

Title

transplant-related mortality (TRM)

Time Frame

2 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qifa Liu

Organizational Affiliation

Nanfang Hospital, Southern Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Hematology,Nanfang Hospital, Southern Medical University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510515

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

24317131

Citation

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.

Results Reference

background

PubMed Identifier

36084276

Citation

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.

Results Reference

derived

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

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