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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02670252
Enrollment
550
Registered
2016-02-01
Start date
2016-01-31
Completion date
2022-02-28
Last updated
2022-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DRUGBusulfan (BU)

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

DRUGCyclophosphamide (CY)

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

RADIATIONTotal Body Irradiation (TBI)

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
14 Years to 65 Years
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)

Design outcomes

Primary

MeasureTime frame
overall survival (OS)2 year

Secondary

MeasureTime frame
leukemia relapse rate2 year
disease-free survival (DFS)2 year
transplant-related mortality (TRM)2 year

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026