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

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.

Conditions

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

Interventions

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.

RADIATION

Total Body Irradiation (TBI)

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

Sponsors & Collaborators

• Guangzhou First People's Hospital

  collaborator OTHER

• Zhujiang Hospital

  collaborator OTHER

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  collaborator OTHER

• Third Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• The Seventh Affiliated Hospital of Sun Yat-sen University

  collaborator OTHER

• The First Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Guangdong Second Provincial General Hospital

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• First People's Hospital of Chenzhou

  collaborator OTHER

• Guangzhou Panyu Central Hospital

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  lead OTHER

Principal Investigators

• Qifa Liu · Nanfang Hospital, Southern Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

14 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2020-02-29

Completion

2022-02-28

Countries

• China

Study Locations