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Completed

NCT Number: NCT02670252

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

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.

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Key information

Conditions

Allogeneic Hematopoietic Stem Cell Transplantation Acute Lymphocytic Leukemia Busulfan Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Total Body Irradiation

Age range

14 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Busulfan (BU)

Drug

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

Cyclophosphamide (CY)

Drug

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

Total body irradiation (TBI)

Radiation

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

Primary outcomes

  1. overall survival (OS)

    Time frame: 2 year

Secondary outcomes

  1. leukemia relapse rate

    Time frame: 2 year

  2. disease-free survival (DFS)

    Time frame: 2 year

  3. transplant-related mortality (TRM)

    Time frame: 2 year

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Collaborators

  • 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

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2020
Study completion
2022
First posted
Feb 1, 2016
Registry last updated
Apr 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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