Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02670252
Recruitment Status : Unknown
Verified January 2016 by Qifa Liu, Nanfang Hospital of Southern Medical University.
Recruitment status was:  Recruiting
First Posted : February 1, 2016
Last Update Posted : December 8, 2017
Sponsor:
Collaborators:
Guangzhou First People's Hospital
Zhujiang Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Peking University People's Hospital
Third Affiliated Hospital, Sun Yat-Sen University
Information provided by (Responsible Party):
Qifa Liu, Nanfang Hospital of Southern Medical University

Tracking Information
First Submitted Date  ICMJE January 28, 2016
First Posted Date  ICMJE February 1, 2016
Last Update Posted Date December 8, 2017
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2016)
overall survival (OS) [ Time Frame: 2 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2016)
  • leukemia relapse rate [ Time Frame: 2 year ]
  • disease-free survival (DFS) [ Time Frame: 2 year ]
  • transplant-related mortality (TRM) [ Time Frame: 2 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BuCY vs TBICY Conditioning Regimen for Standard-risk ALL Undergoing Allo-HSCT
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Allogeneic Hematopoietic Stem Cell Transplantation
  • Busulfan
  • Total Body Irradiation
  • Acute Lymphocytic Leukemia
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Busulfan (BU)
    • Drug: Cyclophosphamide (CY)
  • 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.
    Interventions:
    • Drug: Cyclophosphamide (CY)
    • Radiation: Total Body Irradiation (TBI)
Publications * 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 Société Française de Greffe de Moelle et de Thérapie Cellulaire. Bone Marrow Transplant. 2014 Mar;49(3):382-8. doi: 10.1038/bmt.2013.185. Epub 2013 Dec 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 6, 2017)
204
Original Estimated Enrollment  ICMJE
 (submitted: January 28, 2016)
160
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Standard-risk ALL
  • Achieving CR after VILP induction regimen,then receiving three cycles of consolidation therapy
  • With negative MRD pre-transplantation
  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02670252
Other Study ID Numbers  ICMJE BUCY vs TBICY-ALL-2016
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Qifa Liu, Nanfang Hospital of Southern Medical University
Study Sponsor  ICMJE Nanfang Hospital of Southern Medical University
Collaborators  ICMJE
  • Guangzhou First People's Hospital
  • Zhujiang Hospital
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • Peking University People's Hospital
  • Third Affiliated Hospital, Sun Yat-Sen University
Investigators  ICMJE
Principal Investigator: Qifa Liu Nanfang Hospital of Southern Medical University
PRS Account Nanfang Hospital of Southern Medical University
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP