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

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ClinicalTrials.gov Identifier: NCT02670252
Recruitment Status : 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

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.

Condition or disease Intervention/treatment Phase
Allogeneic Hematopoietic Stem Cell Transplantation Busulfan Total Body Irradiation Acute Lymphocytic Leukemia Drug: Busulfan (BU) Drug: Cyclophosphamide (CY) Radiation: Total Body Irradiation (TBI) Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arm Intervention/treatment
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.
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.

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.
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.




Primary Outcome Measures :
  1. overall survival (OS) [ Time Frame: 2 year ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670252


Contacts
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Contact: Qifa Liu +862061641611 liuqifa628@163.com

Locations
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China, Guangdong
Department of Hematology,Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Li Xuan    +86-020-61641613    356135708@qq.com   
Principal Investigator: Qifa Liu         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
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
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Principal Investigator: Qifa Liu Nanfang Hospital of Southern Medical University

Publications:
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Responsible Party: Qifa Liu, Professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT02670252     History of Changes
Other Study ID Numbers: BUCY vs TBICY-ALL-2016
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Busulfan
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists