Back to resultsIDA+BUCY vs BUCY Conditioning Regimen for Intermediate-risk AML Undergoing Auto-HSCT
Primary Purpose
Autologous Hematopoietic Stem Cell Transplantation, Acute Myeloid Leukemia, Conditioning
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Idarubicin（IDA）
Busulfan (BU)
Cyclophosphamide (CY)
Sponsored by
About this trial
This is an interventional treatment trial for Autologous Hematopoietic Stem Cell Transplantation
Eligibility Criteria
Inclusion Criteria:
- Intermediate-risk AML
- Achieving CR after one cycle induction,then receiving three cycles of consolidation therapy including moderate and high doses of Ara-c combined regimens
- With negative MRD before mobilization and collect of peripheral blood stem cells
- Without HLA-matched donors (related and unrelated)
- Refusal of haploidentical hematopoietic stem cell transplantation
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)
Sites / Locations
- Department of Hematology,Nanfang Hospital, Southern Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IDA+BUCY
BUCY
Arm Description
For intermediate-risk AML undergoing auto-HSCT，IDA+BUCY conditioning regimen was IDA 15mg/m2/day on days -12 and -10；BU 3.2 mg/kg/day on days -7 and -4；CY 60 mg/kg/day on days -3 and -2.
For intermediate-risk AML undergoing auto-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.
Outcomes
Primary Outcome Measures
leukemia relapse rate
Secondary Outcome Measures
overall survival (OS)
disease-free survival (DFS)
transplant-related mortality (TRM)
Full Information
NCT ID
NCT02671708
First Posted
January 30, 2016
Last Updated
March 2, 2020
Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Third Affiliated Hospital, Sun Yat-Sen University, Peking University People's Hospital, Zhujiang Hospital, Guangzhou First People's Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT02671708
Brief Title
IDA+BUCY vs BUCY Conditioning Regimen for Intermediate-risk AML Undergoing Auto-HSCT
Official Title
Idarubicin+Busulfan+Cyclophosphamide vs Busulfan+Cyclophosphamide Conditioning Regimen for Intermediate-risk Acute Myeloid Leukemia Undergoing Autologous Hematopoietic Stem Cell Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
February 28, 2019 (Actual)
Study Completion Date
February 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Third Affiliated Hospital, Sun Yat-Sen University, Peking University People's Hospital, Zhujiang Hospital, Guangzhou First People's Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Autologous hematopoietic stem cell transplantation (Auto-HSCT) is an effective alternative to allogeneic HSCT for intermediate-risk acute myeloid leukemia (AML) without HLA-matched donors. At present, the best conditioning regimen for AML undergoing auto-HSCT remains in discussion. In this study, the safety and efficacy of IDA+BUCY and BUCY myeloablative conditioning regimens in intermediate-risk AML undergoing auto-HSCT are evaluated.
Detailed Description
Auto-HSCT is an effective alternative to allogeneic HSCT for intermediate-risk AML without HLA-matched donors. BUCY conditioning regimen is the standard myeloablative regimen. However, auto-HSCT with BUCY conditioning regimen appears to have higher relapse rate. To reduce the relapse rate, IDA is added in the conditioning regimen. In this study, the safety and efficacy of IDA+BUCY and BUCY myeloablative conditioning regimens in intermediate-risk AML patients undergoing auto-HSCT are evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autologous Hematopoietic Stem Cell Transplantation, Acute Myeloid Leukemia, Conditioning
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IDA+BUCY
Arm Type
Experimental
Arm Description
For intermediate-risk AML undergoing auto-HSCT，IDA+BUCY conditioning regimen was IDA 15mg/m2/day on days -12 and -10；BU 3.2 mg/kg/day on days -7 and -4；CY 60 mg/kg/day on days -3 and -2.
Arm Title
BUCY
Arm Type
Active Comparator
Arm Description
For intermediate-risk AML undergoing auto-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.
Intervention Type
Drug
Intervention Name(s)
Idarubicin（IDA）
Intervention Description
Idarubicin was administered at 15mg/m2/day on days -12 and -10.
Intervention Type
Drug
Intervention Name(s)
Busulfan (BU)
Intervention Description
Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide (CY)
Intervention Description
Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.
Primary Outcome Measure Information:
Title
leukemia relapse rate
Time Frame
2 year
Secondary Outcome Measure Information:
Title
overall survival (OS)
Time Frame
2 year
Title
disease-free survival (DFS)
Time Frame
2 year
Title
transplant-related mortality (TRM)
Time Frame
2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Intermediate-risk AML
Achieving CR after one cycle induction,then receiving three cycles of consolidation therapy including moderate and high doses of Ara-c combined regimens
With negative MRD before mobilization and collect of peripheral blood stem cells
Without HLA-matched donors (related and unrelated)
Refusal of haploidentical hematopoietic stem cell transplantation
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qifa Liu
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Hematology,Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
IDA+BUCY vs BUCY Conditioning Regimen for Intermediate-risk AML Undergoing Auto-HSCT
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