Back to resultsMicrotransplantation in Older Patients With Acute Myeloid Leukemia
Primary Purpose
Acute Myeloid Leukemia
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
microtransplantation
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia
Eligibility Criteria
Inclusion Criteria:
- de novo acute myeloid leukemia
- age 60-90
- have HLA mismatched donor
Exclusion Criteria:
- have no suitable donor or donor refused
- patient refused to accept donor cells
Sites / Locations
- Affiliated Hospital of Academy of Military Medical Sciences ,
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MST（microtransplantation）
Arm Description
Outcomes
Primary Outcome Measures
Graft versus host disease
Secondary Outcome Measures
overall survival
leukemia free survival
complete remission rate
Full Information
NCT ID
NCT02831192
First Posted
July 3, 2016
Last Updated
July 12, 2016
Sponsor
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02831192
Brief Title
Microtransplantation in Older Patients With Acute Myeloid Leukemia
Official Title
International Multi-center Clinical Study on Microtransplantation for Treatment of Newly Diagnosed Elderly Acute Myeloid Leukemia (EAML)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to see whether HLA-mismatched donor cells infusion with chemotherapy (microtransplantation，MST) could increase complete remission (CR) and improve survival in older patients with acute myeloid leukemia (AML)，the investigators conducted a prospective, multicenter clinical trial of HLA-mismatched MST to estimate outcomes and toxicities.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MST（microtransplantation）
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
microtransplantation
Intervention Description
HLA mismatched donor mobilized prepheral stem cell infusion
Primary Outcome Measure Information:
Title
Graft versus host disease
Time Frame
1 month
Secondary Outcome Measure Information:
Title
overall survival
Time Frame
2 years
Title
leukemia free survival
Time Frame
2 years
Title
complete remission rate
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
de novo acute myeloid leukemia
age 60-90
have HLA mismatched donor
Exclusion Criteria:
have no suitable donor or donor refused
patient refused to accept donor cells
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AI huisheng, MD
Organizational Affiliation
Affiliated Hospital of Academy of Military Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Affiliated Hospital of Academy of Military Medical Sciences ,
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100071
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Microtransplantation in Older Patients With Acute Myeloid Leukemia
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