Microtransplantation in Older Patients With Acute Myeloid Leukemia
Sponsor
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT02831192
Collaborator
(none)
150
1
1
110
1.4
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
150 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
International Multi-center Clinical Study on Microtransplantation for Treatment of Newly Diagnosed Elderly Acute Myeloid Leukemia (EAML)
Study Start Date
:
May 1, 2006
Actual Primary Completion Date
:
Jul 1, 2015
Actual Study Completion Date
:
Jul 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MST（microtransplantation）
|
Biological: microtransplantation
HLA mismatched donor mobilized prepheral stem cell infusion
|
Outcome Measures
Primary Outcome Measures
- Graft versus host disease [1 month]
Secondary Outcome Measures
- overall survival [2 years]
- leukemia free survival [2 years]
- complete remission rate [2 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
60 Years
to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Affiliated Hospital of Academy of Military Medical Sciences , | Beijing | Beijing | China | 100071 |
Sponsors and Collaborators
- The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Investigators
- Study Chair: AI huisheng, MD, Affiliated Hospital of Academy of Military Medical Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
ClinicalTrials.gov Identifier:
NCT02831192
Other Study ID Numbers:
- EAML-MST
First Posted:
Jul 13, 2016
Last Update Posted:
Jul 13, 2016
Last Verified:
Jul 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Additional relevant MeSH terms: