Interferon for the Intervention of Molecular Relapse in t (8; 21) AML After Allo-HSCT
Sponsor
Peking University People's Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02027064
Collaborator
(none)
40
1
1
48
0.8
Study Details
Study Description
Brief Summary
molecular relapse in t (8; 21) acute myeloid leukemia (AML) after allogeneic stem cell transplantation (allo-SCT) is still a problem even after donor lymphocyte infusion.
Interferon seemed to augment graft-versus-leukemia (GVL) effect in this part of patients.
the study is to evaluate the safety and efficacy of interferon for the intervention of molecular relapse in t (8; 21) acute myeloid leukemia (AML) after allogeneic stem cell transplantation (allo-SCT)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Study Start Date
:
Oct 1, 2013
Anticipated Primary Completion Date
:
Oct 1, 2017
Anticipated Study Completion Date
:
Oct 1, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: interferon
|
Drug: Interferon-alpha
|
Outcome Measures
Primary Outcome Measures
- relapse rate [participants will be followed for an expected average of 365 days]
number of participants with morphologic relapse at one year
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
high risk t (8; 21) AML
-
molecular relapse after allo-SCT
Exclusion Criteria:
-
active graft-versus-host disease
-
uncontrolled severe infection
-
organ function failure
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University People's Hospital | Beijing | China | 100044 |
Sponsors and Collaborators
- Peking University People's Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Xiaojun Huang,
director of Peking University People's Hospital, institute of hematology,
Peking University People's Hospital
ClinicalTrials.gov Identifier:
NCT02027064
Other Study ID Numbers:
- PUPH IRB [2013](38)
First Posted:
Jan 3, 2014
Last Update Posted:
Sep 29, 2016
Last Verified:
Sep 1, 2016