Maintenance Therapy in Acute Myeloid Leukemia (AML) Patients
Study Details
Study Description
Brief Summary
The purpose of this study is to determine if Revlimid will help maintain patients with acute myeloid leukemia in remission.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Detailed Description
At present, the majority of AML patients >60 years of age that achieve CR and thereafter successfully complete further chemotherapy, are not candidates for allogeneic bone marrow transplantation (alloBMT) due to their age. Rather, this group of patients is simply observed until relapse occurs. In this age group, the median duration of CR is only ~10 months. The survival of patients <60 years of age who are not candidates for transplantation (due to donor unavailability), and who are in CR2 or higher is also extremely poor. Several lines of evidence suggest that the immune system - and in particular AML specific CTLs and NK cells - is capable of recognizing and clearing AML cells.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: A Arm A will receive Revlimid. |
Drug: Revlimid
10mgs PO daily for 21 days of each 28 day cycle. Number of cycles: total of 24 or until subject relapses or unacceptable toxicity develops.
Other Names:
|
No Intervention: B Arm B will not receive Revlimid but an observational arm |
Outcome Measures
Primary Outcome Measures
- To assess the feasibility and assess the effect on relapse free survival by giving Revlimid in the post complete remission maintenance setting [The 1st interim analysis will be done once all subjects have completed 12 cycles, and the 2nd interim analysis will be done once all subjects have completed treatment.]
Secondary Outcome Measures
- To determine the toxicity of Revlimid when given in the maintenance setting. [The 1st interim analysis will be done after all subjects have receieved 12 cycles and the 2nd when all subjects have completed treatment.]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of Acute myeloid leukemia in remission.
-
Able to take aspirin 81mgs daily.
Exclusion Criteria:
-
Pregnant or breast feeding females.
-
Known hypersensitivity to thalidomide.
-
Any prior use of lenalidomide.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | University Health Network, Princess Margaret Hospital | Toronto | Ontario | Canada | M5G 2M9 |
Sponsors and Collaborators
- University Health Network, Toronto
- Celgene Corporation
Investigators
- Principal Investigator: Andre Schuh, MD.FRCP(C), University Health Network Princess Margaret Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RV-AML-PI-166