A Randomized Phase II Study of Lenalidomide Maintenance Therapy in AML Patients Aged > 60 Years in CR1 or Higher and < 60 Years in CR2 or Higher
Overview
- Phase
- Phase 2
- Intervention
- Revlimid
- Conditions
- Acute Myeloid Leukemia
- Sponsor
- University Health Network, Toronto
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- To assess the feasibility and assess the effect on relapse free survival by giving Revlimid in the post complete remission maintenance setting
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to determine if Revlimid will help maintain patients with acute myeloid leukemia in remission.
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.
Investigators
Eligibility 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.
Arms & Interventions
A
Arm A will receive Revlimid.
Intervention: Revlimid
Outcomes
Primary Outcomes
To assess the feasibility and assess the effect on relapse free survival by giving Revlimid in the post complete remission maintenance setting
Time Frame: 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 Outcomes
- 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.)