Maintenance Therapy in Acute Myeloid Leukemia (AML) Patients
The purpose of this study is to determine if Revlimid will help maintain patients with acute myeloid leukemia in remission.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- 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. ] [ Designated as safety issue: Yes ]
- To determine the toxicity of Revlimid when given in the maintenance setting. [ Time Frame: The 1st interim analysis will be done after all subjects have receieved 12 cycles and the 2nd when all subjects have completed treatment. ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2008|
|Study Completion Date:||April 2015|
|Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Active Comparator: A
Arm A will receive 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 Name: Lenalidomide
No Intervention: B
Arm B will not receive Revlimid but an observational arm
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00957385
|University Health Network, Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Andre Schuh, MD.FRCP(C)||University Health Network Princess Margaret Hospital|