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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Andre Schuh, MD.FRCP(C)
University Health Network Princess Margaret Hospital
Canada: Health Canada