Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Phase I-II Multicenter Study to Assess the Efficacy and Safety of the Chlorambucil + Lenalidomide Combination and Lenalidomide Maintenance Therapy in Untreated Elderly Pts With CLL. EudraCT Number 2009-013415-35
This is a phase I multicenter, open label study in previously untreated and elderly patients (> 60 years) with CLL: a non-comparative phase aimed at defining the MTD of lenalidomide given in combination with chlorambucil and the efficacy and safety of the lenalidomide and chlorambucil combination.
All patients will receive six monthly courses of the chlorambucil (C) and lenalidomide (L)
schedule consisting of 8 days of C (d1-d8) combined with L given daily until response
assessment which will take place 12 weeks from the start (d+1) of course VI, while patients
continue their treatment with lenalidomide daily.
In the first phase of the induction phase of the study the dose of L given with C will be
gradually escalated to reach the MTD.
Patients who will achieve a response after 6 courses of CL induction phase -PR, CRi, CR
The study was first designed to be a phase I-II trial, yet the second phase of the study was
not conducted due to different reasons, among which: poor accrual and lack of interest.
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