Conditions: Chronic Lymphocytic Leukemia
Keywords: CLL Lenalidomide Chlorambucil No previous treatment
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 9
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: None

Interventions: intervention 1: Lenalidomide; Chlorambucil
Intervention descriptions: intervention 1: MTD of lenalidomide given in combination with chlorambucil

Protocol document: