NCT01403246

Chlorambucil + Lenalidomide and Lenalidomide Maintenance in Untreated Elderly With Chronic Lymphocytic Leukemia (CLL)

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	Lenalidomide; Chlorambucil	MTD of lenalidomide given in combination with chlorambucil

Timeline

• Start date: 2011-11-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2011-07-27
• Last updated: 2019-02-12
• Results posted: 2019-01-23

Locations

10 sites across 1 country: Italy