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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
9
MTD of lenalidomide given in combination with chlorambucil
Azienda Spedali Civili
Brescia, Italy
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
Catania, Italy
Azienda Ospedaliera Pugliese Ciaccio
Catanzaro, Italy
Number of Dose Limiting Toxic Events (DLT) of Lenalidomide Given in Combination With Chlorambucil.
Time frame: At maximum 8 months from induction therapy start
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
Catanzaro, Italy
Clinica Ematologica - Università degli Studi
Genova, Italy
UO Centro Trapianti di Midollo - IRCCS Ospedale Maggiore Policlinico
Milan, Italy
U.O. Ematologia Clinica - Azienda USL di Pescara
Pescara, Italy
Umberto I di Roma - Dipartimento di Biotecnologie Cellulari ed Ematologia
Roma, Italy
U.O. Ematologia, Azienda Ospedaliera Universitaria Senese
Siena, Italy
SS.C. di Oncoematologia - Dipartimento di Medicina Clinica e Sperimentale - Azienda Ospedaliera - S. Maria Di Terni
Terni, Italy