Spots Global Cancer Trial Database for Chlorambucil + Lenalidomide and Lenalidomide Maintenance in Untreated Elderly With Chronic Lymphocytic Leukemia (CLL)
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Trial Identification
Brief Title: Chlorambucil + Lenalidomide and Lenalidomide Maintenance in Untreated Elderly With Chronic Lymphocytic Leukemia (CLL)
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
Study ID: NCT01403246
Conditions
Interventions
Study Description
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.
Eligibility
Minimum Age: 60 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Azienda Spedali Civili, Brescia, , Italy
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto", Catania, , Italy
Azienda Ospedaliera Pugliese Ciaccio, Catanzaro, , Italy
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, Milano, , 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
Contact Details
Name: Roberto Foà
Affiliation: Umberto I - Dipartimento di Biotecnologie Cellulari ed Ematologia Cellulari
Role: PRINCIPAL_INVESTIGATOR
Name: Francesca Romana Mauro, Co-Coordinator
Affiliation: Umberto I - Dipartimento di Biotecnologie Cellulari ed Ematologia
Role: PRINCIPAL_INVESTIGATOR
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