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
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. In the second phase of the induction phase, C will be
given in combination with the Maximum Tolerated Dose of L (either the MTD or the maximum
planned dose of 10mg).
Patients who will achieve a response after 6 courses of CL induction phase -PR, CRi, CR and
MRD negative CR- will be eligible for the post-induction phase of the study. Patients will
be randomized (1:1), stratifying according to the quality of response (PR vs CR, CRi,
MRD-CR) and the genetic profile (11q, 17p-, p53mut vs other), to receive L daily, (L arm) or
no further therapy (Clinical observation arm) until day 364 or until PD or unacceptable
toxicity develops, whichever occurs first. During maintenance (L arm), L will be given at
the dose tolerated by the patient during the period interval from d+28 of the 6th course of
CL and the day of evaluation of the response (d+84 from the start of 6th course of CL). At
screening, blood samples will be drawn and a physical examination, a CT scan or a thorax
radiography and an abdomen ultrasound, a bone marrow biopsy and aspirate will be performed.
A clinical examination will be carried out and blood samples will be harvested weekly during
CL treatment. Twelve weeks from the start (d+1) of 6th CL course (d+84), clinical response
will be assessed. During the post-remissional phase, a monthly clinical examination will be
performed in all patients. Patients randomized to receive L as maintenance therapy will have
an additional blood examination during treatment. Eight weeks after the completion of the
post-remissional phase (d+420), a new response assessment will be performed (physical
examination and blood samples, a CT scan or a thorax radiography and an abdomen ultrasound,
a bone marrow biopsy and aspirate). Thereafter, patients will be monitored for response
duration at least over the following 18 months.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
PhI: MTD of Lenalidomide given in combination with Chlorambucil.
PhI: MTD will be identified according to all adverse events and DLTs tabulated for each dose level.
At maximum 8 months from induction therapy start
Yes
Roberto Foà
Principal Investigator
Umberto I - Dipartimento di Biotecnologie Cellulari ed Ematologia Cellulari
Italy: National Institute of Health
CLL0709
NCT01403246
November 2011
January 2014
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