Chronic Lymphocytic Leukemia Clinical Trial
Official title:
A Prospective Multicenter Pilot Trial to Evaluate the Efficacy of a Treatment With Fludarabine, Cyclophosphamide, Lenalidomide (FCL) for Advanced Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) Patients.
This is a phase I - II multicenter, non-comparative, open label study in patients with previously treated CLL aimed at defining the MTD of Lenalidomide given in combination with Fludarabine, Cyclophosphamide and at evaluating the (CR) rate of FC given in combination with the MTD of Lenalidomide (FCL).
OBJECTIVES:
Primary
- To define the maximum tolerated dose (MTD) of Lenalidomide given in combination with
FC.(Phase I)
- To evaluate the complete remission (CR) rate of FC given in combination with the MTD of
Lenalidomide (FCL). (Phase II)
Secondary
- To define the toxicity and the infection rate of patients treated with FCL and the
median number of delivered courses of FCL, overall response rate and the
progression-free survival and the relationship between the response and the baseline
biologic factors (IgVH, FISH, ZAP-70, CD38).
- To evaluate the overall response rate (complete and partial responses).
- To evaluate the progression-free survival.
OUTLINE: This is a phase I - II multicenter, non-comparative, open label study in patients
with previously treated CLL aimed at defining the MTD of Lenalidomide given in combination
with Fludarabine, Cyclophosphamide and at evaluating the (CR) rate of FC given in combination
with the MTD of Lenalidomide (FCL).
All patients will receive six monthly courses of FCL schedule consisting of three days of
Fludarabine and Cyclophosphamide administration (d1-d3) combined with 14 days of Lenalidomide
administration (d1-d14).
After completion of study treatment, patients are followed periodically for up to 18 months.
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