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.
- To define the maximum tolerated dose (MTD) of Lenalidomide given in combination with
- To evaluate the complete remission (CR) rate of FC given in combination with the MTD of
Lenalidomide (FCL). (Phase II)
- 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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of lenalidomide (Phase I)
Maximum tolerated dose of lenalidomide given in combination with fludarabine.
The MTD of Lenalinomide will be evaluated during the two courses given with the escalated dose of Lenalinomide defined by the respective dose level.
Roberto Foa, MD
Universita Degli Studi "La Sapeinza"
Italy: Ethics Committee