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.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Chronic Lymphocytic Leukemia
- Sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Enrollment
- 42
- Locations
- 23
- Primary Endpoint
- Overall Complete Response (CR) Rate (Phase II)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Overall Complete Response (CR) Rate (Phase II)
Time Frame: After 6 months from study entry (end of treatment).
Response will be assessed by clinical examination, peripheral blood, bone marrow aspirate and biopsy, radiographic evaluation. Response will be evaluated at three different levels: clinical, cytometric and molecular.
Maximum Tolerated Dose of Lenalidomide (Phase I)
Time Frame: The MTD of Lenalinomide will be evaluated during the two courses given with the escalated dose of Lenalinomide defined by the respective dose level.
Maximum tolerated dose of lenalidomide given in combination with fludarabine.
Secondary Outcomes
- Number of Patients Reaching Disease-free Survival (DSF) Overall(After 6 months from study entry (end of treatment))
- Correlation Between Complete Response (CR) and Baseline Biologic Parameters (i.e., IgHV, CD38, Etc.).(After 6 months from study entry (end of treatment).)
- Toxicity as Assessed by NCI CTCAE v3.0(At 24 months from study entry (end of follow-up))
- Number of Patients With Severe Infections(At 24 months from study entry (end of follow-up))