Lenalidomide, Fludarabine & Cyclophosphamide in Advanced Chronic Lymphocytic Leukemia Not Responding to Therapy
- Conditions
- Chronic Lymphocytic Leukemia
- Registration Number
- NCT00727415
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Overall Complete Response (CR) Rate (Phase II) 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) 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 Outcome Measures
Name Time Method Number of Patients Reaching Disease-free Survival (DSF) Overall 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.
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) Data from all subjects who receive any study drug will be included in the safety analyses.
Number of Patients With Severe Infections At 24 months from study entry (end of follow-up) Severe infection requiring more than 2 weeks of antibiotic therapy.
Trial Locations
- Locations (23)
Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori- IRST
🇮🇹Meldola, Italy
Unità Operativa Ematologia 1 - Università degli Studi di Bari
🇮🇹Bari, Italy
Istituto di Ematologia e Oncologia Medica "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
🇮🇹Bologna, Italy
Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"
🇮🇹Messina, Italy
Azienda Ospedaliera Pugliese Ciaccio
🇮🇹Catanzaro, Italy
Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna
🇮🇹Ferrara, Italy
Divisione di Ematologia Ospedale "Santa Maria Goretti"
🇮🇹Latina, Italy
Clinica Ematologica - Università degli Studi
🇮🇹Genova, Italy
UO Centro Trapianti di Midollo - IRCCS Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
(SA) U.O. di Oncoematologia di Nocera Inferiore-plesso ospedaliero "A. Tortora" di Pagani del DEA Nocera-Pagani
🇮🇹Nocera Inferiore, Italy
Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza
🇮🇹Piacenza, Italy
Università degli Studi di Padova - Ematologia ed Immunologia Clinica
🇮🇹Padova, Italy
Ospedale S. M. delle Croci
🇮🇹Ravenna, Italy
Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
🇮🇹Rome, Italy
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
🇮🇹Roma, Italy
Azienda Ospedaliera Bianchi Melacrino Morelli
🇮🇹Reggio Calabria, Italy
Universita Degli Studi "La Sapeinza"
🇮🇹Rome, Italy
Ospedale "Infermi"
🇮🇹Rimini, 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
U.O.C. Ematologia - Ospedale S.Eugenio
🇮🇹Rome, Italy
Clinica Ematologica - Policlinico Universitario
🇮🇹Udine, Italy
U.O. Ematologia Clinica - Azienda USL di Pescara
🇮🇹Pescara, Italy