Fludarabine, Cyclophosphamide, and Rituximab or Alemtuzumab in Treating CLL2007 CLL 2007 FMP
- Conditions
- Leukemia
- Interventions
- Registration Number
- NCT00564512
- Lead Sponsor
- French Innovative Leukemia Organisation
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to kill cancer cells or stop them from growing. Monoclonal antibodies, such as rituximab and alemtuzumab, can block cancer growth in different ways. Some find cancer cells and help kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. It is not yet known whether giving fludarabine and cyclophosphamide together with rituximab is more effective than giving fludarabine and cyclophosphamide together with alemtuzumab in treating B-cell chronic lymphocytic leukemia.
PURPOSE: This randomized phase III trial is studying giving fludarabine together with cyclophosphamide and rituximab to see how well it works as first-line therapy compared with giving fludarabine together with cyclophosphamide and alemtuzumab in treating patients with B-cell chronic lymphocytic leukemia.
- Detailed Description
OBJECTIVES:
Primary
* To compare 36-month progression-free survival in patients with Binet stage B or C B-cell chronic lymphocytic leukemia treated with first-line therapy comprising fludarabine phosphate and cyclophosphamide and either rituximab or alemtuzumab.
Secondary
* To compare the disease-free survival, event-free survival, and overall survival of patients treated with these regimens.
* To compare time to next treatment in patients treated with these regimens.
* To compare the overall response rate (complete response \[CR\] and partial response \[PR\]) in patients treated with these regimens.
* To compare the rate of phenotypic and molecular response in patients treated with these regimens.
* To compare the duration of phenotypic, molecular, complete and partial responses in patients treated with these regimens.
* To compare the response rates and survival times in biological subgroups.
* To compare the rates of treatment-related adverse effects in patients treated with these regimens.
* To compare the quality of life of patients treated with these regimens.
* Minimal residual disease study.
OUTLINE: This is a multicenter study. Patients are stratified according to Ig mutational status and cytogenetic abnormalities. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive rituximab IV on day 1 and fludarabine phosphate and cyclophosphamide IV or orally on days 2-4 of course 1. Beginning in course 2 and for all subsequent courses, patients receive rituximab IV on day 1 and fludarabine phosphate and cyclophosphamide IV or orally on days 1-3.
* Arm II: Patients receive alemtuzumab subcutaneously, oral fludarabine phosphate, and oral cyclophosphamide on days 1-3.
In both arms, treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 178
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FCR cyclophosphamide Fludarabine-Cyclophosphamide-Rituximab (FCR) First course: Rituximab 375 mg/m2 on D1. D2 to D4: oral Fludarabine: 40 mg/m2/day as a single morning dose oral Cyclophosphamide: 250 mg/m2/day as a single dose at noon Subsequent courses (2 to 6) Rituximab 500 mg/m2 on D1 D1 to D3: oral Fludarabine: 40 mg/m2/day as a single morning dose oral Cyclophosphamide: 250 mg/m2/day as a single dose at noon FCR Campath Fludarabine-Cyclophosphamide-Rituximab (FCR) First course: Rituximab 375 mg/m2 on D1. D2 to D4: oral Fludarabine: 40 mg/m2/day as a single morning dose oral Cyclophosphamide: 250 mg/m2/day as a single dose at noon Subsequent courses (2 to 6) Rituximab 500 mg/m2 on D1 D1 to D3: oral Fludarabine: 40 mg/m2/day as a single morning dose oral Cyclophosphamide: 250 mg/m2/day as a single dose at noon FCCAM rituximab Fludarabine-Cyclophosphamide-Campath (FCCam) Oral Fludarabine: 40 mg/m2 per os, D1 to D3 Oral Cyclophosphamide: 250 mg/m2/day as one dose at noon, D1 to D3 Campath®: 30 mg sc, D1 to D3 without dose escalation FCCAM fludarabine Fludarabine-Cyclophosphamide-Campath (FCCam) Oral Fludarabine: 40 mg/m2 per os, D1 to D3 Oral Cyclophosphamide: 250 mg/m2/day as one dose at noon, D1 to D3 Campath®: 30 mg sc, D1 to D3 without dose escalation FCCAM cyclophosphamide Fludarabine-Cyclophosphamide-Campath (FCCam) Oral Fludarabine: 40 mg/m2 per os, D1 to D3 Oral Cyclophosphamide: 250 mg/m2/day as one dose at noon, D1 to D3 Campath®: 30 mg sc, D1 to D3 without dose escalation
- Primary Outcome Measures
Name Time Method Progression-free survival at 36 months 36 months follow up
- Secondary Outcome Measures
Name Time Method Disease-free survival 36 months follow up Event-free survival 36 months follow up Overall survival 36 months follow up Time to next treatment 36 months follow up Overall response rate (complete response [CR] and partial response [PR]) 36 months follow up Duration of phenotypic, molecular, NCI complete and partial responses 36 months follow up Response rates and survival times in biological subgroups 36 months follow up Treatment-related adverse effects 36 months follow up
Trial Locations
- Locations (1)
Centre Henri Becquerel
🇫🇷Rouen, France