Fludarabine or Chlorambucil as First-Line Therapy in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia
RATIONALE: Drugs used in chemotherapy, such as fludarabine and chlorambucil, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether fludarabine is more effective than chlorambucil in treating chronic lymphocytic leukemia.
PURPOSE: This randomized phase III trial is studying fludarabine to see how well it works as first-line therapy compared to chlorambucil in treating older patients with previously untreated chronic lymphocytic leukemia.
Chronic Lymphocytic Leukemia
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Fludarabine Versus Chlorambucil in First Line Therapy of Elderly Patients (More Than 65 Years) With Advanced Chronic Lymphocytic Leukemia|
|Study Start Date:||September 2003|
|Study Completion Date:||October 2005|
|Primary Completion Date:||January 2005 (Final data collection date for primary outcome measure)|
Fludarabine i.v. (25 mg/m2/d, d1-5) q28d; max 6 cycles
|Active Comparator: CLB||
Chlorambucil p.o. (0,4 mg - max. 0,8 mg/kg/d, d1) q15d, max. 12 month
- Compare the overall and progression-free survival of older patients with previously untreated chronic lymphocytic leukemia treated with fludarabine vs chlorambucil.
- Compare the duration of remission in patients treated with these regimens.
- Compare the incidence of toxicity, especially infections, in patients treated with these regimens.
- Compare the quality of life in patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive fludarabine IV on days 1-5. Treatment repeats every 28 days for up to 6 courses.
- Arm II: Patients receive oral chlorambucil on day 1. Treatment repeats every 15 days for up to 12 months.
PROJECTED ACCRUAL: A total of 205 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00262795
Show 88 Study Locations
|Study Chair:||Michael Hallek, MD||Medizinische Universitaetsklinik I at the University of Cologne|