Fludarabine or Chlorambucil as First-Line Therapy in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia
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|ClinicalTrials.gov Identifier: NCT00262795|
Recruitment Status : Completed
First Posted : December 7, 2005
Last Update Posted : September 29, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia||Drug: Fludarabine Drug: Chlorambucil||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||206 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Primary Completion Date :||January 2005|
|Study Completion Date :||October 2005|
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00262795
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|Study Chair:||Michael Hallek, MD||Medizinische Universitaetsklinik I at the University of Cologne|