NCT00262795

Fludarabine or Chlorambucil as First-Line Therapy in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia

Fludarabine Versus Chlorambucil in First Line Therapy of Elderly Patients (More Than 65 Years) With Advanced Chronic Lymphocytic Leukemia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: German CLL Study Group · Academic / Other
• Sex: All
• Age: 65 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: Primary * 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. Secondary * 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.

Conditions

• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	Fludarabine	Fludarabine i.v. (25 mg/m2/d, d1-5) q28d; max 6 cycles
DRUG	Chlorambucil	Chlorambucil p.o. (0,4 mg - max. 0,8 mg/kg/d, d1) q15d, max. 12 month

Timeline

• Start date: 2003-09-01
• Primary completion: 2005-01-01
• Completion: 2005-10-01
• First posted: 2005-12-07
• Last updated: 2019-05-23

Locations

88 sites across 2 countries: Austria, Germany