NCT00281892

Fludarabine and Darbepoetin Alfa in Treating Older Patients With Chronic Lymphocytic Leukemia

Darbepoetin Alfa in Patients With Chronic Lymphocytic Leukemia and Comorbidity

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: German CLL Study Group · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Darbepoetin alfa may cause the body to make more red blood cells. It is not yet known whether fludarabine is more effective with or without darbepoetin alfa in treating chronic lymphocytic leukemia. PURPOSE: This phase III trial is studying fludarabine to see how well it works when given together with or without darbepoetin alfa in treating older patients with chronic lymphocytic leukemia.

Detailed description

OBJECTIVES: * Compare the efficacy of fludarabine with or without darbepoetin alfa in geriatric patients with chronic lymphocytic leukemia and relevant comorbidities. * Determine the effect of these regimens in reducing anemia, lowering the requirements of transfusion, and reducing the duration and frequency of hospitalization in these patients. * Determine the quality of life of patients treated with these regimens. * Determine event-free, progression-free, and overall survival of patients treated with these regimens. * Evaluate the medical-economical aspects of these regimens in these patients OUTLINE: This is a multicenter study. Patients are stratified according to hemoglobin value (\< 12 g/dL \[stratum 1\] vs \> 12 g/dL \[stratum 2\]). Patients are assigned to 1 of 2 treatment strata. * Stratum 1: Patients receive fludarabine IV on days 1, 3, and 5. Treatment repeats every 28 days for up to 6 courses. Patients also receive darbepoetin alfa subcutaneously once weekly for up to 6 weeks. * Stratum 2: Patients receive fludarabine as in stratum 1. Quality of life is evaluated periodically. PROJECTED ACCRUAL: A total of 348 patients will be accrued for this study.

Conditions

• Chronic Lymphocytic Leukemia
• Anemia

Interventions

Type	Name	Description
BIOLOGICAL	Fludarabine plus Darbopoetin	Group 1 - Patients with an initial Hb-value of less than 12 g/dl receive fludarabine (30 mg/m² intravenously on day 1, 3, 5; repeated every 28 days for 6 cycles and 500 mcg of darbepoetin alfa subcutaneously every 3 weeks
DRUG	Fludarabine mono	Group 1 - Patients with an initial Hb-value of less than 12 g/dl receive fludarabine (30 mg/m² intravenously on day 1, 3, 5; repeated every 28 days for 6 cycles with no additional growth factor support. Group 2 - Patients with an initial Hb-value more than 12 g/dl start to receive fludarabine (30 mg/m² intravenously on day 1, 3, 5; repeated every 28 days for 6 cycles . Patients of group 2 will be eventually randomized at later timepoints, if the Hb-value drops below 12 g/dl. Randomized patients will receive either 500 mcg darbepoetin alfa subcutaneously every 3 weeks or continue therapy with fludarabine without additional administration of darbepoetin alfa.

Timeline

• Start date: 2004-09-01
• Primary completion: 2008-05-01
• Completion: 2010-10-01
• First posted: 2006-01-25
• Last updated: 2018-05-11

Locations

46 sites across 1 country: Germany