Darbepoetin Alfa in Patients With Chronic Lymphocytic Leukemia and Comorbidity
- 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
- Determine the quality of life of patients treated with these regimens.
- Determine event-free, progression-free, and overall survival of patients treated with
- 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
- 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
PROJECTED ACCRUAL: A total of 348 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Michael Hallek, MD
Medizinische Universitaetsklinik I at the University of Cologne