Anemia Clinical Trial
Official title:
Darbepoetin Alfa in Patients With Chronic Lymphocytic Leukemia and Comorbidity
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.
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.
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