Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT00281892
Brief 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.
Study:
NCT00281892
Study Brief:
Protocol Section:
NCT00281892