drugset / Trial / NCT00281892

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

NCT00281892

Phase 3 Completed 97 enrolled German CLL Study Group
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2004-09
Primary completion
2008-05
Completion
2010-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Darbepoetin alfa Protein / enzyme biologic 500 ug Subcutaneous
Subject Fludarabine Small molecule 30 mg/m2 Intravenous