drugset / Trial / NCT00230282

Phase 2 Fludarabine, Cytoxan and FCCAM <Alemtuzumab> in Untreated B-Cell Chronic Lymphocytic Leukemia

NCT00230282 ↗

Phase 2 Completed 25 enrolled Steven E. Coutre Bayer · collab
NaSingle-groupOpen-labelTreatment

Summary

The primary objective of this study was to evaluate the safety and efficacy of the combination of fludarabine and cyclophosphamide in previously untreated CLL patients. Participants will receive fludarabine and cyclophosphamide on days 1, 2, and 3 of six 28-day cycles.

Timeline

Start
2004-07
Primary completion
2010-12
Completion
2011-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Alemtuzumab Monoclonal antibody 30 mg Intravenous
Subject Cyclophosphamide Other / unclassified 250 mg/m2 Subcutaneous
Subject Fludarabine Small molecule 25 mg/m2 Intravenous