Bendamustine Versus Fludarabine in Chronic Lymphocytic Leukemia (CLL)
Status:
Completed
Trial end date:
2009-05-01
Target enrollment:
Participant gender:
Summary
Bendamustine demonstrated clinical activity in pre-treated hematological malignancies due to
its unique mechanism of action distinct from standard alkylating agents. This study assesses
its efficacy in patients with chronic lymphocytic leukemia pre-treated with an alkylator, in
comparison to fludarabine.
Patients with relapsed chronic lymphocytic leukemia requiring treatment after one previous
systemic regimen (usually chlorambucil-based) are randomized to either receive bendamustine
100 mg/m² on days 1 and 2 of a 4-week cycle, or standard fludarabine treatment consisting of
25 mg/m² on days 1 to 5 every four weeks. The primary objective was to achieve non-inferior
progression-free survival with bendamustine.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
WiSP Wissenschaftlicher Service Pharma GmbH
Collaborators:
Klinikum Leverkusen gGmbH Mundipharma Research GmbH & Co KG ribosepharm GmbH