Chronic Lymphocytic Leukemia Clinical Trial
Official title:
Bendamustine Versus Fludarabine as 2nd-line Treatment in Chronic Lymphocytic Leukemia, Stage BINET B+C / RAI II-IV
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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