Bendamustine Versus Fludarabine in Chronic Lymphocytic Leukemia (CLL)
Bendamustine Versus Fludarabine as 2nd-line Treatment in Chronic Lymphocytic Leukemia, Stage BINET B+C / RAI II-IV
PhasePhase 2/Phase 3
Lead SponsorWiSP GmbH
StatusCompleted No Results Posted
Indication/ConditionChronic Lymphocytic Leukemia
Intervention/Treatmentbendamustine fludarabine ...
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.
100 mg/m² iv, day 1+2, q4w
25 mg/m² iv, days 1-5, q4w
Inclusion Criteria: histologically or immunologically confirmed chronic B-cell leukemia refractory (i.e. no response or progression during initial chemotherapy) or relapsed situation after first-line treatment regimen disease stage II-IV according to Rai or B/C according to Binet staging system, respectively Eastern Cooperative Oncology Group (ECOG) performance status of 3 or better negative pregnancy test/ adequate method of contraception Exclusion Criteria: T-CLL, PLL (prolymphocytic leukemia) presence of Richter's transformation first-line treatment containing either fludarabine or bendamustine acute infections or distinctly reduced organ function precluding the application of chemotherapy, as for pulmonary, heart, liver (total bilirubin > 5mg/dl), renal system (creatinine > 2 mg/dl), or metabolic disorders secondary malignancy (except for curative treated basal cell carcinoma or cervical cancer)