At a glance
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A Randomized Study to Assess the Effect on Response Rate of MabThera (Rituximab) Added to a Standard Chemotherapy, Bendamustine or Chlorambucil, in Patients With Chronic Lymphocytic Leukemia
In Brief
A Phase 4 clinical trial evaluating bendamustine, chlorambucil, and 1 other intervention for Lymphocytic Leukemia, Chronic. Completed, enrolled 357 participants across 85 sites in 8 countries.
Detailed Summary
This randomized, open-label, parallel group study will assess the effect on response rate and the safety of MabThera added to either bendamustine or chlorambucil in patients with chronic lymphocytic leukemia. Patients will be randomized to receive six 4-week cycles of either A) MabThera (375mg/m2 iv day 1 of cycle 1, 500mg/m2 iv cycles 2-6) plus bendamustine (90mg/m2 as first-line or 70mg/m2 as second-line therapy, iv on days 1 and 2, cycles 1-6), or B)MabThera plus chlorambucil (10mg/m2 po daily, days 1-7, cycles 1-6). Patients in group B can receive up to 6 further cycles of chlorambucil as monotherapy. Anticipated time on study treatment is 6-12 months, and target sample size is 600-700 individuals.
Study Details
Timeline
Interventions
90mg/m2 (first-line) or 70mg/m2 (second-line) iv, days 1 and 2 every 4 weeks, cycles 1-6
10mg/m2 po days 1-7 every 4 weeks, for up to 12 cycles
375mg/m2 iv day 1 of cycle 1, followed by 500mg/m2 iv every 4 weeks cycles 2-6