A Study of MabThera Added to Bendamustine or Chlorambucil in Patients With Chronic Lymphocytic Leukemia (MaBLe)
Status:
Completed
Trial end date:
2014-03-01
Target enrollment:
Participant gender:
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.