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: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Bendamustine Hydrochloride; Chlorambucil; Rituximab

Criteria

Inclusion Criteria:

• adult patients, >/=18 years of age

• chronic lymphocytic leukemia

• active CLL with progressive Binet stage B or C

• ineligible for treatment with fludarabine

• for second line patients, only pretreatment with rituximab and/or chlorambucil is allowed

• EOCG performance status >/=2

Exclusion Criteria:

• patients who have relapsed within <12 months of first dose of prior rituximab or chlorambucil first-line therapy

• previous or planned stem cell transplantation

• radioimmunotherapy within 6 months prior to starting study treatment

• transformation to aggressive B-cell malignancy

• any other concurrent anti-cancer therapy, or glucocorticoid >/=20mg daily prednisolone or equivalent