A Study of MabThera Added to Bendamustine or Chlorambucil in Patients With Chronic Lymphocytic Leukemia (MaBLe)

Roche

Status and phase

Completed

Phase 4

Conditions

Lymphocytic Leukemia, Chronic

Treatments

Drug: bendamustine

Drug: rituximab [MabThera/Rituxan]

Drug: chlorambucil

Study type

Interventional

Funder types

Industry

Identifiers

NCT01056510

MO22468

2009-012072-28

Details and patient eligibility

About

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.

Enrollment

357 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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