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

Conditions	Phase	Intervention Type
CLL (Chronic Lymphocytic Leukemia) CLL (Chronic Lymphocytic Leukemia)	Phase 4	Drug rituximab [MabThera/Rituxan] Drug bendamustine Drug chlorambucil

View trial NCT01056510 on www.clinicaltrials.gov

Contacts

Please use the information below to contact the trial coordinators.

Please reference Study ID Number: MO22468 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Eligibility

Ages Eligible for Study: 18 years and up
Genders Eligible for Study: Both

Keywords

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 /=20mg daily
prednisolone or equivalent

Detailed Description

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01056510

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