NCT01056510

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 357 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lymphocytic Leukemia, Chronic

Interventions

Type	Name	Description
DRUG	bendamustine	90mg/m2 (first-line) or 70mg/m2 (second-line) iv, days 1 and 2 every 4 weeks, cycles 1-6
DRUG	chlorambucil	10mg/m2 po days 1-7 every 4 weeks, for up to 12 cycles
DRUG	rituximab [MabThera/Rituxan]	375mg/m2 iv day 1 of cycle 1, followed by 500mg/m2 iv every 4 weeks cycles 2-6

Timeline

• Start date: 2010-03-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2010-01-26
• Last updated: 2015-06-25
• Results posted: 2015-06-25

Locations

85 sites across 8 countries: Finland, France, Portugal, Spain, Sweden, Tunisia, Turkey (Türkiye), United Kingdom