A Study to Compare Mabthera (Rituximab), Fludarabine and Cyclophosphamide to Mabthera and Chlorambucil in Participants With Chronic Lymphocytic Leukemia and Unfavorable Somatic Status

Sponsor
Hoffmann-La Roche
Study ID
NCT01283386
Phase
PHASE4
Status
Terminated

Conditions

  • Lymphocytic Leukemia, Chronic

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Chlorambucil — DRUG
    10 mg/m\^2 orally on Days 1-7 of each 28-day cycle for 6 cycles
  • Cyclophosphamide — DRUG
    150 mg/m\^2 IV or orally on Days 1-3 of each 28-day cycle for 6 cycles
  • Fludarabine — DRUG
    20 mg/m\^2 IV or 32 mg/m2 orally Days 1-3 of each 28-day cycle for 6 cycles
  • Rituximab — DRUG
    375 mg/m2 IV on Day 1 of Cycle 1; 500 mg/m2 IV on Day 1 of Cycles 2-6 (28-day cycles)

Study Details

This multi-center, randomized study compared the efficacy and safety of MabThera (rituximab) in combination with either fludarabine and cyclophosphamide or with chlorambucil in participants with previously untreated B-cell chronic lymphocytic leukemia and unfavorable somatic status. Participants were randomized to receive Mabthera (375 mg/m2 intravenously \[IV\] Day 1 of Cycle 1, 500 mg/m2 IV Day 1 Cycles 2-6) with either fludarabine (20 mg/m2 IV or 32 mg/m2 orally Days 1-3) and cyclophosphamide (150 mg/m2 IV or orally Days 1-3) or with chlorambucil (10 mg/m2 orally Days 1-7) for 6 cycles of 28 days. Anticipated time on study treatment was 24 weeks.

Key Dates

Start date
Apr 27, 2011
Status verified
Nov 2018
Primary completion
Mar 16, 2016
Completion
Mar 16, 2016

Study Design

Enrollment
26 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: FCR-lite
    Rituximab, fludarabine, and cyclophosphamide
  • Active Comparator: LR Therapy
    Rituximab and chlorambucile

Primary Outcome Measure

Percentage of Participants With Complete Remission [ Time Frame: Up to approximately 5 years ]

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