Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia

Sponsor
Hoffmann-La Roche
Study ID
NCT00281918
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Rituximab — DRUG
    Intravenous repeating dose
  • Cyclophosphamide — DRUG
    Intravenous repeating dose
  • Fludarabine Phosphate — DRUG
    Intravenous repeating dose

Study Details

This randomized phase III trial is studying fludarabine, cyclophosphamide, and rituximab to see how well they work compared to fludarabine and cyclophosphamide in treating patients with B-cell chronic lymphocytic leukemia.

Key Dates

Start date
Jul 31, 2003
Status verified
Sep 2013
Primary completion
Jul 31, 2007
Completion
Oct 31, 2011

Study Design

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

Arms

  • Experimental: Fludarabine+Cyclophosphamide+Rituximab (FCR)
  • Active Comparator: Fludarabine+Cyclophosphamide (FC)

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Median observation time at time of analysis was approximately 21 months ]

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