FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Hoffmann-La Roche
Study ID
NCT00090051
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

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

Study Details

The purpose of this study is to provide treatment for patients who have chronic lymphocytic leukemia (CLL), and to compare the use of rituximab added to fludarabine+cyclophosphamide (FC) with FC alone, to determine if rituximab lengthens the time a patient remains free of leukemia symptoms.

Key Dates

Start date
Jul 31, 2003
Status verified
Jul 2017
Primary completion
Jul 23, 2008
Completion
May 31, 2012

Study Design

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

Arms

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

Primary Outcome Measure

Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC) [ Time Frame: Mean observation time at time of analysis was approximately 26 months ]

Locations (6)

FacilityCityStateZIPSite coordinators
Uab Comprehensive Cancer CenterBirminghamAlabama35294-3300-
Pacific Coast Hematology/Oncology Medical GroupFountain ValleyCalifornia92708-
California Cancer Center Woodward Park; Community Medical CentersFresnoCalifornia93720-
Rush-Presbyterian St. Luke'S Medical CenterChicagoIllinois60612-
Duke University Medical CenterDurhamNorth Carolina27710-
Milton S. Hershey Medical Center; Penn State Cancer Inst.HersheyPennsylvania17033-

Find similar trials in Birmingham, AL

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Uab Comprehensive Cancer Center· Birmingham, ALPacific Coast Hematology/Oncology Medical Group· Fountain Valley, CACalifornia Cancer Center Woodward Park; Community Medical Centers· Fresno, CARush-Presbyterian St. Luke'S Medical Center· Chicago, ILDuke University Medical Center· Durham, NCMilton S. Hershey Medical Center; Penn State Cancer Inst.· Hershey, PA

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