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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT00090051

Public ClinicalTrials.gov record NCT00090051. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 8, 2026, 10:36 AM EST

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Official title

Open-label, Multicenter, Randomized, Comparative, Phase III Study to Evaluate the Efficacy and Safety of FCR vs. FC Alone in Previously Treated Patients With CD20 Positive B-cell CLL

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00090051
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
552 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 31, 2003 (Actual)
Primary completion
Jul 23, 2008 (Actual)
Completion
May 31, 2012 (Actual)
Last update posted
Aug 1, 2017

2003 – 2012

United States locations

U.S. sites
6
U.S. states
5
U.S. cities
6
Facility City State ZIP Site status
Uab Comprehensive Cancer Center Birmingham Alabama 35294-3300 —
Pacific Coast Hematology/Oncology Medical Group Fountain Valley California 92708 —
California Cancer Center Woodward Park; Community Medical Centers Fresno California 93720 —
Rush-Presbyterian St. Luke'S Medical Center Chicago Illinois 60612 —
Duke University Medical Center Durham North Carolina 27710 —
Milton S. Hershey Medical Center; Penn State Cancer Inst. Hershey Pennsylvania 17033 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 100 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00090051, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 1, 2017 · Synced Nov 8, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00090051 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →