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

NCT00090051 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 552

Last updated 2017-08-01

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Rituximab

Intravenous repeating dose

DRUG

Fludarabine Phosphate

Intravenous repeating dose

DRUG

Cyclophosphamide

Intravenous repeating dose

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-07-31
Primary Completion
2008-07-23
Completion
2012-05-31

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Denmark
  • France
  • Hungary
  • Italy
  • Netherlands
  • New Zealand
  • Norway
  • Poland
  • Romania
  • Russia
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00090051 on ClinicalTrials.gov