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

NCT00281918 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 817

Last updated 2013-09-19

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Rituximab

Intravenous repeating dose

DRUG

Cyclophosphamide

Intravenous repeating dose

DRUG

Fludarabine Phosphate

Intravenous repeating dose

Sponsors & Collaborators

Principal Investigators

  • Michael Hallek, MD · Medizinische Universitaetsklinik I at the University of Cologne

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
2007-07-31
Completion
2011-10-31

Countries

  • Australia
  • Austria
  • Belgium
  • Czechia
  • Denmark
  • France
  • Germany
  • Israel
  • Italy
  • New Zealand
  • Spain

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 NCT00281918 on ClinicalTrials.gov