CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 552 enrolled
Drug / intervention
Rituximab +2 moredrug
Likely dose
Rituximab (intravenous repeating dose), Fludarabine Phosphate (intravenous repeating dose), Cyclophosphamide (intravenous repeating dose) - specific doses not provided in published protocolAI-extracted
Key inclusion· 5
  • ✓Age ≥18 years
  • ✓Confirmed B-cell CLL diagnosis by NCI Working Group criteria
  • ✓≤1 previous line of chemotherapy
  • ✓Expected survival >6 months
Key exclusion· 14
  • ✕Prior treatment with interferon, rituximab, or other monoclonal antibody
  • ✕Prior allogeneic or autologous BMT, PBSCT, or considered candidate for such transplantation
  • ✕Severe Grade 3 or 4 non-hematological toxicity or prolonged (>2 weeks) Grade 3 or 4 cytopenia on prior fludarabine or nucleoside analogue
  • ✕History of fludarabine-induced or clinically significant autoimmune cytopenia

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00090051
NCT00090051Phase 3Completed
CompareCT.gov

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

Hoffmann-La Roche·interventional·Posted Aug 25, 2004·Updated Aug 1, 2017

In Brief

A Phase 3 clinical trial evaluating Rituximab, Fludarabine Phosphate, and 1 other intervention for Chronic Lymphocytic Leukemia. Completed, enrolled 552 participants across 106 sites in 17 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Lymphocytic Leukemia
CountriesAustralia, Belgium, Canada, Denmark, France, Hungary, Italy, Netherlands, New Zealand, Norway, Poland, Romania, Russia, Spain, Sweden, United Kingdom, United States
CollaboratorsBiogen, Genentech, Inc.

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 25, 2004
Enrollment StartJul 31, 2003
Primary CompletionJul 23, 2008
Study CompletionMay 31, 2012
TodayJul 2, 2026
Enrollment to primary: 5.0 yearsPosted 21.9 years ago

Interventions

Rituximabdrug

Intravenous repeating dose

Fludarabine Phosphatedrug

Intravenous repeating dose

Cyclophosphamidedrug

Intravenous repeating dose