CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 817 enrolled
Drug / intervention
Rituximab +2 moredrug
Likely dose
Fludarabine, cyclophosphamide, and rituximab (FCR) as intravenous repeating doses, versus fludarabine and cyclophosphamide (FC) alone as intravenous repeating dosesAI-extracted
Key inclusion· 6
  • ✓Diagnosis of B-cell chronic lymphocytic leukemia (CLL) per NCI Working Group criteria
  • ✓Binet stage C disease OR Binet stage B with at least one sign/symptom (B symptoms, lymphocyte doubling, marrow failure, splenomegaly, lymphadenopathy, or hyperviscosity)
  • ✓ECOG performance status 0-1
  • ✓Creatinine clearance ≥ 70 mL/min
Key exclusion· 8
  • ✕Binet stage A disease
  • ✕Transformation to aggressive B-cell malignancy (e.g., diffuse large cell lymphoma, Richter's syndrome, prolymphocytic leukemia)
  • ✕Known hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or study drugs
  • ✕Active bacterial, viral, or fungal infection

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

Search/NCT00281918
NCT00281918Phase 3Completed
CompareCT.gov

Phase III Trial of Combined Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab (FCR) Versus Chemotherapy With Fludarabine and Cyclophosphamide (FC) Alone in Patients With Previously Untreated Chronic Lymphocytic Leukaemia

Hoffmann-La Roche·interventional·Posted Jan 25, 2006·Updated Sep 19, 2013

In Brief

A Phase 3 clinical trial evaluating Rituximab, Cyclophosphamide, and 1 other intervention for Leukemia. Completed, enrolled 817 participants across 162 sites in 11 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia
CountriesAustralia, Austria, Belgium, Czechia, Denmark, France, Germany, Israel, Italy, New Zealand, Spain
CollaboratorsGerman CLL Study Group

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 25, 2006
Enrollment StartJul 1, 2003
Primary CompletionJul 1, 2007
Study CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 20.4 years ago

Interventions

Rituximabdrug

Intravenous repeating dose

Cyclophosphamidedrug

Intravenous repeating dose

Fludarabine Phosphatedrug

Intravenous repeating dose