CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 34 enrolled
Drug / intervention
Cyclophosphamide +2 moredrug
Likely dose
Cyclophosphamide 250 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT02533401
NCT02533401Phase 2Completed
CompareCT.gov

A Multicenter, Single-Arm, Phase II Study to Evaluate the Efficacy and Safety of Rituximab Plus Fludarabine and Cyclophosphamide (FCR) as First-Line Treatment in Patients With B-Cell Chronic Lymphocytic Leukemia (CLL)

Hoffmann-La Roche·interventional·Posted Aug 26, 2015·Updated May 2, 2016

In Brief

A Phase 2 clinical trial evaluating Cyclophosphamide, Fludarabine, and 1 other intervention for Lymphocytic Leukemia, Chronic. Completed, enrolled 34 participants across 9 sites in 2 countries.

Detailed Summary

This study will evaluate the efficacy and safety of rituximab in combination with chemotherapy (fludarabine and cyclophosphamide) in participants with B-cell CLL.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphocytic Leukemia, Chronic
CountriesArgentina, Venezuela
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 26, 2015
Enrollment StartFeb 1, 2006
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 10.8 years ago

Interventions

Cyclophosphamidedrug

Cyclophosphamide will be administered IV at 250 mg/m\^2/day on Day 2-4 of Cycle 1 and then on Day 1-3 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length.

Fludarabinedrug

Fludarabine will be administered IV at 25 mg/m\^2/day on Day 2-4 of Cycle 1 and then on Day 1-3 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length.

Rituximabdrug

Rituximab will be administered IV at 375 mg/m\^2 on Day 1 of Cycle 1 and then at 500 mg/m\^2 on Day 1 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length.