CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 365 enrolled
Drug / intervention
OFC Infusion +1 moredrug
Likely dose
OFC Infusion 300mgfrom 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/NCT00824265
NCT00824265Phase 3Completed
CompareCT.gov

A Phase III, Open Label, Randomized Trial of Ofatumumab Added to Fludarabine-Cyclophosphamide vs. Fludarabine-Cyclophosphamide Combination in Subjects With Relapsed Chronic Lymphocytic Leukemia

Novartis Pharmaceuticals·interventional·Posted Jan 16, 2009·Updated Jun 18, 2020

In Brief

A Phase 3 clinical trial evaluating OFC Infusion and FC infusion for Leukaemia, Lymphocytic, Chronic. Completed, enrolled 365 participants across 135 sites in 18 countries.

Detailed Summary

The purpose of this study was to evaluate the safety and efficacy of ofatumumab added to fludarabine-cyclophosphamide in patients with relapsed Chronic Lymphocytic Leukemia (CLL).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukaemia, Lymphocytic, Chronic
CountriesBrazil, Bulgaria, Canada, Germany, Greece, India, Italy, Mexico, Netherlands, Poland, Romania, Russia, Spain, Taiwan, Thailand, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 16, 2009
Enrollment StartMar 12, 2009
Primary CompletionDec 17, 2014
Study CompletionOct 25, 2017
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 17.5 years ago

Interventions

OFC Infusiondrug

Ofatumumab Cycle 1-Day 1 300mg, Cycle 1-Day 8 1000mg, then Cycles 2-6 Day 1 1000mg every 28 days, Fludarabine 25mg/m2 Days 1-3 every 28 days for 6 cycles, Cyclophosphamide 250 mg/m2 Days 1-3 every 28 days for 6 cycles

FC infusiondrug

Fludarabine 25mg/m2 Days 1-3 every 28 days for 6 cycles, Cyclophosphamide 250mg/m2 Days 1-3 every 28 days for 6 cycles