CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 59 enrolled
Drug / intervention
Ofatumumab +4 moredrug
Likely dose
Ofatumumab 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/NCT00494780
NCT00494780Phase 2Completed
CompareCT.gov

An Open-labeled, Randomized, Two-dose, Parallel Group Trial of Ofatumumab, a Fully Human Monoclonal Anti-CD20 Antibody, in Combination With CHOP, in Patients With Previously Untreated Follicular Lymphoma (FL).

GlaxoSmithKline·interventional·Posted Jul 2, 2007·Updated Jul 11, 2014

In Brief

A Phase 2 clinical trial evaluating Ofatumumab, Cyclophosphamide, and 3 other interventions for Lymphoma, Follicular. Completed, enrolled 59 participants across 1 site.

Detailed Summary

To investigate the efficacy in two dose regimens of ofatumumab in combination with CHOP (cyclophosphamide,doxorubicin, vincristine,prednisolone) in previously untreated patients with Follicular Lymphoma (FL)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, Follicular
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 2, 2007
Enrollment StartJun 1, 2007
Primary CompletionApr 1, 2009
Study CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19 years ago

Interventions

Ofatumumabdrug

ofatumumab 300mg, 500mg or 1000mg should be diluted into 1000mL pyrogen free saline and administered as an IV infusion.Duration of infusion will be approximately 4 hours.Infusions should be given every 3 weeks until a total of 6 infusions has been given

Cyclophosphamidedrug

Cyclophosphamide 750 mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start

Doxorubicindrug

Doxorubicin : 50mg/m2 iv for 1 day, 24-48h post-ofatumumumab infusion start

Vincristinedrug

Vincristine : 1.4mg/m2 iv for 1 day, 24-48h post-ofatumumab infusion start

Prednisolone, Prednisone or equivalentdrug

100mg p.o daily for 5 days, 24-48h post-ofatumumab infusion start