Trial intelligence / Profile preview

Ofatumumab + CHOP in Untreated Follicular Lymphoma

NCT00494780Phase 2

Key facts

Status: Completed
Start: Jun 2007
Primary completion: Apr 2009
Countries: 1
Sponsor: GSK
Modality: Monoclonal Antibodies

Drugs: ofatumumab
Conditions: follicular lymphoma (FL)

Overview

Phase 2, randomised, open-label trial of ofatumumab in follicular lymphoma (FL) (2 arms), sponsored by GSK. Primary endpoint: Overall Best Response. Started Jun 2007; status: completed.

Design

2 arms

Study design: RandomizedOpen-label

Ofatumumab 500mg + CHOP
Ofatumumab (300mg dose 1, then 500mg doses 2-6) + CHOP every 3 weeks
Ofatumumab 1000mg + CHOP
Ofatumumab (300mg dose 1, then 1000mg doses 2-6) + CHOP every 3 weeks

Who it enrols

Patients with confirmed previously untreated Follicular Lymphoma, 18 years or above. Excludes patients with transformed lymphoma, other malignancies, or prior FL treatment.

Endpoints

Primary

Overall Best Response3 months post-treatment

Secondary

Complete Remission3 months post-treatment
Percent Change in Tumor Size24 months post-treatment
Time to New Anti-follicular Lymphoma Therapy5 years
Progression-Free Survival5 years
Duration of Response5 years
Peripheral CD19+ and CD20+ Cell Counts24 months post-treatment
Adverse Events24 months post-treatment
Human Anti-human Antibodies24 months post-treatment

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