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Rituximab maintenance in advanced follicular lymphoma

NCT02569996Phase 3

Key facts

Status: Completed
Start: Jul 2005
Primary completion: Aug 2013
Countries: 1
Sponsor: Roche

Drugs: rituximab
Conditions: follicular lymphoma (FL)

Overview

Phase 3, randomised, open-label trial of rituximab in follicular lymphoma (FL), sponsored by Roche. Primary endpoint: Event-free Survival at 5 years. Started Jul 2005; status: completed.

Design

1 arm

Study design: RandomizedOpen-label

Rituximab Arm
Participants receiving rituximab maintenance therapy every 8 weeks.

Who it enrols

Adults with histologically confirmed Grade 1, 2, or 3a follicular lymphoma who achieved complete or partial remission after first-line rituximab-containing induction therapy.

Endpoints

Primary

Event-free Survival5 years

Secondary

Number of Participants With Adverse Events27 months
Overall Survival5 years
Time to Progression5 years
Time to Next Anti-lymphoma Treatment5 years
Duration of Response5 years
Disease-free Survival5 years

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