Trial intelligence / Profile preview

Ibrutinib in Refractory Follicular Lymphoma

NCT01779791Phase 2

Key facts

Status: Completed
Start: Apr 2013
Primary completion: May 2016
Countries: 9
Sponsor: Janssen Pharmaceutical
Modality: Small Molecules

Drugs: ibrutinib
Conditions: follicular lymphoma (FL)

Overview

Phase 2, open-label, single-arm trial of ibrutinib in follicular lymphoma (FL), sponsored by Janssen Pharmaceutical. Primary endpoint: Overall Response Rate up to 2 years. Started Apr 2013; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

PCI-32765 (Ibrutinib)
Ibrutinib 560 mg orally once daily

Who it enrols

Patients with Grade 1, 2, or 3a follicular lymphoma resistant to at least 2 prior lines of therapy including rituximab combination chemotherapy.

Endpoints

Primary

Overall Response RateUp to 2 years

Secondary

Duration of ResponseUp to 2 years
Progression-Free SurvivalUp to 2 years
Overall SurvivalUp to 2 years
Time to ResponseUp to 2 years
Resolution of Lymphoma-Related B SymptomsUp to 2 years
Blood BiomarkersDisease progression
Minimum Plasma ConcentrationCycles 1-3
Oral Plasma ClearanceCycles 1-3

Beyond the preview

Go deeper on NCT01779791.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT01779791.