Trial intelligence / Profile preview

Tazemetostat Plus Mosunetuzumab in Untreated Follicular Lymphoma

NCT05994235Phase 2

Key facts

Status: Active, not recruiting
Start: Nov 2023
Primary completion: Oct 2033
Countries: 1
Sponsor: Weill Cornell Medicine
Modality: Small Molecules, Bispecific Antibodies, Monoclonal Antibodies

Drugs: mosunetuzumabtazemetostat
Conditions: follicular lymphoma (FL)

Overview

Phase 2, open-label, single-arm trial of mosunetuzumab and tazemetostat in follicular lymphoma (FL), sponsored by Weill Cornell Medicine. Primary endpoint: Complete Response at Day 336. Started Nov 2023; status: active, not recruiting.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Subcutaneous Mosunetuzumab and Oral Tazemetostat
Patients receive standard dosing of subcutaneous mosunetuzumab and oral tazemetostat 800 mg twice daily.

Who it enrols

Adults with previously untreated, histologically documented follicular lymphoma meeting GELF or BNLI criteria for systemic therapy, with adequate organ function and ECOG PS 0-2.

Endpoints

Primary

Complete ResponseDay 336

Secondary

Cytokine Release SyndromeDay 0 to Day 28
Immune effector cell-associated neurotoxicity syndromeDay 0 to Day 28
Progression-Free SurvivalUp to 10 years
Overall SurvivalUp to 10 years
Objective Response RateDay 336
Complete ResponseUp to 10 years
Duration of ResponseUp to 10 years

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