NCT06084936

A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma

A Phase III, Open-Label, Multicenter Randomized Study Evaluating Glofitamab as a Single Agent Versus Investigator's Choice in Patients With Relapsed/Refractory Mantle Cell Lymphoma

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 182 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of glofitamab monotherapy compared with an investigator's choice of either rituximab plus bendamustine (BR), or lenalidomide with rituximab (R-Len) in patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL).

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	Obinutuzumab	Participants will receive two 1000 mg pretreatments of intravenous (IV) obinutuzumab from Cycle 1 Day 1
DRUG	Glofitamab	Participants will receive IV glofitamab beginning Cycle 1 Day 8 for 12 cycles (cycle length = 21 days).
DRUG	Rituximab	Participants will receive IV rituximab every 28 days for up to 6 cycles (when in combination with bendamustine), or until disease progression (when in combination with lenalidomide).
DRUG	Bendamustine	Participants will receive IV bendamustine on Days 1 and 2 Q4W for 6 cycles (cycle length = 28 days).
DRUG	Lenalidomide	Participants will receive oral lenalidomide once daily on Days 1-21 Q4W until disease progression.
DRUG	Tocilizumab	Participants will receive IV tocilizumab as required to manage cytokine release syndrome (CRS) events.

Timeline

• Start date: 2023-10-22
• Primary completion: 2027-08-31
• Completion: 2028-03-31
• First posted: 2023-10-16
• Last updated: 2026-04-02

Locations

75 sites across 13 countries: United States, Australia, Brazil, Canada, China, France, Italy, Puerto Rico, South Korea, Spain, Sweden, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study