MedTrace Logo

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

NCT06084936 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2026-05-04

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-22
Primary Completion
2027-08-31
Completion
2028-03-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • China
  • France
  • Italy
  • Puerto Rico
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06084936 on ClinicalTrials.gov