← Back to Search

Monoclonal Antibodies

Glofitamab for Mantle Cell Lymphoma (GLOBRYTE Trial)

Phase 3

Recruiting

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 1 line of prior systemic therapy including a BTK inhibitor and additional systemic therapy option

Histologically-confirmed MCL, with documentation of either overexpression of cyclin D1 or the presence of t(11:14)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from randomization to a 10-point decrease in physical functioning/10-point increase in fatigue compared to baseline (up to approximately 24 months)

Awards & highlights

GLOBRYTE Trial Summary

This trial will compare a new drug (glofitamab) to existing treatments for relapsed/refractory mantle cell lymphoma.

Who is the study for?

This trial is for people with Mantle Cell Lymphoma who've had at least one prior treatment including a BTK inhibitor. They should have measurable cancer on a CT scan, be expected to live at least 12 more weeks, and be fairly active (ECOG status 0-2). HIV-positive individuals or those without adequate blood function cannot join.Check my eligibility

What is being tested?

The study tests Glofitamab alone against either Rituximab plus Bendamustine or Lenalidomide with Rituximab in patients whose MCL has returned or didn't respond after treatment. The goal is to see which option works better for these patients.See study design

What are the potential side effects?

Potential side effects include reactions related to the infusion of drugs, changes in blood counts leading to increased infection risk or bleeding problems, fatigue, and possible organ inflammation due to immune system activation.

GLOBRYTE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had treatment with a BTK inhibitor and one other systemic therapy.

Select...

My Mantle Cell Lymphoma (MCL) diagnosis is confirmed with specific genetic markers.

Select...

My condition worsened after the last treatment or didn't improve with the last treatment.

Select...

I have a tumor that can be measured on a CT scan.

Select...

I can take care of myself and am up and about more than half of my waking hours.

GLOBRYTE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from randomization to a 10-point decrease in physical functioning/10-point increase in fatigue compared to baseline (up to approximately 24 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from randomization to a 10-point decrease in physical functioning/10-point increase in fatigue compared to baseline (up to approximately 24 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to a 10-point decrease in physical functioning/10-point increase in fatigue compared to baseline (up to approximately 24 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free survival (PFS)

Secondary outcome measures

Change from baseline in lymphoma symptoms at each cycle as assessed by the FACT-Lym LymS

Change from baseline in physical functioning and fatigue at each cycle as assessed by the European Organization for Research and Treatment (EORTC) core Quality of Life Questionnaire (QLQ-C30)

Complete response (CR) rate

+13 more

GLOBRYTE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Glofitamab monotherapyExperimental Treatment3 Interventions

Participants will receive two intravenous (IV) obinutuzumab pretreatments prior to receiving IV glofitamab for 12 cycles (cycle length = 21 days).

Group II: BR or R-LenActive Control4 Interventions

Participants will receive bendamustine + rituximab for up to 6 cycles (cycle length = 28 days), or rituximab + lenalidomide (cycle length = 28 days) until disease progression.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tocilizumab

2012

Completed Phase 4

~1840

Glofitamab

2021

Completed Phase 1

~60

Obinutuzumab

2015

Completed Phase 3

~3250

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,432 Previous Clinical Trials

1,090,041 Total Patients Enrolled

117 Trials studying Lymphoma

25,544 Patients Enrolled for Lymphoma

Clinical TrialsStudy DirectorHoffmann-La Roche

2,201 Previous Clinical Trials

888,758 Total Patients Enrolled

95 Trials studying Lymphoma

23,957 Patients Enrolled for Lymphoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any Canadian health facilities participating in the trial of this drug?

"The current clinical trial is accepting patients from 23 sites located in Beijing, Chongqing, Fuzhou City and other cities. If a patient wishes to enrol they should select the closest location in order to reduce the amount of travel required."

Answered by AI

Does this medical study currently accept new participants?

"According to the clinicaltrials.gov listing, this medical trial has opened its doors for patient recruitment on October 22nd 2023 and was recently updated on December 5th of the same year."

Answered by AI

What is the cap on participants in this medical experiment?

"Affirmative. The clinicaltrials.gov website displays that this experiment, which was initially published on October 22nd 2023, is actively recruiting patients. A total of 182 participants are needed across 23 different medical sites."

Answered by AI

Could you please elaborate on the safety of Glofitamab when given as a standalone treatment?

"Our team at Power evaluated Glofitamab monotherapy's safety, and due to its Phase 3 status, we ranked it as a 3. This signifies that there is evidence of efficacy in addition to multiple layers of security data."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06084936.

All > Toronto > Mantle Cell Lymphoma