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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 up to approximately 24 months

Awards & highlights

No Placebo-Only Group

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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

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

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

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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