Glofitamab vs Investigator's Choice for Mantle Cell Lymphoma

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

Recruiting Phase 3 Interventional Study
Lymphoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
182 (estimated)
Sponsor
Hoffmann-La Roche · Industry
Who this trial is looking for

This trial is looking for patients with relapsed or refractory mantle cell lymphoma. Participants will receive either glofitamab alone or a treatment chosen by the investigator.

Are You a Good Fit for This Trial?
Rules you out Active autoimmune diseaseSevere allergic reactionsInfection historyActive hepatitis BActive hepatitis C

You may be able to join if

  • I have been diagnosed with mantle cell lymphoma.
  • I have had at least one previous treatment for my cancer.
  • I have a life expectancy of at least 12 weeks.
  • I have at least one measurable tumor.
  • I have a negative HIV test.
  • I am able to provide tumor tissue for testing, unless it's unsafe.
  • I have a good performance status (ECOG 0, 1, or 2).
  • I have adequate blood counts.

You may not be able to join if

  • I am pregnant or breastfeeding.
  • I have a history of severe allergic reactions to monoclonal antibodies.
  • I have active infections or a history of certain serious neurological diseases.
  • I have had recent major surgery.
  • I have a known active hepatitis B or C infection.
  • I have a history of other cancers that could affect my treatment.
  • I have received treatment for cancer within the past 2 weeks.
  • I have untreated autoimmune disease.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Life expectancy at least 12 weeks * Histologically-confirmed MCL, with documentation of either overexpression of cyclin D1 or the presence of t(11:14) within 12 months of study entry * Relapsed (disease progression after the last treatment regimen) or refractory (failure to ac…
Contacts

Reference Study ID Number: GO43878 https://forpatients.roche.com/ No attachments to email below.

888-662-6728

global-roche-genentech-trials@gene.com

CONTACT

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT