RecruitingPhase 2NCT06558604

Phase II Study of Glofitamab With Venetoclax +/- Zanubrutinib in High-risk Mantle-cell Lymphoma

A Phase II, Multicenter, Open-label Study Evaluating Glofitamab in Combination With Venetoclax Plus Zanubrutinib or Venetoclax Alone in Subjects With Untreated or Relapsed/Refractory High-risk Mantle-cell Lymphoma


Sponsor

The Lymphoma Academic Research Organisation

Enrollment

100 participants

Start Date

Feb 21, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This open-label, multicenter, three cohorts, phase II study is designed to assess a combination of Zanubrutinib/Venetoclax/Glofitamab or Venetoclax/Glofitamab in high-risk subjects with either first line or R/R Mantle Cell Lymphoma (MCL). Three independent cohorts will be run: * Cohort A will include subjects with a primary refractory or progressive disease within 24 months from initiation of first line treatment (POD 24). * Cohort B will be open for subjects with R/R MCL and refractory or progressive to a BTK inhibitor given previously (\>24 months if first line). * Cohort C will only enrol newly diagnosed and untreated MCL subjects with very high-risk features.


Eligibility

Min Age: 18 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This Phase II study is testing a combination of drugs — glofitamab (a bispecific antibody that redirects the immune system to attack cancer), venetoclax (a targeted therapy), and optionally zanubrutinib (a BTK inhibitor) — for patients with high-risk mantle cell lymphoma, a type of blood cancer. **You may be eligible if...** - You have mantle cell lymphoma that is high-risk, has relapsed early, or has not responded to prior treatments including BTK inhibitors or CAR T-cell therapy (depending on which cohort you qualify for) - You have not previously been treated and have high-risk features (for cohort C) - CD20 expression is present on your cancer cells **You may NOT be eligible if...** - Your disease progressed while on both a BTK inhibitor and venetoclax at the same time - You have active brain involvement of lymphoma - You have uncontrolled infection or serious organ problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGObinutuzumab

1000 mg/40mL

DRUGGlofitamab

10mg/mL

DRUGVenetoclax Oral Product

10mg, 50mg and 100mg tablets

DRUGZanubrutinib Oral Capsule

80mg capsules


Locations(16)

Az Sint-Jan Brugge - Oostende Av

Bruges, Belgium

Institut Jules Bordet

Brussels, Belgium

Chu de Liege

Liège, Belgium

Chu Ucl Namur - Site Godinne

Yvoir, Belgium

Aphp - Hopital Henri Mondor

Créteil, France

Chu Dijon Bourgogne

Dijon, France

Chu de Lille - Hopital Claude Huriez

Lille, France

Institut Paoli Calmettes

Marseille, France

Chu de Montpellier

Montpellier, France

Chu de Nantes

Nantes, France

Chu Lyon-Sud

Pierre-Bénite, France

Chu de Reims - Hopital Robert Debre

Reims, France

Chu Pontchaillou

Rennes, France

Centre Henri Becquerel

Rouen, France

Institut Curie

Saint-Cloud, France

Institut de Cancerologie Strasbourg Europe

Strasbourg, France

View Full Details on ClinicalTrials.gov

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NCT06558604


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