Phase II Study of Glofitamab With Venetoclax +/- Zanubrutinib in High-risk Mantle-cell Lymphoma
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek co najmniej 18 lat i poniżej 80 lat
- •Grupa A: Choroba wraca lub nie reaguje na leczenie w ciągu 24 miesięcy od początku pierwszego leczenia
- •Grupa B: Choroba wraca po leczeniu inhibitorem BTK, z przerwą ponad 24 miesięcy od diagnozy
- •Grupa C: Nowo rozpoznany chłoniak płaszcza bez wcześniejszego leczenia
- •Grupa C: Co najmniej dwa czynniki wysokiego ryzyka (mutacja TP53, typ blastoïdny, złożone aberracje chromosomowe, wysoki Ki67, wysoki wynik MIPI)
✗ Disqualifies
- •Grupa A: Choroba nie reaguje na kombinację inhibitora BTK i venetoclaxu
- •Grupa B: Choroba nie reaguje na kombinację inhibitora BTK i venetoclaxu
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 79 Years
- Last updated (source)
- July 10, 2026
- Sex
- No restrictions
Therapies / drugs in trial
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
Hopitaux Universitaires de Strasbourg (Hus)
Strasbourg, France
Trial contact
Julie JULIE ASSEMAT
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/11/2026.
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