Phase II Study of Glofitamab With Venetoclax +/- Zanubrutinib in High-risk Mantle-cell Lymphoma
Recruiting now · Phase 2
Conditions studied: Lymphoma, Mantle-Cell
In brief
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.
Key facts
- Study ID
- NCT06558604
- Run by
- The Lymphoma Academic Research Organisation
- People needed
- 100
- Starts
- 2025-02-21
- Expected to finish
- 2032-03-01
- Last updated by the study team
- 2026-07-10
Who can join
Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Az Sint-Jan Brugge - Oostende Av — Bruges, Belgium (enrolling)
- Institut Jules Bordet — Brussels, Belgium (enrolling)
- Chu de Liege — Liège, Belgium (enrolling)
- Chu Ucl Namur - Site Godinne — Yvoir, Belgium (enrolling)
- Aphp - Hopital Henri Mondor — Créteil, France (enrolling)
- Chu Dijon Bourgogne — Dijon, France (enrolling)
- Chu de Lille - Hopital Claude Huriez — Lille, France (enrolling)
- Institut Paoli Calmettes — Marseille, France (enrolling)
- Chu de Montpellier — Montpellier, France (enrolling)
- Chu de Nantes — Nantes, France (enrolling)
- Chu Lyon-Sud — Pierre-Bénite, France (enrolling)
- Chu de Reims - Hopital Robert Debre — Reims, France (enrolling)
- Chu Pontchaillou — Rennes, France (enrolling)
- Centre Henri Becquerel — Rouen, France (enrolling)
- Institut Curie — Saint-Cloud, France (enrolling)
- Hopitaux Universitaires de Strasbourg (Hus) — Strasbourg, France (enrolling)
Full record on ClinicalTrials.gov
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