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

NCT06558604 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-02-11

No results posted yet for this study

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.

Conditions

  • Lymphoma, Mantle-Cell

Interventions

DRUG

Obinutuzumab

1000 mg/40mL

DRUG

Glofitamab

10mg/mL

DRUG

Venetoclax Oral Product

10mg, 50mg and 100mg tablets

DRUG

Zanubrutinib Oral Capsule

80mg capsules

Sponsors & Collaborators

  • BeiGene

    collaborator INDUSTRY

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • The Lymphoma Academic Research Organisation

    lead OTHER

Principal Investigators

  • Steven LE GOUILL, Pr · Institut Curie

  • Clementine SARKOZY, MD · Institut Curie

  • Louise ROULIN, MD · Hôpital Henri-Mondor - AP-HP

  • Gilles CROCHET, MD · CHU Dinant Godinne UCL Namur - YVOIR

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-21
Primary Completion
2028-05-31
Completion
2032-03-31

Countries

  • Belgium
  • France

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06558604 on ClinicalTrials.gov