NCT06558604

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: The Lymphoma Academic Research Organisation · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Cohort A : 40 subjects will be included and treated Cohort B : 36 subjects will be included and treated Cohort C : 24 subjects will be included and treated Subjects in cohorts A and C will receive during induction phase 12 cycles of Zanubrutinib/Venetoclax/Glofitamab and during maintenance phase 23 cycles of Zanubrutinib/Venetoclax Subjects in cohort B will receive during induction phase 12 cycles of Venetoclax/Glofitamab and during maintenance phase 23 cycles of Venetoclax

Conditions

• Lymphoma, Mantle-Cell

Interventions

Type	Name	Description
DRUG	Obinutuzumab	1000 mg/40mL
DRUG	Glofitamab	10mg/mL
DRUG	Venetoclax Oral Product	10mg, 50mg and 100mg tablets
DRUG	Zanubrutinib Oral Capsule	80mg capsules

Timeline

• Start date: 2025-02-21
• Primary completion: 2028-05-01
• Completion: 2032-03-01
• First posted: 2024-08-16
• Last updated: 2026-02-11

Locations

16 sites across 2 countries: Belgium, France