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 (GLOASIS)

NCT06558604 Phase 2 RECRUITING

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.

Details

Lead sponsor	The Lymphoma Academic Research Organisation
Phase	Phase 2
Status	RECRUITING
Enrolment	100
Start date	2025-02-21
Completion	2032-03

Conditions

• Lymphoma, Mantle-Cell

Interventions

• Obinutuzumab
• Glofitamab
• Venetoclax Oral Product
• Zanubrutinib Oral Capsule

Primary outcomes

• PFS at the end of C17 (each cycle is 21 days) — end of cycle 17 (each cycle is 21 days)
  The primary efficacy endpoint is the PFS at 12 months (end of C17) from first dose of study treatment, in each cohort: Zanubrutinib/Venetoclax/Glofitamab for cohorts A and C, Venetoclax/Glofitamab for cohort B, as determined by imaging central review (Lugano 2014 criteria),

Countries

Belgium, France