NCT06656221

A Prospective, Single-Center Study Evaluating the Efficacy and Safety of Glofitamab Combined With Orelabrutinib and Bortezomib in Patients With High-Risk Mantle Cell Lymphoma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the efficacy and safety of Glofitamab combined with Orelabrutinib and Bortezomib in patients with high-risk mantle cell lymphoma

Conditions

• Mantle Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Obinutuzumab	Obinutuzumab pre-treatment is given intravenously at a dose of 2000mg on Cycle 1 Days 1-2
DRUG	Glofitamab	Glofitamab is given intravenously at a dose of 2.5mg on Cycle 1 Day 8. Glofitamab is given intravenously at a dose of 10mg on Cycle 1 Day 15. Glofitamab is given intravenously at a dose of 30mg on Day 1 of Cycles 2-6
DRUG	Bortezomib	Bortezomib is given intravenously at a dose of 1.6 mg/m² on Days 1, 8, and 15 of Cycles 1-12.
DRUG	Orelabrutinib	Orelabrutinib is given orally at a dose of 150 mg daily on Days 1-21 of Cycles 1-12.

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-12-01
• Completion: 2028-05-01
• First posted: 2024-10-24
• Last updated: 2024-11-19