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NOT YET RECRUITING
NCT06656221
PHASE2

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

Sponsor: Ruijin Hospital

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

29

Start Date

2024-12-01

Completion Date

2028-05-01

Last Updated

2024-11-19

Healthy Volunteers

No

Interventions

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.