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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

StatusNot Yet Recruiting
PhasePhase 2
Primary completion (estimated)
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Record History

All 2 versions: 1 with changes below, 1 re-verified with no change.

  1. Study First Submitted

Endpoints

Primary

Complete Response (CR) Rate
Timeframe: Up to 2 years

Secondary (6)

Objective Response Rate (ORR)
Duration of Response (DoR)
Duration of Complete Response (DoCR)
Progression-Free Survival (PFS)
Overall Survival (OS)
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Incidence and severity of adverse events

Arms and interventions

Glofitamab-Orelabrutinib-BortezomibExperimental

Participants will receive 2000 mg of obinutuzumab on Days 1-2 of Cycle 1, 2.5 mg of glofitamab on Day 8 of Cycle 1, 10 mg of glofitamab on Day 15 of Cycle 1, followed by 30 mg of glofitamab on Day 1 of Cycles 2-12. Participants will receive 1.6 mg/m² of bortezomib on Days 1, 8, and 15 of Cycles 1-12. Participants will receive 150 mg/day of orelabrutinib on Days 1-21of Cycles 1-12. The duration of one cycle is 21 days.

Drugs: Obinutuzumab, Glofitamab, Bortezomib, Orelabrutinib