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
Study ID
NCT06656221
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Obinutuzumab — DRUG
    Obinutuzumab pre-treatment is given intravenously at a dose of 2000mg on Cycle 1 Days 1-2
  • Glofitamab — DRUG
    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
  • Bortezomib — DRUG
    Bortezomib is given intravenously at a dose of 1.6 mg/m² on Days 1, 8, and 15 of Cycles 1-12.
  • Orelabrutinib — DRUG
    Orelabrutinib is given orally at a dose of 150 mg daily on Days 1-21 of Cycles 1-12.

Study Details

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 Dates

Start date
Dec 1, 2024
Status verified
Nov 2024
Primary completion
Dec 1, 2026
Completion
May 1, 2028

Study Design

Enrollment
29 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Glofitamab-Orelabrutinib-Bortezomib
    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.

Primary Outcome Measure

Complete Response (CR) Rate [ Time Frame: Up to 2 years ]

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