Glofitamab, Polatuzumab Vedotin and Zanubrutinib in First-line Elderly DLBCL
NCT07012980 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38
Last updated 2025-06-10
Summary
This study aims to assess the efficacy and safety of the chemotherapy-light combination of glofitamab, polatuzumab vedotin and zanubrutinib (GPZ) in elderly patients with previously untreated diffuse large B-cell lymphoma.
Conditions
- Diffuse Large B-Cell Lymphoma
Interventions
- DRUG
-
Glofitamab
Glofitamab will be administered i.v. on a step-up dosing schedule starting on Day 8 of Cycle 1 (2.5 mg), Day 15 of Cycle 1 (10 mg), followed by 30 mg on Day 1 of Cycles 2-6, with each cycle being 21 days. A single dose of obinutuzumab 1000 mg will be administered intravenously on Day 1 of Cycle 1.
- DRUG
-
Polatuzumab Vedotin
Polatuzumab vedotin (1.8 mg/kg) will be administered intravenously on Day 2 of Cycle 1 and on Day 1 of the subsequent Cycle 2-6 (each Q3W).
- DRUG
-
Zanubrutinib (160mg bid p.o.) will be administered for 7 days as pretreatment and from D1 to D21 through all 12 cycles Q3W.
Sponsors & Collaborators
- collaborator INDUSTRY
-
BeiGene
collaborator INDUSTRY -
Shanghai Zhongshan Hospital
lead OTHER
Principal Investigators
-
Peng Liu · Fudan University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-06-01
- Primary Completion
- 2026-07-31
- Completion
- 2026-07-31
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