NCT07012980

Glofitamab, Polatuzumab Vedotin and Zanubrutinib in First-line Elderly DLBCL

Efficacy and Safety of Glofitamab, Polatuzumab Vedotin and Zanubrutinib in the First-line Treatment of Elderly Patients With Diffuse Large B-cell Lymphoma (DLBCL): A Single-center, Single-arm, Prospective, Phase II Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a prospective, single-center, interventional, phase 2 study. Each patient screend eligible for this study will receive a combination therapy of glofitamab, zanubrutinib and polatuzumab vedotin.

Conditions

• Diffuse Large B-Cell Lymphoma

Interventions

Type	Name	Description
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	Zanubrutinib (160mg bid p.o.) will be administered for 7 days as pretreatment and from D1 to D21 through all 12 cycles Q3W.

Timeline

• Start date: 2025-06-01
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2025-06-10
• Last updated: 2025-06-10