NCT05940064

Prospective Clinical Study of ZPR Regimen in Elderly Treatment-naive Diffuse Large B-cell Lymphoma

Prospective Single-arm, Single-center Clinical Study of Zanubrutinib, Polatuzumab Vedotin and Rituximab (ZPR) Regimen in Elderly Treatment-naive Patients With Diffuse Large B-cell Lymphoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Peng Liu · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-arm, single-center clinical study. This clinical study aims to explore the efficacy and safety of the ZPR（Zanubrutinib, Polatuzumab vedotin and Rituximab）regimen in elderly patients with treatment-naive diffuse large B-cell lymphoma.

Detailed description

This is a prospective, single-arm, single-center clinical study. This clinical study aims to explore the efficacy and safety of the ZPR（Zanubrutinib, Polatuzumab vedotin and Rituximab）regimen in elderly patients with treatment-naive diffuse large B-cell lymphoma. Primary objective: use ORR to evaluate the efficacy of ZPR in treating elderly treatment-naive DLBCL patients Secondary objective: Evaluate the safety of ZPR treatment for elderly treatment-naive DLBCL patients The subjects received 6 cycles of ZPR regimen, one cycle every 21 days. Then Zanubrutinib alone will continue to be used until Zanubrutinib has been used for 1 year or disease progression or intolerable adverse effects, death, withdrawal of informed consent or study termination. Zanubrutinib（Z）160 mg bid po Day 1-21; Polatuzumab vedotin（P）1.8 mg/kg ivgtt D1; Rituximab（R）375 mg/m\^2 ivgtt D1.

Conditions

• Diffuse Large B Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Zanubrutinib, Polatuzumab Vedotin, Rituximab	Drug: Zanubrutinib, Polatuzumab Vedotin and Rituximab Zanubrutinib（Z）160 mg bid po Day 1-21; Polatuzumab Vedotin（P）1.8 mg/kg ivgtt D1; Rituximab（R）375 mg/m\^2 ivgtt D1

Timeline

• Start date: 2023-07-20
• Primary completion: 2025-07-20
• Completion: 2025-12-31
• First posted: 2023-07-11
• Last updated: 2023-07-11

Locations

1 site across 1 country: China