NCT05887726

Zanubrutinib Combined With R-CHOP Regimen in the Treatment of Newly Diagnosed DLBCL With High-risk Factors

A Single-arm, Prospective Clinical Study on the Antitumor Activity and Safety of Zanubrutinib Combined With R-CHOP Regimen in the Treatment of Newly Diagnosed DLBCL With High-risk Factors

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Liaoning Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, open-label, single-arm phase II clinical study to evaluate the safety and efficacy of zanubrutinib plus R-CHOP (ZR-CHOP) as the first-line therapy for newly diagnosed diffuse large B-cell lymphoma patients with high-risk factors.

Conditions

• Diffuse Large B Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Zanubrutinib	Zanubrutinib 160mg bid p.o d0-d20(21-day cycles)
DRUG	Rituximab	Rituximab 375 mg/m2 i.v d0(21-day cycles)
DRUG	Cyclophosphamide	Cyclophosphamide 750 mg/m2 i.v d1(21-day cycles)
DRUG	Epirubicin	Epirubicin 75 mg/m2 i.v d1 or liposome adriamycin 35mg/m2 i.v d1(21-day cycles)
DRUG	Vincristine	Vincristine 1.4 mg/m2 i.v d1 (2 mg max) (21-day cycles)
DRUG	Prednisone	Prednisone 100 mg p.o d1-d5 (21-day cycles)

Timeline

• Start date: 2023-08-01
• Primary completion: 2024-08-01
• Completion: 2025-08-01
• First posted: 2023-06-05
• Last updated: 2023-07-27

Locations

1 site across 1 country: China