NCT04705129

Zanubrutinib Combined With Tislelizumab in the Treatment of r/r PMBCL and EBV+ DLBCL

A Phase II Study on the Safety and Efficacy of Zanubrutinib Combined With Tislelizumab in the Treatment of Relapsed/Refractory Primary Mediastinal Large B-cell Lymphoma and Epstein-Barr Virus-positive Diffuse Large B-cell Lymphoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study is to investigate the safety and efficacy of Zanubrutinib combined with Tislelizumab in the treatment of relapsed/refractory primary mediastinal large B-cell lymphoma and Epstein-Barr Virus-positive diffuse large B-cell lymphoma.

Detailed description

R-CHOP regimen is the first-line therapy in DLBCL which greatly improved the efficacy of diffuse large B-cell lymphoma (DLBCL) and achieved good long-term survival. However, among DLBCL patients treated with R-CHOP, EBV+ had a lower 5-year OS than EBV- patients (65% vs 82%). For primary mediastinal large B-cell lymphoma (PMBCL), although the initial treatment has a better prognosis than DLBCL, there are still 10% to 30% of PMBCL patients with primary refractory or relapsed disease, and the prognosis is poor. Zanubrutinib combined with Tislelizumab has been proved efficient in relapsed or refractory NHLs, with ORR rate 37%, CR rate of 16.7%. This phase II, prospective, open-label, single-arm study will evaluate the efficacy and safety of Zanubrutinib combined with Tislelizumab in the treatment of relapsed/refractory primary mediastinal large B-cell lymphoma and Epstein-Barr Virus-positive diffuse large B-cell lymphoma.

Conditions

• Primary Mediastinal Large B Cell Lymphoma
• EBV-Positive DLBCL, Nos

Interventions

Type	Name	Description
DRUG	Zanubrutinib	160mg Bid, D1-21, po
DRUG	Tislelizumab	200mg, D1, ivgtt

Timeline

• Start date: 2021-01-01
• Primary completion: 2023-01-01
• Completion: 2024-01-01
• First posted: 2021-01-12
• Last updated: 2021-03-30

Locations

1 site across 1 country: China