NCT06554600

A Study of Zanubrutinib in Combination With Polatuzumab Vedotin, Bendamustine and Rituximab in the Treatment of Relapsed/Refractory Diffuse Large B-cell Lymphoma

The Efficiency and Safety of Zanubrutinib in Combination With Polatuzumab Vedotin, Bendamustine and Rituximab in the Treatment of Relapsed/Refractory Diffuse Large B-cell Lymphoma: a Prospective, Single-arm, Multicenter Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, multicenter, single-arm, open phase II study to explore the efficacy and safety of Zanubrutinib in combination with Polatuzumab Vedotin, bendamustine, and rituximab (Polo-ZBR) in subjects with relapsed/refractory diffuse large B-cell lymphoma. Subjects with relapsed/refractory DLBCL who met the inclusion/exclusion criteria were screened and treated with 4 courses of Pola-ZBR regimen after signing informed consent. Subjects achieving PR or CR were consolidated with autologous transplantation consolidation or the original regimen for 2 additional courses, and then given Zanubrutinib maintenance therapy for 1 year. The final follow-up was observed until 2 years after enrollment.

Conditions

• Refractory or Relapsed Diffuse Large B Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Zanubrutinib	160mg bid PO（d0-d20）
DRUG	Polatuzumab Vedotin	Participants will receive a total of 4-6 cycles (a cycle being 21 days) of 1.8mg/kg Polatuzumab Vedotin on Day 2 of each cycle.
DRUG	Bendamustine	Participants will receive a total of 4-6 cycles (a cycle being 21 days) of 70 mg/m2 Bendamustine on Days 2 and 3 of each cycle.
DRUG	Rituximab	Participants will receive a total of 4-6 cycles (a cycle being 21 days) of 375 mg/m2 Rituximab on Day 1 of each cycle.

Timeline

• Start date: 2024-08-31
• Primary completion: 2026-08-31
• Completion: 2028-08-31
• First posted: 2024-08-15
• Last updated: 2024-08-15

Locations

1 site across 1 country: China