drugset / Trial / NCT06554600

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

NCT06554600

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-08-31
Primary completion
2026-08-31
Completion
2028-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Bendamustine Small molecule 70 mg/m2
Subject Polatuzumab Vedotin Other / unclassified 1.8 mg/kg
Subject Rituximab Monoclonal antibody 375 mg/m2
Subject Zanubrutinib Small molecule 160 mg Oral