drugset / Trial / NCT04850495

Zanubrutinib in Combination With R-PolaCHP (ZaR-PolaCHP) for Newly Diagnosed Diffuse Large B-Cell Lymphoma

NCT04850495

Phase 1 Active not recruiting 38 enrolled Yazeed Sawalha
NaSingle-groupOpen-labelTreatment

Summary

This phase Ib trial seeks to find out the best dose and possible side effects and/or benefits of zanubrutinib in combination with the R-PolaCHP in treating patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL). Zanubrutinib is designed to block a protein called Bruton Tyrosine Kinase in order to stop cancer growth. R-CHOP is the acronym for the combination of five drugs: rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone. It is the most widely used chemoimmunotherapy regimen for DLBCL and is considered the standard-of-care treatment for patients with DLBCL. Three of the drugs in R-CHOP (cyclophosphamide, doxorubicin and vincristine) are chemotherapy drugs. Rituximab is a type of immunotherapy and prednisone is a type of steroids.

Timeline

Start
2021-11-16
Primary completion
2026-06-23
Completion
2026-12-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Zanubrutinib Small molecule Oral
Background Cyclophosphamide Other / unclassified Intravenous
Background Doxorubicin Other / unclassified Intravenous
Background Prednisone Other / unclassified Oral
Background Rituximab Monoclonal antibody Intravenous
Background Vincristine Small molecule Intravenous