Zanubrutinib Combined With R-CHOP in the Treatment of Newly Diagnosed DLBCL With p53 Protein Expression

Diffuse Large B Cell Lymphoma Clinical Trial

Official title: Zanubrutinib Combined With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in the Treatment of Newly Diagnosed Diffuse Large B-cell Lymphoma With p53 Protein Expression

Status Recruiting

Clinical Trial Summary

This study aim to evaluate the efficacy and safety of zanubrutinib combined with R-CHOP in the treatment of DLBCL patients with p53 protein expression.

Clinical Trial Description

This is a prospective, single arm, single center study,it plans to recruit 41 newly diagnosed DLBCL patients with p53 protein expression(≥50%).According to Simon's two-stage optimal design criteria, 19 eligible patients were recruited in the first phase, and at least 12 patients were required to achieve complete response to enter the second phase. In phase 2, additional 22 patients were recruited. These patients will receive zanubrutinib plus RCHOP for 6 cycles. After 4 treatment cycles, an interim response assessment will be performed to evaluate disease progression for each participant. Participants with progressive or stable disease will be discontinued from treatment，Participants with complete/partial response will continue ZRCHOP until 6 cycles are completed.After completion of study drug, participants will undergo assessment of tumor response based on the Revised Response Criteria for Malignant Lymphoma. ;

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

• NCT number: NCT06005870
• Study type: Interventional
• Source: Huazhong University of Science and Technology
• Contact: Liling Zhang, M.D
• Phone: 15871725926
• Email: 15871725926lily1228@sina.com
• Status: Recruiting
• Phase: Phase 2
• Start date: November 26, 2022
• Completion date: December 2026