NCT06468943

Polatuzumab Vedotin and Zanubrutinib Plus R-CHP for Patients With Newly Diagnosed Untreated Non-GCB DLBCL

Polatuzumab Vedotin and Zanubrutinib Plus R-CHP for Patients in Treatment of Newly Diagnosed Untreated Non-GCB DLBCL With Extranodal Involvement.

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Aim of this study will evaluate the efficacy and safety of Polatuzumab Vedotin and Zanubrutinib in combination with R-CHP for newly diagnosed untreated Non-GCB DLBCL Patients with extranodal involvement.

Detailed description

Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin's lymphoma. According to Hans' algorithms, DLBCL can be identified as 2 subtypes: germinal b-cell-like(GCB) and non-germinal b-cell-like(non-GCB). Approximately 50 to 60% of DLBCL was non-GCB subtype DLBCL.The non-GCB DLBCL revealed poor clinical outcomes. Bruton's tyrosine kinase (BTK) inhibitors have established therapeutic activity in B cell malignancies, with potential activity in non-GCB DLBCL. The POLARIX study also observed an benefit in the efficacy of Polatuzumab Vedotin in first-line treatment of DLBCL patients. This study will evaluate the efficacy and safety of Polatuzumab Vedotin and Zanubrutinib in combination with R-CHP for newly diagnosed untreated Non-GCB DLBCL Patients with extranodal involvement.

Conditions

• Effects of Chemotherapy
• Safety Issues

Interventions

Type	Name	Description
DRUG	Polatuzumab Vedotin	1.8mg/kg/21d（d0） Intravenous infusion
DRUG	Zanubrutinib	160mg bid PO（d0-d20）
DRUG	Rituximab	375mg/㎡/21d（d0） Intravenous infusion
DRUG	Cyclophosphamide	750mg/㎡/21d（d1） Intravenous infusion
DRUG	Doxorubicin	50mg/㎡/21d（d1） Intravenous infusion
DRUG	Prednisone	100mg PO （d1-d5）/21d

Timeline

• Start date: 2023-07-01
• Primary completion: 2026-05-01
• Completion: 2028-05-01
• First posted: 2024-06-21
• Last updated: 2024-06-21

Locations

1 site across 1 country: China