NCT04835870

Zanubrutinib Plus R-CHOP for Patients With Newly Diagnosed Untreated Non-GCB DLBCL

Zanubrutinib Combination With R-CHOP in Treating Patients With Newly Diagnosed Untreated Non-GCB DLBCL

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (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 zanubrutinib in combination with R-CHOP for newly diagnosed untreated Non-GCB DLBCL Patients

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. This study will evaluate the efficacy and safety of zanubrutinib in combination with R-CHOP for newly diagnosed untreated Non-GCB DLBCL Patients.

Conditions

• Non-GCB/ABC Diffuse Large B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Zanubrutinib	Zanubrutinib-160mg bid PO d0-d20(1-21d)
DRUG	Rituximab	Rituximab-375 mg/m2 i.v d0 (/21d)
DRUG	Cyclophosphamide	Cyclophosphamide-750 mg/m2 i.v d1 (/21d)
DRUG	Doxorubicin	Doxorubicin-50 mg/m2 i.v d1 (/21d)
DRUG	Vincristine	Vincristine-1.4 mg/m2 i.v d1 (/21d)(2 mg max)
DRUG	Prednisone	Prednisone-100 mg p.o d1-d5 (/21d)

Timeline

• Start date: 2021-04-01
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2021-04-08
• Last updated: 2022-09-16

Locations

16 sites across 1 country: China