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RECRUITING
NCT07778212
NA

Orelabrutinib Combined With Pola-R-CHP as First-Line Treatment for Patients With Intermediate- to High-Risk DLBCL

Sponsor: The First Affiliated Hospital of Xiamen University

View on ClinicalTrials.gov

Summary

To evaluate orelabrutinib in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) as first-line treatment for patients with intermediate- to high-risk diffuse large B-cell lymphoma (DLBCL).

Official title: A Translational Study of Orelabrutinib Combined With Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP) as First-Line Treatment for Patients With Intermediate- to High-Risk Diffuse Large B-Cell Lymphoma (DLBCL)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-08-30

Completion Date

2028-12-31

Last Updated

2026-08-21

Healthy Volunteers

No

Interventions

DRUG

Orelabrutinib Combined with Pola-R-CHP Regimen

Participants will receive orelabrutinib 150 mg orally once daily on Days 1-21 of each 21-day cycle. Polatuzumab vedotin will be administered intravenously at 1.8 mg/kg once every 21 days in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for 6 cycles. During Cycles 7 and 8, participants will receive rituximab in combination with orelabrutinib. Thereafter, orelabrutinib maintenance therapy will be continued for up to 1 year.

Locations (2)

the First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

the First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China