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NOT YET RECRUITING
NCT07712588
PHASE2/PHASE3

Birelentinib Plus R-CHOP in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma (TAI-SHAN19)

Sponsor: Dizal Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study will treat patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL). It will assess the anti-tumor efficacy and safety of birelentinib plus rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) vs placebo plus R-CHOP.

Official title: A Phase 2/3, Randomized, Double-Blind, Multi-center Study of Birelentinib Combined With R-CHOP in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

880

Start Date

2026-09

Completion Date

2032-02

Last Updated

2026-08-05

Healthy Volunteers

No

Interventions

DRUG

Birelentinib

Specified dose on specified days

DRUG

Rituximab

Specified dose on specified days

DRUG

Cyclophosphamid

Specified dose on specified days

DRUG

Doxorubicin

Specified dose on specified days

DRUG

Vincristine

Specified dose on specified days

DRUG

Prednisone

Specified dose on specified days

DRUG

Placebo

Specified dose on specified days

Locations (5)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Hunan Cancer Hospital

Changsha, Hunan, China

Cancer Hospital of Shandong Frist Medical University

Jinan, Shangdong, China

Shanghai Jiao Tong University School of Medicine, Ruijin Hospital

Shanghai, Shanghai Municipality, China