Birelentinib Plus R-CHOP in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma (TAI-SHAN19)
NCT07712588 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 880
Last updated 2026-08-05
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.
Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL)
Interventions
- DRUG
-
Birelentinib
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- DRUG
-
Cyclophosphamid
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- DRUG
-
Vincristine
Specified dose on specified days
- DRUG
-
Specified dose on specified days
- DRUG
-
Specified dose on specified days
Sponsors & Collaborators
-
Dizal Pharmaceuticals
lead INDUSTRY
Principal Investigators
-
Zhao · Ruijin Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-30
- Primary Completion
- 2031-01-31
- Completion
- 2032-02-29
Countries
- China
Study Locations
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