Birelentinib Added to R-CHOP Chemotherapy for Newly Diagnosed Diffuse Large B-Cell Lymphoma
Tests birelentinib with R-CHOP in adults newly diagnosed with diffuse large B-cell lymphoma.
Plain-language title generated from the registry record
Registry title: Birelentinib Plus R-CHOP in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma (TAI-SHAN19)
Key facts
- Where
- Changsha, Chongqing, Harbin, Jinan, and Shanghai, ChinaSee the 5 sites
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07712588, who can take part
Where in China
- Hunan Cancer HospitalChangsha, ChinaNo longer taking part
- Chongqing University Cancer HospitalChongqing, ChinaNo longer taking part
- Harbin Medical University Cancer HospitalHarbin, ChinaNo longer taking part
- Cancer Hospital of Shandong Frist Medical UniversityJinan, ChinaNo longer taking part
- Shanghai Jiao Tong University School of Medicine - Ruijin HospitalShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Dizal Pharmaceuticals
- Trial code
- NCT07712588
- Record updated
- 5 August 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Age 18-70 years; ECOG score 0-2; Pathologically confirmed DLBCL unspecified (DLBCL, NOS); No prior anti-lymphoma therapy; Ann Arbor Stages II - IV; IPI score ≥ 3, or IPI score 1 - 2 and LDH > 1.3 × ULN and/or lesion diameter ≥ 7 cm; Adequate bone marrow and organ function; Willing to comply with contraceptive restrictions.
Exclusion: Vaccination with live attenuated vaccines or viral vector vaccines within 4 weeks prior to treatment; Taking vitamin K antagonists, taking 2 or more antiplatelet/anticoagulant drugs at the same time, drugs/herbs or supplements known to potently induce or inhibit CYP3A enzyme activity, anti-tumor traditional Chinese medicine; Major surgery within 4 weeks or anticipated surgery after the start of this study; Intractable nausea and vomiting that cannot be well controlled by supportive treatment, chronic gastrointestinal diseases, dysphagia, or previous surgical resection of the intestinal segment may affect the adequate absorption of the drug; Clinically significant cardiac disorders. History of thrombotic diseases, stroke or intracranial hemorrhage within 6 months; Active infectious diseases; Diagnosed with other malignant diseases other than B-cell lymphoma within the past 2 years; Patients with severe or uncontrolled systemic diseases, including poorly controlled hypertension and active bleeding constitution; Patients with a history of hypersensitivity to any component of the R-CHOP regimen, DZD8586 drug excipients, or other chemical analogues; Serious medical or psychiatric illness that could affect participation in the study or could compromise the ability to consent; Indolent lymphoma or Richter transformation, primary mediastinal lymphoma, lymphoma invading the central nervous system or high-grade lymphoma with MYC and BCL2 rearrangements; Peripheral neuropathy ≥ Grade 2 (as defined by CTCAE version 6.0); Women who are pregnant or breastfeeding.