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Clinical Trials in China / NCT07712588
Starting soon Phase 2/3

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

NCT07712588 · tracked via the Priya Life Science China tracker
Sponsor
Dizal Pharmaceuticals
Phase
Phase 2/3
Started
2026-09
Last updated
2026-08-05

Condition(s) studied

Diffuse Large B-Cell Lymphoma (DLBCL)

Investigational drug(s) / intervention(s)

BirelentinibRituximabCyclophosphamidDoxorubicinVincristinePrednisonePlacebo

Birelentinib: Specified dose on specified days

Rituximab: Specified dose on specified days

Cyclophosphamid: Specified dose on specified days

Doxorubicin: Specified dose on specified days

Vincristine: Specified dose on specified days

Prednisone: Specified dose on specified days

Placebo: Specified dose on specified days

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * Indolent lymphoma or Richter transformation, primary mediastinal lymphoma, lymphoma invading the central nervous system or high-grade lymphoma with MYC and BCL2 rearrangements. * 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. * Clinically significant cardiac disorders. History of thrombotic diseases, stroke or intracranial hemorrhage within 6 months. * Active infectious diseases. * Peripheral neuropathy ≥ Grade 2 (as defined by CTCAE version 6.0) * 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. * 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. * Women who are pregnant or breastfeeding.

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
Chongqing University Cancer Hospital Chongqing Chongqing Municipality
Harbin Medical University Cancer Hospital Harbin Heilongjiang
Hunan Cancer Hospital Changsha Hunan
Cancer Hospital of Shandong Frist Medical University Jinan Shangdong
Shanghai Jiao Tong University School of Medicine, Ruijin Hospital Shanghai Shanghai Municipality

On this site

📄 Rituxan (rituximab) drug profile → 📄 Deltasone (prednisone) drug profile →

More Dizal Pharmaceuticals trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07712588 on ClinicalTrials.gov ↗ ← All trials in China