NCT07712588Not yet recruitingPhase 2/3
Birelentinib Plus R-CHOP in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma (TAI-SHAN19)
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
Source: ClinicalTrials.gov · Last updated 5 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 880 (estimated)
- First submitted
- 14 Jul 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 31 Jan 2031
- Lead sponsor
- Dizal Pharmaceuticals
- Diseases
- Diffuse large B-cell lymphoma
- NCT number
- NCT07712588
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 880
- From 1 Sept 2026 to the primary completion date, 31 Jan 2031
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hunan Cancer Hospital Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
| Chongqing University Cancer Hospital Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Unknown status |
| Cancer Hospital of Shandong Frist Medical University Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Shanghai Jiao Tong University School of Medicine - Ruijin Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.