Not Yet RecruitingPhase 2/3

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

China880 participantsStarted 2026-09

Plain-language 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.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 ly…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part A: Incidence and severity of adverse events

Timeframe: Up to 2 years

Part B: Progression-free survival (PFS)

Timeframe: Up to 5 years

Trial details

NCT IDNCT07712588

SponsorDizal Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2031-01

Contact for this trial

Liu

+86-21-61095852 ziyi.liu@dizalpharma.com

View on ClinicalTrials.gov More Diffuse Large B-Cell Lymphoma (DLBCL) trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.