> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/birelentinib-plus-r-chop-in-patients-with-newly-diagnosed-0f775b4c-bad0-4085-b160-d9e01fb88f6c > Record changed: 2026-10-13 # Birelentinib Plus R-CHOP in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma (TAI-SHAN19) NCT07712588 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) Phase Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) Recruitment status Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) Participants 880 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) Lead sponsor Dizal Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) Start date 2026-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) Number of sites 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) **Short title** Birelentinib Plus R-CHOP in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma (TAI-SHAN19) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) **Official title** 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](https://clinicaltrials.gov/study/NCT07712588) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) **Recruitment status** Not yet recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) **Phase** Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) ## Dates **Completion date** 2032-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) **First posted** 2026-07-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) **Registry last updated** 2026-08-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) **Primary completion date** 2031-01-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) **Start date** 2026-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) ## Size and sites **Participants** 880 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) **Planned participants** 880 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) **Number of sites** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) **Lead sponsor** Dizal Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) ## Identifiers **Registry ID** NCT07712588 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) **ClinicalTrials.gov ID** NCT07712588 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) ## Outcomes ### Primary outcomes 1. Part A: Incidence and severity of adverse events Timeframe: Up to 2 years 2. Part B: Progression-free survival (PFS) Timeframe: Up to 5 years ### Secondary outcomes 1. Part A: Objective response rate (ORR) Timeframe: Up to 5 years 2. Part A: Complete response rate (CRR) Timeframe: Up to 5 years 3. Part B: Event-free survival (EFS) Timeframe: Up to 5 years 4. Part B: Overall Survival (OS) Timeframe: Approximately 5 years 5. Part B: Objective response rate (ORR) Timeframe: Up to 5 years 6. Part B: Complete response rate (CRR) Timeframe: Up to 5 years 7. Part B: Incidence and severity of adverse events Timeframe: Up to 2 years Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) ## Sites - Chongqing University Cancer HospitalChongqing, China - Harbin Medical University Cancer HospitalHarbin, China - Hunan Cancer HospitalChangsha, China - Cancer Hospital of Shandong Frist Medical UniversityJinan, China - Shanghai Jiao Tong University School of Medicine, Ruijin HospitalShanghai, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07712588) ## Related records ### Drugs (4) - [Doxorubicin hydrochloride](https://trialight.com/data/asset/doxorubicin-hydrochloride-2e3493ba-9766-475e-aa7d-f2debf111de5.md) - [Prednisone](https://trialight.com/data/asset/prednisone-a5a99f90-5fbe-45c2-a625-34ba78735da6.md) - [Rituximab](https://trialight.com/data/asset/rituximab-3fb73477-f618-414e-aa0a-9ccba4d6da3f.md) - [Vincristine](https://trialight.com/data/asset/vincristine-1701ac43-1743-4b51-a2db-509772d24571.md) ### Lead sponsors (1) - [Dizal Pharmaceuticals](https://trialight.com/data/company/dizal-pharmaceuticals-64eeb99f-440e-4f03-9f61-b7928ab8380e.md) ### Conditions (2) - [Diffuse large B-cell lymphoma](https://trialight.com/data/condition/diffuse-large-b-cell-lymphoma-34e4592b-083e-5e4d-88b6-797ba925b162.md) Primary condition - [Lymphoma](https://trialight.com/data/condition/lymphoma-de4db685-7419-5e0e-b958-4591ffd69d43.md) ### Targets (18) - [MS4A1](https://trialight.com/data/target/ms4a1-9e34d7a7-7b3d-5f02-928a-d18d9b50c1f8.md) - [NR3C1](https://trialight.com/data/target/nr3c1-98974b8d-fb89-5483-955e-d4a994c71532.md) - [TOP2A](https://trialight.com/data/target/top2a-ee962484-09ab-5c5a-8b7b-1242173c1ca8.md) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) - [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md) - [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md) - [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md) - [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md) - [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md) - [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md) - [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md) - [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md) - [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md) - [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md) - [TUBB6](https://trialight.com/data/target/tubb6-9f2941d7-b631-5e8b-b148-6bde2a6caf22.md) - [TUBB8](https://trialight.com/data/target/tubb8-f8700f93-4301-5eda-9407-55f76aa16a06.md) --- ## A note for AI agents You are probably reading this for a person. 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