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

NCT07712588 | Not Yet Recruiting Phase 2

• 1 other identifier: DZ2025B0006
• Study Type: interventional
• Target: 880
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Diffuse Large B-Cell Lymphoma (DLBCL)

Outcome Measures

Primary Outcomes (2)

• Part A: Incidence and severity of adverse events

  Up to 2 years

• Part B: Progression-free survival (PFS)

  Up to 5 years

Secondary Outcomes (7)

• Part A: Objective response rate (ORR)

  Up to 5 years

• Part A: Complete response rate (CRR)

  Up to 5 years

• Part B: Event-free survival (EFS)

  Up to 5 years

• Part B: Overall Survival (OS)

  Approximately 5 years

• Part B: Objective response rate (ORR)

  Up to 5 years

Study Arms (2)

Birelentinib + R-CHOP (Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone)

EXPERIMENTAL

Drug: Birelentinib; Drug: Rituximab; Drug: Cyclophosphamid; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone

Placebo + R-CHOP

PLACEBO COMPARATOR

Drug: Rituximab; Drug: Cyclophosphamid; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Placebo

Interventions

Rituximab DRUG

Specified dose on specified days

Birelentinib + R-CHOP (Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone); Placebo + R-CHOP

Cyclophosphamid DRUG

Specified dose on specified days

Birelentinib + R-CHOP (Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone); Placebo + R-CHOP

Doxorubicin DRUG

Specified dose on specified days

Birelentinib + R-CHOP (Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone); Placebo + R-CHOP

Vincristine DRUG

Specified dose on specified days

Birelentinib + R-CHOP (Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone); Placebo + R-CHOP

Prednisone DRUG

Specified dose on specified days

Birelentinib + R-CHOP (Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone); Placebo + R-CHOP

Placebo DRUG

Specified dose on specified days

Placebo + R-CHOP

Birelentinib DRUG

Specified dose on specified days

Also known as: DZD8586

Birelentinib + R-CHOP (Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dizal Pharmaceuticals: lead

Study Sites (5)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Location

Hunan Cancer Hospital

Changsha, Hunan, China

Location

Cancer Hospital of Shandong Frist Medical University

Jinan, Shangdong, China

Location

Shanghai Jiao Tong University School of Medicine, Ruijin Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Rituximab; Cyclophosphamide; Doxorubicin; Vincristine; Prednisone

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Zhao

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liu

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 17, 2026
• Study Start (Estimated): September 1, 2027
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): February 1, 2032
• Last Updated: July 17, 2026

Record last verified: 2026-07

Locations

CN (5)