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

July 14, 2026 updated by: Dizal Pharmaceuticals

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

880

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • Chongqing University Cancer Hospital
        • Contact:
          • Liu
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Harbin Medical University Cancer Hospital
        • Contact:
          • Zhang
    • Hunan
      • Changsha, Hunan, China
        • Hunan Cancer Hospital
        • Contact:
          • Zhou
    • Shangdong
      • Jinan, Shangdong, China
        • Cancer Hospital of Shandong Frist Medical University
        • Contact:
          • Li
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Shanghai Jiao Tong University School of Medicine, Ruijin Hospital
        • Contact:
          • Zhao

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo + R-CHOP
Drug: Placebo
Specified dose on specified days
Drug: Rituximab
Specified dose on specified days
Drug: Prednisone
Specified dose on specified days
Drug: Doxorubicin
Specified dose on specified days
Drug: Vincristine
Specified dose on specified days
Drug: Cyclophosphamid
Specified dose on specified days
Experimental: Birelentinib + R-CHOP (Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone)
Drug: Rituximab
Specified dose on specified days
Drug: Prednisone
Specified dose on specified days
Drug: Doxorubicin
Specified dose on specified days
Drug: Vincristine
Specified dose on specified days
Drug: Birelentinib
Specified dose on specified days
Other Names:
  • DZD8586
Drug: Cyclophosphamid
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Part A: Incidence and severity of adverse events
Time Frame: Up to 2 years
Up to 2 years
Part B: Progression-free survival (PFS)
Time Frame: Up to 5 years
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Part B: Overall Survival (OS)
Time Frame: Approximately 5 years
Approximately 5 years
Part A: Objective response rate (ORR)
Time Frame: Up to 5 years
Up to 5 years
Part A: Complete response rate (CRR)
Time Frame: Up to 5 years
Up to 5 years
Part B: Event-free survival (EFS)
Time Frame: Up to 5 years
Up to 5 years
Part B: Objective response rate (ORR)
Time Frame: Up to 5 years
Up to 5 years
Part B: Complete response rate (CRR)
Time Frame: Up to 5 years
Up to 5 years
Part B: Incidence and severity of adverse events
Time Frame: Up to 2 years
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dizal Pharmaceuticals

Investigators

  • Principal Investigator: Zhao, Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2027

Primary Completion (Estimated)

January 1, 2031

Study Completion (Estimated)

February 1, 2032

Study Registration Dates

First Submitted

July 14, 2026

First Submitted That Met QC Criteria

July 14, 2026

First Posted (Actual)

July 17, 2026

Study Record Updates

Last Update Posted (Actual)

July 17, 2026

Last Update Submitted That Met QC Criteria

July 14, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DZ2025B0006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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