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Not yet recruitingNCT07712588Updated Aug 5, 2026

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

A Phase 2/3 interventional study of Birelentinib and Rituximab in Diffuse Large B-Cell Lymphoma (DLBCL), sponsored by Dizal Pharmaceuticals. Not yet recruiting at 5 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-05.

Sponsored by Dizal Pharmaceuticals · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
880
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diffuse Large B-Cell Lymphoma (DLBCL)
03

In context

Lymphoma, Large B-Cell, Diffuse

1,390 studies on the registry are indexed under Lymphoma, Large B-Cell, Diffuse; 350 are open to participants now.

This study's planned enrollment of 880 is above the median of 47 across 1,185 interventional studies indexed under Lymphoma, Large B-Cell, Diffuse.

Browse Lymphoma, Large B-Cell, Diffuse studies →

Lead sponsor

Dizal Pharmaceuticals is the lead sponsor of 37 studies on the registry; 15 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 1 (7%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
880 participants (estimated)

Study arms

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

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

  • Placebo comparator
    Placebo + R-CHOP

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

Interventions

  • DrugBirelentinib

    Specified dose on specified days

    Also known as: DZD8586

  • DrugRituximab

    Specified dose on specified days

  • DrugCyclophosphamid

    Specified dose on specified days

  • DrugDoxorubicin

    Specified dose on specified days

  • DrugVincristine

    Specified dose on specified days

  • DrugPrednisone

    Specified dose on specified days

  • DrugPlacebo

    Specified dose on specified days

06

What researchers measure

Primary outcomes

  1. Part A: Incidence and severity of adverse events

    Time frame: Up to 2 years

  2. Part B: Progression-free survival (PFS)

    Time frame: Up to 5 years

Secondary outcomes

  1. Part A: Objective response rate (ORR)

    Time frame: Up to 5 years

  2. Part A: Complete response rate (CRR)

    Time frame: Up to 5 years

  3. Part B: Event-free survival (EFS)

    Time frame: Up to 5 years

  4. Part B: Overall Survival (OS)

    Time frame: Approximately 5 years

  5. Part B: Objective response rate (ORR)

    Time frame: Up to 5 years

  6. Part B: Complete response rate (CRR)

    Time frame: Up to 5 years

  7. Part B: Incidence and severity of adverse events

    Time frame: Up to 2 years

07

Study locations

5 sites
  • Chongqing University Cancer Hospital
    Chongqing, Chongqing Municipality, China
    • Liu · Contact
  • Harbin Medical University Cancer Hospital
    Harbin, Heilongjiang, China
    • Zhang · Contact
  • Hunan Cancer Hospital
    Changsha, Hunan, China
    • Zhou · Contact
  • Cancer Hospital of Shandong Frist Medical University
    Jinan, Shangdong, China
    • Li · Contact
  • Shanghai Jiao Tong University School of Medicine, Ruijin Hospital
    Shanghai, Shanghai Municipality, China
    • Zhao · Contact
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07712588
Lead sponsor
Dizal Pharmaceuticals
Responsible party
Sponsor
First posted
Jul 17, 2026
Start date
Sep 2026 (estimated)
Primary completion
Jan 2031 (estimated)
Completion
Feb 2032 (estimated)
Last update
Aug 5, 2026

Study contacts

Liu
Contact
ziyi.liu@dizalpharma.com
+86-21-61095852
Zhao
principal investigator · Ruijin Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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