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

NCT07712588
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Phase
Phase 2/Phase 3
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Recruitment status
Not yet recruiting
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Participants
880
clinicaltrials.gov
Lead sponsor
Dizal Pharmaceuticals
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Start date
2026-09-01
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Number of sites
5
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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.
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Short title
Birelentinib Plus R-CHOP in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma (TAI-SHAN19)
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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
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Not yet recruiting
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Phase
Phase 2/Phase 3
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Study type
Interventional
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Completion date
2032-02-01
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First posted
2026-07-17
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Registry last updated
2026-08-05
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Primary completion date
2031-01-01
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Start date
2026-09-01
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Participants
880
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Participant count basis
Estimated
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Planned participants
880
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Protocol amendments
0
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Number of sites
5
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Registry sponsor category
Industry
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Lead sponsor
Dizal Pharmaceuticals
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07712588
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ClinicalTrials.gov ID
NCT07712588
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  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

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
70 Years
Healthy volunteers
No

  • 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

  • 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
clinicaltrials.gov

  • 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
clinicaltrials.gov

Related records

Drugs (4)

Lead sponsors (1)

Conditions (2)

Targets (18)