Not yet recruiting NCT07712588
Birelentinib Plus R-CHOP in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma (TAI-SHAN19)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Birelentinib, Rituximab, Cyclophosphamid, Doxorubicin.
- Who it may be relevant to
- Registry conditions: Diffuse Large B-Cell Lymphoma (DLBCL). Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug Birelentinib
Specified dose on specified days - Drug Rituximab
Specified dose on specified days - Drug Cyclophosphamid
Specified dose on specified days - Drug Doxorubicin
Specified dose on specified days - Drug Vincristine
Specified dose on specified days - Drug Prednisone
Specified dose on specified days - Drug Placebo
Specified dose on specified days
Primary outcome measures
- Part A: Incidence and severity of adverse events [Time frame: Up to 2 years]
- Part B: Progression-free survival (PFS) [Time frame: Up to 5 years]
Secondary outcome measures (7)
- Part A: Objective response rate (ORR) [Time frame: Up to 5 years]
- Part A: Complete response rate (CRR) [Time frame: Up to 5 years]
- Part B: Event-free survival (EFS) [Time frame: Up to 5 years]
- Part B: Overall Survival (OS) [Time frame: Approximately 5 years]
- Part B: Objective response rate (ORR) [Time frame: Up to 5 years]
- Part B: Complete response rate (CRR) [Time frame: Up to 5 years]
- Part B: Incidence and severity of adverse events [Time frame: Up to 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 5 centers
- Chongqing University Cancer Hospital — Chongqing
- Harbin Medical University Cancer Hospital — Harbin
- Hunan Cancer Hospital — Changsha
- Cancer Hospital of Shandong Frist Medical University — Jinan
- Shanghai Jiao Tong University School of Medicine, Ruijin Hospital — Shanghai
Identifiers
NCT: NCT07712588 · DZ2025B0006