Clinical trial · Interventional
Birelentinib Plus R-CHOP in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma (TAI-SHAN19)
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
NCT07712588CI-TRIAL-00120563not yet recruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-Cell Lymphoma (DLBCL) | Diffuse Large B-Cell Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Birelentinib | Drug | — | UNRESOLVED |
| Cyclophosphamid | Drug | — | UNRESOLVED |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| Prednisone | Drug | Prednisone | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Birelentinib + R-CHOP (Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone)
- interventionNames
- Drug: Birelentinib
- Drug: Rituximab
- Drug: Cyclophosphamid
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Prednisone
- type
- PLACEBO_COMPARATOR
- label
- Placebo + R-CHOP
- interventionNames
- Drug: Rituximab
- Drug: Cyclophosphamid
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Prednisone
- Drug: Placebo
Primary outcomes (2)
- measure
- Part A: Incidence and severity of adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.