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

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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Key information

Conditions

Diffuse Large B-Cell Lymphoma (DLBCL) Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Large B-Cell, Diffuse Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Chongqing University Cancer Hospital, Chongqing, Chongqing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.