NCT07712588尚未招募2 期
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
Dizal Pharmaceuticals5 个研究点 分布在 1 个国家目标入组 880 人开始时间: 2026年9月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 880
- 试验地点
- 5
- 主要终点
- Part B: Progression-free survival (PFS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Placebo + R-CHOP
Placebo Comparator
干预措施: Vincristine (Drug)
Placebo + R-CHOP
Placebo Comparator
干预措施: Doxorubicin (Drug)
Birelentinib + R-CHOP (Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone)
Experimental
干预措施: Rituximab (Drug)
Birelentinib + R-CHOP (Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone)
Experimental
干预措施: Doxorubicin (Drug)
Birelentinib + R-CHOP (Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone)
Experimental
干预措施: Vincristine (Drug)
Placebo + R-CHOP
Placebo Comparator
干预措施: Rituximab (Drug)
Birelentinib + R-CHOP (Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone)
Experimental
干预措施: Prednisone (Drug)
Birelentinib + R-CHOP (Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone)
Experimental
干预措施: Birelentinib (Drug)
Placebo + R-CHOP
Placebo Comparator
干预措施: Placebo (Drug)
Birelentinib + R-CHOP (Rituximab, Cyclosphosphamide, Doxorubicin, Vincristine and Prednisone)
Experimental
干预措施: Cyclophosphamid (Drug)
Placebo + R-CHOP
Placebo Comparator
干预措施: Prednisone (Drug)
Placebo + R-CHOP
Placebo Comparator
干预措施: Cyclophosphamid (Drug)
结局指标
主要结局
Part B: Progression-free survival (PFS)
时间窗: Up to 5 years
Part A: Incidence and severity of adverse events
时间窗: Up to 2 years
次要结局
- Part A: Objective response rate (ORR)(Up to 5 years)
- Part A: Complete response rate (CRR)(Up to 5 years)
- Part B: Event-free survival (EFS)(Up to 5 years)
- Part B: Overall Survival (OS)(Approximately 5 years)
- Part B: Objective response rate (ORR)(Up to 5 years)
- Part B: Complete response rate (CRR)(Up to 5 years)
- Part B: Incidence and severity of adverse events(Up to 2 years)
研究者
研究点 (5)
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