A Multicenter, Phase Ib/II Clinical Study of Polatuzumab Vedotin in Combination With Rituximab and Chidamide for Untreated Elderly Diffuse Large B-cell Lymphoma Patients With Double Expression of MYC and BCL2
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 主要终点
- DLT for Phase 1b
研究概览
简要总结
This is a single-arm, prospective, multicenter, open-label phase Ib/II study to evaluate the safety and efficacy of polatuzumab vedotin in combination with rituximab and chidamide in previously untreated elderly patients with MYC/BCL2 double-expressor diffuse large B-cell lymphoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily participate in the clinical study; fully understand and be informed about the study and sign the Informed Consent Form (ICF); willing to comply with and capable of completing all trial procedures;
- •Age ≥70 years, or age 60-69 years with frailty determined by comprehensive geriatric assessment (CGA).
- •Pathologically confirmed diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) with MYC/BCL2 double expression, and no double-hit or triple-hit lymphoma.
- •At least one measurable or evaluable lesion according to the Lugano 2014 criteria.
- •No prior systemic therapy for DLBCL.
- •Adequate organ and bone marrow function.
排除标准
- •Other subtypes of DLBCL.
- •Lymphoma involvement in the central nervous system or meninges.
- •Active infections.
- •History of Human Immunodeficiency Virus (HIV) infection and/or Acquired Immunodeficiency Syndrome (AIDS).
- •Patients with mental disorders or those unable to provide informed consent
- •Any other condition deemed by the investigator to be unsuitable for study enrollment.
- •Known hypersensitivity to any investigational drug.
研究组 & 干预措施
Polatuzumab Vedotin in Combination With Rituximab and Chidamide
Participants receive polatuzumab vedotin in combination with rituximab and chidamide. Polatuzumab vedotin and rituximab are administered intravenously on Day 1 of each 21-day cycle according to the protocol-specified schedule. Chidamide is administered orally twice weekly, with an initial dose of 20 mg from Day 1 to Day 14, and at the RP2D dose level in the extension phase. Combination therapy is given for up to six cycles. Patients achieving complete response after combination therapy may receive chidamide monotherapy as maintenance treatment according to the study protocol.
干预措施: Polatuzumab Vedotin (Drug)
Polatuzumab Vedotin in Combination With Rituximab and Chidamide
Participants receive polatuzumab vedotin in combination with rituximab and chidamide. Polatuzumab vedotin and rituximab are administered intravenously on Day 1 of each 21-day cycle according to the protocol-specified schedule. Chidamide is administered orally twice weekly, with an initial dose of 20 mg from Day 1 to Day 14, and at the RP2D dose level in the extension phase. Combination therapy is given for up to six cycles. Patients achieving complete response after combination therapy may receive chidamide monotherapy as maintenance treatment according to the study protocol.
干预措施: Rituximab (R) (Drug)
Polatuzumab Vedotin in Combination With Rituximab and Chidamide
Participants receive polatuzumab vedotin in combination with rituximab and chidamide. Polatuzumab vedotin and rituximab are administered intravenously on Day 1 of each 21-day cycle according to the protocol-specified schedule. Chidamide is administered orally twice weekly, with an initial dose of 20 mg from Day 1 to Day 14, and at the RP2D dose level in the extension phase. Combination therapy is given for up to six cycles. Patients achieving complete response after combination therapy may receive chidamide monotherapy as maintenance treatment according to the study protocol.
干预措施: Chidamide (Drug)
结局指标
主要结局
DLT for Phase 1b
时间窗: The first cycle after administration (each cycle is 21 days)
To identify the dose-limiting toxicity
RP2D for phase Ib
时间窗: The first cycle after administration (each cycle is 21 days)
To identify the recommended phase 2 dose
Complete response rate (CRR) for Phase 2
时间窗: Up to 6 cycles (every cycle is 21 days)
The proportion of patients who achieve complete remission (CR).
次要结局
- Overall survival (OS)(Up to 5 years)
- Progression-free survival (PFS)(Up to 5 years)
- Overall response rate (ORR)(Up to 6 cycles (every cycle is 21 days))
- Duration of Response (DOR)(Up to 5 years)
研究者
Qingqing Cai
Principal Investigator
Sun Yat-sen University