A Phase Ib/II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Lisatoclax in Combination With R-CHOP or Pola-R-CHP in Patients With Previously Untreated DLBCL
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicity (DLT) for Phase 1b
研究概览
简要总结
This is a prospective, multicenter, open-label Phase Ib/II clinical study designed to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics of lisatoclax in combination with R-CHOP or Pola-R-CHP in patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. 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.
- •2. Diagnosed with DLBCL according to 2022 revised WHO lymphoma classification standards based on pathological diagnosis by the research center. For the dose-expansion phase, BCL-2 positivity (≥50% by IHC) is required.
- •3. Age 18-70 years.
- •4. No prior systemic anti-lymphoma therapy.
- •5. Adequate organ and bone marrow function.
- •6. At least one measurable or evaluable disease site according to the Lugano 2014 lymphoma efficacy evaluation criteria.
- •7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
排除标准
- •1. Lymphoma involvement in the central nervous system or meninges.
- •2. Active infections.
- •3. Uncontrolled clinical cardiac symptoms or diseases.
- •4. Currently using (or unable to stop at least one week prior to the first dose) a known CYP3A strong inducer or strong inhibitor.
- •5. Pregnant and lactating women, and subjects of childbearing age who do not want to use contraception.
- •6. History of Human Immunodeficiency Virus (HIV) infection and/or Acquired Immunodeficiency Syndrome (AIDS).
- •7. Patients with mental disorders or those unable to provide informed consent
研究组 & 干预措施
Lisatoclax Combined with R-CHOP or Pola-R-CHP
In Cohort 1, patients will receive standard-dose R-CHOP in combination with an initial dose of 400 mg of lisaftoclax. Each treatment cycle is 21 days. The lisaftoclax will be combined with R-CHOP at the RP2D dose level for an extension study.
In Cohort 2, patients will receive standard-dose Pola-R-CHP in combination with an initial dose of 400 mg of lisaftoclax. Each treatment cycle is 21 days. The lisaftoclax will be combined with Pola-R-CHP at the RP2D dose level for an extension study.
干预措施: R-CHOP (Drug)
Lisatoclax Combined with R-CHOP or Pola-R-CHP
In Cohort 1, patients will receive standard-dose R-CHOP in combination with an initial dose of 400 mg of lisaftoclax. Each treatment cycle is 21 days. The lisaftoclax will be combined with R-CHOP at the RP2D dose level for an extension study.
In Cohort 2, patients will receive standard-dose Pola-R-CHP in combination with an initial dose of 400 mg of lisaftoclax. Each treatment cycle is 21 days. The lisaftoclax will be combined with Pola-R-CHP at the RP2D dose level for an extension study.
干预措施: POLA-R-CHP (Drug)
Lisatoclax Combined with R-CHOP or Pola-R-CHP
In Cohort 1, patients will receive standard-dose R-CHOP in combination with an initial dose of 400 mg of lisaftoclax. Each treatment cycle is 21 days. The lisaftoclax will be combined with R-CHOP at the RP2D dose level for an extension study.
In Cohort 2, patients will receive standard-dose Pola-R-CHP in combination with an initial dose of 400 mg of lisaftoclax. Each treatment cycle is 21 days. The lisaftoclax will be combined with Pola-R-CHP at the RP2D dose level for an extension study.
干预措施: Lisaftoclax (Drug)
结局指标
主要结局
Dose-limiting toxicity (DLT) for Phase 1b
时间窗: The first cycle (each cycle is 21 days) after lisaftoclax administration.
To identify the DLT
Complete response rate (CRR) for Phase 2
时间窗: Up to 8 cycles (each cycle is 21 days)
The proportion of patients who achieve complete response (CR)
次要结局
- Overall response rate (ORR)(Up to 8 cycles (each cycle is 21 days))
- Duration of Response (DOR)(Up to 5 years)
- Progression-free survival (PFS)(Up to 5 years)
- Overall survival (OS)(Up to 5 years)
研究者
Qingqing Cai
chief physician
Sun Yat-sen University