Phase I/II Study of Linperlisib in Combination With Chidamide for Relapsed and Refractory Peripheral T-cell Lymphoma: a Prospective, Multi-center Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Recommended phase 2 dose (RP2D)
研究概览
简要总结
HDAC inhibitor chidamide and PI3K inhibitor linperlisib has shown clinical activity as mono-therapy in PTCL. The combination of duvelisib and romidepsin is highly active for relapsed and refractory PTCLs. The aim of this study is to further explore the efficacy and safety of HDAC inhibitor chidamide combined with PI3K inhibitor linperlisib in the treatment of relapsed and refractory PTCLs.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-75;
- •Pathologically confirmed diagnosis of PTCL, not otherwise specified (PTCL, NOS), anaplastic large cell lymphoma (ALCL), angioimmunoblastic T-cell lymphoma (AITL), or other PTCL subtypes that the researchers considered to be eligible;
- •Fulfills the criteria for relapsed/refractory lymphoma;
- •There must be at least one measurable lesion: for measurable lymph node, the longest diameter should be > 1.5cm, for measurable extranodal lesion, the longest diameter should be > 1.0cm;
- •ECOG score of 0-2;
- •Adequate bone marrow hematopoietic function: neutrophil count (ANC)
- •≥1.5×109/L, platelet count (PLT) ≥80×109/L, hemoglobin (HGB) ≥90g/L;
- •Adequate organ function: NYHA grade 1-2, LVEF≥50%, ALT<3UNL, TBil<2ULN, SPO2 > 93%@RA, SCr>60ml/(min·1.73m2);
排除标准
- •Extranodal natural killer/T cell lymphoma;
- •Previously treated with PI3K inhibitors;
- •Acute myocardial infarction or unstable angina, congestive heart failure, symptomatic arrhythmia, and significantly prolonged QT interval (> 450ms in men and > 470ms in women) within 6 months;
- •Uncontrolled active infections;
- •Active hepatitis B and C infection (hepatitis B virus DNA over 1×103 copies /mL is excluded, hepatitis C virus RNA over 1×103 copies /mL is excluded);
- •Pregnant or lactating women;
研究组 & 干预措施
Linperlisib plus Chidamide
Linperlisib combined with chidamide
干预措施: Linperlisib in combined with Chidamide (Drug)
结局指标
主要结局
Recommended phase 2 dose (RP2D)
时间窗: 4 weeks since the date of first dose
Recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) will be established according to the incidence of dose-limiting toxicities (DLTs) of escalated doses of linperlisib.
Objective response rate (ORR)
时间窗: evaluated every 3 months (up to 24 months)
Objective response rate (ORR) for phase 2 study
次要结局
- Progression-free survival(recruitment to data cut-off (up to 5 years))
- Overall survival(recruitment to data cut-off (up to 5 years))
- complete remission (CR) rate(evaluated every 3 months (up to 24 months))
- adverse events(evaluated every treatment cycle (up to 24 months))