Phase I/II Study of Linperlisib in Combination With Chidamide for Relapsed and Refractory Cutaneous T-cell Lymphoma: a Prospective, Single-center Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Recommended phase 2 dose (RP2D)（Phase 1）
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 against relapsed and refractory T-cell lymphomas including cutaneous T-cell lymphomas (CTCLs). 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 CTCLs.
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;
- •Mycosis fungoides and Sezary syndrome confirmed by histopathology;
- •Patients with measurable lesions, with or without extra-cutaneous lesions, and clinical stage IIB-IVB;
- •No remission or relapse after at least one systemic therapy (including total body electron irradiation, becarodine, retinoic acid, interferon, photoseparation and replacement, methotrexate, chidamide, etc.);
- •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<2.5UNL, TBil<1.5ULN, SPO2 > 93%@RA, SCr>60ml/(min·1.73m2);
排除标准
- •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;
- •Investigators judged that they were not suitable to participate in the study
研究组 & 干预措施
Linperlisib + 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)（Phase 1）
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)（Phase 2）
时间窗: evaluated every 3 months (up to 24 months）
次要结局
- Progression-free survival(Baseline up to data cut-off (up to 5 years))
- Overall survival(Baseline up 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）)