A Multicenter, Single-arm, Prospective Phase I/II Trial of Mitoxantrone Hydrochloride Liposome Injection Combined With Chidamide in Relapsed or Refractory Peripheral T-cell Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- RP2D
研究概览
简要总结
Peripheral T-cell lymphoma (PTCL) is a highly heterogeneous group of aggressive non-Hodgkin lymphoma (NHL) originating from mature thymus T cells.Mitoxantrone Hydrochloride Liposome Injection can accelerate the entry of mitoxantrone into cells, reduce the efflux of mitoxantrone, ensure the concentration of intracellular drugs, reverse the drug resistance mechanism, and enhance anti-tumor activity.We will explore the dose-limiting toxicity (DLT) of Mitoxantrone Hydrochloride Liposome Injection combined with Chidamide in the treatment of relapsed or refractory peripheral T-cell lymphoma, estimate the maximum tolerated dose (MTD) of the combination, and determine the phase II recommended dose RP2D.In the phase II study, we will evaluate the safety and efficacy of the combination regimen.
详细描述
This study was a single-arm, open, multicenter phase I/II clinical study. An estimated 87 to 96 patients with relapsed or refractory PTCL will be enrolled. This program is divided into two parts:
The phase I study is expected to enroll 9 to 18 patients with relapsed or refractory PTCL who will be treated with Mitoxantrone Hydrochloride Liposome Injection combined with Chidamide.The phase II study is expected to enroll 78 patients.
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
- •Patients participated voluntarily and signed informed consent；
- •PTCL confirmed by histopathology；
- •There must be at least one evaluable or measurable lesion that meets Lugano2014 criteria；
- •The ECOG score is 0 to 1；
- •ANC≥1.5×10*9/L，PLT≥75 × 10*9/L；HB≥80 g/L；TBIL≤1.5ULN；ALT or AST≤2.5 ULN； Scr≤1.5ULN；
- •Use contraception during treatment and for one year after the end of treatment.
排除标准
- •Patients with central nervous system (CNS) involvement and/or hemophagocytic syndrome；
- •The estimated survival time is less than 6 months；
- •History of allergy to anthracyclines or liposomes; Previous recipients of mitoxantrone or mitoxantrone liposome;Previous treatment with doxorubicin or other anthracyclines had a cumulative dose of doxorubicin > 360 mg/m2（For other anthracyclines, 1 mg of doxorubicin is equivalent to 2 mg of epirubicin, and the maximum cumulative dose of liposomal doxorubicin is 2460mg/m2）；
- •The use of Chidamide is contraindicated;
- •Impaired heart function or significant heart disease;
- •Hepatitis B, hepatitis C active stage infection;
- •Had undergone major surgery within 4 to 6 weeks prior or expected to undergo major surgery during the study;
- •severe infection;
- •Poorly controlled high blood pressure or diabetes;
- •A history of active visceral bleeding within the previous 3 months
- •A history of malignancy within five years;
- •History of mental illness;
- •A history of substance abuse or dependence;
- •pregnant or lactating woman;
- •The investigators did not consider it appropriate to participate in this study.
研究组 & 干预措施
Mitoxantrone Hydrochloride Liposome Injection Combined With Chidamide
干预措施: Mitoxantrone liposome combine with Chidamide (Drug)
结局指标
主要结局
RP2D
时间窗: 24 months
Phase II recommended dose
ORR
时间窗: 24 months
Objective remission rate
次要结局
- MTD(24 months)
- DLT(24 months)
- DOR(24 months)
研究者
Li Zhiming
Sun Yat-sen University Cancer Center
Sun Yat-sen University