NCT02597153终止2 期
A Single-arm, Open, Multi-center Phase II Clinical Trial of Mitoxantrone HCL Liposome Injection in Subjects With Relapsed Cutaneous T Cell Lymphomas
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR; complete response + partial response [CR + PR])
研究概览
简要总结
To study efficacy and safety of Mitoxantrone HCL Liposome Injection in patients with relapsed cutaneous T cell lymphomasell
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
- •The subjects are voluntary and sign the informed consent form;
- •ECOG score 0 to 2;
- •The expected survival time ≥3 months;
- •Patients with cutaneous T-cell lymphoma confirmed by histopathology, with measurable lesions, with or without systemic lymph node involvement; clinical stage IB-IVA;
- •The patients previously receive at least once of systemic therapy (including systemic electron beam irradiation or chemotherapy, stem cell transplantation) and do not achieve remission (including remission period shorter than 30 days after the treatment;
- •An interval of at least four weeks after the target tumor was treated with chemotherapy, radiotherapy, biological therapy, stem cell transplantation or other study drugs;
- •Subjects at childbearing age agree to take effective contraceptive measures during the study; blood pregnancy test result is negative (except infertility due to menopause or operation);
- •Laboratory tests (blood routine, liver and kidney function) meet the following requirements:
- •ANC≥ 1.5×109/L; b) PLT ≥ 75×109/L; c) Hb ≥ 9 g/dL; d) Cr) ≤ 1.5x ULN ; e) TBIL ≤ 1.5x ULN; f) AST or ALT ≤2.5 x ULN.
排除标准
- •Pregnant or lactating women;
- •An allergic history to anthracyclines or liposome drugs;
- •Disease progression or recurrence after anthracycline treatment within six months before the enrollment;"
- •Patients who once used mitoxantrone injection;
- •Patients who have used doxorubicin (or pirarubicin) with the total cumulative dose> 360mg/m2, or epirubicin with the total cumulative dose > 600mg/m2;
- •Left ventricular ejection fraction is < 50% or < the lower limit of normal; clinically significant QT interval prolongation (>450ms in male, >470ms in female); a past history of cardiac disease caused by anthracyclines; a history of severe heart disease;
- •Concomitant treatment as other anticancer drugs are needed;
- •With internal organ involvement (including bone marrow, central nervous system;
- •Clinically active infection that can significantly affect the clinical trial;
- •Within 6 weeks after organ transplantation or major organ surgery;
- •Those who are inappropriate to be enrolled as evaluated by the researchers.
研究组 & 干预措施
Mitoxantrone HCL Liposome Injection
Experimental
Each treatment cycle lasts for 28 days with 20mg/m2
干预措施: Mitoxantrone HCL Liposome Injection (Drug)
结局指标
主要结局
Objective response rate (ORR; complete response + partial response [CR + PR])
时间窗: Up to 6 months
次要结局
- Duration of Response (DOR)(Time from the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression is documented (assessed up to approximately 24 months))
- Time to Response (TTR)(Time from the date of registration to the date at which the patient's objective status is first noted to be a CR or PR (assessed up to approximately 24 months))
- Progression-free survival (PFS)(Up to a total of 24 months after first dose or until disease progression, withdrawal from study, or death)
- Pruritus remission rate(Up to a total of 24 months after first dose or until disease progression, withdrawal from study, or death)
研究者
研究点 (1)
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