NCT02597387Unknown2 期
A Single-arm, Open, Multi-center Phase II Clinical Trial of Mitoxantrone HCL Liposome Injection in Subjects With Relapsed Diffuse Large B-cell Lymphoma and and Peripheral T/NK Lymphomas
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 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 diffuse large B-cell lymphoma and lymphoma peripheral T cell.
详细描述
A Single-arm, Open, Multi-center Phase II Clinical Trial of Mitoxantrone HCL Liposome Injection in Subjects With Relapsed Diffuse Large B-cell Lymphoma and and Peripheral T/NK Lymphomas with dose of 20 mg/m2.
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;
- •Diffuse large B-cell and peripheral T/NK cell non-Hodgkin's lymphomas confirmed with histopathology, and the peripheral T/NK cell lymphomas that are only limited to the following types: peripheral T-cell lymphoma (not otherwise specified), angioimmunobl;
- •Failure or relapse after at least once of systemic treatment, and patients who can not receive autologous peripheral blood stem cell transplantation
- •The major diameter of a single measurable lesion ≥1.5 cm in at least one measurable lesion;
- •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, for those with bone marrow involvement, ANC ≥ 1.0×109/L;
- •PLT ≥ 75×109/L, for those with bone marrow involvement, PLT ≥ 50 × 109/L;
- •Hb ≥ 9 g/dL; d) Cr) ≤ 1.5x ULN ;
- •TBIL ≤ 1.5x ULN;
- •AST or ALT ≤2.5 x ULN (for patients with liver metastases, ≤ 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;
- •Lymphoma involving the 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)
研究者
研究点 (1)
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