NCT03273452Unknown2 期
Chidamide With PET Regimen for Angioimmunoblastic T Cell Lymphoma, a Multicentric, Single Arm, Open Label Phase II Clinical Trial
Qingdao University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年3月1日最近更新:
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
- 30
- 试验地点
- 1
- 主要终点
- Objective remission rate(ORR)
研究概览
简要总结
This study aims to investigate the efficacy and safety of PET regimen combined with Chidamide for angioimmunoblastic T cell lymphoma patients.
详细描述
Patients enrolled in the trial would be given prednisone, etoposide, thalidomide and Chidamide, and the response and side effects are observed and documented.
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
- •Pathologically diagnosed as angioimmunoblastic T cell lymphoma (diagnosed by pathologic department in IIIA hospitals or verified by certified institutions), immunohistochemistry should include: CD3, CD4, CD8, CD20, CD10, CD21, CD35, Bcl6, CXCL13, EBER, PD-1, Ki
- •At least on measurable focus (≥1.0*1.0cm by imaging), or at least one evaluable focus;
- •Age 18-75 years, both male and female;
- •ECOG 0-2, KPS≥ 70points;
- •Expected survival ≥3 months;
- •Peripheral blood neutrophil count ≥1.5×10^9/L, platelet count≥ 75×10^9/L, Hb≥ 90g/L;
- •Liver function: bilirubin ≤1.5 times of the normal maximum; AST、ALT≤2 times of the normal maximum (for patients with liver infiltration AST、ALT≤3 times of the normal maximum); renal function: blood creatinine ≤2 times the normal maximum;
- •Negative random pregnancy test for fertile women patients within 7 days before enrollment;
- •No radiation therapy, chemotherapy, targeted therapy nor hemopoietic stem cell transplantation within 4 weeks before enrollment;
- •No anti-tumor therapy at enrollment, including herbal therapy, immunotherapy and biologic therapy, symptomatic treatment is not within this range;
排除标准
- •Women during pregnancy or lactation, and fertile women that are not willing to take contraceptive measurements;
- •Patients with other malignant tumors simultaneously that have not been effectively controlled;
- •Patients with history of using HDAC inhibitors;
- •Patients who are allergic to medicine used in the trial, or have metabolic disorders toward these medicine;
- •Patients with severe active infection;
- •Patients with HIV or syphilis infection;
- •Patients with prolonged QT interval (male > 450ms，female > 470ms), or chronic heart failure patients with level III or IV cardiac function; or those have the following heart disease within 6 months before enrollment: acute coronary syndrome, acute heart failure (heart function level III or IV), distinctive ventricular arrhythmias (prolonged ventricular tachycardia, ventricular fibrillation, etc);
- •Patients with history of organ transplantation;
- •Patients with history of thrombosis and embolism;
- •Patients with mental disorders or those who are unable to sign a written consent;
- •Patients with drug abuse or long-time alcoholism that may influence the result of the trial;
- •Patients who do not have capacity of legal transactions;
- •Patients currently in other clinical trials;
- •Those who are recognized as inappropriate for the trial by the investigators;
研究组 & 干预措施
treatment group
Experimental
In this group, patients will be given prednisone 100mg,qd,d1-5; etoposide 100mg,qd,d1-5; thalidomide 100mg,qn,d1-14; Chidamide 30mg,biw;
干预措施: Chidamide (Drug)
结局指标
主要结局
Objective remission rate(ORR)
时间窗: every 3 months until 24 months after the last patient's enrollment
the rate of patients who achieve objective remission after the treatment,including CR (complete remission),CRu (complete remission with unrecovered platelet count) and PR (partial remission).
次要结局
- progression free survival(from the day of treatment to the date of first documented progression，up to 24 months after the last patient's enrollment)
- overall survival(24 months after the last patient's enrollment)
- duration of remission(from the day of remission to the date of first documented progression，up to 24 months after the last patient's enrollment)
研究者
Hongwei Xue
MD.
Qingdao University
研究点 (1)
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