NCT02944812Unknown2 期
Chidamide for Refractory/Relapsed Peripheral T Cell Lymphoma, a Single-Center, Nonrandomized Phase II Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change of Chidamide concentration within the serum
研究概览
简要总结
This trial intends: 1.To evaluate the concentration of Chidamide in the serum and cerebral-spinal fluid of PTCL patients at certain time points after taking the medicine, to evaluate the pharmacokinetics of Chidamide in these patients and its CNS (central nervous system) distribution.
- To evaluate the efficiency and safety of Chidamide in PTCL 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PTCL patients confirmed by histopathology examination.
- •Did not accept radiotherapy, chemotherapy, targeted-therapy or hematopoietic stem cell transplantation within 4 weeks prior to inclusion;
- •Age 18-75 years old, male or female;
- •ECOG: 0-1 point;
- •Body weight: male 67±20 kilograms (47-87 kg), female 55±20 kilograms (35-75 kg);
- •Blood-routine test should satisfy (except lymphoma-related abnormalities): Hb≥90g/L，ANC≥1.5×109/L，PLT≥90×109/L；
- •Estimated survival ≥ 3 months;
- •Willing to sign the written consent before the trial.
排除标准
- •Women during pregnancy or lactation, or fertile women unwilling to take contraceptive measures.
- •QTc elongation with clinical significance (˃ 480ms), ventricular tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease that requires treatment.
- •Cardiac B ultrasound show end-diastolic pericardial dark zone≥ 10mm
- •Patients who have received organ transplantation.
- •Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment.
- •Patients with active hemorrhage.
- •Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction.
- •Patients with active infection, or with continuous fever within 14 days prior to enrollment.
- •Had major organ surgery within 6 weeks prior to enrollment.
- •Impaired liver function ( Total bilirubin ˃ 1.5 times of normal maximum, ALT/AST˃ 2.5 times of normal maximum, for patients with infiltrative liver disease ALT/AST ˃ 5 times of normal maximum), impaired renal function (serum creatinin˃ 1.5 times of normal maximum).
- •Patients with mental disorders or those do not have the ability to consent;
- •Patients with drug abuse, long term alcoholism that may impact the results of the trial.
研究组 & 干预措施
Chidamide
Experimental
Chidamide is given to the patients, the dosage is 30mg,biw,po.
干预措施: Chidamide (Drug)
结局指标
主要结局
Change of Chidamide concentration within the serum
时间窗: 5 minutes before taking Chidamide (0h) and 1h, 2h, 4h, 8h and 12h after taking Chidamide (1h，2h，4h，8h，12h), assessed up to 1 week from date of enrollment.
Change of Chidamide concentration within the cerebral-spinal fluid (CSF)
时间窗: 5 minutes before the first dosage of Chidamide (0h) and 4 hours after the second dosage (4h) of Chidamide
次要结局
- white blood cell count(every week though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
- blood Hb level(every week though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
- blood platelet count(every week though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
- vital signs(every week though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
- Serum aspartate transaminase level(every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
- blood LDH level(every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
- Serum creatinin level(every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
- Serum alanine aminotransferase level(every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
- Serum direct bilirubin level(every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
- Serum indirect bilirubin level(every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
- Serum albumin level(every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
- blood electrolytes level（K+, Na+，Cl-，Ca2+，Mg2+）(every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
- QTc from ECG(every 6 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
- red blood cell count(every week though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
- Serum total bilirubin level(every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
- Serum glutamyltranspeptidase level(every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
- Serum ureal nitrogen level(every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 30 months)
研究者
Wenyu Li
Professor
Guangdong Provincial People's Hospital
研究点 (1)
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