Chidamide With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide for Peripheral T Cell Lymphoma Patients : a Prospective, Randomized Controlled, Open Label, Phase II Clinical Trial

Peking University1 个研究点分布在 1 个国家目标入组 114 人开始时间: 2018年8月28日最近更新: 2018年9月4日

适应症

干预措施

试验速览

阶段: 2 期
发起方
入组人数: 114
试验地点: 1
主要终点: complete remission (CR）rate

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Chidamide With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide for Peripheral T Cell Lymphoma Patients : a Prospective, Randomized Controlled, Open Label, Phase II Clinical Trial

详细描述

Chidamide，a novel histone deacetylase inhibitor has been approved for the treatment of relapsed or refractory peripheral T-cell lymphoma in China. The aim of this study was to observe the efficacy and safety of Chidamide With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide for Peripheral T Cell Lymphoma Patients.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
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

•Histopathology / cytology diagnosed as peripheral T cell lymphoma (PTCL) according to WHO 2016 classification criteria（NK/T cell lymphoma and ALK positive anaplastic large cell lymphoma excluded）including:Peripheral T-cell lymphoma, NOS，Angioimmunoblastic T-cell lymphoma，Anaplastic large-cell lymphoma, ALK negative，Enteropathy-associated T-cell lymphoma，Hepatosplenic T-cell lymphoma，Subcutaneous panniculitis T-cell lymphoma，Mycosis fungoides，Other T-cell lymphoma that investigators consider to be appropriate to be enrolled;
•Patients have received CHOPE regimen for 2 cycles therapy and achieve PR or SD;
•Patients should have at least one evaluable foci ( lymph nodes with diameter≥1.5cm, or evaluable skin foci);
•Age 18-70 years, male or female;
•ECOG performance status 0-2;
•Absolute neutrophil count ≥1.5×109/L, platelet ≥75×109/L, Hb ≥ 90g/L;
•ALT and serum creatinine <1.5 times of normal maximum;
•Life expectancy no less than 3 months;
•Willing to sign the Informed Consent Form.

排除标准

•NK/T cell lymphoma or ALK positive anaplastic large cell lymphoma;
•Female patients in lactation or pregnancy, Childbearing female or male patients unwilling to take contraceptive measures;
•QTc elongation with clinical significance ( male> 450ms, female> 470ms), ventricular tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease that requires treatment;
•Patients have undergone 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 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 creatinine> 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;
•Patients with invasion of central nervous system ;
•Non-appropriate patients for the trial according to the judgment of the investigators.

研究组 & 干预措施

Control group

Experimental

Control group will be treated by CHOPE (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Etoposide ) regimen for 6 cycles.

干预措施: Doxorubicin (Drug)