A Multicenter, Single-arm, Open II Phase Clinical Trial Evaluating the Efficacy of Chidamide Combined With Prednisone, Cyclophosphamide, Etoposide, and Methotrexate (PECM) in Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

Sun Yat-sen University1 个研究点分布在 1 个国家目标入组 102 人开始时间: 2017年3月7日最近更新: 2017年10月26日

适应症

干预措施

试验速览

阶段: 2 期
发起方
入组人数: 102
试验地点: 1
主要终点: Objective response 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

To observe the efficacy and safety of Chidamide combined with prednisone, cyclophosphamide, etoposide and methotrexate in relapsed or refractory PTCL.

详细描述

Prednisone, cyclophosphamide, etoposide, and methotrexate regimens are derived from a "metronidazole, etoposide, procarbazine and cyclophosphamide (PEPC) regimen" regimen that differs from the traditional "maximal Tolerance "chemotherapy, and the use of low-dose chemotherapy, frequent drug therapy, the purpose is to anti-angiogenesis and reduce drug resistance. At present, the program in our treatment of relapsed or refractory PTCL patients effective, safe and controllable, but also look forward to other joint treatment, so as to achieve better curative effect. To provide new treatment options for such 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

•Histopathologically confirmed peripheral T-cell lymphoma (PTCL) patients;
•Patients who have had at least one systemic treatment (including chemotherapy, hematopoietic stem cell transplantation, etc.) who have not remission or relapsed after remission;
•For various reasons can not be hematopoietic stem cell transplantation in patients;
•The age of 18-75 years old, male, female open;
•ECOG (Eastern Cooperative Oncology Group) physical scoring 0-1 points;
•Absolute value of neutrophil≥1.5 × 109 / L, platelet≥90 × 109 / L, hemoglobin≥90g / L;
•The expected survival time ≥ 3 months;
•No radiotherapy, chemotherapy, targeted therapy or hematopoietic stem cell transplantation were performed within 4 weeks prior to enrollment.
•Voluntary signature of written informed consent.

排除标准

•Pregnancy, breastfeeding women and unwilling to take contraceptive measures of reproductive age patients;
•B-mode ultrasonography showed that the width of end-diastolic pericardial dark area was ≥10mm;
•Patients receiving organ transplants;
•Patients receiving symptomatic treatment of pre-bone marrow toxicity within 7 days prior to enrollment;
•Patients with active bleeding;
•Liver function abnormalities (total bilirubin> 1.5 times the upper limit of normal, ALT( alanine aminotransferase) / AST (Aspartate aminotransferase)> 2.5 times the upper limit of normal or hepatic involvement of ALT / AST> 5 times the upper limit of normal), renal dysfunction Creatinine> 1.5 times the upper limit of normal), electrolyte abnormalities;
•Persons with mental disabilities / those who can not obtain informed consent;
•Patients with drug abuse and long-term alcohol abuse that may affect the evaluation of test results;
•The investigators determined that they were not fit to participate in the trial.