An Open-Label, Uncontrolled, Single Centered Phase Ⅱ Study of Avastin Combined With Gemcitabine, Oxaliplatin, Pegaspargase and Dexamethasone (Avastin+ GemAOD) As First-Line Treatment in Patients With Untreated NK/T Cell Lymphoma

Sun Yat-sen University1 个研究点分布在 1 个国家目标入组 30 人开始时间: 2013年8月最近更新: 2013年8月22日

适应症

干预措施

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: Overall Response Rate(ORR)

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

The purpose of this study is to evaluate the efficacy and safety of avastin combined with gemcitabine, oxaliplatin, pegaspargase and dexamethasone(Avastin+ GemAOD) as first-line treatment in patients with untreated natural killer(NK)/T cell lymphoma

详细描述

Recent study showed that vascular endothelial growth factor (VEGF) was associated with a poorer outcome in patients with Non-Hodgkin's Lymphoma,and Avastin impacted on tumor endothelial cells to make standard chemotherapy work better for T cell lymphoma. Many researches on Gemcitabine combined with Oxaliplatin for treatments of recurrent and refractory Non-Hodgkin's lymphoma showed patients could benefit from the combination treatment . Pegaspargase plays an important role for treatment of NK/T cell lymphoma. Dexamethasone is used in combination with other agents for the treatment of lymphomas which may be implicated in the development or growth of some cancers.So we explored to evaluate the efficacy and safety of Avastin combined with gemcitabine, oxaliplatin, pegaspargase and dexamethasone(Avastin+ GemAOD) as first-line treatment in patients with untreated NK/T cell lymphoma

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 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Histologic diagnosis of NK/T Cell Lymphoma;
•Age:18-80 years;
•Eastern Cooperative Oncology Group (ECOG) status 0-3, Estimated survival time > 3 months;
•Normal haematological, liver and renal function (WBC count≥4×109/L, Hemoglobin≥100g/L, platelet count≥100×109/L, bilirubin<1.5×ULN, Alanine transaminase (ALT) or Aspartate Aminotransferase (AST)<2.5×ULN, serum creatinine<1.5×ULN), normal coagulation function and cardiac function;
•Appreciable and measurable lesions ;
•No history of other malignancies;
•No previous treatments including chemotherapy, radiotherapy, targeted therapy or stem cell transplantation;
•No other serious diseases which conflict with the treatment in the present trial;
•No concurrent treatments that conflict with the treatments in the present trial(including steroid drugs);
•Voluntary participation and signed the informed consent.

排除标准

•The patients had the conditions below: clinically significant ventricular tachycardia (VT), atrial fibrillation (AF), heart block, myocardial infarction (MI), congestive heart failure (CHF), symptomatic coronary artery heart disease requiring medication;
•The patients suffered from organ transplant
•The patients participated in other clinical trials within the 30 days before enrollment or who are participating in other clinical studies;
•The patients with active bleeding or new thrombotic disease, who are taking anticoagulant drugs or with a history of bleeding tendencies;
•The patients suffered before surgery less than four weeks, or after less than six weeks;
•The patients with major vascular invasion;
•The patients with abnormal liver function (total bilirubin> 1.5 times the normal value, ALT / AST> 2.5 times normal), abnormal renal function (serum creatinine> 1.5 times normal), blood abnormalities (absolute neutrophil count <1.5 × 109 / L, platelets <80 × 109 / L, hemoglobin <90g /L) ;
•The patients with moderate to severe proteinuria;
•Severe hypertension,BP≥160/100mmHg;
•The patients with mentally ill / unable to obtain informed consent;
•The patients with drug addiction, alcohol abuse which affects the long-term evaluation of test results;
•The patients in pregnancy, lactation and women of childbearing age who do not want to take contraceptive measures subjects;
•Clinical and laboratory support brain metastases;
•The patients with a history of allergy to test drug;
•The patients not suitable to participate in the investigator judged by researchers.