JPRN-UMIN000034499已完成未知
Investigation of efficacy of nivolumab in patients with recurrent and refractory peripheral T cell lymphoma: Investigator initiated phase 2 clinical trial. - W-JHS NHL02 study
Cooperative study between the West Japan Hematology Study Group and Clinical Research Support Center Kyushu0 个研究点目标入组 20 人开始时间: 2018年10月15日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1)CNS lymphoma, intracerebral or BM infiltration 2)Autoimmune disease or history of chronic or recurrent autoimmune disease 3)History of interstitial lung disease or pulmonary fibrosis 4)Diverticulitis or symptomatic gastrointestinal ulcer 5)Auto-HSCT within 90days before the administration start 6)Anticancer therapy within 28days before the administration start 7)Mogamulizumab within 28days before the administration start 8)Other investigational new drugs within 28days or within less than 5times of elimination half-time before the administration start 9)Radiotherapy within 28days before the administration start 10)Systemic adrenal cortical hormone more than 10mg/day by prednisolone conversion or immunosuppressant within 28days before the administration start 11)All other investigational new drugs within 28days before the administration start(antibody preparation: within 90days) 12)Local or surface anesthesia, or operative treatment associated with general anesthesia within 14days before the administration start 13)Active double cancer. 14)Anamnesis of transient cerebral ischemic attack, cerebrovascular attack, thrombosis or the thromboembolism within 180days before enrollment 15)Remained influence of side effect of pre-treatment or operative treatmen 16)Following uncontrollable or severe cardiovascular diseases within 180days before enrollment a)Myocardial infarction b)Uncontrollable angina pectoris c)Congestive heart failure of NYHA classification grade III or IV d)Uncontrollable hypertension e)Arrhythmia 17)Systemic infection 18)Either HIV ab+, HTLV-1 ab+, HBs ag+ or HCV ab+. 19)History of severe allergic reaction 20)History of organ allotransplantation or allogeneic hematopoietic stem cell transplantation 21)Uncontrollable DM 22)Pregnant or lactating women or possibility of pregnancy 23)It is judged to lack in ability for agreement by complication of such as dementia 24)Any other patients who are regarded as unsuitable for study enrollment
研究者
相似试验
进行中（未招募）
2 期
W-JHS NHL02 studyPeripheral T-cell lymphoma (including extranodal NK/T-cell lymphoma)JPRN-jRCT2071210101Akashi Koichi20
已完成
2 期
A clinical trial of nivolumab in patients with unresectable clear cell sarcoma and alveolar soft part sarcoma (NCCH1510,OSCAR trial)clear cell sarcoma and alveolar soft part sarcomaJPRN-UMIN000023665ational Cancer Center20
进行中（未招募）
1 期
A phase II study of nivolumab monotherapy in patients with relapsed/refractory Hodgkin lymphoma fit for autologous stem cell transplant who fail to reach complete metabolic remission after first or second line salvage therapyEUCTR2017-002544-32-GBniversity College London120
已完成
2 期
A single arm confirmatory study of nivolumab in patients with previously treated advanced sarcomatoid carcinoma of the lungadvanced sarcomatoid carcinoma of the lungJPRN-UMIN000023433ational Cancer Center Hospital42
进行中（未招募）
1 期
A study of nivolumab alone, or in combination with vinblastin in patients aged 61 years and older, with Hodgkin LymphomaEUCTR2017-001939-38-FRYSARC64