JPRN-UMIN000033794已完成2 期
Phase II study of Nivolumab in patients with relapsed/refractory hematologic malignancies - NIVOMAT study
ational Cancer Center Hospital East0 个研究点目标入组 40 人开始时间: 2018年9月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
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) Received systemic chemotherapy, radiotherapy, surgery, hormonal therapy within 2weeks prior to enrollment Received immunotherapy within 28 days prior to enrollment. 2) Patients with therapeutic history of immune checkpoint inhibitor 3) Patients with hypertension that is difficult to control despite taking multiple medications 4) Patients with a history or finding of congestive heart failure of NYHA classification III or higher 5) Patients with acute coronary syndrome, coronary angioplasty, or stent placement, within 6 months prior to enrollment. 6) Patients with grade 3 or higher active infections according to CTCAE v 4.0 7) Patients with complication or previous history of interstitial lung disease with active symptoms or signs 8) Patients with autoimmune disease complications or a history of chronic / recurrent autoimmune disease 9) Patients requiring systemic adrenocortical hormone or an immunosuppressant, or patients received these treatments within 14 days prior to enrollment. 10) Have type I diabetes, or have type II diabetes mellitus which cannot be adequately controlled by insulin therapy 11) Have history of organ transplantation or allogeneic hematopoietic stem cell transplantation. 12) Patients with seizure disorder requiring drug treatment 13) Grade 3 or more bleeding was confirmed 4 weeks before enrollment 14) Patients with double cancer 15) Major surgery within 2 weeks 16)Patients with wounds, ulcers, or fractures that have not healed 17) Either HIV antibody, HBs antigen or HCV antibody test is positive. 18) Patients with a history of hypersensitivity to investigational drugs, similar drugs or excipients 19) Pregnant women, lactating women or possibly pregnant women 20) Patients judged unsuitable to evaluation of Nivolumab or interpretation of the result
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