A phase II study of Nivolumab for relapsed/refractory adult T-cell leukemia/lymphoma (ATL) - A phase II study of Nivolumab for relapsed/refractory AT

The study group for investigator-oriented clinical trial for the development of treatment of ATL.0 个研究点目标入组 22 人开始时间: 2016年1月17日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1)Synchronous or metachronous malignancy except carcinoma in situ or cancer confined to the mucosa and curatively treated by local resection. 2)Active infection requiring systemic treatment 3)Pregnant or nursing women 4)Psychological disturbance 5)Administration of systemic adrenocorticoids more than 10mg/day of predonisolone or equivalents except for the treatment of ATL, medical examination, or prophylactic use for allergic reaction, and/or immunosuppressants. 6)Diabetes mellitus poorly controlled and regularly treated by insulin. 7)Poorly controlled hypertension 8)Unstable angina and/or myocardial infarction within 6 months. 9)HBs-Ag positive or HBc-Ab positive with HBV-DNA positive. 10)HCV-Ab positive 11)HIV-Ab positive 12)Complication or history of interstitial pneumonia or pulmonary fibrosis diagnosed by image and/or symptoms 13)Complication or history of autoimmune diseases. 14)Suspicious findings of central nervous invasion. 15)Other inadequate conditions determined by investigators.

发起方

The study group for investigator-oriented clinical trial for the development of treatment of ATL.