JPRN-UMIN000022253招募中1 期
A Phase I/IIa Study of Low Dose Subcutaneous Interleukin-2 (IL-2) for Treatment of Refractory Chronic Graft Versus Host Disease (GVHD) - A Phase I/IIa Study of Low Dose Subcutaneous Interleukin-2 (IL-2) for Treatment of Refractory Chronic Graft Versus Host Disease (GVHD)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 18
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
- 18years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Ongoing prednisone requirement >= 1 mg/kg/day 2) Post-transplant exposure to immunosuppressive medication (TNF-alfa inhibitor, bortezomib, anti-CD20 monoclonal antibody or imatinib) for treatment of chronic GVHD within 2 weeks prior to enrollment 3) Post-transplant exposure to investigational immunosuppressive medication (Extracorporeal photopheresis, Ultraviolet therapy, tamibarotene) within 4 weeks prior to enrollment 4) Exposure to medication (Antithymocyte globulin, Anti- CD52, CD3, CCR4, CD25, CD30, PD-1, PD-L1, CTLA4, alpha-Integrin antibody, CTLA4-Ig or any other antibodies that potentially affect regulatory T cells) within 180 days prior to enrollment 5) Active malignant disease relapse 6) Active, uncontrolled infection 7) Active infection with hepatitis B virus or hepatitis C virus 8) Life expectancy <3 months 9) Pregnancy or lactation 10) Inability to comply with IL-2 treatment regimen 11) Uncontrolled cardiac angina or symptomatic congestive heart failure (NYHA Class III or IV) 12) Organ transplant (allograft) recipient 13) HLA >=2 locus mismatches transplantation (except for cord blood transplantation) 14) Unstable cardiac angina, cardiac infarction, deep vein thrombosis or cerebral infarction (CTCAE Grade>=3) 15) Anticoagulant therapy 16) Severe Thrombotic microangiopathy 17) Hematological malignancy expressing CD25 (IL-2 receptor) 18) Intolerance or hypersensitivity to any biological products 19) Patients judged inappropriate for this study by attending physicians
研究者
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