KCT0006331尚未招募未知
A Phase 2 , single center, Safety and efficacy of rituximab biosimilar(Truxima®)-based first line treatment of chronic graft-versus-host disease
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 38
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 16?(Year) 至 90?(Year)（—）
- 性别
- All
入选标准
- •1) cGVHD patients who were newly diagnosed with above moderate levels of cGVHD by NIH criteria
- •a.Distinction from acute GVHD
- •b.Presence of at least 1 diagnostic clinical sign of chronic GVHD or presence of at least 1 distinctive manifestation confirmed by pertinent biopsy or other relevant tests
- •c.Exclusion of other possible diagnosis
- •2) Age >16 years
- •3) ECOG (Eastern Cooperative Oncology Group) 0-2
- •4) Patients expected to comply with the clinical protocol at the judgment of the investigator
- •5) Patients understand the content of the research and voluntarily consent to it in writing
排除标准
- •1) Progression of underlying disease
- •2) Uncontrolled ischemia and heart failure, arrhythmia requiring medication.
- •3) Cardiac ejection fraction < Normal
- •4) Active hepatitis and HIV Infection
- •5) Other malignancy disease except underlying disease
- •6) Hypersensitivity to Rituximab
- •7) Pregnancy
研究者
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