NL-OMON38045已完成不适用
Infusion of ex vivo-cultured allogeneic NK cells in acute myeloid leukemia patients not eligible for stem cell transplantation (a phase I dose escalation study) - Allogeneic NK-cell therapy in AM
niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 15 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
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
- 18 至 99（—）
入选标准
- •* AML patients * 55 year of age
- •* Absence of anti-HLA antibodies
- •* CR after first line standard chemotherapy
- •* CR after second line chemotherapy
- •* WHO performance 0-1 (see appendix 3)
- •* Life expectancy > 6 months
排除标准
- •- Patients candidates for SCT
- •- Progressive disease, no change or only minor response following induction and consolidation therapy
- •- Patients on immunosuppressive drugs
- •- Patients with active infections (viral, bacterial or fungal) that requires specific therapy. Acute anti-infectious therapy must have been completed within 14 days prior to study treatment
- •- Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure or symptomatic ischemic heart disease (appendix 2)
- •- Severe pulmonary dysfunction (CTCAE III-IV) (appendix 2)
- •- Severe renal dysfunction (serum creatinine > 3 times normal level) (appendix 2)
- •- Severe hepatic dysfunction (serum bilirubin or transaminases > 3 times normal level) (appendix 2)
- •- Presence of anti-HLA antibodies
研究者
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