NL-OMON55708招募中不适用
Infusion of ex vivo-generated allogeneic natural killer cells in combination with subcutaneous IL-2 in patients with acute myeloid leukemia: a phase I/IIa study* - NK4AML: Allogeneic NK-cell therapy for AM
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 23
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
- •MDS with excess blasts, MDS/AML or AML patients (de novo and secondary)
- •according to ELN 2022 criteria, who have stable disease or non-rapidly
- •progressive disease with or without disease controlling medication, who are not
- •eligible for allogeneic SCT
- •- Age > 18 years
- •- WHO performance 0-2
- •- Life expectancy of > 4 months
- •- Written informed consent
- •- Hydrea is allowed as pre-treatment to control blast count until day -3
- •- Other disease controlling medication is allowed until day -7
排除标准
- •- Progressive disease in case of previous therapy
- •- Patients on immunosuppressive drugs or active GvHD
- •- Patients with active infections (viral, bacterial or fungal); acute
- •anti-infectious therapy must have been completed within 7 days prior to study
- •- Severe cardiovascular disease (CTCAE III-IV)
- •- Severe pulmonary dysfunction (CTCAE III-IV)
- •- Severe renal dysfunction (CTCAE III-IV)
- •- Severe hepatic dysfunction (CTCAE III-IV)
- •- Severe neurological or psychiatric dysfunction (CTCAE III-IV)
- •- Patients on concurrent chemotherapy or interferon-alpha treatment
- •- Pregnancy or breastfeeding
研究者
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