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

Radboudumc0 个研究点目标入组 23 人开始时间: 待定最近更新: 2024年6月11日

试验速览

•Newly diagnosed AML or MDS EB-2 defined according to WHO 2016 criteria; AML may be secondary to prior hematological disorders, including MDS, and/or therapy-related.
•- Stable or at least non-rapidly progressive disease with or without disease controlling medication.
•- Patients may belong to any of the following categories:
•o Relapsed/refractory disease after treatment with intensive chemotherapy, hypomethylating agents, targeted agents, autologous or allo-SCT (at least 6 months ago) and DLI
•o Newly diagnosed, untreated patients ineligible for allo-SCT
•- Age = 18 years
•- WHO performance 0- 2 (Appendix 2)
•- Life expectancy of > 4 months
•- Written informed consent
•- Hydrea is allowed as pre-treatment to control blast count until day -3
•- Hypomethylating agents decitabine or azacitidine are allowed until day -7

•- Rapid-progressive disease in case of previous therapy (see Appendix 1).
•- Patients on immunosuppressive drugs or active GvHD
•- Patients with active infections (viral, bacterial or fungal); acute anti-infectious therapy must have been completed within 14 days prior to study treatment
•- 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)
•- Presence of anti-HLA class I antibodies
•- Patients on concurrent chemotherapy or interferon-alpha treatment
•- Pregnancy or breastfeeding

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