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

Radboud University Medical Centre0 个研究点目标入组 23 人开始时间: 2020年9月17日最近更新: 2024年5月21日

适应症

试验速览

暂无简介。

•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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 5
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 19

•- 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 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)
•- Patients on concurrent chemotherapy or interferon-alpha treatment
•- Pregnancy or breastfeeding

发起方

Radboud University Medical Centre