Infusion of IL-15 activated NK cells after allogeneic stem cell transplantation in children transplanted for relapsed/refractory leukemia: a feasibility study - NK cell infusions after allogeneic stem cell transplantation

eids Universitair Medisch Centrum0 个研究点目标入组 12 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•1. Aged between 1-18 years at the time of HSCT;
•2. Undergoing HSCT for ALL or AML according to existing indications;
•3. Receiving a stem cell graft from a mismatched family (MMFD) or volunteer unrelated (MUD) donor;
•4. Life expectancy > 3 months.
•5. Availability of a stem cell donor willing to donate white blood cells by means of a non-mobilized leukapheresis procedure.

•1. Progressive uncontrollable malignant disease after HSCT but before or at the day of NK cell infusion, defined as overt leukemia relapse, i.e., >= 25% blasts in the marrow and/or 5% circulating blasts in the peripheral blood or progressive extra-medullary disease;
•2. Lack of evidence for donor myeloid engraftment at the day of infusion (< 0.5 x 106
•neutrophils/L);
•3. Active acute GvHD >= grade II (overall grade);
•4. Patient is receiving (or received less than 2 weeks before IMP infusion) pharmacological GvHD prophylaxis or immunosuppressive drugs used for non-GvHD indications;
•5. Any medical condition, which in the opinion of the treating physician, would interfere
•with the adequate evaluation of the patient (e.g. end-stage irreversible multi-system
•organ failure).
•6. Cord blood stem cell donor.
•7. Patient received a second cellular product after the stem cell graft;Donor exclusion criteria:
•1. Donor cord blood;
•2. Lack of consent for leukapheresis.

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