Infusion of IL-15 activated NK cells after allogeneic stem cell transplantation in children transplanted for relapsed/refractory leukemia: a feasibility study - IL-15 activated NK cell infusion after alloSCT in pediatric high-risk hematological malignancies

eiden University Medical Center0 个研究点开始时间: 2015年1月8日最近更新: 2015年1月12日

适应症

试验速览

暂无简介。

•Patient inclusion criteria:
•1. Aged between 1-18 years at the time of HSCT;
•2. Undergoing HSCT for ALL or AML according to existing indications as defined in
•protocols/guidelines Dutch Childhood Oncolgy Group;
•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.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 12
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Patient exclusion criteria:
•1. Progressive leukemia 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;
•4. Administration of steroids >1 mg/kg/day for any indication at the day of infusion;
•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 as stem cells donor

发起方

eiden University Medical Center