atural killer cell infusion after stem cell transplantation for leukemia
- Conditions
- Acute lymphoblastic leukemia (ALL)Acute myeloid leukemia (AML)Allogeneic stem cell transplantation
- Registration Number
- NL-OMON26066
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 12
Aged between 1-18 years at the time of hematopietic stem cell tranplantation (HSCT)
- Undergoing HSCT for acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML) according to existing indications
- Receiving a stem cell graft from a mismatched family or volunteer unrelated donor
- Life expectancy>3 months
- Availability of a stem cell donor willing to donate white blood cells by means of a non-mobilized leukapheresis procedure
- Progressive uncontrollable malignant disease after HSCT but before or at the day of NK cell infusion, defined as overt leukemia relapse, i.e., ¡Ý 25% blasts in the marrow and/or 5% circulating blasts in the peripheral blood or progressive extra-medullary disease
- Lack of evidence for donor myeloid engraftment at the day of infusion (< 0.5 x 10e6 neutrophils/L);
- Active acute GvHD ¡Ý grade II (overall grade)
- Administration of steroids >1 mg/kg/day for any indication at the day of infusion
- 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)
- Cord blood stem cell donor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method In addition to the standard evaluation following HSCT of children treated for leukemia, the following investigations will be performed in the context of the investigational NK cell infusion:<br>- To determine the number of patients for whom an investigational medicinal product (IMP), meeting all release criteria, can be generated. The protocol is considered feasible if:<br>> 50 % of transplanted patients can be included<br>> 66 % of included patients can be infused with the IMP. <br>- Registration of post infusion status of the patient, fever, nausea, chills, rash, erythema, and all serious adverse events, potentially linked to infusion. The IMP is considered safe and well-tolerated if no more than 2 out of 12 patients develop severe adverse reactions that are likely due to the NK cell infusion.
- Secondary Outcome Measures
Name Time Method