Infusion of IL-15 activated NK cells after allogeneic stem cell transplantation in children transplanted for relapsed/refractory leukemia: a feasibility study
- Conditions
- blood cell cancerLeukemia10024324
- Registration Number
- NL-OMON43758
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To document the feasibility to generate sufficient numbers of IL-15 activated<br /><br>NK cells from HSCT donors in real time, i.e. the Investigational Medicinal<br /><br>Product (IMP), meeting the release criteria and the safety of infusion and<br /><br>tolerability of the IMP post HSCT in children transplanted for refractory/<br /><br>relapsed leukemia.</p><br>
- Secondary Outcome Measures
Name Time Method