Infusion of activated donor-derived NK cells after stem cell transplantation in children transplanted with high-risk leukemia
- Conditions
- Children with high-risk and recurrent acute leukemia are eligible for allogeneic hematopoietic stem cell transplantation (HSCT). However, leukemia relapse and viral infections after HSCT remain main reasons for treatment failure.MedDRA version: 14.1Level: LLTClassification code 10023685Term: LAK cell therapySystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2011-001514-34-NL
- Lead Sponsor
- eiden University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method