K cells as post consolidation therapie in AML.
- Conditions
- Hematopoietic stem cells, umbilical cord blood, NK cells, ex vivo expansion, cellular immunotherapy,acute myeloid leukemia, cancer immunotherapy, Elderly patients, Phase I, dose escalation study, safety and toxicity.Hematopoietische stamcellen, navelstrengbloed, NK cellen, ex vivo expansie, cellulaire immunotherapie, acute myeloide leukemie, immunotherapie tegen kanker, oudere patiënten, fase I dosis escalatie studie, veiligheid en toxiciteit.
- Registration Number
- NL-OMON22174
- Lead Sponsor
- Radboud University Nijmegen Medical Centre
- Brief Summary
Spanholtz J, Tordoir M, Eissens D, Preijers F, van der Meer A, Joosten I, Schaap N, de Witte T, Dolstra H. High log-scale expansion of functional human natural killer cells from umbilical cord blood CD34-positive cells for adoptive cancer immunotherapy. PLoS One. 2010;5(2):e9221.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion Criteria
1. AML patients > 65 year of age;
2. Absence of a HLA-Cw ligand for an inhibitory KIR (i.e. homozygous Cw group 1 or 2);
Exclusion Criteria
1. Patients candidates for SCT;
2. Progressive disease, no change or only minor response following induction and consolidation therapy;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The study is designated as a phase I dose escalation study in a series of 15 patients with primary or secondary AML to evaluate the safety and toxicity of allogeneic NK cell infusions with an escalating dose up to 10x107/kg body weight ex vivo-expanded NK cells following immunosuppressive conditioning therapy in patients with AML.
- Secondary Outcome Measures
Name Time Method 1. Evaluation of the in vivo lifespan of the expanded NK cells following adoptive transfer;<br /><br>2. Exploration of the biological and clinical activity of NK cell infusion in study participants.