The study examines the application of expanded natural killer cells (NK cells) following haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT) for AML or MDS. Haplo-HSCT is a preferred treatment option for patients with AML or MDS without a HLA-matched donor. With administration of cyclophosphamide post-transplant , the safety of the procedure is similar to a HSCT from a HLA-identical donor. Relapse of AML/MDS represents a serious problem following haplo-HSCT. NK cells are immune cells able to destroy tumor cells. Their potency has been established particularly in the setting of a haplo-HSCT. In the current study, study participants undergoing haplo-HSCT will receive expanded NK cells from their respective stem-cell donors following haplo-HSCT. The primary goal of the study is to establish the safety and feasibility of this approach. In addition, the activity of the NK cells will be examined.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Application of three infusions of ex vivo expanded NK cells on days +10, +15 and +20 with increasing NK cell doses (1x107/kg, 1x108/kg and the remaining cells up to 1x109/kg) following haplo-HSCT. Maximal cumulative T-cell dose is fixed at \<1x105/kg.
University Hospital Basel
Basel, Switzerland
RECRUITINGIncidence and severity of adverse events including GvHD and infections.
As defined by the CTCAE version 4.03 and the NIH Scoring of GvHD.
Time frame: 1 year following haplo HSCT
Progression-free survival (PFS)
Time frame: 1 year following haplo HSCT
Incidence of AML/MDS-EB complete morphological and molecular remission (CR) at day + 30, + 90, +180 and 1 year post allo-HSCT
rejection.
Time frame: 1 year following haplo HSCT
Incidence of graft rejection
Time frame: 1 year following haplo HSCT
Number of NK cells given per kg body weight
Time frame: 30 days following haplo-HSCT
Number of NK-DLI infusions applied
Time frame: 30 days following haplo-HSCT
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