Overview
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.
Eligibility
Inclusion Criteria:
- Patient
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- >18 years of age
- No HLA-matched related or unrelated donor available
- AML or MDS-EB with indication for a haplo-HSCT according to the guidelines of the University Hospital Basel Stem Cell Transplant Team
- Judged by the transplant physicians to have adequate organ function and no contraindications to haplo-HSCT
- Available related haploidentical donor
- Written informed consent
- Donor
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- >18 years old, haploidentical parent, sibling or other relative
- Donor suitable for cell donation and apheresis according to standard criteria
- Written informed consent
Exclusion Criteria:
- Patient
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- APL diagnosis
- Presence of relevant (mean fluorescence intensity >2000) donor-specific anti-HLA antibodies
- Pregnancy
- Necessity of immunosuppression apart from GvHD prophylaxis
Exclusion Criteria:
- Donor
• Pregnancy