Donor natural killer cells after stem cell transplant for leukemia or myelodysplastic syndromes
Tests donor-derived natural killer cells after transplant in adults with leukemia or myelodysplastic syndromes.
Plain-language title generated from the registry record
Registry title: Expanded Natural Killer Cells Following Haploidentical HSCT for AML/MDS
Key facts
- Where
- Basel, SwitzerlandSee the site
- Phase
- Phase 1/2
Where in Switzerland
- University Hospital BaselBasel, SwitzerlandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Basel, Switzerland
- Trial code
- NCT03300492
- Record updated
- 4 December 2025
- Original description
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.Read full original descriptionShow less
A Phase I/II Single Center Study to Assess the Safety, Tolerability and Feasibility of Pre-emptive Immunotherapy With in Vitro Expanded Natural Killer Cells in Patients Treated With Haplo-HSCT for AML/MDS
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.
Inclusion: Patient:; >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:; >18 years old, haploidentical parent, sibling or other relative; Donor suitable for cell donation and apheresis according to standard criteria; Written informed consent.
Exclusion: Presence of relevant (mean fluorescence intensity >2000) donor-specific anti-HLA antibodies; Patient:; APL diagnosis; Pregnancy; Necessity of immunosuppression apart from GvHD prophylaxis; Donor:; Pregnancy.