NCT03300492Recruiting
Expanded Natural Killer Cells Following Haploidentical HSCT for AML/MDS
Summary
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 criteria
Inclusion Criteria: 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 Criteria: Patient: • 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
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 1 · Phase 2
- Study type
- Interventional
- Countries
- Switzerland
- Sponsor
- University Hospital, Basel, Switzerland(Other)
- Protocol no.
- Haplo-NK-DLI for AML/MDS
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Interventions
- Other
Treatments studied
- NK-DLI
Locations · 1
- Basel, SwitzerlandUniversity Hospital BaselRecruiting at this site
In total, worldwide, the only site listed in the registry is recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: December 4, 2025).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.