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

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

Conditions3

Browse More Trials