Expanded Natural Killer Cells Following Haploidentical HSCT for AML/MDS

Acute Myeloid Leukemia Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Myelodysplastic Syndromes

• NCT number: NCT03300492
• Study type: Interventional
• Source: University Hospital, Basel, Switzerland
• Contact: Matyas Ecsedi, MD-PhD
• Phone: +41612652525
• Email: matyas.ecsedi@usb.ch
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 12, 2018
• Completion date: January 31, 2026