Immunotherapy Using Expanded Haploidentical Natural Killer Cells as Consolidation Treatment for Children and Young Adults with Acute Myeloid Leukemia

What this Trial Is About

Researchers are evaluating the effectiveness of immunotherapy using ex vivo expanded haploidentical natural killer NK cells as a consolidation treatment for children and young adults with intermediate risk acute myeloid leukemia AML. This study focuses on improving outcomes by using high doses or multiple infusions of NK cells after chemotherapy. It is a Phase 1 and Phase 2 clinical trial sponsored by the Belarusian Research Center for Pediatric Oncology, Hematology and Immunology. The treatment involves a chemotherapy cycle using cyclophosphamide and fludarabine, followed by two intravenous infusions of expanded haploidentical NK cells. These NK cells are grown in the lab with a special feeder cell line to increase their number and effectiveness. Patients receive two doses of these NK cells, ranging from 30 to 100 million cells per kilogram of body weight, after chemotherapy. Participants will be monitored for relapse-free survival and overall survival over two years. Additional assessments include tracking the persistence of donor NK cells 21 days after the first infusion and measuring various immune cells 28 days post-infusion. Throughout the study, researchers will evaluate immune response and safety, with participation lasting through these follow-up periods.

Expanded Haploidentical Natural Killer Cells as Consolidation Strategy for Children/Young Adults With AML