Immunotherapy Using Expanded Haploidentical Natural Killer Cells for Children and Young Adults with High-Risk, Refractory, or Relapsed Acute Myeloid Leukemia

What this Trial Is About

Researchers are evaluating the effectiveness of immunotherapy using ex vivo expanded haploidentical natural killer NK cells in children and young adults with primary high risk, refractory, or relapsed acute myeloid leukemia AML. This study aims to improve treatment outcomes by using high doses or multiple infusions of NK cells. The trial is a Phase 12 interventional study sponsored by the Belarusian Research Center for Pediatric Oncology, Hematology and Immunology. The immunotherapy involves expanding donor NK cells with a specific feeder cell line before infusion. For patients with high-risk primary AML, treatment includes chemotherapy with HD-ARA-C and IDA, followed by three intravenous infusions of expanded haploidentical NK cells. Patients with refractory or relapsed AML receive chemotherapy with fludarabine, cytarabine, and G-CSF FLAG, followed by the same NK cell infusion schedule. If eligible, a second therapy cycle may be given. Participants will be monitored for responses 30 days after each NK cell immunotherapy course, including measuring objective response rate, leukemia-free survival, and overall survival at one year. Additional assessments include the duration of NK cell persistence and immune cell counts after infusion. The study involves written consent and performance status evaluation, with treatment and follow-up extending up to a year to assess long-term outcomes.

Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells for Children/Young Adults With AML