Randomized Study of Haploidentical Hct and Subsequent Donor nk Cell Infusion in High-risk AML and MDS

Summary

This is a single center, open label, random comparison phase 2b study. The primary objective of this study is, by random comparison, to assess the anti-leukemia effect of allogeneic, donor-derived natural killer (NK) cells infused after HLA-haploidentical hematopoietic cell transplantation (HCT) in patients with refractory acute myelogenous leukemia (AML). The secondary objectives of the study are to assess the side effects of donor NK cell infusion, effects of donor NK cell infusion upon HCT outcomes, as well as effects upon post-HCT immune recovery.

Timeline

Start

2015-06

Primary completion

2019-06

Completion

2019-06

Outcome

Outcome not reported

Stopped: “upon recommendation from the Data Monitoring Committee”

Publications

• Lee KH, Yoon SR, Gong JR, Choi EJ, Kim HS, Park CJ, Yun SC, Park SY, Jung SJ, Kim H, Lee SY, Jung H, Byun JE, Kim M, Kim SY, Kim JH, Lee JH, Lee JH, Choi Y, Park HS, Lee YS, Kang YA, Jeon M, Woo J, Kang H, Baek S, Kim SM, Kim HM, Cho KH, Choi I. The infusion of ex vivo, interleukin-15 and -21-activated donor NK cells after haploidentical HCT in high-risk AML and MDS patients-a randomized trial. Leukemia. 2023 Apr;37(4):807-819. doi: 10.1038/s41375-023-01849-5. Epub 2023 Mar 17.

Drugs

Indications