The purpose of this study is to estimate the efficacy of immunotherapy with ex vivo expanded haploidentical NK cells as consolidation therapy for children/young adults with intermediate risk AML.
Immunotherapy with NK cells may improve the treatment results in AML. For better efficiency high cell doses or several infusions of NK cells are required. For this purpose, donor NK cells are expanded in the presence of feeder K562-mbIL21-41BBL cell line. The cycle of immunotherapy includes chemotherapy (cyclophosphamide, fludarabine) followed by two doses of NK cells infusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Two doses of expanded haploidentical NK cells (30-100 x 10\^6 cells /kg).
Belarussian Research Center for Pediatric Oncology, Hematology and Immunology
Minsk, Minsk Oblast, Belarus
RECRUITINGRelapse-free survival (RFS)
Time from achievement of CR to the time of relapse or death from any cause.
Time frame: 2 years
Overall survival (OS)
The proportion of patients with overall survival
Time frame: 2 years
Persistence of donor NK cells
Days of persistence of donor NK cells
Time frame: 21 days after the first infusion
Number of T, B, NK, activated T and NK cells after immunotherapy
Analysis of T, B, NK, activated T and NK cells numbers (cells/microL) after NK infusions.
Time frame: 28 days after the first infusion
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