The purpose of this study is to estimate the efficacy of immunotherapy with ex vivo expanded haploidentical NK cells for children/young adults with primary high risk or refractory AML and relapsed 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. For patients with high-risk primary AML a cycle of immunotherapy includes chemotherapy (HD-ARA-C+IDA) followed by three doses of NK cells infusion. For patients with refractory/relapsed AML a cycle of immunotherapy includes chemotherapy (FLAG - fludarabine, cytarabine, G-CSF) followed by three doses of NK cells infusion. A 2nd cycle of therapy may be administered if a recipient continues to meet the eligibility criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Three 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
RECRUITINGObjective Response Rate (ORR) (PR+ MLFS+CRi +CR)
The proportion of patients with complete remission (CR), CR with incomplete hematologic recovery (CRi), morphologic leukemia-free state (MLFS), and partial remission (PR) as measured by response criteria definitions for acute myeloid leukemia.
Time frame: 30 days after every a course of NK immunotherapy
Leukemia-free survival (LFS)
Time from achievement of CR/CRi/MLFS to the time of relapse, death in remission, or last follow-up.
Time frame: 1 year
Overall survival (OS)
The proportion of patients with overall survival
Time frame: 1 year
Duration of persistence of infused 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: 30 days after the first infusion
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