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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT05272293
Study type Interventional
Source Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
Contact Tatsiana Shman, PhD
Phone +375296341853
Email shman@oncology.by
Status Recruiting
Phase Phase 1/Phase 2
Start date November 1, 2021
Completion date June 2026

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