Belarussian Research Center for Pediatric Oncology, Hematology and Immunology
Minsk, Minsk Oblast, 223053, Belarus
Location status: Recruiting
NCT Number: NCT05334693
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.
Interested in participating?
Request Info6 month–21 year
All sexes
Interventional
Phase 1 / Phase 2
Minsk, Minsk Oblast, 223053, Belarus
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients:
Donors:
Exclusion criteria
Patients:
Donors:
Two doses of expanded haploidentical NK cells (30-100 x 10^6 cells /kg).
Time frame: 2 years
Time from achievement of CR to the time of relapse or death from any cause.
Time frame: 2 years
The proportion of patients with overall survival
Time frame: 21 days after the first infusion
Days of persistence of donor NK cells
Time frame: 28 days after the first infusion
Analysis of T, B, NK, activated T and NK cells numbers (cells/microL) after NK infusions.
Contact information is provided by the study sponsor or research team.
Mariya Naumovich, MD
CONTACT
Tatsiana Shman, PhD
CONTACT
Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
Other
Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells as Consolidation Strategy for Children/Young Adults With AML
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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