RecruitingPhase 1Phase 2NCT05334693

Expanded Haploidentical Natural Killer Cells as Consolidation Strategy for Children/Young Adults With AML

Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells as Consolidation Strategy for Children/Young Adults With AML

Sponsor

Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

Enrollment

15 participants

Start Date

Nov 1, 2021

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia

Summary

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.

Eligibility

Min Age: 6 MonthsMax Age: 21 Years

Inclusion Criteria9

Patients:
primary intermediate risk AML in molecular complete remission;
primary high risk AML in molecular complete remission awaiting unrelated HSCT;
Karnofsky or Lansky performance scale greater or equal to 70;
written informed consent.
Donors:
haploidentical family donor;
donor suitable for cell donation and apheresis according to standard criteria;
written informed consent.

Exclusion Criteria7

Patients:
uncontrolled infection;
severe hepatic dysfunction: SGOT or SCPT \>=5x upper limit of normal for age;
positive serology for human immunodeficiency virus (HIV).
Donors:
pregnancy;
positive serology for HIV, hepatitis B or C.

Interventions

BIOLOGICALExpanded haploidentical NK cells

Two doses of expanded haploidentical NK cells (30-100 x 10\^6 cells /kg).

Locations(1)

Belarussian Research Center for Pediatric Oncology, Hematology and Immunology

Minsk, Minsk Oblast, Belarus

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NCT05334693

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