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

RECRUITINGPhase 1/2Sponsored by Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
Actively Recruiting
PhasePhase 1/2
SponsorBelarusian Research Center for Pediatric Oncology, Hematology and Immunology
Started2021-11-01
Est. completion2025-12
Eligibility
Age6 Months – 21 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05334693

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

Age: 6 Months – 21 YearsHealthy volunteers accepted
Inclusion Criteria:

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 Criteria:

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.

Conditions2

Acute Myeloid LeukemiaCancer

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