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Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells 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 – 30 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT05272293

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.

Eligibility

Age: 6 Months – 30 YearsHealthy volunteers accepted
Inclusion Criteria:

Patients:

* primary high risk AML
* primary refractory AML
* relapsed AML
* 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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