Status:
RECRUITING
Expanded Haploidentical Natural Killer Cells as Consolidation Strategy for Children/Young Adults With AML
Lead Sponsor:
Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
6-21 years
Phase:
PHASE1
PHASE2
Brief 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.
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05334693
Start Date
November 1 2021
End Date
June 1 2026
Last Update
August 28 2024
Active Locations (1)
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1
Belarussian Research Center for Pediatric Oncology, Hematology and Immunology
Minsk, Minsk Oblast, Belarus, 223053