Expanded Haploidentical Natural Killer Cells as Consolidation Strategy for Children/Young Adults With AML
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Biological: Expanded haploidentical NK cells
- Registration Number
- NCT05334693
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Expanded haploidentical NK cell immunotherapy Expanded haploidentical NK cells After a lymphodepleting chemotherapy a patient receive two intravenous infusions of expanded haploidentical NK cells.
- Primary Outcome Measures
Name Time Method Relapse-free survival (RFS) 2 years Time from achievement of CR to the time of relapse or death from any cause.
Overall survival (OS) 2 years The proportion of patients with overall survival
- Secondary Outcome Measures
Name Time Method Persistence of donor NK cells 21 days after the first infusion Days of persistence of donor NK cells
Number of T, B, NK, activated T and NK cells after immunotherapy 28 days after the first infusion Analysis of T, B, NK, activated T and NK cells numbers (cells/microL) after NK infusions.
Trial Locations
- Locations (1)
Belarussian Research Center for Pediatric Oncology, Hematology and Immunology
🇧🇾Minsk, Minsk Region, Belarus