Expanded Haploidentical Natural Killer Cells as Consolidation Strategy for Children/Young
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.
| Condition(s) | Acute Myeloid Leukemia |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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. |
| Ages | 6 Months to 21 Years |
| Sex | All |
| Lead sponsor | Belarusian Research Center for Pediatric Oncology, Hematology and Immunology |
| Locations | Minsk, Minsk Oblast, Belarus |
| Start date | 2021-11-01 |
| NCT ID | NCT05334693 |
| Official listing | https://clinicaltrials.gov/study/NCT05334693 |