Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells for Children/Young
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.
| 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 for children/young adults with primary high risk or refractory AML and relapsed AML. |
| Who can participate | 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 |
| Ages | 6 Months to 30 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 | NCT05272293 |
| Official listing | https://clinicaltrials.gov/study/NCT05272293 |