Using expanded natural killer cells to treat children and young adults with acute myeloid leukemia
Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells as Consolidation Strategy for Children/Young Adults With AML
This study is testing if giving children and young adults with acute myeloid leukemia special immune cells from a donor after chemotherapy can help them fight the cancer better.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 6 Months to 21 Years |
| Sex | All |
| Sponsor | Belarusian Research Center for Pediatric Oncology, Hematology and Immunology Academic / other |
| Drugs / interventions | immunotherapy, chemotherapy, cyclophosphamide, fludarabine |
| Locations | 1 site (Minsk, Minsk Oblast) |
| Trial ID | NCT05334693 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of immunotherapy using ex vivo expanded haploidentical natural killer (NK) cells as a consolidation treatment for children and young adults with intermediate risk acute myeloid leukemia (AML). The approach involves administering chemotherapy followed by two infusions of NK cells that are expanded from donor cells. The goal is to improve treatment outcomes by utilizing high doses of NK cells to enhance the immune response against leukemia cells. Participants will be monitored for efficacy and safety throughout the treatment process.
Who should consider this trial
Good fit: Ideal candidates include children and young adults with intermediate risk AML in molecular complete remission or high risk AML awaiting unrelated hematopoietic stem cell transplantation.
Not a fit: Patients with uncontrolled infections or severe hepatic dysfunction, as well as those with positive HIV serology, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for children and young adults with AML by enhancing their immune response.
How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches using NK cells, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Minsk, Minsk Oblast
- Belarussian Research Center for Pediatric Oncology, Hematology and Immunology — Minsk, Minsk Oblast, Belarus (Recruiting)
Study contacts
- Principal investigator: Olga Aleinikova, MD, Prof — Belarussian Research Center for Pediatric Oncology, Hematology and Immunology
- Study coordinator: Tatsiana Shman, PhD
- Email: shman@oncology.by
- Phone: +375296341853
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.