Immunotherapy using expanded natural killer cells for children and young adults with acute myeloid leukemia
Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells for Children/Young Adults With High-risk, Refractory or Relapsed AML
This study is testing if giving children and young adults with tough-to-treat acute myeloid leukemia special immune cells from a family member can help them fight the cancer better after chemotherapy.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 6 Months to 30 Years |
| Sex | All |
| Sponsor | Belarusian Research Center for Pediatric Oncology, Hematology and Immunology Academic / other |
| Drugs / interventions | immunotherapy, chemotherapy, fludarabine |
| Locations | 1 site (Minsk, Minsk Oblast) |
| Trial ID | NCT05272293 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 in treating children and young adults with high-risk or refractory acute myeloid leukemia (AML). Participants will receive chemotherapy followed by multiple infusions of NK cells derived from a haploidentical family donor. The study includes two treatment cycles for eligible patients, allowing for continued therapy if criteria are met. The approach focuses on enhancing the immune response against AML through NK cell therapy.
Who should consider this trial
Good fit: Ideal candidates are children and young adults with primary high-risk, refractory, or relapsed acute myeloid leukemia.
Not a fit: Patients with uncontrolled infections or severe hepatic dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for young patients with high-risk or relapsed AML.
How similar studies have performed: While the use of NK cell therapy is gaining traction, this specific approach with haploidentical NK cells in pediatric AML is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
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.