NCT05334693 Expanded Haploidentical Natural Killer Cells as Consolidation Strategy for Children/Young Adults With AML
| NCT ID | NCT05334693 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Belarusian Research Center for Pediatric Oncology, Hematology and Immunology |
| Condition | Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2021-11-01 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 15 participants in total. It began in 2021-11-01 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Olga Aleinikova, MD, Prof
PRINCIPAL INVESTIGATOR
Belarussian Research Center for Pediatric Oncology, Hematology and Immunology
Frequently Asked Questions
Who can join the NCT05334693 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, up to 21 Years, studying Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05334693 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05334693 currently recruiting?
Yes, NCT05334693 is actively recruiting participants. Contact the research team at shman@oncology.by for enrollment information.
Where is the NCT05334693 trial being conducted?
This trial is being conducted at Minsk, Belarus.
Who is sponsoring the NCT05334693 clinical trial?
NCT05334693 is sponsored by Belarusian Research Center for Pediatric Oncology, Hematology and Immunology. The principal investigator is Olga Aleinikova, MD, Prof at Belarussian Research Center for Pediatric Oncology, Hematology and Immunology. The trial plans to enroll 15 participants.
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