Expanded Haploidentical Natural Killer Cells as Consolidation Strategy for Children/Young Adults With AML
Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells as Consolidation Strategy for Children/Young Adults With AML
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Nov 2021
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2021
CompletedFirst Submitted
Initial submission to the registry
April 12, 2022
CompletedFirst Posted
Study publicly available on registry
April 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedAugust 28, 2024
August 1, 2024
4.1 years
April 12, 2022
August 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Relapse-free survival (RFS)
Time from achievement of CR to the time of relapse or death from any cause.
2 years
Overall survival (OS)
The proportion of patients with overall survival
2 years
Secondary Outcomes (2)
Persistence of donor NK cells
21 days after the first infusion
Number of T, B, NK, activated T and NK cells after immunotherapy
28 days after the first infusion
Study Arms (1)
Expanded haploidentical NK cell immunotherapy
EXPERIMENTALAfter a lymphodepleting chemotherapy a patient receive two intravenous infusions of expanded haploidentical NK cells.
Interventions
Two doses of expanded haploidentical NK cells (30-100 x 10\^6 cells /kg).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Belarussian Research Center for Pediatric Oncology, Hematology and Immunology
Minsk, Minsk Oblast, 223053, Belarus
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olga Aleinikova, MD, Prof
Belarussian Research Center for Pediatric Oncology, Hematology and Immunology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2022
First Posted
April 19, 2022
Study Start
November 1, 2021
Primary Completion
December 1, 2025
Study Completion (Estimated)
June 1, 2026
Last Updated
August 28, 2024
Record last verified: 2024-08