Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells 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 for children/young adults with primary high risk or refractory AML and relapsed 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
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2021
CompletedFirst Submitted
Initial submission to the registry
February 28, 2022
CompletedFirst Posted
Study publicly available on registry
March 9, 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
February 28, 2022
August 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Objective Response Rate (ORR) (PR+ MLFS+CRi +CR)
The proportion of patients with complete remission (CR), CR with incomplete hematologic recovery (CRi), morphologic leukemia-free state (MLFS), and partial remission (PR) as measured by response criteria definitions for acute myeloid leukemia.
30 days after every a course of NK immunotherapy
Leukemia-free survival (LFS)
Time from achievement of CR/CRi/MLFS to the time of relapse, death in remission, or last follow-up.
1 year
Overall survival (OS)
The proportion of patients with overall survival
1 year
Secondary Outcomes (2)
Duration of persistence of infused NK cells
21 days after the first infusion
Number of T, B, NK, activated T and NK cells after immunotherapy
30 days after the first infusion
Study Arms (1)
expanded haploidentical NK cell immunotherapy
EXPERIMENTALAfter a cycle of chemotherapy a patient receive three intravenous infusions of expanded haploidentical NK cells.
Interventions
Three doses of expanded haploidentical NK cells (30-100 x 10\^6 cells /kg).
Eligibility Criteria
You may qualify if:
- 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
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
February 28, 2022
First Posted
March 9, 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