Actively Recruiting
Feasibility and Safety of Donor-derived NK-cell Infusions for Leukemia Relapse Prophylaxis After Hematopoietic Stem Cell Transplantation
Led by Federal Research Institute of Pediatric Hematology, Oncology and Immunology · Updated on 2025-12-01
15
Participants Needed
1
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This pilot clinical trial aims to evaluate the feasibility, adverse reactions and maximum tolerated dose of mbIL21 ex vivo-expanded donor-derived NK-cell infusions before and after haploidentical or matched-related hematopoietic stem cell transplantation in a cohort of pediatric and young adult patients with chemorefractory or minimal residual disease (MRD) positive acute leukemia.
CONDITIONS
Official Title
Feasibility and Safety of Donor-derived NK-cell Infusions for Leukemia Relapse Prophylaxis After Hematopoietic Stem Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient or legal representative provides written informed consent
- Patients aged 14 to 25 years (or legal representative aged 0 to 18 years)
- Diagnosis of acute myeloid leukemia, acute T-lymphoblastic leukemia, or acute mixed phenotype leukemia with primary refractory disease, refractory relapse, or pre-transplant minimal residual disease persistence
- Patient is scheduled to receive allogeneic hematopoietic stem cell transplantation
- Haploidentical or matched related donor is chosen and available
- Clinical status with Lansky/Karnowsky index 50% or higher
- Kidney function clearance or glomerular filtration rate of 50 ml/min/1.73 m2 or greater
- Liver function with total bilirubin not exceeding 3 times upper limit of normal (ULN) except Gilbert's disease, and ALT/AST not exceeding 3 times ULN
- Heart function with left ventricular ejection fraction 40% or higher
- Lung function with capacity 50% or higher, or oxygen saturation 92% or higher without supplemental oxygen for children unable to perform lung function tests
- Life expectancy of 8 weeks or more
- Agreement to long-term follow-up for up to 2 years
You will not qualify if you...
- Inability or withdrawal of written informed consent
- Cellular therapy including allogeneic hematopoietic stem cell transplantation within prior 4 months with active graft-versus-host disease or related syndromes
- Active hepatitis B, hepatitis C, or HIV infection
- Pregnancy or breastfeeding
- Uncontrolled infection as determined by the principal investigator
- Clinical signs of grade 3 or higher central nervous system disorders
- Mental illness in participant or caregivers preventing study understanding or compliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Dmitry Rogachev Federal Research and Clinical Centre of Paediatric Haematology, Oncology and Immunology
Moscow, Russia, 117997
Actively Recruiting
Research Team
T
Timofei Y Zavidnyi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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