Feasibility and Safety of Donor-derived NK-cell Infusions for Leukemia Relapse Prophylaxis After Hematopoietic Stem Cell Transplantation

Recruiting Phase 2 Interventional Study
Acute Myeloid Leukemia Acute Lymphoblastic T-cell Leukemia Mixed Phenotype Acute Leukemia
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
1 Month – 25
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
15 (estimated)
Sponsor
Federal Research Institute of Pediatric Hematology, Oncology and Immunology · Other
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Patient (age from 14 to 25 years) and/or patient's legal representative (age from 0 to 18 years) should provide written informed consent. 2. Patients with one of the following disease: * Acute myeloid leukemia: a. primary refractory disease (absence of complete remission …
Contacts

Timofei Y Zavidnyi, MD

+79153492188

timofey.zavidnyy@dgoi.ru

CONTACT