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Study identifier: NCT07366801 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Co-infusion of Treg-enriched Donor Lymphocytes With CD3-depleted Hematopoietic Stem Cell Graft to Prevent Graft-versus Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation Among Children With Hematologic Malignancies

Condition: Acute Myeloid Leukemia, Relapsed · Acute Lymphoblastic Leukemia, High Risk · Acute Myeloid Leukemia, High Risk  ·  Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology

PhasePhase 2/Phase 3
Planned participants64
Who can joinAll sexes, 1 Year to 25 Years
Healthy volunteersNo

About this study

Two key methods of GVHD prevention in allogeneic HSCT have a number of limitations: ex vivo T depletion is associated with an excess of infectious complications, and pharmacological immunosuppression with insufficient efficacy of GVHD prevention. Modern graft engineering technologies make it possible to create a graft with a balanced cell composition, reducing the risk of adverse events, in particular, severe forms of acute and chronic GVHD, while preserving the immunological function of the graft. In the proposed concept, enrichment of the T graft with regulatory cells will reduce the risk of GVHD and preserve a sufficient number of T lymphocytes in the graft for the formation of protective anti-infective immunity in the early stages after HSCT. The combination of partial T depletion and pharmacological immunosuppression minimized in volume and duration will combine the advantages of T depletion (early engraftment, low risk of GVHD, low risk of organ complications) and pharmacological prophylaxis (restoration of anti-infective immunity).

This description comes directly from the study's public registry record.

Talk to the study team

Michael Maschan, Prof  ·  +79166512145  ·  mmaschan@yandex.ru

Always discuss trial participation with your own doctor first.

Locations (1)

National medical research center of pediatric haematology, oncology and immulogy named after Dmytriy Rogachyov, Moscow, 117198Moscow, RussiaRecruiting

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Source record: clinicaltrials.gov/study/NCT07366801