Actively 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
Led by Federal Research Institute of Pediatric Hematology, Oncology and Immunology · Updated on 2026-01-26
64
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent by patient (14-25 years) or legal representative (0-18 years)
- Indication for allogeneic hematopoietic stem cell transplantation per regulations
- Planned HSCT from a haploidentical donor
- Karnofsky or Lansky score above 70%
- Life expectancy of at least 8 weeks
- Heart ejection fraction at least 40%
- Consent to follow-up for 3 years
You will not qualify if you...
- Acute viral hepatitis or acute HIV infection
- Blood oxygen saturation below 90%
- Bilirubin levels greater than 3 times normal
- Creatinine levels greater than 3 times normal
- Pregnancy or breastfeeding
- Life-threatening infection
- Severe central nervous system disease such as epilepsy, dementia, or organic damage
- Karnofsky or Lansky score below 70%
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National medical research center of pediatric haematology, oncology and immulogy named after Dmytriy Rogachyov, Moscow, 117198
Moscow, Russia
Actively Recruiting
Research Team
M
Michael Maschan, Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here