Co‑infusing regulatory T cell–enriched donor lymphocytes with CD3‑depleted stem cell grafts to prevent GVHD after haploidentical transplant in children and young adults
Pilot Study of Co-Infusion of Donor Lymphocytes Enriched With Regulatory T Lymphocytes With Ex-vivo CD3-Depleted Hematopoietic Stem Cell Graft for the Prevention of Graft-versus-Host Disease in Children With Hematopoietic and Lymphoid Tissue Neoplasms
This trial will try adding donor regulatory T cells to a partially T‑cell depleted stem cell graft plus short immunosuppression in children and young adults getting a haploidentical transplant to see if it reduces graft‑versus‑host disease.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 1 Year to 25 Years |
| Sex | All |
| Sponsor | Federal Research Institute of Pediatric Hematology, Oncology and Immunology Academic / other |
| Drugs / interventions | Ruxolitinib |
| Locations | 1 site (Moscow) |
| Trial ID | NCT07366801 on ClinicalTrials.gov |
What this trial studies
This Phase 2/3 interventional protocol gives a CD3‑depleted peripheral blood hematopoietic stem cell graft together with a donor lymphocyte product enriched for regulatory T cells (CD25‑selected). Participants also receive pharmacologic GVHD prophylaxis that includes cyclosporine A and one of sirolimus, ruxolitinib, or abatacept with minimized duration. The goal is to combine partial T‑cell depletion with regulatory T cell supplementation to lower rates of severe acute and chronic GVHD while preserving early anti‑infective immunity and promoting timely engraftment. The trial enrolls patients receiving haploidentical allogeneic HSCT and includes planned follow‑up for three years at the coordinating center in Moscow.
Who should consider this trial
Good fit: Children and young adults (up to about 25 years) with high‑risk or relapsed acute myeloid or lymphoblastic leukemia who are planned for a haploidentical allogeneic HSCT with adequate organ function and performance status are the intended participants.
Not a fit: Patients with active severe infections, acute viral hepatitis or HIV, significant organ dysfunction (very high bilirubin or creatinine), severe CNS disease, poor performance status (<70), pregnancy or lactation, or those without a haploidentical donor are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, this approach could reduce severe acute and chronic GVHD while preserving early immune protection and lowering transplant‑related complications.
How similar studies have performed: Small early‑phase trials of adoptive regulatory T cell transfer and tailored T‑cell depletion have shown promising reductions in GVHD, so this approach builds on limited but encouraging prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Informed consent signed by the patient (age 14 to 25 years) and/or his/her legal representative (age 0 to 18 years). 2. The patient has an indication for allogeneic hematopoietic stem cell transplantation (HSCT) established in accordance with the current regulatory framework 3. Planned HSCT from a haploidentical donor 4. The Karnofsky or Lansky score is more than 70% 5. Life expectancy of at least 8 weeks 6. Heart function: ejection fraction of at least 40% 7. Consent to continue follow-up for 3 years Exclusion Criteria: 1. Acute viral hepatitis or acute HIV infection 2. Hypoxemia with SaO2 \<90% 3. Bilirubin \>3 normal 4. Creatinine \>3 norms 5. Pregnancy and lactation 6. Life-threatening infection 7. Severe (\>?) pathology of the central nervous system (epilepsy, dementia, organic damage to the central nervous system) 8. Karnofsky score or Lansky score \<70%
Where this trial is running
Moscow
- National medical research center of pediatric haematology, oncology and immulogy named after Dmytriy Rogachyov, Moscow, 117198 — Moscow, Russia (Recruiting)
Study contacts
- Study coordinator: Michael Maschan, Prof
- Email: mmaschan@yandex.ru
- Phone: +79166512145
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.