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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.