Protocol adding anti-CD25 antibody to myeloablative allogeneic stem cell transplant to prevent graft-versus-host disease in children with EBV T/NK lymphoproliferative disease

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 4 interventional protocol enrolls patients age 18 or younger with EBV-T/NK lymphoproliferative disease undergoing myeloablative allogeneic hematopoietic stem cell transplantation at Beijing Children's Hospital and adds a recombinant humanized anti-CD25 monoclonal antibody to the conditioning regimen. The antibody targets CD25-expressing activated T cells to blunt the alloreactive immune responses that drive acute and chronic graft-versus-host disease. Key outcomes include incidence and severity of acute and chronic GVHD, engraftment success, thrombotic microvascular disease, early EBV reactivation, relapse, and other transplant-related complications. Donor eligibility requires meeting specified age, related/unrelated or mismatch, T-cell dose, or disease-activity criteria, and participants must provide informed consent and complete inpatient transplant care at the center.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Meet the diagnosis of EBV-T/NK lymphoproliferative disease (EBV-T/NK LPD) according to the ICC2022 diagnostic criteria
* Plan to undergo allogeneic hematopoietic stem cell transplantation (allo HSCT) in our hospital
* Age ≤ 18 years old
* Sign informed consent form
* Meet one of the following conditions (haploid donors must meet one of the above conditions, unrelated donors must meet two of the above conditions): ① donor age≥40 years old; ② The donor source is unrelated donor or haplotype related female or collateral donor (brother sisters, etc.) with ≥ 1 point mismatch; ③ CD3≥4 x 10 \^ 8/kg before transplantation; ④ The primary disease is in an HLH (hemophagocytic lymphohistiocytosis) flare or active disease phase; ⑤ ATG (or ATLG (1:2)/ALG (1:20) equivalent dose)\<10mg/kg

Exclusion Criteria:

* The expected survival period for multiple organ failure is no more than 3 months
* Not signing the informed consent form

Where it's running

• Beijing Children's Hospital Capital Medical University
  Beijing, China Recruiting

Study contacts

• Study coordinator: Jun Yang
• Email: yangjundabby@outlook.com
• Phone: +86 01059612403

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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.