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Improved Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation Protocol for the Treatment of Epstein Barr Virus T/NK Lymphoproliferative Disease (EBV-T/NK LPD) and Prevention of Post Transplant Graft-versus-host Disease

RecruitingPhase 4Ages 0 Years - 18 YearsAllBeijing Children's Hospital
NCT07029958 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

To investigate whether the addition of recombinant humanized anti-CD25 monoclonal antibody to the conventional EBV-T/NK LPD conditioning regimen can prevent acute and chronic GVHD after transplantation, improve the severity of GVHD and have a corresponding impact on other related post-transplant complications such as poor engraftment, thrombotic microvascular disease, early EBV reactivation and relapse.

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📋 Eligibility rules (as published)
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
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What it tests

  • recombinant humanized anti-CD25 monoclonal antibody
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Where

1 site
Beijing Children's Hospital Capital Medical University
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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