About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
The expected survival period for multiple organ failure is no more than 3 months
Not signing the informed consent form
Trial design
Single group
Treatments tested in this trial
recombinant humanized anti-CD25 monoclonal antibody
DrugFor children at high risk of GVHD, one of the following conditions must be met (haploidentical donors must meet one condition, while unrelated donors must meet two conditions): 1. The donor is ≥40 years old; 2. The donor is an unrelated donor with ≥1 locus mismatch, a haploidentical female donor, or collateral consanguinity (e.g., cousin, uncle/aunt); 3. Pre-transplant CD3 count ≥4 x 10\^8/kg; 4. The primary disease is in an HLH (hemophagocytic lymphohistiocytosis) flare or active disease phase; 5. ATG (or biologically equivalent doses of ATLG \[1:2\] or ALG \[1:20\]) \<10mg/kg. Combining recombinant anti-CD25 humanized monoclonal antibody with conventional pretreatment regimen, before peripheral blood stem cell transfusion (i.e. 0d) and+3d, 1mg/kg,\<40kg the maximum dose should not exceed25mg/dose, ≥40kg 1mg/kg, and the maximum dose should not exceed 50mg/dose.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of aGVHD
Secondary outcomes
Incidence of TMA
Incidence of VOD
Overall survival
Incidence of adverse events
Sponsors and contacts
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