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
Beijing Children's Hospital
48 participants
Nov 12, 2024
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria5
- 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 Criteria2
- The expected survival period for multiple organ failure is no more than 3 months
- Not signing the informed consent form
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Interventions
For 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.
Locations(1)
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NCT07029958