EBV-T/NK LPD
Conditions
Brief 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.
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.
Sponsors
Beijing Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of aGVHD | post-HSCT 100days |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of TMA | post-HSCT 1year |
| Incidence of VOD | post-HSCT 1year |
| Overall survival | post-HSCT 1year |
| Incidence of adverse events | 30 days after discontinuation of medication |
Countries
China
Contacts
Primary ContactJun Yang
Outcome results
None listed