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

ConditionEBV-T/NK LPD
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age0-18
SponsorBeijing Children's Hospital

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • recombinant humanized anti-CD25 monoclonal antibody

    Drug

    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.

Treatment groups

48 Participants
are divided into 1 treatment group
Group A: treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of aGVHD

Time frame
post-HSCT 100days

Secondary outcomes

1

Incidence of TMA

Time frame
post-HSCT 1year
2

Incidence of VOD

Time frame
post-HSCT 1year
3

Overall survival

Time frame
post-HSCT 1year
4

Incidence of adverse events

Time frame
30 days after discontinuation of medication

Other outcomes

Sponsors and contacts

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