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

PHASE4RecruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

November 12, 2024

Primary Completion Date

October 30, 2029

Study Completion Date

October 30, 2029

Conditions
EBV-T/NK LPD
Interventions
DRUG

recombinant humanized anti-CD25 monoclonal antibody

"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."

Trial Locations (1)

100045

RECRUITING

Beijing Children's Hospital Capital Medical University, Beijing

All Listed Sponsors
lead

Beijing Children's Hospital

OTHER