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
Recruiting now · Phase 4
Conditions studied: EBV-T/NK LPD
In brief
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.
Key facts
- Study ID
- NCT07029958
- Run by
- Beijing Children's Hospital
- People needed
- 48
- Starts
- 2024-11-12
- Expected to finish
- 2029-10-30
- Last updated by the study team
- 2025-06-19
Who can join
Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- The expected survival period for multiple organ failure is no more than 3 months
- Not signing the informed consent form
Where it is running
- Beijing Children's Hospital Capital Medical University — Beijing, China (enrolling)
Full record on ClinicalTrials.gov
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