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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Beijing Children's Hospital Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Jun Yang
yangjundabby@outlook.com
+86 01059612403
Time Frame
Start Date: 2024-11-12
Estimated Completion Date: 2029-10-30
Participants
Target number of participants: 48
Treatments
Experimental: treatment group
Sponsors
Leads: Beijing Children's Hospital

This content was sourced from clinicaltrials.gov

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