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

NCT07029958 | Recruiting Phase 4

• 1 other identifier: [2024]-Y-254-D
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

EBV-T/NK LPD

Outcome Measures

Primary Outcomes (1)

• Incidence of aGVHD

  post-HSCT 100days

Secondary Outcomes (4)

• 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

Study Arms (1)

treatment group

EXPERIMENTAL

Drug: recombinant humanized anti-CD25 monoclonal antibody

Interventions

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 group

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• Beijing Children's Hospital: lead

Study Sites (1)

Beijing Children's Hospital Capital Medical University

Beijing, 100045, China

RECRUITING

Central Study Contacts

Jun Yang

CONTACT

+86 01059612403; yangjundabby@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 19, 2025
• Study Start: November 12, 2024
• Primary Completion (Estimated): October 30, 2029
• Study Completion (Estimated): October 30, 2029
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

CN (1)