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

NCT ID: NCT07029958

Last Updated: 2025-06-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-12
• Study Completion Date: 2029-10-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment group

Group Type: EXPERIMENTAL

recombinant humanized anti-CD25 monoclonal antibody

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• The expected survival period for multiple organ failure is no more than 3 months
• Not signing the informed consent form

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jun Yang

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Children's Hospital Capital Medical University

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jun Yang

Role: CONTACT

yangjundabby@outlook.com

+86 01059612403

Facility Contacts

Jun Yang

Role: primary

yangjundabby@outlook.com

+8601059612403

Other Identifiers

[2024]-Y-254-D

Identifier Type: -

Identifier Source: org_study_id