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Recruiting NCT07693881

Prevention of Epstein-Barr Virus Reactivation With the ATG-based Haploidentical Protocol Combined With Rituximab in Children Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

No phase Interventional EBV Infection After Allogenic HSCT

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rituximab (R).
Who it may be relevant to
Registry conditions: EBV Infection After Allogenic HSCT. Basic parameters: up to 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prevention of Epstein-Barr Virus Reactivation With the ATG-based Haploidentical Protocol Combined With Rituximab in Children Undergoing Allogeneic Hematopoietic Stem Cell Transplantation: A Prospective, Multicenter, Open-Label, Randomized Controlled Clinical Trial

Overview

The goal of this clinical trial is to learn if adding rituximab to the ATG-based Protocol can prevent Epstein-Barr virus (EBV) from reactivating in children who have received an allogeneic haploidentical hematopoietic stem cell transplant. It will also learn about the safety of adding rituximab. The main questions it aims to answer are: Does giving rituximab twice during the conditioning regimen lower the number of children who have EBV reactivation after transplant? What medical problems or side effects do children experience when they receive rituximab in addition to the ATG-based Protocol? Researchers will compare the group that receives rituximab (two doses before transplant) with a control group that receives no rituximab, to see if the addition of rituximab effectively prevents EBV reactivation. Participants will: Receive either rituximab (two doses during the preconditioning phase) or no extra treatment (control group), depending on which group they are assigned to Have regular follow-up visits for blood tests to monitor their EBV-DNA levels Keep a record of any symptoms or health changes they notice between visits

Interventions

  • Drug Rituximab (R)
    Day -8 and -1 apply rituximab in conditioning

Primary outcome measures

  • Incidence of Epstein-Barr virus (EBV) infection [Time frame: +6 month post-transplant]

Eligibility criteria

Inclusion criteria

  • ECOG performance status score of 0-1, or Karnofsky Performance Status (KPS) score > 80.
  • Diagnosis of a disease that has an indication for allogeneic hematopoietic stem cell transplantation.
  • Donor source is a related HLA haploidentical (half-matched) family donor.
  • Use of an "ATG-based" transplantation conditioning/protocol.
  • Written informed consent obtained from the patient's legal guardian prior to enrollment in this study.

Exclusion criteria

  • Lansky performance score < 60.
  • Diagnosis of EBV-associated hemophagocytic lymphohistiocytosis (HLH) or chronic active EBV infection.
  • Serum EBV DNA level > 100 U/mL before transplantation.
  • Use of B-cell depleting immunotherapy (e.g., rituximab, blinatumomab, etc.) within 2 weeks prior to preconditioning.
  • Known allergy or hypersensitivity to rituximab.
  • Severe organ dysfunction
  • The subject or their legal guardian is unwilling or unable to comply with the protocol, or refuses to sign the informed consent document.
  • Patients deemed by the investigator to be unsuitable for participation in this trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

China · 1 center
  • Nanfang Hospital, Southern Medical University — Guangzhou

Publications

  • Ruan Y, Chen L, Luo T, Xie D, Cao W, Liu X, Liu Q, Xiao Y, Wu C, Wen J, Li J, Meng J, Wu X, Feng X. Applying Rituximab During the Conditioning Regimen Prevents Epstein-Barr Virus Infection Following Allogeneic Hematopoietic Stem Cell Transplant in a Children's Cohort: A Retrospective Case-Control Study. Infect Dis Ther. 2023 Aug;12(8):2071-2086. doi: 10.1007/s40121-023-00841-x. Epub 2023 Jul 20. PMID 37470925

Identifiers

NCT: NCT07693881 · NFEC-2026-433

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗