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RecruitingNCT07693881Updated Jul 23, 2026

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

An interventional study of Rituximab (R) in EBV Infection After Allogenic HSCT, sponsored by Nanfang Hospital, Southern Medical University. Recruiting at 1 site in China. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-07-23.

Sponsored by Nanfang Hospital, Southern Medical University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
106
Allocation
Randomized
Ages
Up to 18 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • EBV Infection After Allogenic HSCT
03

In context

Lead sponsor

Nanfang Hospital, Southern Medical University is the lead sponsor of 480 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
106 participants (estimated)

Study arms

  • Experimental
    Rituximab

    Rituximab applied in conditioning

    Drug: Rituximab (R)

  • No intervention
    Blank

    blank control

Interventions

  • DrugRituximab (R)

    Day -8 and -1 apply rituximab in conditioning

06

What researchers measure

Primary outcomes

  1. Incidence of Epstein-Barr virus (EBV) infection

    To determine the incidence of Epstein-Barr virus (EBV) infection within 6 months after haploidentical hematopoietic stem cell transplantation when the ATG-based Protocol is combined with rituximab for prevention.

    Time frame: +6 month post-transplant

07

Study locations

1 of 1 sites recruiting
  • Nanfang Hospital, Southern Medical University
    Guangzhou, China
    Recruiting
08

References and documents

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. PubMed 37470925 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07693881
Lead sponsor
Nanfang Hospital, Southern Medical University
Responsible party
Sponsor
First posted
Jul 9, 2026
Start date
Jul 1, 2026 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Jul 23, 2026

Study contacts

Yongsheng Ruan
Contact
vimmer@smu.edu.cn
+8602062787966

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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