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

July 3, 2026 updated by: Nanfang Hospital, Southern Medical University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: prevention
Rituximab applied in conditioning
Drug: Rituximab (R)
Day -8 and -1 apply rituximab in conditioning
No Intervention: control
blank control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Epstein-Barr virus (EBV) infection
Time Frame: +6 month post-transplant
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.
+6 month post-transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital, Southern Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

July 3, 2026

First Submitted That Met QC Criteria

July 3, 2026

First Posted (Actual)

July 9, 2026

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 3, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2026-433

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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