Nanfang Hospital, Southern Medical University
Guangzhou, China
Location status: Recruiting
Recruiting
NCT Number: NCT07693881
Prevention of Epstein-Barr Virus Reactivation With the ATG-based Haploidentical Protocol Combined With Rituximab in Children Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
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
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
Up to 18 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Rituximab (R)
DrugDay -8 and -1 apply rituximab in conditioning
Primary outcomes
-
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Nanfang Hospital, Southern Medical University
Other
Registry information
Official study 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
Important dates
- Study start
- 2026
- Primary completion
- 2028
- Study completion
- 2029
- First posted
- Jul 9, 2026
- Registry last updated
- Jul 23, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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