Prevention of Epstein-Barr Virus Reactivation With the ATG-based Haploidentical Protocol Combined… (NCT07693881) | Clinical Trial Compass
RecruitingNot Applicable
Prevention of Epstein-Barr Virus Reactivation With the ATG-based Haploidentical Protocol Combined With Rituximab in Children Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
China106 participantsStarted 2026-07-01
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Epstein-Barr virus (EBV) infection
Timeframe: +6 month post-transplant
Trial details
NCT IDNCT07693881
SponsorNanfang Hospital, Southern Medical University