Two doses of rituximab before transplant may shield children from Epstein-Barr virus
NCT ID NCT07693881
First seen Jul 09, 2026 · Last updated Jul 24, 2026 · Updated 5 times
Summary
This trial tests whether giving two doses of rituximab before a stem cell transplant can prevent Epstein-Barr virus (EBV) from reactivating in children. EBV is a common virus that can cause serious illness in children with weakened immune systems after transplant. The study compares children who receive rituximab plus standard care to those who receive standard care alone, tracking EBV levels and side effects for six months after transplant.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- rituximab
- What this could lead to
- If it works, this approach could reduce serious EBV-related complications in children receiving half-matched stem cell transplants, making the procedure safer.
- What could go wrong
- This is a relatively small, early-stage trial, and rituximab may cause side effects like infusion reactions or increased risk of other infections. The benefit may not be confirmed in larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 106 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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Up to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Nanfang Hospital, Southern Medical University
RECRUITINGGuangzhou, China
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