EBV Infection After Allogenic HSCTNCT07693881
Prevention of Epstein-Barr Virus Reactivation With the ATG-based Haploidentical Protocol Combined With Rituximab in Children Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
A study testing Rituximab (R) in people with EBV Infection After Allogenic HSCT, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- EBV Infection After Allogenic HSCT
- What is being tested?
- Rituximab (R)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou
Yongsheng Ruan, +8602062787966, vimmer@smu.edu.cn
About this study
Official 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
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?
Read more
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
- Conditions
- EBV Infection After Allogenic HSCT
- Being tested
- Rituximab (R)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rituximab (R)Drug
Day -8 and -1 apply rituximab in conditioning
| Study group | Role | What they receive |
|---|---|---|
| Rituximab | Experimental | Rituximab applied in conditioning Receives: Drug: Rituximab (R) |
| Blank | No intervention | blank control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: +6 month post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EBV Infection After Allogenic HSCTStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693881
- Sponsor's protocol ID
- NFEC-2026-433
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07693881
- Acronym / sponsor ID
- NFEC-2026-433
- Conditions
- EBV Infection After Allogenic HSCT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rituximab | Experimental | Drug: Rituximab (R)Rituximab applied in conditioning |
| Blank | No intervention | –blank control |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rituximab (R)Day -8 and -1 apply rituximab in conditioning | Drug | Rituximab |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Background: PubMed 37470925Ruan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rituximab (R) in people with EBV Infection After Allogenic HSCT, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongsheng Ruan (+8602062787966, vimmer@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Epstein-Barr virus (EBV) infection (time frame: +6 month post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07693881, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.