Prevention of Epstein-Barr Virus Reactivation With the AT... | NCT07693881

Studies
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

NCT07693881

Sponsor

Nanfang Hospital, Southern Medical University

Status

Not yet recruiting

Last Update Posted

Jul 9, 2026Actual

Enrollment

106Estimated

Phase

Not Applicable

Conditions

EBV Infection After Allogenic HSCT

Interventions

Rituximab (R)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jul 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2026Estimated

Primary Completion Date

Dec 31, 2028Estimated

Completion Date

Dec 31, 2029Estimated

First Submitted Date

Jul 3, 2026

First Submission Date that Met QC Criteria

Jul 3, 2026

First Posted Date

Jul 9, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 3, 2026

Last Update Posted Date

Jul 9, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

106Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
prevention	Experimental	Rituximab applied in conditioning	Drug: Rituximab (R)
control	No Intervention	blank control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rituximab (R)	Drug	Day -8 and -1 apply rituximab in conditioning	prevention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	+6 month post-transplant

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Yongsheng Ruan	Contact	+8602062787966		vimmer@smu.edu.cn

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37470925	Background	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.

ID	Term
D058846	Antibodies, Monoclonal, Murine-Derived
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins