NCT07693881

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
42mo left

Started Jul 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Jul 2026Dec 2029

Study Start

First participant enrolled

July 1, 2026

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

2.5 years

First QC Date

July 3, 2026

Last Update Submit

July 21, 2026

Conditions

EBV Infection After Allogenic HSCT

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Rituximab

EXPERIMENTAL

Rituximab applied in conditioning

Drug: Rituximab (R)

Blank

NO INTERVENTION

blank control

Interventions

Rituximab (R)DRUG

Day -8 and -1 apply rituximab in conditioning

Rituximab

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37470925BACKGROUND

MeSH Terms

Interventions

Rituximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Yongsheng Ruan

CONTACT

+8602062787966vimmer@smu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2026

First Posted

July 9, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Last Updated

July 23, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)