Prevention of EBV Reactivation in Kids Undergoing Haploidentical Stem Cell Transplant with Rituximab Added to ATG Conditioning

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study in children compares adding two rituximab doses during the preconditioning phase to the standard ATG-based transplant protocol without rituximab. The goal is to see if rituximab reduces EBV reactivation after allogeneic haploidentical HSCT and to monitor related safety and potential side effects. Eligible participants are children with diseases requiring haploidentical HSCT from a related donor, with adequate performance status and no recent rituximab exposure. Outcomes focus on EBV reactivation rates and treatment-emergent adverse events, guiding whether rituximab adds protective benefit in this setting. The study is conducted at Nanfang Hospital, Southern Medical University, with guardian consent required for enrollment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Nanfang Hospital, Southern Medical University
  Guangzhou, China Recruiting

Study contacts

• Study coordinator: Yongsheng Ruan
• Email: vimmer@smu.edu.cn
• Phone: +8602062787966

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.