CD20 antibody to prevent early EBV activation after a first allogeneic stem cell transplant

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 evaluates the preventive use of a CD20 monoclonal antibody to clear B cells and see if it reduces EBV activation within 180 days after allogeneic hematopoietic stem cell transplantation. The trial also monitors potential effects on EBV-PTLD, CMV reactivation, immune reconstitution, graft-versus-host disease, and overall survival. Participants are adults and adolescents undergoing their first transplant with a higher risk of EBV reactivation, and the study tracks safety and feasibility in a multi-center setting. Primary endpoints focus on EBV activation, with secondary observations on related post-transplant outcomes. Enrollment requires informed consent and commitment to at least 180 days of follow-up.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 1\) Age range of 14-70 years old (including threshold), gender not limited; 2) Receiving allogeneic hematopoietic stem cell transplantation for the first time; 3) Accept allogeneic hematopoietic stem cell transplantation with pre-treatment regimen containing ATG (total dose ≥ 4.5mg/kg), or determine by the researcher to be a high-risk transplant population for EBV reactivation; 4) At the time of enrollment, there were no uncontrolled severe infections, shock, severe organ failure, or other intolerance to the study treatment; 5) Expected to complete at least 180 days of follow-up for the primary endpoint, and the researcher's assessment of compliance is good; 6) The subject voluntarily signs the informed consent form; Individuals under the age of 18 are required to have their legal guardian sign an informed consent form and obtain their informed consent/consent expression if their understanding ability allows.

Exclusion Criteria:

* 1\) Previously used CD20 monoclonal antibody or known to have allergic reactions to its excipients; 2) Secondary transplantation; 3) Previous history of EB virus infection related hemophilic cell syndrome, lymphoma, and other diseases; 4) EBV activation that meets the protocol definition has occurred within the 6 months prior to joining the group; 5) Patients who have received B-cell targeted therapy for any reason within the first 6 months of enrollment, including anti B-cell antibodies, B-cell antibody conjugates, BTK inhibitors, and B-cell targeted CAR-T cell therapy such as CD19; 6) There are uncontrolled infections; 7) Severe liver and kidney dysfunction, heart and lung dysfunction; 8) Those who cannot understand or comply with the research protocol or cannot sign the informed consent form; 9) The researchers believe that the patient has other circumstances that are not suitable for participating in this study.

Where it's running

• The first Affiliated Hospital of Soochow University
  Suzhou, China Recruiting
• Anhui Provincial Hospital
  Hefei, Anhui, China Not yet recruiting
• The First Affiliated Hospital of Zhengzhou University School of Medicine
  Zhengzhou, Henan, China Not yet recruiting
• Huai'an Second People's Hospital
  Huai'an, Jiangsu, China Not yet recruiting
• Jiangsu Provincial People's Hospital
  Nanjing, Jiangsu, China Not yet recruiting
• Xuzhou Medical University Affiliated Hospital
  Xuzhou, Jiangsu, China Not yet recruiting

Study contacts

• Study coordinator: Jia Chen
• Email: drchenjia@163.com
• Phone: +86 051267976801

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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.