Clinical Study on CD20 Monoclonal Antibody for Preventing Early EB Virus Activation After Allogeneic Hematopoietic Stem Cell Transplantation

November 5, 2026 updated by: CHEN Jia, The First Affiliated Hospital of Soochow University

Efficacy and Safety of B-cell Clearance in Preventing Early Epstein-Barr Virus Activation After Allogeneic Hematopoietic Stem Cell Transplantation: A Multicenter, Prospective, Randomized Controlled Clinical Study

The main purpose of this study is to evaluate the preventive effect and safety of CD20 monoclonal antibody clearing B cells on EBV activation 180 days after allogeneic hematopoietic stem cell transplantation. The study will also observe the effects of this strategy on EBV-PTLD, CMV reactivation, hematopoietic reconstruction, acute and chronic graft-versus-host disease (GVHD), non recurrent death, recurrence, survival, and post transplant immune reconstruction.

In this study, CD20 monoclonal antibody was used for the prevention of EBV activation after transplantation, which is an investigational prophylactic drug/beyond the indications stated in the instructions. The research doctor will explain the relevant basis, potential benefits, and potential risks to you during the informed consent process.

The research subjects were patients who received their first allogeneic hematopoietic stem cell transplantation in each enrolled transplantation center. After evaluating the inclusion and exclusion criteria and signing the informed consent form, they were randomly divided into an experimental group and a control group at a 1:1 ratio. The experimental group received prophylactic CD20 monoclonal antibody treatment (dose of 375mg/m2, intravenous application, once) 5 days after transplantation; If medication cannot be administered on time due to special clinical circumstances, it can be completed within 5 to 30 days after transplantation. The control group did not receive prophylactic CD20 monoclonal antibody within 30 days after transplantation, and EBV-DNA, CMV-DNA, and transplant related complications were monitored according to the routine procedures of the center. All subjects were followed up according to the protocol until 2 years after transplantation or death/loss to follow-up/withdrawal of informed consent. Primary endpoint evaluation will be conducted 180 days after transplantation, and continuous collection of PTLD, CMV reactivation, hematopoietic reconstruction, etc. will be conducted GVHD、 Data on recurrence, survival, safety, and immune reconstitution. Among them, allogeneic hematopoietic stem cell transplantation, routine blood routine/liver and kidney function tests, EBV-DNA/CMV-DNA monitoring, infection and GVHD management are procedures that need to be performed for diagnosis and treatment; Randomized grouping, prophylactic CD20 monoclonal antibody administration in the experimental group, data collection, and protocol specified follow-up are the relevant procedures of this study.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

214

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China, 100000
        • Not yet recruiting
        • Peking University People's Hospita
      • Chongqing, China, 400000
        • Not yet recruiting
        • The Second Affiliated Hospital of the Third Military Medical University
      • Shanghai, China, 200000
        • Not yet recruiting
        • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
      • Suzhou, China, 215000
        • Recruiting
        • The first Affiliated Hospital of Soochow University
        • Contact:
    • Anhui
      • Hefei, Anhui, China, 230000
        • Not yet recruiting
        • Anhui Provincial Hospital
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Not yet recruiting
        • The First Affiliated Hospital of Zhengzhou University School of Medicine
    • Jiangsu
      • Huai'an, Jiangsu, China, 223200
        • Not yet recruiting
        • Huai'an Second People's Hospital
      • Nanjing, Jiangsu, China, 210000
        • Not yet recruiting
        • Jiangsu Provincial People's Hospital
      • Xuzhou, Jiangsu, China, 221000
        • Not yet recruiting
        • Xuzhou Medical University Affiliated Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Not yet recruiting
        • The First Affiliated Hospital of Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Biological: CD20 monoclonal antibody

The experimental group will receive prophylactic CD20 monoclonal antibody treatment (dose of 375mg/m2, intravenous application, once) 5 days after transplantation; If medication cannot be administered on time due to special clinical circumstances, it can be completed within 5 to 30 days after transplantation.
No Intervention: Control group

The control group won't receive prophylactic CD20 monoclonal antibody within 30 days after transplantation, and EBV-DNA, CMV-DNA, and transplant related complications will be monitored according to the routine procedures of the center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
EBV activation rate
Time Frame: 180 days after transplantation
180 days after transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

July 1, 2029

Study Registration Dates

First Submitted

November 5, 2026

First Submitted That Met QC Criteria

November 5, 2026

First Posted (Actual)

November 10, 2026

Study Record Updates

Last Update Posted (Actual)

November 10, 2026

Last Update Submitted That Met QC Criteria

November 5, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD20antiEBV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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