A Phase 2/3 interventional study of CD20 monoclonal antibody in EBV Activation and EBV-PTLD After Allogeneic Hematopoietic Stem Cell Transplantation, sponsored by The First Affiliated Hospital of Soochow University. Recruiting at 10 sites in China. Open to participants aged 14 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by The First Affiliated Hospital of Soochow University · Phase 2/3, Interventional, and Prevention
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.
The First Affiliated Hospital of Soochow University is the lead sponsor of 261 studies on the registry; 150 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: CD20 monoclonal antibody
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.
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.
EBV activation rate
Time frame: 180 days after transplantation
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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