A Randomized Controlled Trial of Prophylactic Rituximab to Reduce Clinically Significant EBV DNAemia After Allogeneic Hematopoietic Stem Cell Transplantation
A Prospective, Randomized, Controlled, Open-Label Clinical Trial With Blinded Endpoint Assessment of Prophylactic Rituximab for Reducing Clinically Significant EBV Viremia After Allogeneic Hematopoietic Stem Cell Transplantation
This is a single-center, prospective, randomized, open-label clinical trial with blinded endpoint assessment for patients receiving allogeneic hematopoietic stem cell transplantation (allo-HSCT). We aim to explore whether low-dose preventive rituximab can lower the risk of clinically significant Epstein-Barr virus (EBV) viremia within 180 days after transplantation.
Patients aged 16-65 years who receive allo-HSCT and carry medium-to-high risks of EBV reactivation will be enrolled. All eligible participants will be randomly split into two groups at day +21 after transplant at a 1:1 ratio.
Intervention group: Standard post-transplant supportive care plus two low doses of rituximab (100mg intravenous infusion on day +21 and day +28).
Control group: Only standard routine post-transplant management without preventive rituximab.
All participants will receive regular scheduled blood tests and outpatient follow-up visits up to 1 year after transplantation. We will monitor EBV viral load, cytomegalovirus (CMV) infection, graft-versus-host disease (GVHD), infection complications, immune function recovery, as well as long-term survival. We will also record all adverse reactions related to rituximab infusion, low immunoglobulin levels and other safety events.
The main study outcome is the cumulative rate of clinically significant EBV viremia within 180 days post transplant. All endpoint judgments will be completed by independent researchers to reduce assessment bias. This trial hopes to confirm the safety and clinical value of low-dose rituximab prevention, and provide reliable clinical evidence for EBV infection prevention after hematopoietic stem cell transplantation.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Donglin Yang
- Telefoonnummer: 02223608592
- E-mail: yangdonglin@ihcams.ac.cn
Studie Locaties
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Tianjin, China
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
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Contact:
- Donglin Yang
- Telefoonnummer: 02223608592
- E-mail: yangdonglin@ihcams.ac.cn
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Aged between 16 and 65 years old. Recipients of allogeneic hematopoietic stem cell transplantation (allo-HSCT). Clinically stable condition allowing administration of study intervention at post-transplant Day +21.
EBV-DNA quantitative test completed within 48 hours prior to randomization. Written informed consent signed by the participant or legal authorized representative.
Exclusion Criteria:
- Presence of clinically significant EBV infection or meeting criteria for EBV preemptive therapy before randomization.
Prior rituximab administration during conditioning regimen. Confirmed or highly suspected post-transplant lymphoproliferative disorder (PTLD).
Severe anaphylactic history to rituximab or any excipients of the preparation. Active uncontrolled severe systemic infection. Active hepatitis B virus (HBV) infection without standardized antiviral prophylaxis or treatment.
Pregnant or breastfeeding female subjects. Subjects judged ineligible for participation by the investigator for any other reason.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: Prophylactic Rituximab Group
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Intervention Description Patients receive uniform standard allo-HSCT post-transplant care plus two low-dose prophylactic rituximab infusions: 100 mg IV on Day +21 and 100 mg IV on Day +28 after transplantation.
Premedication is given before each infusion to avoid infusion reactions.
Uniform routine allo-HSCT follow-up care including GVHD prophylaxis, letermovir CMV prophylaxis, blood transfusion, regular viral load monitoring.
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Ander: Standard Care Control Group
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Uniform routine allo-HSCT follow-up care including GVHD prophylaxis, letermovir CMV prophylaxis, blood transfusion, regular viral load monitoring.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Cumulative incidence of clinically significant EBV DNAemia within 180 days after allogeneic hematopoietic stem cell transplantation
Tijdsspanne: From the date of allogeneic hematopoietic stem cell transplantation to Day 180 post-transplant
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From the date of allogeneic hematopoietic stem cell transplantation to Day 180 post-transplant
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Incidence of any EBV DNAemia from randomization to Day +180 post-transplant
Tijdsspanne: Randomization day to post-transplant Day 180
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Randomization day to post-transplant Day 180
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Cumulative incidence of post-transplant lymphoproliferative disorder (PTLD) within 1 year
Tijdsspanne: Randomization day to post-transplant Day 365
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Randomization day to post-transplant Day 365
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1-year overall survival (OS)
Tijdsspanne: Randomization day to post-transplant Day 365
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Randomization day to post-transplant Day 365
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IIT2026080-EC-1
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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