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

De qué trata este estudio

El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.

Tipo de estudio

De intervención

Fase

Fase 2 / Fase 3

Rango de edad

14 años - 70 años

Sexo admitido

Todos los sexos

Voluntarios sanos

No aceptados

Participantes

214 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Acerca de la investigación

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.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

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.

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación

Asignación al azar

Enmascaramiento

Sin enmascaramiento

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Centros de investigación (10)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

10 centros

Equipo y fechas

Patrocinador principal

The First Affiliated Hospital of Soochow University

Inicio del estudio

2026-11 Estimado

Finalización primaria

2029-01 Estimado

Finalización del estudio

2029-07 Estimado

Primera publicación

10 nov 2026 Real

Última actualización

10 nov 2026 Real

Contactos oficiales del estudio