Resumen

Elegibilidad

Detalles del diseño

Brazos e Intervenciones

Medidas de resultado

Sitios del ensayo

Fuente: NCT04657146

Suspendido

LAMB-G: Longitudinal Assessment of Marrow and Blood in Patients With Glioblastoma

Observacional

Fase no especificada

Duke University Medical Center

Patrocinador: Duke University

Última actualización: 10 de octubre de 2024
Aviso: La información proviene de registros públicos y puede no reflejar cambios en tiempo real en el centro local.

The main goal of this study is to provide foundational data to drive translational approaches for an entirely novel category of immunotherapy.

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Categoría de tratamiento

Otros

Erforderliche Mutationen

Ninguna

Ensayo iniciado

5 de febrero de 2024

Última actualización por el patrocinador

10 de octubre de 2024

Finalización estimada

1 de noviembre de 2025

Contacto del estudio

Nombre:Peter Fecci, M.D., Ph.D.

Correo electrónico:peter.fecci@duke.edu

Teléfono:919 681 2610

Nombre:Beth Mancuso-Mills, M.B.A.

Correo electrónico:beth.mancuso@duke.edu

Teléfono:919 668 9002

Elegibilidad

Criterios de inclusión

* Age ≥18 years of age.

* Suspected newly-diagnosed GBM, World Health Organization (WHO) Grade IV with intent for gross total resection (as defined above).

* Accessibility for treatment and follow up.

* Patient consent obtained according to Duke institutional policy.

* Women of child bearing potential (WOCBP) must have a negative serum pregnancy test according to standard of care prior to surgery.

Criterios de exclusión

* Prior therapy (other than steroids or stereotactic biopsy) or concomitant immunotherapy.

* Pregnant or breast-feeding during the study period.

* Patients with an active infection, or febrile within 24 hours of surgery.

* Patients with inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, or other autoimmune disease.

* Patients with history of or active hematologic or bone marrow diseases, including but not limited to diagnosed lymphomas, leukemias, sickle cell or other anemias not associated with their current condition or polycythemia vera.

* Prior bone marrow harvests preceding this study.

* Patients with known or suspected immunodeficiency or human immunodeficiency virus (HIV).

* Hematocrit < 24 % pre-operatively.

* Patients with a serious active infection or other serious underlying medical conditions that would impair the ability of the patient to receive protocol treatment or comply with protocol.

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Detalles del diseño

AsignaciónN/A

Modelo de intervenciónN/A

EnmascaramientoN/A

Número a inscribir40

Brazos e Intervenciones

Brazos

Intervenciones

Tipo: N/A

Descripción: Patients, ≥18 years of age, with newly diagnosed GBM, World Health Organization (WHO) Grade IV, undergoing gross total resection (defined as >90% of contrast enhancing volume removed on post-operative MRI) and collection of blood, bone marrow, and tumor.

Intervenciones:

Biorepository

Medidas de resultado

Medidas de resultado primarias

Variations in blood and bone marrow T cell counts2 years

Assess variations in blood and bone marrow T cell counts as they relate to treatment time-points in patients with glioblastoma.

Variations in Sphingosine-1-phosphate receptor 1 (S1P1) levels2 years

Assess variations in S1P1 levels and their correlation with blood and bone marrow T cell counts over the course of treatment in patients with glioblastoma.

Medidas de resultado secundarias

Ninguno

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Sitios del ensayo

Este estudio tiene 1 sitio de ensayo

Duke University Medical Center

Durham, North Carolina, US

Nombre:Peter Fecci, M.D., Ph.D.

Reclutando

Durham, North Carolina, 27710 US

Duke University Medical Center

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