SUSPENDED

Longitudinal Assessment of Marrow and Blood in Patients With Glioblastoma

Conditions

Glioblastoma Glioblastoma, T cells, Sequestration Sphingosine-1-phosphate receptor 1 β-arrestin, Bone marrow, Immunotherapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Longitudinal Assessment of Marrow and Blood in Patients With Glioblastoma

Quick Facts

Study Start:2024-02-05

Study Completion:2026-11-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:SUSPENDED

Study ID

NCT04657146

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* Patients who previously received other conventional therapeutic interventions for newly diagnosed glioblastoma with the exception of surgical intervention. * Patients with prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin * 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.

Inclusion Criteria

Exclusion Criteria

* 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.

* Patients who previously received other conventional therapeutic interventions for newly diagnosed glioblastoma with the exception of surgical intervention.
* Patients with prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin
* 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.

Contacts and Locations

Principal Investigator

Anoop Patel, M.D.

PRINCIPAL_INVESTIGATOR

Duke University

Katayoun Ayasoufi, Ph.D.

PRINCIPAL_INVESTIGATOR

Duke University

Study Locations (Sites)

Duke University Medical Center

Durham, North Carolina, 27710

United States

Collaborators and Investigators

Sponsor: Duke University

Anoop Patel, M.D., PRINCIPAL_INVESTIGATOR, Duke University
Katayoun Ayasoufi, Ph.D., PRINCIPAL_INVESTIGATOR, Duke University

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 Registration Dates

Study Start Date2024-02-05

Study Completion Date2026-11-01

Study Record Updates

Study Start Date2024-02-05

Study Completion Date2026-11-01

Terms related to this study

Keywords Provided by Researchers

Glioblastoma, T cells, Sequestration
Sphingosine-1-phosphate receptor 1
β-arrestin, Bone marrow, Immunotherapy

Additional Relevant MeSH Terms

Glioblastoma