Clinical trial · Observational
Longitudinal Assessment of Marrow and Blood in Patients With Glioblastoma
NCT04657146CI-TRIAL-00097157LAMB-GsuspendedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study undergoing amendment and funding changes.
Summary
Brief summary (as posted)
The main goal of this study is to provide foundational data to drive translational approaches for an entirely novel category of immunotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biorepository | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with suspected newly-diagnosed Glioblastoma (GBM)
- description
- 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.
- interventionNames
- Other: Biorepository
Primary outcomes (2)
- measure
- Variations in blood and bone marrow T cell counts
- timeFrame
- 2 years
- description
- Assess variations in blood and bone marrow T cell counts as they relate to treatment time-points in patients with glioblastoma.
- measure
- Variations in Sphingosine-1-phosphate receptor 1 (S1P1) levels
- timeFrame
- 2 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.