GlioblastomaLAMB-GNCT04657146
Longitudinal Assessment of Marrow and Blood in Patients With Glioblastoma
An observational study of Glioblastoma, run by Duke University at 1 site in United States.
Trial summary
The main goal of this study is to provide foundational data to drive translational approaches for an entirely novel category of immunotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Biorepository
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2024to 1 Nov 2028
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients meeting the terms of the inclusion and exclusion criteria above will be eligible to participate in the study. This includes all patients over 18 years of age, both sexes, and all minorities. A total of 40 patients will be enrolled in the study. Patients who are not confirmed to have GBM on histopathological analysis, or who do not qualify as gross total resection per the definition above will be removed from the study and replaced until a total of 40 patients is reached.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
The main goal of this study is to provide foundational data to drive translational approaches for an entirely novel category of immunotherapy.
Read the detailed description
The investigators' recent studies show that large numbers of T cells in patients and mice with intracranial tumors are sequestered in bone marrow. This phenomenon mysteriously confines a pool of functional, naïve T cells with anti-tumor capacity to a compartment where they are unable to access tumor, eliciting a mode of T cell dysfunction categorized as "ignorance." The investigators have uncovered that loss of the sphingosine-1-phosphate receptor 1 (S1P1) from the surface of T cells mediates their sequestration in bone marrow, while blocking internalization of S1P1 facilitates stabilization of the receptor on T cells and frees them for anti-tumor activities. As the investigators look to design interventions targeting β-arrestin mediated S1P1 internalization as a novel anti-tumor strategy, they need to better understand variations in sequestration across patients, over time, and with treatment. Assessing these variations and biomarkers that may accompany them will help to establish a target treatment population, as well as the optimal timing for intervention.
Primary Objectives:
- Assess variations in blood and bone marrow T cell counts as they relate to treatment time-points in patients with glioblastoma (GBM).
- Assess variations in S1P1 levels and their correlation with blood and bone marrow T cell counts over the course of treatment in patients with GBM
Exploratory Objectives:
- Assess the associations between tumor size and degree of lymphopenia and bone marrow T cell sequestration observed.
- Compare The Cancer Genome Atlas (TCGA) subclasses with respect to the degree of lymphopenia and bone marrow T cell sequestration observed at diagnosis.
- Examine patient plasma, tumor supernatant, and tumor ribonucleic acid (RNA) for markers that are associated with lymphopenia, T cell S1P1 levels, and bone marrow T cell sequestration. Initial candidates will include transforming growth factor-β (TGFβ) 1/2, tumor necrosis factor (TNF), interleukin (IL)-33, IL-6, catecholamines, signal transducer and activator of transcription 3 (STAT3) RNA, and Kruppel-like factor 2 (KLF2) RNA.
- Compare T cell phenotypes in the blood and bone marrow of patients exhibiting versus not exhibiting T cell lymphopenia or sequestration.
- Compare differences in tumor-infiltrating lymphocyte numbers and phenotypes between patients with and without lymphopenia / sequestration at diagnosis.
- Establish baseline β-arrestin 1 and 2 expression in patients and assess variation across individuals.
- To determine cellular component of the bone marrow upon collection of enough samples to batch. Numbers of various bone marrow resident cells will be evaluated.
- Conditions
- Glioblastoma
- Being tested
- Biorepository
- Keywords
- Glioblastoma, T cells, Sequestration, Sphingosine-1-phosphate receptor 1, β-arrestin, Bone marrow, Immunotherapy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiorepositoryOther
Tumor collection (> 1cm3): Intraoperatively
Peripheral blood collection:
- Intraoperatively (60mL +/- 5mL)
- Post-resection (30mL +/- 5mL)
- Post- standard of care treatment (30mL +/- 5 mL)
Bone marrow aspiration:
- Intraoperatively (10mL +/- 5 mL)
- Post-resection (5mL +/- 5 mL)
- Post- standard of care treatment (5mL +/- 5 mL)
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspected newly-diagnosed Glioblastoma (GBM) | 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. Receives: Other: Biorepository |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variations in blood and bone marrow T cell counts
Assess variations in blood and bone marrow T cell counts as they relate to treatment time-points in patients with glioblastoma.
Measured: 2 years
Variations in Sphingosine-1-phosphate receptor 1 (S1P1) levels
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020
- Study start5 Feb 2024
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2028 (estimated)
Why it stopped: Study undergoing amendment and funding changes.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anoop Patel, M.D., Principal investigator, Duke UniversityKatayoun Ayasoufi, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04657146
- Sponsor's protocol ID
- Pro00107040
- Acronym
- LAMB-G
- Status last verified
- Nov 2025
- First submitted
- 1 Dec 2020
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Assessment of Marrow and Blood in Patients With Glioblastoma
- ClinicalTrials.gov ID
- NCT04657146
- Acronym / sponsor ID
- LAMB-G / Pro00107040
- Conditions
- Glioblastoma
- Keywords
- Glioblastoma, T cells, Sequestration, Sphingosine-1-phosphate receptor 1, β-arrestin, Bone marrow, Immunotherapy
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Study undergoing amendment and funding changes.
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 8 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goal of this study is to provide foundational data to drive translational approaches for an entirely novel category of immunotherapy.
Detailed description
The investigators' recent studies show that large numbers of T cells in patients and mice with intracranial tumors are sequestered in bone marrow. This phenomenon mysteriously confines a pool of functional, naïve T cells with anti-tumor capacity to a compartment where they are unable to access tumor, eliciting a mode of T cell dysfunction categorized as "ignorance." The investigators have uncovered that loss of the sphingosine-1-phosphate receptor 1 (S1P1) from the surface of T cells mediates their sequestration in bone marrow, while blocking internalization of S1P1 facilitates stabilization of the receptor on T cells and frees them for anti-tumor activities. As the investigators look to design interventions targeting β-arrestin mediated S1P1 internalization as a novel anti-tumor strategy, they need to better understand variations in sequestration across patients, over time, and with treatment. Assessing these variations and biomarkers that may accompany them will help to establish a target treatment population, as well as the optimal timing for intervention.
Primary Objectives:
- Assess variations in blood and bone marrow T cell counts as they relate to treatment time-points in patients with glioblastoma (GBM).
- Assess variations in S1P1 levels and their correlation with blood and bone marrow T cell counts over the course of treatment in patients with GBM
Exploratory Objectives:
- Assess the associations between tumor size and degree of lymphopenia and bone marrow T cell sequestration observed.
- Compare The Cancer Genome Atlas (TCGA) subclasses with respect to the degree of lymphopenia and bone marrow T cell sequestration observed at diagnosis.
- Examine patient plasma, tumor supernatant, and tumor ribonucleic acid (RNA) for markers that are associated with lymphopenia, T cell S1P1 levels, and bone marrow T cell sequestration. Initial candidates will include transforming growth factor-β (TGFβ) 1/2, tumor necrosis factor (TNF), interleukin (IL)-33, IL-6, catecholamines, signal transducer and activator of transcription 3 (STAT3) RNA, and Kruppel-like factor 2 (KLF2) RNA.
- Compare T cell phenotypes in the blood and bone marrow of patients exhibiting versus not exhibiting T cell lymphopenia or sequestration.
- Compare differences in tumor-infiltrating lymphocyte numbers and phenotypes between patients with and without lymphopenia / sequestration at diagnosis.
- Establish baseline β-arrestin 1 and 2 expression in patients and assess variation across individuals.
- To determine cellular component of the bone marrow upon collection of enough samples to batch. Numbers of various bone marrow resident cells will be evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected newly-diagnosed Glioblastoma (GBM) | – | Other: BiorepositoryPatients, ≥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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients meeting the terms of the inclusion and exclusion criteria above will be eligible to participate in the study. This includes all patients over 18 years of age, both sexes, and all minorities. A total of 40 patients will be enrolled in the study. Patients who are not confirmed to have GBM on histopathological analysis, or who do not qualify as gross total resection per the definition above will be removed from the study and replaced until a total of 40 patients is reached.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiorepositoryTumor collection (> 1cm3): Intraoperatively Peripheral blood collection: * Intraoperatively (60mL +/- 5mL) * Post-resection (30mL +/- 5mL) * Post- standard of care treatment (30mL +/- 5 mL) Bone marrow aspiration: * Intraoperatively (10mL +/- 5 mL) * Post-resection (5mL +/- 5 mL) * Post- standard of care treatment (5mL +/- 5 mL) | Other | Patients with suspected newly-diagnosed Glioblastoma (GBM) |
Primary outcome
Variations in blood and bone marrow T cell counts
Time frame: 2 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) levels
Time frame: 2 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anoop Patel, M.D. principal investigator
Duke University
Katayoun Ayasoufi, Ph.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variations in blood and bone marrow T cell counts (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.