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| ID | Type | Description | Link |
|---|---|---|---|
| K12CA167540 | U.S. NIH Grant/Contract | View source |
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PI decided to close study early.
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| Name | Class |
|---|---|
| McDonnell Center | UNKNOWN |
| Paula and Roger Riney Blood Cancer Research | UNKNOWN |
| National Cancer Institute (NCI) | NIH |
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The investigators propose that immune effector cell-associated neurotoxicity syndrome (ICANS) is predicated upon the early loss of blood brain barrier (BBB) integrity with subsequent monocyte infiltration leading to cross-activation of native glial cells. Glial overstimulation leads to neuroinflammation, synaptic dysfunction, and ultimately neuronal injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants undergoing CAR T transfusion | Participants will undergo baseline examination followed by evaluations between Days 3 and 5 post-transfusion, on Day 30 post-transfusion date (PTD), PTD 90, and PTD 180. At baseline this will include plasma testing, lumbar puncture (voluntary), neuroimaging (voluntary) and neuropsychiatric performance testing (voluntary). Between post-transfusion Day 3 and day 5, participants will undergo repeat exam, plasma testing, lumbar puncture (voluntary), and neuroimaging (voluntary). Day 30 testing will again test all modalities, including serum, CSF/lumbar puncture (voluntary), brain imaging (voluntary), and formal neuropsychiatric performance testing (voluntary). Finally, Day 90 and 180 will repeat serum testing, brain imaging, and formal neuropsychological performance testing. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percent changes in given biomarker levels |
| From baseline to up to 180 days post-transfusion (estimated to be 7 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Cross-sectional biomarker profiles | -Serum (GFAP, NfL) and CSF biomarkers (NfL, VILIP-1, YKL-40, TREM2, and Neurogranin) as measured using a single molecule array in pg/ml will be compared between participants who develop ICANS compared to participants who do not develop ICANS using descriptive statistics | From baseline to up to 180 days post-transfusion (estimated to be 7 months) |
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Inclusion Criteria:
Exclusion Criteria:
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Participants scheduled to undergo treatment at Siteman Cancer Center at Washington University School of Medicine with tisagenlecleucel, axicabtagene ciloleucel, brexucabtagene autoleucel, or lisocabtagene maraleucel.
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| Name | Affiliation | Role |
|---|---|---|
| Armin Ghobadi, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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All individual participant data collected during the trial will be available, after deidentification. This will include the study protocol, statistical analysis plan, and analytic code, beginning 3 months after the start of the study with no end date. This will be made available to researchers who provide a methodologically sound proposal which has been approved by an independent review committee. Interested parties may reach out to Armin Ghobadi, M.D. arminghobadi@wustl.edu
Beginning 3 months after the start of the study with no end date.
This will be made available to researchers who provide a methodologically sound proposal which has been approved by an independent review committee. Interested parties may reach out to Armin Ghobadi, M.D. arminghobadi@wustl.edu
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| ID | Term |
|---|---|
| D020258 | Neurotoxicity Syndromes |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
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| Cross-sectional imaging profile | -Diffusion basis spectrum imaging (DBSI) separates the point diffusion properties of water by magnitude and direction to provide a non-invasive measurement of cellularity, extracellular edema, and axonal integrity/myelination in μm^2/msec. All three components will then be compared between participants who develop ICANS compared to participants who do not develop ICANS using descriptive statistics | From baseline to up to 180 days post-transfusion (estimated to be 7 months) |
| Cytokine profiles | -Elisa-based assays will measure the CSF cytokine profile measurements of IL-2, IL-6, IL10, IFN-y, TNFα, GM-CSF (ng/ml), with descriptive statistics used to compare between participants who develop ICANS compared to participants who do not develop ICANS | From baseline to up to 180 days post-transfusion (estimated to be 7 months) |
| Changes in cognitive assessment as measured by Symbol Digit Modalities Test (SDMT) | -The SDMT is a brief written test where participants use a key to match abstract symbols paired with numbers. The scale ranges from 0 to 110, with higher scores reflecting better function. By doing so, an indirect measure of attention, processing speed, motor speed, and visual scanning is obtained. Scores on formal testing will be then be analyzed in conjunction with quantification of imaging features (as parceled using DBSI) observed between participants who develop ICANS compared to participants who do not develop ICANs | Baseline, 30 days, 90 days, and 180 days post-transfusion (estimated to be 7 months) |
| Changes in cognitive assessment as measured by Trail Making Test A/B | This brief written test has participants connect lines between sequential numbers and/or letters in a given pattern. By doing so, an indirect measure of executive function tests task switching, visual search, scanning, processing speed, and visual attention is obtained. Scores on formal testing will be then be analyzed in conjunction with quantification of imaging features (as parceled using DBSI) observed between participants who develop ICANS compared to participants who do not develop ICANs | Baseline, 30 days, 90 days, and 180 days post-transfusion (estimated to be 7 months) |
| Changes in cognitive assessment as measured by Letter-Number Sequencing | -This brief cognitive test has participants listen to variable length strings of alphanumeric characters and repeat the characters back verbally in a specific order. They are then scored on the number of correct responses. Scores range from 0 to 21, with higher scores associated with improved cognitive function. By doing so, a direct measure of working memory is obtained. Scores on formal testing will be then be analyzed in conjunction with quantification of imaging features (as parceled using DBSI) observed between participants who develop ICANS compared to participants who do not develop ICANs | Baseline, 30 days, 90 days, and 180 days post-transfusion (estimated to be 7 months) |
| Changes in cognitive assessment as measured by Hopkins Verbal Learning Test-Received (HVLT-R3) | -This approximately 30 minute long cognitive test has participants learn and free-recall a collection of words from different categories. By doing so, a direct measure of recall and memory is obtained. Scores range from 0 to 30, with higher scores indicating improved cognitive function. Scores on formal testing will be then be analyzed in conjunction with quantification of imaging features (as parceled using DBSI) observed between participants who develop ICANS compared to participants who do not develop ICANs | Baseline, 30 days, 90 days, and 180 days post-transfusion (estimated to be 7 months) |
| Changes in cognitive assessment as measured by Montreal-Cognitive Assessment (MocA) | -This approximately 15 minute long cognitive test consists of both written and verbal sections. Participants are scored on the number of correct answers out of 30 (i.e. scores range from 0-30), with higher scores reflecting improved cognitive performance. By doing so, an indirect measure surveying multiple cognitive domains is obtained. Scores on formal testing will be then be analyzed in conjunction with quantification of imaging features (as parceled using DBSI) observed between participants who develop ICANS compared to participants who do not develop ICANs | Baseline, 30 days, 90 days, and 180 days post-transfusion (estimated to be 7 months) |