NCT04614987终止不适用
Serum Neurofilament Light (NfL) as a Marker for Brain Injury in Individuals Undergoing Chimeric Antigen Receptor-modified T Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Percent changes in given biomarker levels
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically scheduled to undergo treatment with tisagenlecleucel, axicabtagene ciloleucel, brexucabtagene autoleucel, or lisocabtagene maraleucel.
- •At least 18 years of age.
- •Able and willing to undergo study testing (blood draws, lumbar punctures, neuro-psychiatric testing, and neuroimaging with MRI)
- •Participants of childbearing potential without documented history of menopause or hysterectomy who choose to participate must not be pregnant at screening and must agree to avoid becoming pregnant prior to scanning.
- •Able to understand and willing to sign an IRB-approved written informed consent document.
排除标准
- •Has any condition that, in the Investigator's opinion, could increase risk to the participant, limit the participant's ability to tolerate the experimental procedures, or interfere with the collection/analysis of the data (for example, participants unable to lie flat for the duration of the MRI scan).
- •Contraindications to MR imaging (e.g. electronic medical devices, inability to lie still for long periods) that make it unsafe for the individual to participate. Patients with pacemakers may only be scanned if approved by CCIR staff and radiology review.
- •Severe claustrophobia.
- •History of multiple sclerosis, Parkinson's disease, dementia (including Alzheimer's disease, frontotemporal dementia, and Pick's disease), or motor neuron disease including amyotrophic lateral sclerosis (ALS)
- •For the lumbar puncture associated with the study only: contraindications to lumbar puncture (e.g. platelets <r 50,000/mm3, INR > 1.5, evidence of midline shift on imaging, presence of local infection at LP site, history of baclofen pump, history of significant spinal surgery/hardware which would preclude safe bedside lumbar puncture). If a contraindication to lumbar puncture develops while on study, patient may remain on study but will be barred from a lumbar puncture until that contraindication resolves.
- •Enrolled in an interventional study of a drug targeting neurotoxicity
结局指标
主要结局
Percent changes in given biomarker levels
时间窗: From baseline to up to 180 days post-transfusion (estimated to be 7 months)
* This includes serum (GFAP and NfL) and CSF biomarkers (NfL, VILIP-1, YKL-40, TREM2, and Neurogranin) measured using a single molecule array in pg/ml * Descriptive statistics will be used to summarize a given biomarker level at different time points.
次要结局
- Cytokine profiles(From baseline to up to 180 days post-transfusion (estimated to be 7 months))
- Cross-sectional biomarker profiles(From baseline to up to 180 days post-transfusion (estimated to be 7 months))
- Cross-sectional imaging profile(From baseline to up to 180 days post-transfusion (estimated to be 7 months))
- Changes in cognitive assessment as measured by Montreal-Cognitive Assessment (MocA)(Baseline, 30 days, 90 days, and 180 days post-transfusion (estimated to be 7 months))
- Changes in cognitive assessment as measured by Symbol Digit Modalities Test (SDMT)(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(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(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)(Baseline, 30 days, 90 days, and 180 days post-transfusion (estimated to be 7 months))
研究者
研究点 (1)
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