Neurocognitive and Patient-Reported Outcomes after Chimeric Antigen Receptor T-Cell Therapy: A Controlled Comparison

嵌合抗原受体 T 细胞治疗后的神经认知和患者报告结果：对照比较

基本信息

批准号：
10444276
负责人：
HEATHER S.L. JIM
金额：
$ 70.73万
依托单位：
H. LEE MOFFITT CANCER CTR & RES INST
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-07-01 至 2027-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10444276
关键词：
Acute Address Admission activity Adult Adverse event Age Attention B-Cell Lymphomas Behavior Behavioral Biological Blood CAR T cell therapy Cancer Survivor Cell Aging Cellular Phone Cognition Cognitive Collaborations Data Delirium Deterioration Disease Disease-Free Survival Ecological momentary assessment Education Encephalopathies Energy Metabolism Event Exhibits FDA approved Family Fatigue Fever Frequencies Future Goals Hypotension Hypoxia Impaired cognition In complete remission Individual Inflammation Internet Intervention Length of Stay Life Long Term Survivorship Malignant Neoplasms Measures Memory Mental Depression Neurocognition Neurocognitive Neurologic Neuropsychological Tests Neuropsychology Outcome Pain Participant Patient Outcomes Assessments Patient Self-Report Patients Performance Performance Status Phase I/II Trial Physical activity Population Prior Chemotherapy Quality of life Questionnaires Refractory Relapse Research Risk Factors Self Assessment Sleep Societies Stress Supportive care Symptoms Technology Time Woman actigraphy base chimeric antigen receptor clinical risk cognitive performance cognitive task comorbidity contextual factors cytokine release syndrome improved innovation insight leukemia/lymphoma malignant breast neoplasm modifiable risk neurotoxic neurotoxicity novel objective response rate processing speed protective factors recruit response sedentary lifestyle sex side effect survivorship

项目摘要

PROJECT SUMMARY There is widespread excitement about chimeric antigen receptor (CAR) T-cell therapy, which causes complete disease response in 40%-54% of adults with relapsed/refractory large B-cell lymphoma (LBCL), compared to a response rate of 7% to chemotherapy prior to the advent of CAR T-cell therapy. For the first time, long-term disease-free survival is possible for patients with advanced LBCL. CAR T-cell therapy causes a unique profile of adverse events, including cytokine release syndrome (CRS) and neurologic events, which may be risk factors for cancer-associated cognitive decline (CACD). However, little is known about neurocognition and patient- reported outcomes (PROs; e.g., symptoms, quality of life or QOL) in CAR T-cell therapy patients. The goal of the current study is to investigate longitudinal changes in PROs and CACD, outcomes that are highly relevant to survivorship, in the first year after CAR T-cell therapy. We will recruit 204 LBCL patients treated with CAR T-cell therapy and 102 age-, sex-, and education-matched individuals without cancer. Participants will be assessed at pre-CAR T-cell therapy baseline and 3 and 12 months later to capture acute and longer-term outcomes. At each time point, participants will complete internet-based neuropsychological testing, validated PRO questionnaires, and 7-day smartphone-based ecological momentary assessment (EMA) of cognition and self-reported risk factors for CACD (i.e., fatigue, depression, pain, stress). Actigraphy during EMA periods will be used to objectively measure sleep, physical activity, and sedentary behavior as behavioral factors for QOL and CACD. Blood will be collected and banked at each assessment for future examination of biological mechanisms (e.g., inflammation, accelerated cellular aging). Data will be used to address the following aims: 1) to examine baseline differences and longitudinal changes in patient-reported outcomes and cognition in CAR T-cell therapy recipients and controls, 2) to identify demographic, contextual, and clinical risk factors that are associated with worse cognition in CAR T-cell therapy recipients compared to controls, and 3) to determine behavioral protective factors associated with better cognition among CAR T-cell therapy recipients and controls. This research will be highly impactful, providing the data needed to educate patients and their families about CAR T-cell therapy in collaboration with the Leukemia and Lymphoma Society. Analyses focused on risk and protective factors will provide insights into potential targets of intervention to improve QOL and CACD in this novel cancer survivor population.

项目摘要关于嵌合抗原受体（CAR）T细胞疗法的广泛兴奋，这会导致完整与A相比在CAR T细胞疗法出现之前，对化疗的反应率为7％。长期晚期LBCL患者可以使用无病生存。汽车T细胞疗法会引起独特的特征不良事件，包括细胞因子释放综合征（CRS）和神经系统事件，这可能是危险因素对于癌症相关的认知下降（CACD）。但是，关于神经认知和患者的知之甚少在汽车T细胞治疗患者中，报告的结果（PROS；例如症状，生活质量或QOL）。目标当前的研究是调查专业人士和CACD的纵向变化，与幸存者，在汽车T细胞疗法后的第一年。我们将招募204名用汽车T细胞治疗的LBCL患者治疗和102岁，性别和教育匹配的人没有癌症。参与者将在车前T细胞疗法基线和3个月后的3个月后捕获急性和长期结局。每个时间点，参与者将完成基于Internet的神经心理学测试，验证Pro问卷，以及基于7天的智能手机的生态瞬时评估（EMA）认知和自我报告的风险 CACD的因素（即疲劳，抑郁，疼痛，压力）。 EMA期间的Actraphy将用于客观地测量睡眠，身体活动和久坐行为，作为QOL和CACD的行为因素。每次评估都将收集和库存血液，以使生物学机制的未来检查（例如，炎症，加速的细胞衰老）。数据将用于解决以下目的：1）检查基线汽车T细胞治疗接受者的患者报告结果和认知的差异和纵向变化 2）识别与恶化相关的人口统计，上下文和临床风险因素与对照组相比，汽车T细胞治疗接受者的认知，3）确定行为保护因素与汽车T细胞疗法接受者和对照组之间的认知更好。这项研究将是高度的有影响力的，提供教育患者及其家人有关汽车T细胞疗法所需的数据与白血病和淋巴瘤协会合作。专注于风险和保护因素的分析将在这种新颖的癌症幸存者中，提供有关改善QOL和CACD的潜在干预措施的见解人口。