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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：
10656253
负责人：
HEATHER S.L. JIM
金额：
$ 65.8万
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/10656253
关键词：
Acceleration 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 chimeric antigen receptor clinical risk cognitive performance cognitive task comorbidity comparison control contextual factors cytokine release syndrome human old age (65+)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.

项目总结嵌合抗原受体(CAR)T细胞疗法引起了广泛的兴奋，这种疗法可以导致完全 40%-54%的复发/难治性大B细胞淋巴瘤(LBCL)成人患者的疾病反应，与在CAR T细胞疗法出现之前，化疗的应答率为7%。第一次，长期的晚期LBCL患者无病生存是可能的。CAR T细胞疗法独树一帜不良事件，包括细胞因子释放综合征(CRS)和神经系统事件，这些可能是危险因素治疗癌症相关认知功能减退(CACD)。然而，人们对神经认知和患者- CAR T细胞治疗患者的报告结果(优点；例如，症状、生活质量或QOL)。的目标是目前的研究是调查PROS和CACD的纵向变化，这两个结果与存活，在CAR T细胞治疗后的第一年。我们将招募204名接受CAR T细胞治疗的LBCL患者治疗和102名年龄、性别和教育程度匹配的非癌症患者。参与者将在以下时间接受评估 CAR前T细胞治疗基线，3个月和12个月后记录急性和长期结果。在每个时间点，参与者将完成基于互联网的神经心理测试，有效的专业问卷，以及基于智能手机的认知和自我报告风险的7天生态瞬时评估(EMA) CACD的因素(即疲劳、抑郁、疼痛、压力)。EMA期间的动作记录将用于客观测量睡眠、体力活动和久坐行为作为生活质量和慢性疾病的行为因素。血液将在每次评估时被收集和储存，以供将来对生物机制的检查(例如，炎症、加速细胞老化)。数据将用于实现以下目标：1)检查基线接受CAR T细胞治疗的患者报告的结果和认知的差异和纵向变化和对照，2)确定与病情恶化相关的人口统计、背景和临床风险因素接受CAR T细胞治疗的患者与对照组的认知比较，以及3)确定行为保护因素与CAR T细胞治疗接受者和对照组之间更好的认知相关。这项研究将高度重视提供必要的数据，教育患者及其家人有关CAR T细胞治疗的知识与白血病和淋巴瘤协会合作。侧重于风险和保护因素的分析将提供对潜在干预目标的见解，以改善这一新型癌症幸存者的生活质量和CACD 人口。