Axicabtagene Ciloleucel:Neurocognitive and Patient-Reported Outcomes

Completed

• Conditions: Diffuse Large B Cell Lymphoma; Transformed Lymphoma
• Interventions: Other: Handgrip strength test; Behavioral: Neuropsychological Assessment - Wechsler Test of Adult Reading (WTAR); Behavioral: Neuropsychological Assessment - Repeatable Battery for the Assessment of Status (RBANS); Behavioral: Neuropsychological Assessment - Color Trails; Behavioral: Neuropsychological Assessment -Stroop Color and Word Test; Behavioral: Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) Questionnaire; Behavioral: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire; Behavioral: Quality of Life (EQ-5D-5L) Questionnaire; Behavioral: PROMIS Cognitive Function 4a Questionnaire; Behavioral: Comprehensive Score for Financial Toxicity (COST) measure

• Registration Number: NCT04319237
• Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Brief Summary

The purpose of the study is to assess self-reported side effects and neurocognitive (brain, mood and thinking) functioning among patients treated with commercial axi-cel therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-10
• Study First Submitted: 2020-03-17
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-24
• Primary Completion: 2023-07-14
• Study Completion: 2023-07-31
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Diagnosed with diffuse large b-cell lymphoma, primary mediastinal b-cell lymphoma or transformed follicular lymphoma
• Scheduled to receive commercial axi-cel at Moffitt Cancer Center
• Able to speak and read standard english
• Have no documented or observable psychiatric or neurological diagnoses that interfere with study participation (e.g., schizophrenia)
• Have no history of traumatic brain injury, stroke, or dementia
• Able to provide informed consent

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Participants	Neuropsychological Assessment -Stroop Color and Word Test	-
All Participants	Neuropsychological Assessment - Color Trails	-
All Participants	Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) Questionnaire	-
All Participants	Handgrip strength test	-
All Participants	Neuropsychological Assessment - Repeatable Battery for the Assessment of Status (RBANS)	-
All Participants	Quality of Life (EQ-5D-5L) Questionnaire	-
All Participants	Neuropsychological Assessment - Wechsler Test of Adult Reading (WTAR)	-
All Participants	European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire	-
All Participants	PROMIS Cognitive Function 4a Questionnaire	-
All Participants	Comprehensive Score for Financial Toxicity (COST) measure	-

Primary Outcome Measures

Name	Time	Method
Change in patient-reported outcomes after axi-cel therapy - QOL Questionnaire	Prior to therapy, then at 7, 14, 30, 60, 90, 180 and 360 days	Change in patient-reported outcomes measured using the Quality of Life (EQ-5D-5L) Questionnaire, which is a 5-item measure that can be used to describe and value current overall health consisting of 5 items assessing mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Participant chooses from 1 of 5 categories (e.g.; "I have no problems washing or dressing myself" to "I am unable to wash or dress myself"). Higher scores indicate worse overall health.
Change in total neuropsychological performance after axi-cel therapy - Executive Functioning	Prior to therapy, then at 30, 90 and 360 days	Executive Functioning will be assessed using Part 2 of the Color Trails Test (CTT-2) and the Stroop Color and Word Test. The CTT-2 consists of a page containing 25 pink circles and 25 yellow circles numbered 1 - 50. Participants connect the circles in consecutive order while alternating colors (1 pink, 2 yellow, 3 pink, etc.). A total score is determined by recording the number of seconds required to complete the task. The Stroop Color and Word Test consists of three tasks, a Word Task, a Color Task, and a Color-Word Task. In the Word Task, participants are required to read a list of color words printed in black ink. In the Color Task, participants are presented with rows of X's printed in colored ink, and asked to name the color of each set of X's. In the Color-Word Task, color names are presented in different color ink, and participants are asked to identify the color ink in which each color name is printed. The Stroop yields a score on each task as well as an interference score.
Change in total neuropsychological performance after axi-cel therapy - Hand grip strength	Prior to therapy, then at 30, 90 and 360 days	The hand grip test assesses hand and forearm strength using a hand dynamometer. Participants without a history of arthritis or hand surgery will be asked to squeeze the dynamometer twice using each hand for a total of two bilateral measurements.
Change in total neuropsychological performance after axi-cel therapy - Memory	Prior to therapy, then at 30, 90 and 360 days	Memory changes will be assessed with the Repeatable Battery for the Assessment of Status (RBANS) which assesses immediate memory (list learning and story memory), visuospatial/constructional abilities (figure copy and line orientation), language (picture naming and semantic fluency), attention (digit span and coding), and delayed memory (list recall, list recognition, story recall, and figure recall) domains. Both total scores and scaled/percentile group scores are calculated for each test and total scores are derived for each cognitive domain. Total scores for each cognitive domain are then summed together to create a total scale score.
Change in total neuropsychological performance after axi-cel therapy - Attention and Concentration	Prior to therapy, then at 30, 90 and 360 days	Attention and concentration are will be assessed using Part 1 of the Color Trails Test (CTT-1) and the Connors Continuous Performance Test Third Edition (CPT3). The CTT is an analogue of the original Trail Making Test without significant influence of language. CTT-1 consists of a page with scattered circles numbered from 1 to 25.; Even numbered circles are colored yellow and odd-numbered ones are colored pink.; Respondents are instructed to connect the circles in consecutive numeric order with a continuous line as quickly as possible. The alternating colors are not mentioned in the instructions. A total score is determined by recording the number of seconds required to complete the task.
Change in patient-reported outcomes after axi-cel therapy - EORTC-QOL Questionnaire	Prior to therapy, then at 14, 30, 60, 90 180 and 360 days	Change in patient-reported outcomes measured using the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) which assess quality of life and symptomatology in the past week using a 4 point Likert scale (1=not at all, 4=very much). Higher scores on the quality of life subscales indicate better quality of life. Higher scores on the symptom items and subscales indicate greater symptomatology.
Change in patient-reported outcomes after axi-cel therapy - Everyday Cognition Questionnaire	Prior to therapy, then at 30, 90 and 360 days	Change in patient-reported outcomes measured using the Everyday Cognition Questionnaire (ECog) assess the subjective evaluation of cognitive function in routine daily activities. 40 items yield scores for 7 domains (Everyday Memory, Language, Visuospatial Abilities, Planning, Organization, and Divided Attention) and a total score. Items evaluate current cognition compared to 10 years ago; responses are evaluated on a 5-point Likert scale ("better or no change" to "consistently much worse") Higher scores indicate worse subjective cognitive function.
Change in patient-reported outcomes after axi-cel therapy - PROMIS 4a Questionnaire	Prior to therapy, then at 30, 90 and 360 days	Change in patient-reported outcomes measured using the PROMIS Cognitive Function 4a Questionnaire asks about cognition in the past 7 days using a 5-point Likert scale (1=very often, several times a day; 5=never). Higher scores indicate better overall perceived cognition.
Change in patient-reported outcomes after axi-cel therapy -PROMIS-29 Questionnaire	Prior to therapy, then at 30, 90 and 360 days	Change in patient-reported outcomes measured using the Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) Questionnaire, which is a 29 item questionnaire assessing aspects of quality of life in the past 7 days on 7 4-item subscales: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance and ability to participate in social activities. Patients rate functioning on a 5-point Likert scale. Higher scores indicate more of the attribute being measured.
Change in patient-reported outcomes after axi-cel therapy - Comprehensive Score for Financial Toxicity	Prior to therapy, then at 90 days	Change in patient-reported outcomes measured using the Comprehensive Score for Financial Toxicity (COST). Financial toxicity is assessed using an 11-item patient-reported measure of financial stress used in cancer patients. The COST yields a total score with higher scores indicating less financial toxicity in the past week.

Trial Locations

Locations (1)

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States