Axicabtagene Ciloleucel:Neurocognitive and Patient-Reported Outcomes
NCT ID: NCT04319237
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2020-03-10
2023-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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All Participants
Handgrip strength test
The purpose of this test is to measure the maximum isometric strength of the hand and forearm muscles.
Neuropsychological Assessment - Wechsler Test of Adult Reading (WTAR)
The Wechsler Test of Adult Reading (WTAR) is a neuropsychological assessment tool used to provide a measure of Intellectual function. Participants are presented with 50 irregularly spelled words and prompted to pronounce each; the irregular grapheme-to-phoneme translations (such as the "gh" in the word tough) in the prompts make it difficult to pronounce without having previously learned the word. A high WTAR score is correlated with higher general intelligence as measured by the Wechsler intelligence scales.
Neuropsychological Assessment - Repeatable Battery for the Assessment of Status (RBANS)
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) consists of twelve subtests which give five scores, one for each of the five domains tested (immediate memory, visuospatial/constructional, language, attention, delayed memory).
Neuropsychological Assessment - Color Trails
The Color Trails test measures sustained attention and sequencing. Numbered circles are printed with vivid pink or yellow backgrounds that are perceptible to color-blind individuals. Participants rapidly connect circles numbered 1-25 in sequence and rapidly connect numbered circles in sequence, but alternates between pink and yellow. The length of time to complete each trial is recorded, along with qualitative features of performance indicative of brain dysfunction, such as near-misses, prompts, number sequence errors, and color sequence errors.
Neuropsychological Assessment -Stroop Color and Word Test
The Stroop Color and Word Test is based on the observation that individuals can read words much faster than they can identify and name colors. The test-taker reads color words or names ink colors from different pages as quickly as possible within a time limit. The test yields three scores based on the number of items completed on each of the three stimulus sheets. An Interference score is useful in determining the individual's cognitive flexibility, creativity, and reaction to cognitive pressures.
Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) Questionnaire
The PROMIS-29 questionnaire assesses each of 7 domains (Depression, Anxiety, Physical Function, Pain Interference, Fatigue, Sleep Disturbance, and Ability to Participate in Social Roles and Activities). A higher score equals more of the concept being measured.
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C-3) and the add-on EORTC QLQ Non-Hodgkin's Lymphoma (EORTC QLQ-NHL-HG29) module. All scales range from 0-100, a high scale score represents a higher response level. For example, a high functional score represents a high level of functioning.
Quality of Life (EQ-5D-5L) Questionnaire
The EQ-5D-5L questionnaire is a self assessed quality of life questionnaire. The scale measures quality of life on a 5 component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The rater selects a number between 1-100 to describe the condition of their health, 100 being the best imaginable.
PROMIS Cognitive Function 4a Questionnaire
The PROMIS measures function, symptoms, behavior and feelings.
Comprehensive Score for Financial Toxicity (COST) measure
The COST is a questionnaire made up of 11 statements around topics including costs, concerns and resources and is designed to measure financial toxicity. The user answers questions about their concern over finances numbered from 0-4, with 0 being not at all and 4 being very much.
Interventions
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Handgrip strength test
The purpose of this test is to measure the maximum isometric strength of the hand and forearm muscles.
Neuropsychological Assessment - Wechsler Test of Adult Reading (WTAR)
The Wechsler Test of Adult Reading (WTAR) is a neuropsychological assessment tool used to provide a measure of Intellectual function. Participants are presented with 50 irregularly spelled words and prompted to pronounce each; the irregular grapheme-to-phoneme translations (such as the "gh" in the word tough) in the prompts make it difficult to pronounce without having previously learned the word. A high WTAR score is correlated with higher general intelligence as measured by the Wechsler intelligence scales.
Neuropsychological Assessment - Repeatable Battery for the Assessment of Status (RBANS)
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) consists of twelve subtests which give five scores, one for each of the five domains tested (immediate memory, visuospatial/constructional, language, attention, delayed memory).
Neuropsychological Assessment - Color Trails
The Color Trails test measures sustained attention and sequencing. Numbered circles are printed with vivid pink or yellow backgrounds that are perceptible to color-blind individuals. Participants rapidly connect circles numbered 1-25 in sequence and rapidly connect numbered circles in sequence, but alternates between pink and yellow. The length of time to complete each trial is recorded, along with qualitative features of performance indicative of brain dysfunction, such as near-misses, prompts, number sequence errors, and color sequence errors.
Neuropsychological Assessment -Stroop Color and Word Test
The Stroop Color and Word Test is based on the observation that individuals can read words much faster than they can identify and name colors. The test-taker reads color words or names ink colors from different pages as quickly as possible within a time limit. The test yields three scores based on the number of items completed on each of the three stimulus sheets. An Interference score is useful in determining the individual's cognitive flexibility, creativity, and reaction to cognitive pressures.
Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) Questionnaire
The PROMIS-29 questionnaire assesses each of 7 domains (Depression, Anxiety, Physical Function, Pain Interference, Fatigue, Sleep Disturbance, and Ability to Participate in Social Roles and Activities). A higher score equals more of the concept being measured.
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C-3) and the add-on EORTC QLQ Non-Hodgkin's Lymphoma (EORTC QLQ-NHL-HG29) module. All scales range from 0-100, a high scale score represents a higher response level. For example, a high functional score represents a high level of functioning.
Quality of Life (EQ-5D-5L) Questionnaire
The EQ-5D-5L questionnaire is a self assessed quality of life questionnaire. The scale measures quality of life on a 5 component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The rater selects a number between 1-100 to describe the condition of their health, 100 being the best imaginable.
PROMIS Cognitive Function 4a Questionnaire
The PROMIS measures function, symptoms, behavior and feelings.
Comprehensive Score for Financial Toxicity (COST) measure
The COST is a questionnaire made up of 11 statements around topics including costs, concerns and resources and is designed to measure financial toxicity. The user answers questions about their concern over finances numbered from 0-4, with 0 being not at all and 4 being very much.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Kite, A Gilead Company
INDUSTRY
H. Lee Moffitt Cancer Center and Research Institute
OTHER
Responsible Party
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Principal Investigators
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Heather Jim, PhD
Role: PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center
Fred Locke, MD
Role: PRINCIPAL_INVESTIGATOR
Moffitt Cancer Center
Locations
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Moffitt Cancer Center
Tampa, Florida, United States
Countries
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Related Links
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Moffitt Cancer Center Clinical Trials Website
Other Identifiers
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MCC-20372
Identifier Type: -
Identifier Source: org_study_id
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