NCT04319237

Axicabtagene Ciloleucel:Neurocognitive and Patient-Reported Outcomes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 60 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diffuse Large B Cell Lymphoma
• Transformed Lymphoma

Interventions

Type	Name	Description
OTHER	Handgrip strength test	The purpose of this test is to measure the maximum isometric strength of the hand and forearm muscles.
BEHAVIORAL	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.
BEHAVIORAL	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).
BEHAVIORAL	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.
BEHAVIORAL	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.
BEHAVIORAL	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.
BEHAVIORAL	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.
BEHAVIORAL	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.
BEHAVIORAL	PROMIS Cognitive Function 4a Questionnaire	The PROMIS measures function, symptoms, behavior and feelings.
BEHAVIORAL	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.

Timeline

• Start date: 2020-03-10
• Primary completion: 2023-07-14
• Completion: 2023-07-31
• First posted: 2020-03-24
• Last updated: 2026-03-02

Locations

1 site across 1 country: United States