Axicabtagene Ciloleucel:Neurocognitive and Patient-Reported Outcomes

H. Lee Moffitt Cancer Center and Research Institute

Status: Completed

Conditions: Diffuse Large B Cell Lymphoma; Transformed Lymphoma

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04319237

MCC-20372

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

60 participants in 1 patient group

All Participants

Treatment:

Behavioral: Neuropsychological Assessment - Color Trails

Behavioral: Comprehensive Score for Financial Toxicity (COST) measure

Behavioral: Neuropsychological Assessment - Wechsler Test of Adult Reading (WTAR)

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: Neuropsychological Assessment - Repeatable Battery for the Assessment of Status (RBANS)

Other: Handgrip strength test