Clinical trial NCT04319237: Axicabtagene Ciloleucel:Neurocognitive and Patient-Reported Outcomes
Official title: Axicabtagene Ciloleucel:Neurocognitive and Patient-Reported Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diffuse Large B Cell Lymphoma
Transformed Lymphoma
Keywords: Axi-cel therapy
CAR-T
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Kite, A Gilead Company
First posted: 2020-03-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are scheduled to receive axi-cel therapy at Moffitt Cancer Center.

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.


Eligibility 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

Primary outcomes:
measure: Change in total neuropsychological performance after axi-cel therapy - Memory
timeFrame: Prior to therapy, then at 30, 90 and 360 days
measure: Change in total neuropsychological performance after axi-cel therapy - Attention and Concentration
timeFrame: Prior to therapy, then at 30, 90 and 360 days
measure: Change in total neuropsychological performance after axi-cel therapy - Executive Functioning
timeFrame: Prior to therapy, then at 30, 90 and 360 days
measure: Change in total neuropsychological performance after axi-cel therapy - Hand grip strength
timeFrame: Prior to therapy, then at 30, 90 and 360 days
measure: Change in patient-reported outcomes after axi-cel therapy -PROMIS-29 Questionnaire
timeFrame: Prior to therapy, then at 30, 90 and 360 days
measure: Change in patient-reported outcomes after axi-cel therapy - EORTC-QOL Questionnaire
timeFrame: Prior to therapy, then at 14, 30, 60, 90 180 and 360 days
measure: Change in patient-reported outcomes after axi-cel therapy - QOL Questionnaire
timeFrame: Prior to therapy, then at 7, 14, 30, 60, 90, 180 and 360 days
measure: Change in patient-reported outcomes after axi-cel therapy - Everyday Cognition Questionnaire
timeFrame: Prior to therapy, then at 30, 90 and 360 days
measure: Change in patient-reported outcomes after axi-cel therapy - PROMIS 4a Questionnaire
timeFrame: Prior to therapy, then at 30, 90 and 360 days
measure: Change in patient-reported outcomes after axi-cel therapy - Comprehensive Score for Financial Toxicity
timeFrame: Prior to therapy, then at 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Heather Jim, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Moffitt Cancer Center
name: Fred Locke, MD
role: PRINCIPAL_INVESTIGATOR
References: