Clinical trial · Observational
Axicabtagene Ciloleucel:Neurocognitive and Patient-Reported Outcomes
NCT04319237CI-TRIAL-00104365completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Transformed Lymphoma | Transformed Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comprehensive Score for Financial Toxicity (COST) measure | Behavioral | — | UNRESOLVED |
| European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire | Behavioral | — | UNRESOLVED |
| Handgrip strength test | Other | — | UNRESOLVED |
| Neuropsychological Assessment - Color Trails | Behavioral | — | UNRESOLVED |
| Neuropsychological Assessment - Repeatable Battery for the Assessment of Status (RBANS) | Behavioral | — | UNRESOLVED |
| Neuropsychological Assessment -Stroop Color and Word Test | Behavioral | — | UNRESOLVED |
| Neuropsychological Assessment - Wechsler Test of Adult Reading (WTAR) | Behavioral |
Design
Arms and outcomes
Arms (1)
- label
- All Participants
- interventionNames
- 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
Primary outcomes (10)
- measure
- Change in total neuropsychological performance after axi-cel therapy - Memory
- timeFrame
- Prior to therapy, then at 30, 90 and 360 days
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.