A Study of Voice as a Way to Monitor for Side Effects in People Receiving CAR T-Cell Therapy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
The purpose of this study is to collect voice recordings and nervous system (neurologic) assessments from people with non-Hodgkin lymphoma (NHL) or multiple myeloma (MM) who are receiving standard treatment with CAR T-cell therapy. Researchers will study whether these voice recordings and assessments are a practical (feasible) way to monitor for immune effector cell-associated neurotoxicity syndrome (ICANS). Feasibility will be measured by tracking how many participants join the study and complete the assessments.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Documentation of Disease
Definition of treatment and ability
Scheduled to receive an FDA-approved CAR-T product: Axi-cel, Liso-cel, Tisa-cel, Ide-cel, Cilta-cel, or Brexu-cel.
Ability to comply with twice daily voice recordings or daily neurologic assessments, as determined by the investigator.
Disqualifiers
None
Trial population
Participants will be identified from the population of patients scheduled to receive CAR T-cell therapy at Memorial Sloan Kettering Cancer Center. The primary treating team or designated research staff will approach eligible patients for participation in this non-therapeutic study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Audio Tasks
Diagnostic testVoice recordings will be collected at baseline (pre-infusion), twice daily from Day 0 through Day +10, and, if ICANS develops, twice daily until three days after clinical resolution. A final voice recording will also be performed on Day +30
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Participants diagnosed with non-Hodgkin lymphoma or multiple myeloma1 intervention
Trial outcomes
Primary outcomes
1
Number of daily voice recordings collected
To prospectively collect and curate a dataset of twice daily smartphone-based voice recordings and daily neurocognitive assessments from patients undergoing CAR T-cell therapy.
Time frame
30 days after baseline2
Number of neurocognitive assessments collected
To prospectively collect and curate a dataset of twice daily smartphone-based voice recordings and daily neurocognitive assessments from patients undergoing CAR T-cell therapy.
Time frame
30 days after baselineSponsors and contacts
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Source ClinicalTrials.gov