Status:
WITHDRAWN
Immunological Parameters, Neurocognitive Changes, Activity, & Driving Fitness in Patients Undergoing CAR-T Cell Therapy
Lead Sponsor:
University of Nebraska
Conditions:
Hematologic Neoplasms
Eligibility:
All Genders
19+ years
Brief Summary
Chimeric antigen receptor (CAR) T-cell therapy is a promising new treatment that re-programs patient immune cells to target and destroy cancer cells. Importantly, CAR T-cell therapy has improved overa...
Detailed Description
Study specific aims are: (1A) Evaluate changes in serum inflammatory cytokine protein markers in patients receiving CAR T-cell therapy; (1B) Evaluate changes in electroencephalographic and radiologic ...
Eligibility Criteria
Inclusion
- R/R DLBCL or R/R ALL diagnosis
- Scheduled to receive commercial CAR-T cell therapy (Axi-Cel or Tisagenlecleucel)
- greater than or equal to 19 years of age
- Legally licensed to drive for at least 5 years
- Previously drove an average of 50 miles/week or at least 1 hour/week
- Normal visual acuity (20/40 or better)
- Fluent in English
Exclusion
- (1) Cognitive impairment (MMSE score \< 21) prior to baseline assessment
Key Trial Info
Start Date :
May 25 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 25 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04275154
Start Date
May 25 2021
End Date
May 25 2021
Last Update
September 3 2024
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