Hematologic Neoplasms Clinical Trial
Official title:
Evaluating Immunological Parameters, Neurocognitive Changes, Activity Levels, and Driving Fitness in Hematological Malignancy Patients Undergoing Chimeric Antigen Receptor (CAR)-T Cell Therapy
NCT number | NCT04275154 |
Other study ID # | 0157-19-FB |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | September 2020 |
Est. completion date | May 25, 2021 |
Verified date | August 2023 |
Source | University of Nebraska |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 overall response rate and durability in patients with refractory or relapsed diffuse large B-cell lymphoma (DLCBL) and acute lymphoblastic leukemia (ALL). Toxicities following CAR T-cell therapy remain a major limitation to expanding access to this promising cancer treatment. Biological predictors of CAR-T-related toxicities are currently lacking, and it remains unknown whether CAR-T-related toxicities lead to subsequent impairments in instrumental activities of daily living. The overarching goal of this project aims to link biological predictors of CAR-T-related toxicities to instrumental activities of daily living, such as physical activity and driving performance. The current study proposes to test the hypothesis that CAR T-cell therapy causes changes in immunological and neurological markers that predict changes in physical activity levels and driving performance.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 25, 2021 |
Est. primary completion date | May 25, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: 1. R/R DLBCL or R/R ALL diagnosis 2. Scheduled to receive commercial CAR-T cell therapy (Axi-Cel or Tisagenlecleucel) 3. greater than or equal to 19 years of age 4. Legally licensed to drive for at least 5 years 5. Previously drove an average of 50 miles/week or at least 1 hour/week 6. Normal visual acuity (20/40 or better) 7. Fluent in English Exclusion Criteria: (1) Cognitive impairment (MMSE score < 21) prior to baseline assessment |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Nebraska |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate the relationship between immunologic markers of CRS and ICANS in hematologic malignancy patients undergoing CAR-T cell therapy | Change in serum inflammatory cytokine (IL-2, IL-4, IL-6, IL-10, TNF-alpha IFN-gamma, and IL-17A) concentrations from baseline | 6 weeks | |
Primary | Evaluate the relationship between neurologic markers of CRS and ICANS in hematologic malignancy patients undergoing CAR-T cell therapy | Change in number of pathological EEG events from baseline | 6 weeks | |
Primary | Activity level parameters- daily number of steps | Change in daily number of steps from baseline | 6 weeks | |
Primary | On-Road Driving Performance | Change in number of driving safety errors from baseline | 6 weeks |
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