Immunological Parameters, Neurocognitive Changes, Activity, & Driving Fitness in Patients Undergoing CAR-T Cell Therapy

NCT04275154 | Withdrawn

• 1 other identifier: 0157-19-FB
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Hematologic Neoplasms

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Activity level parameters- daily number of steps

  Change in daily number of steps from baseline

  6 weeks

• On-Road Driving Performance

  Change in number of driving safety errors from baseline

  6 weeks

Study Arms (1)

CAR-T patients

Relapsed or refractory Diffuse large B-cell lymphoma (DLBCL) or acute lymphoblastic leukemia (ALL) with intent to undergo commercially available CAR-T cell therapy

Eligibility Criteria

• Age: 19 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Relapsed or refractory DLBCL or ALL with intent to undergo commercially available CAR-T cell therapy

You may qualify if:

• 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

You may not qualify if:

• (1) Cognitive impairment (MMSE score \< 21) prior to baseline assessment

Sponsors & Collaborators

• University of Nebraska: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

We expect that serum inflammatory cytokine protein concentrations will be elevated in patients showing symptoms of high-grade CRS relative to patients showing symptoms of low-grade or no CRS. We expect that CRS grade will be positively associated with changes in concentrations of IL-6, IL-10, IFN-gamma, and TNF-alpha.

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Matthew Lunning, DO

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 19, 2020
• Study Start: May 25, 2021
• Primary Completion: May 25, 2021
• Study Completion: May 25, 2021
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share