Clinical trial · Observational
Immunological Parameters, Neurocognitive Changes, Activity, & Driving Fitness in Patients Undergoing CAR-T Cell Therapy
Evaluating Immunological Parameters, Neurocognitive Changes, Activity Levels, and Driving Fitness in Hematological Malignancy Patients Undergoing Chimeric Antigen Receptor (CAR)-T Cell Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Covid-19 did suspend the study for a period, then when trying to re-open the collaborating department had restructured fees which made it impossible to do the study with the limited grant funds available for this project.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- CAR-T patients
- description
- Relapsed or refractory Diffuse large B-cell lymphoma (DLBCL) or acute lymphoblastic leukemia (ALL) with intent to undergo commercially available CAR-T cell therapy
Primary outcomes (4)
- measure
- Evaluate the relationship between immunologic markers of CRS and ICANS in hematologic malignancy patients undergoing CAR-T cell therapy
- timeFrame
- 6 weeks
- description
- Change in serum inflammatory cytokine (IL-2, IL-4, IL-6, IL-10, TNF-alpha IFN-gamma, and IL-17A) concentrations from baseline
- measure
- Evaluate the relationship between neurologic markers of CRS and ICANS in hematologic malignancy patients undergoing CAR-T cell therapy
- timeFrame
- 6 weeks
- description
- Change in number of pathological EEG events from baseline
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available