Clinical trial · Observational
Study of CAR-T Therapy in Older Patients
Observational Study of Commercial Chimeric Antigen Receptor T-cell (CAR T) Therapy in Older Patients With Hematologic Malignancies and With an Embedded Pilot Study of Longitudinal Geriatric and Neurocognitive Evaluation
NCT04300998CI-TRIAL-00107549recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is being done to find out how older patients respond to CAR-T cell therapy and how the treatment affects their quality of life. This is a quality of life study and participating in the study does not involve receiving any treatment, other than the standard treatment for participants' disease.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| DLBCL NOS | Diffuse Large B-Cell Lymphoma | ALIAS | 0.90 |
| High-grade B-cell Lymphoma | High Grade B-Cell Lymphoma | CURATED_BROADER | 0.80 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Lymphoma, B-Cell | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Refractory B-Cell Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (11)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Activities of Daily Living/ADLs | Behavioral | — | UNRESOLVED |
| Blood draw | Other | — | UNRESOLVED |
| Brief Test of Attention | Behavioral | — | UNRESOLVED |
| Cognition | Behavioral | — | UNRESOLVED |
| Controlled Oral Word Association Test | Behavioral | — | UNRESOLVED |
| Geriatric Depression Scale | Behavioral | — | UNRESOLVED |
| Hopkins Verbal Learning Test-Revised | Behavioral | — | UNRESOLVED |
| Instrumental Activity of Daily Living | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- older lymphoma patients
- description
- This is a prospective observational cohort where 18 older patients (≥60yo) undergoing CAR T therapy for relapsed refractory high-grade B-cell lymphoma will undergo serial comprehensive geriatric assessment, neurocognitive testing, and quality of life evaluation prior to and following CAR T therapy. The standard follow-up period is one year.
- interventionNames
- Behavioral: Activities of Daily Living/ADLs
- Behavioral: Instrumental Activity of Daily Living
- Behavioral: Timed Up and Go
- Behavioral: Cognition
- Behavioral: Geriatric Depression Scale
- Behavioral: Social Support
- Behavioral: Brief Test of Attention
- Behavioral: Trail Making Test
- Behavioral: Controlled Oral Word Association Test
- Behavioral: Hopkins Verbal Learning Test-Revised
- label
- older patients with lymphoma and other lymphoid malignancies
- description
- This is a prospective observational cohort where 80 older patients (≥60yo) undergoing CAR T therapy for relapsed refractory lymphoma and lymphoid malignancies will undergo comprehensive geriatric assessment, aging biomarker analysis, and quality of life evaluation prior to and following CAR T therapy. The standard follow-up period is one year.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * are ≥60 years old (all cohorts) * have pathologically confirmed, relapsed refractory lymphoid malignancy or plasma cell disorder receiving a commercial CAR T-cell product (all cohorts) * able to speak and understand English (cohort 1 and 4 only) * have a MoCA score of less than 26 out of 30 during the GA visit by a geriatrician prior to CAR T-cell treatment (cohort 4 only) Exclusion Criteria: * Any prior commercial or investigational CAR T therapy (all cohorts) * Current diagnosis of major Axis I psychiatric disorder (DSM-IV), major depression, bipolar disorder, or schizophrenia, as per medical records or patient report (cohort 1 only) * History of a neurological disorder, neurodegenerative disease, or traumatic brain injury with loss of consciousness (\>60 minutes), as per medical records or patient report (cohort 1 only) * Current ongoing substance abuse and/or history of substance abuse, as per medical records or patient report (cohort 1 only) * History of CNS disease (cohort 4 only)
References
Publications (0)
Data not yet available
No reference posted for this study.