Lymphoma Receiving CAR-T Therapy Clinical Trial
Official title:
Pilot Study of Neurocognitive and Neuroimaging Evaluations for Adult Patients Receiving CD19 CART Therapy
| NCT number | NCT04107285 |
| Other study ID # | 19-268 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | September 25, 2019 |
| Est. completion date | September 2025 |
The purpose of this study is to learn about possible changes in cognitive (mental) abilities, such as memory skills and concentration, and in brain anatomy (structure) and function, in people with lymphoma receiving CAR-T therapy.
| Status | Recruiting |
| Enrollment | 21 |
| Est. completion date | September 2025 |
| Est. primary completion date | September 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - = 18 years old - Pathologically confirmed, relapsed refractory large B-cell lymphoma including DLBCL (de novo disease or transformed follicular lymphoma), DLBCL NOS, high grade B-cell lymphoma, and primary mediastinum B-cell lymphoma - Planned treatment with commercially approved CD19-specific CART cells (e.g. axicabtagene ciloleucel or tisagenlecleucel). - Eastern Cooperative Group (ECOG) performance status of 0 to 2 - No evidence of central nervous system disease at study entry - Meet cardiac, pulmonary, hepatic, and renal requirement for CART therapy as described in corresponding product package insert - Fluent and able to communicate well enough in English to complete the study assessments and provide informed consent, in the judgment of the consenting professional. °Patients who report that English is not their primary language will be asked the US Census English proficiency question: "How well do you speak English," and the answer "very well" will be required Exclusion Criteria: - Signs and/or symptoms of central nervous system cancers (e.g., tumors, metastases, leptomeningeal disease) as determined by their physician, medical records, or by a brain MRI, either at the time of enrollment or during the study period. - Current diagnosis of major Axis I psychiatric disorder (DSM-IV), major depression, bipolar disorder, or schizophrenia, as per medical records or patient report - History of neurodegenerative disease, or traumatic brain injury with loss of consciousness (>60 minutes), as per medical records or patient report - A history of epilepsy as per medical records or patient report - Current ongoing substance abuse and/or history of substance abuse, as per medical records or patient report - Evidence of visual or auditory impairment that would preclude completion of the assessments, as per medical records or patient report - Contraindications to MRI examinations as per standard screening guidelines used in the Department of Radiology (i.e., ferromagnetic material or implants, pacemakers or defibrillators, stents, claustrophobia) |
| Country | Name | City | State |
|---|---|---|---|
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Memorial Sloan Kettering Cancer Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | changes in neurocognitive functions | correlations of neurocognitive scores with the FACIT-FS (fatigue) scale score The Functional Assessment of Chronic Illness Therapy-Fatigue Subscale, Version 4 (FACITFS V-4 56, is a 13-item questionnaire designed to assess symptoms and concerns specific to the QOL of patients with fatigue [66]. The questionnaire asks respondents to indicate the extent to which each item applied to them over "the past 7 days" using a 5-point Likert-type response format ranging from "0 - Not at all" to "4 - Very much". The 13 items produce the Fatigue Subscale (FS) score (range 0 - 52). | 1 year | |
| Primary | changes in functional connectivity | MRIs | 1 year |