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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| older lymphoma patients | 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. |
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| older patients with lymphoma and other lymphoid malignancies | 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. |
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| older patients with myeloma and other plasma cell disorders | This is a prospective observational cohort where 40 older patients (≥60yo) undergoing CAR T therapy for relapsed refractory plasma cell disorders will undergo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activities of Daily Living/ADLs | Behavioral | 7 activities: bathing, dressing, grooming, feeding, walking inside the home, walking outside the home, and bladder and bowel control. Participants get 2 points for each activity that is not limited at all, 1 point for limited a little, and 0 points for limited a lot. Total ADL score ranges from 0 to 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who complete all required assessment visits prior to disease progression or death | Participants who complete all assessment visits prior to disease progression or death will be considered as a success for a feasibility endpoint. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be recruited from all oncologists and all transplant physicians at the Memorial Sloan Kettering Cancer Center. Patients are recruited without consideration of gender, country of origin, educational level, or income. There will be no reimbursement or payment toward the participation of this study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard Lin, MD, PhD | Contact | 646-608-2646 | ABMTTrials@mskcc.org | |
| Sergio Giralt, MD | Contact | ABMTTrials@mskcc.org |
| Name | Affiliation | Role |
|---|---|---|
| Richard Lin, MD, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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blood samples
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| older patients with lymphoma | This is prospective observational cohort where 16 older (≥60yo) lymphoma patients with pre-CAR T cognitive impairment. |
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| Instrumental Activity of Daily Living | Behavioral | 8 activities: telephone use, doing laundry, shopping, preparing meals, doing housework, handling own medications, handling money and finances, and transportation to visit one's doctor. Participants get 2 points for each activity that can be done without help, 1 point for needing some help, and 0 point for being unable to do. Total iADL score ranges from 0 to16. |
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| Timed Up and Go | Behavioral | Participants are asked to get up from the chair, walk 10 feet, turn, and walk back to the char (<10 seconds, 10-20 seconds, >20 seconds) |
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| Cognition | Behavioral | Mini-Cognition test: CDT and 3-word recall |
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| Geriatric Depression Scale | Behavioral | Four yes/no questions regarding patient's psychological status. Score ranges from 0 to 4, and a score of >/=1 is usually indicative of depression. |
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| Social Support | Behavioral | Four 5-point Likert scale questions addressing 4 domains of social support: emotional/ informational, tangible, affectionate, and positive social interaction. Score for each item ranges from 1 to 5, and total score ranges from 4 to 20. A higher score means better social support. |
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| Brief Test of Attention | Behavioral | assess selective auditory attention. |
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| Trail Making Test | Behavioral | Assesses visual scanning, graphomotor speed, and set shifting. |
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| Controlled Oral Word Association Test | Behavioral | A timed test of verbal fluency |
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| Hopkins Verbal Learning Test-Revised | Behavioral | The HVLT-R is a test of verbal learning and recall. Scores obtained are the total number of words: 1) recalled over three trials; 2)recalled after a delay; 3) correctly recognized. |
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| Blood draw | Other | collection of blood tests |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D016393 | Lymphoma, B-Cell |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| D000203 | Activities of Daily Living |
| D014145 | Trail Making Test |
| D009483 | Neuropsychological Tests |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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