Study of CAR-T Therapy in Older Patients

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

  • 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.

  • 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)

  • Cognition

    Behavioral

    Mini-Cognition test: CDT and 3-word recall

  • 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.

  • 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.

  • Brief Test of Attention

    Behavioral

    assess selective auditory attention.

  • Trail Making Test

    Behavioral

    Assesses visual scanning, graphomotor speed, and set shifting.

  • Controlled Oral Word Association Test

    Behavioral

    A timed test of verbal fluency

  • 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.

  • Blood draw

    Other intervention

    collection of blood tests

Treatment groups

154 Participants
are divided into 4 treatment groups
Group A: older lymphoma patients10 interventions
Group B: older patients with lymphoma and other lymphoid malignancies11 interventions
Group C: older patients with myeloma and other plasma cell disorders11 interventions
Group D: older patients with lymphoma11 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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