RECRUITING

Study of CAR-T Therapy in Older Patients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-03-04
Study Completion:2026-03-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04300998

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * are ≥60 years old (all cohorts)
  2. * have pathologically confirmed, relapsed refractory lymphoid malignancy or plasma cell disorder receiving a commercial CAR T-cell product (all cohorts)
  3. * able to speak and understand English (cohort 1 and 4 only)
  4. * 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)
  1. * Any prior commercial or investigational CAR T therapy (all cohorts)
  2. * 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)
  3. * 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)
  4. * Current ongoing substance abuse and/or history of substance abuse, as per medical records or patient report (cohort 1 only)
  5. * History of CNS disease (cohort 4 only)

Contacts and Locations

Study Contact

Richard Lin, MD, PhD
CONTACT
646-608-2646
ABMTTrials@mskcc.org
Sergio Giralt, MD
CONTACT
ABMTTrials@mskcc.org

Principal Investigator

Richard Lin, MD, PhD
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Richard Lin, MD, PhD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-03-04
Study Completion Date2026-03-04

Study Record Updates

Study Start Date2020-03-04
Study Completion Date2026-03-04

Terms related to this study

Keywords Provided by Researchers

  • Lymphoma
  • CART therapy
  • relapsed refractory large B-cell lymphoma
  • High-grade B-cell Lymphoma
  • DLBCL NOS
  • Refractory B-Cell Lymphoma
  • 19-452
  • Memorial Sloan Kettering Cancer Center

Additional Relevant MeSH Terms

  • Lymphoma
  • Refractory B-Cell Lymphoma
  • Lymphoma, B-Cell
  • DLBCL NOS
  • High-grade B-cell Lymphoma
  • Multiple Myeloma