Gene Therapy Follow-up Protocol for People Previously Enrolled in CAR-T Cell Studies

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02473757
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

Background: \- Gene therapy is a way to treat or prevent disease using genes. It is monitored very closely by regulators because there can be long-term, unexpected side effects. NIH is required to try to contact people who have been treated with gene therapy at least annually for up to 15 years. This is to see if they have had any bad side effects. This trial does not include any therapy and is only for patients previously treated on gene-therapy trials at the NCI Surgery Branch who are no longer enrolled on their original gene therapy clinical trial. Objective: \- To collect of long-term follow-up data on people who have been in gene transfer studies. This follow-up is required by regulators. Eligibility: \- People age 18 and older who have been in a previous NCI Surgery Branch gene therapy research study. Design: * After they get the genetically modified cells, participants will: * Have blood drawn 3, 6, and 12 months later. * Have an annual clinic visit for the next 4 years. They will have a physical exam. They will answer questions about any signs of neurological, autoimmune, or blood disorders, or any new cancers. Blood may be drawn. * Be called or emailed annually for the next 10 years. They will answer health questions. Blood samples may need to be taken. * Participants will be asked for their current address and phone number. They will also be asked for the address and phone number of 1 or 2 people who will know their whereabouts. One of these should be a family member if possible, * At the time of the participant s death, researchers will request permission from their family for an autopsy.

Key Dates

Start date
Sep 24, 2015
Status verified
Nov 2025
Primary completion
Jul 1, 2034
Completion
Aug 1, 2050

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: 1/Cohort 1
    Subjects who have received treatment on an NCI Surgery Branch CAR T-cell gene therapy protocols.

Primary Outcome Measure

To provide long term follow up of patients previously enrolled on treatment protocols in the NCI ETIB Branch. [ Time Frame: 15 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-

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