Follow-Up Evaluation for Gene-Therapy-Related Delayed Adverse Events After Participation in Pediatric Oncology Branch Clinical Trials

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02315599
Status
Enrolling By Invitation

Conditions

  • Hematologic Malignancies
  • Pediatric Cancers
  • Solid Tumors

Eligibility Criteria

Sex
ALL
Age
1 Year - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • anti-CD19 CAR — DRUG

Study Details

Background: \- Gene therapy involves changing the genes inside the body s cells to stop disease. It is very closely regulated. People who have had this therapy may have problems months or even years later. Researchers do not know the long-term side effects, so they want to study people who have had the therapy. They want the study to continue over the next 15 years. Objective: \- To study over time the negative side effects from genetically engineered cellular therapy. This will be studied in people who have been in Pediatric Oncology Branch (POB) gene therapy trials. Eligibility: \- People who are currently or were previously in a research study with gene therapy in the National Cancer Institute POB. Design: * Participants blood will be tested right before they get the genetically changed cells. They will get the cells as part of another study. * For the next year, they will come back to the clinic or see their doctor at home at least every 3 months. They will answer questions about their health and blood will be drawn. * For the next 5 years, they will go to the clinic or see their own doctor once a year. They will have physical exam and blood will be drawn. * For 10 years after that, they will be asked every year for health information. * Participants will keep their contact information up to date with researchers. They may be phoned for more health information. * If the participant was under 18 years old when given the gene therapy and turns 18 during this follow-up, they will be asked to sign a new consent form when they turn 18.

Key Dates

Start date
Dec 23, 2014
Status verified
May 2026
Primary completion
Apr 1, 2035
Completion
Aug 1, 2050

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: 1
    Patients screening for, participating in, or have participated in a POB gene therapy clinical trial and have received/or be scheduled to receive a genetically engineered cellular therapy.

Primary Outcome Measure

Conduct long term safety evaluations after gene therapy [ Time Frame: Every 3 months X 1 year then annually X 15 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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