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

NCT02315599 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2026-05-06

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

anti-CD19 CAR

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • John W Glod, M.D. · National Cancer Institute (NCI)

Eligibility

Min Age
1 Year
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-23
Primary Completion
2035-04-01
Completion
2050-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02315599 on ClinicalTrials.gov