Protocol Details
Follow-Up Evaluation for Gene-Therapy Related Delayed Adverse Events After Participation in Pediatric Oncology Branch Clinical Trials
This study is currently recruiting participants.
Summary
Number | 15-C-0028 |
Sponsoring Institute | National Cancer Institute (NCI) |
Recruitment Detail | Type: Enrolling by Invitation
Gender: Male & Female
Min Age: 1 Years
Max Age: 99 Years |
Referral Letter Required | Yes |
Population Exclusion(s) | Neonates |
Keywords | Replication Competent Retrovirus (RCR);
Replication Competent Lentivirus (RCL);
T Cell Persistence;
Natural History |
Recruitment Keyword(s) | None |
Condition(s) | Pediatric Cancers;
Hematologic Malignancies;
Solid Tumors |
Investigational Drug(s) | anti-CD22 CAR
anti-CD19/CD22 CAR
|
Investigational Device(s) | None |
Intervention(s) | Drug: anti-CD19 CAR
|
Supporting Site | National Cancer Institute |
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.
Eligibility
INCLUSION CRITERIA:
-Participants must be identified eligible for, participating in, or have participated in a POB genetically engineered cellular therapy clinical trial and have received/or be scheduled to receive a genetically engineered cellular therapy.
-All monitoring and testing described in this protocol will pertain ONLY to genetically engineered cellular therapy received at the National Institutes of Health (NIH). RCR/RCL monitoring and persistence will NOT be followed for cells administered at another institution.
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT02315599