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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 | Eligibility | Citations | Contacts

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.

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Eligibility

INCLUSION CRITERIA:

-Subjects 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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Nirali N. Shah, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 1-5750
10 CENTER DR
BETHESDA MD 20892
(240) 760-6970
shahnn@mail.nih.gov

Lauren Little
National Cancer Institute (NCI)
BG 10-CRC RM 1-3752
10 CENTER DR
BETHESDA MD 20814
(240) 858-3536
lauren.little@nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT02315599

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