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

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Enrolling by invitation

CT.gov ID

NCT02473757

Collaborator

(none)

1,000

Enrollment

Location

418.2

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lyphoma, B-Cell Leukemia, B-cell Multiple Myeloma Hematologic Malignancies

Detailed Description

Background:

-The National Cancer Institute Surgery Branch (NCI-SB) Branch investigator conducts clinical trials utilizing gene transfer. The current U.S. Food and Drug Administration (FDA) requirements for long term follow up may be up to fifteen years for some products. As this time period is frequently longer than studies are expected to be open, a long-term follow-up protocol is necessary to ensure the follow up of these subjects

Objectives:

-To facilitate collection of long term, follow up information on subjects who have participated in gene transfer studies as required by the U.S. Food and Drug Administration and other regulatory groups

Eligibility:

-Enrollment on a CAR T-cell treatment protocol for gene therapy.

Design:

-Patients will undergo physical exams; laboratory evaluation or phone follow up as required by the treatment protocol and/or as clinically indicated.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 24, 2015

Anticipated Primary Completion Date :

Jul 1, 2034

Anticipated Study Completion Date :

Aug 1, 2050

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

To provide long term follow up of patients previously enrolled on treatment protocols in the NCI ETIB Branch. [15 years]
List of long time adverse event frequency after Gene therapy drug

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

INCLUSION CRITERIA:
Subjects who have received treatment on a CAR T-cell gene therapy protocol. Age >= 18 years as children are generally excluded from CAR T-cell gene therapy studies.