Protocol Details
Long-Term Follow-up Protocol for Subjects Treated with Gene-Modified T cells.
This study is NOT currently recruiting participants.
Summary
Number | 19-C-0046 |
Sponsoring Institute | National Cancer Institute (NCI) |
Recruitment Detail | Type: No longer recruiting/follow-up only
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A |
Referral Letter Required | Yes |
Population Exclusion(s) | Children |
Keywords | Peripheral Blood Cells;
Multiple Myeloma;
Lentiviral Vector;
Human BCMA;
Natural History |
Recruitment Keyword(s) | None |
Condition(s) | Myeloma, Plasma-Cell;
Myeloma-Multiple |
Investigational Drug(s) | Anti-BCMA CAR+ T cells
|
Investigational Device(s) | None |
Intervention(s) | None |
Supporting Site | National Cancer Institute |
Background:
Gene therapy is one kind of treatment for disease. Researchers have experience with gene therapy over the past decade, but they want to learn more about long-term effects. They want to study people who were previously treated with a gene-modified (GM) T cell therapy. Their T cells were collected and changed. New genes were put into the T cells to help those cells identify and kill specific cancer cells. Researchers want to monitor the long-term health of people who had this therapy.
Objective:
To continuously monitor the health and quality of life of people who had GM T cell therapy.
Eligibility:
People enrolled in study GC-LTFU-001 who were over 18 years old when they had the GM T cell therapy
Design:
Participants will be screened with a review of their medicines and medical history.
Participants will be in the study for 15 years after their last GM T cell infusion.
Participants will have three visits in year 1. They will have two visits a year in years 2-5. Then they will have one visit a year in years 6-15.
Visits will include some or all of the following:
Medical history
Physical exam
Questions about quality of life and cancer treatment
Blood tests
Tumor samples
Researchers may contact participants' doctors during the study.
Participants will be asked to inform study staff if they develop certain conditions.
Participants will be asked to give permission for researchers to get a tissue sample if the participant dies during the study period.
Sponsoring Institute: National Cancer Institute
Eligibility
INCLUSION CRITERIA:
Subjects who meet the following criteria will be eligible to participate in the LTFU study:
-All adult and pediatric subjects who received at least one GM T-cell infusion in a trial sponsored by Celgene, or Celgene alliance partner-sponsored trials, and have discontinued, or completed the post-treatment follow-up period (ie, EOS visit, Survival follow-up visit, Progression Free Survival follow-up visit) in the parent protocol, as applicable.
Note: Enrollment in LTFU can occur any time after EOS procedures required per parent protocol have started. Subject (and parental/legal representative, when applicable) must understand and voluntarily sign an Informed Consent Form (ICF)/Informed Assent Form (IAF) prior to any study-related assessments/procedures being conducted.
EXCLUSION CRITERIA:
Not Applicable.
Citations:
Not Provided
Contacts:
Clinical Trials Number:
NCT03435796