An observational study in Lyphoma, B-Cell, Leukemia, B-cell and Multiple Myeloma, sponsored by National Cancer Institute (NCI). Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by National Cancer Institute (NCI) · Observational
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:
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.
190 studies on the registry are indexed under Leukemia, B-Cell; 52 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 120 across 22 observational studies indexed under Leukemia, B-Cell.
Browse Leukemia, B-Cell studies →National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.
Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Subjects who have received treatment on an NCI Surgery Branch CAR T-cell gene therapy protocols.
To provide long term follow up of patients previously enrolled on treatment protocols in the NCI ETIB Branch.
List of long time adverse event frequency after Gene therapy drug
Time frame: 15 years
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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