Lyphoma, B-CellNCT02473757
Gene Therapy Follow-up Protocol for People Previously Enrolled in CAR-T Cell Studies
An observational study of Lyphoma, B-Cell and Leukemia, B-cell, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lyphoma, B-Cell, Leukemia, B-cell, Multiple Myeloma
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2015to 1 Aug 2050
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Gene Therapy Follow up Protocol for Subjects Previously Enrolled in CAR T-Cell Studies
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.
Read more
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.
Read the 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.
- Keywords
- Recombinant DNA Product, Laboratory Evaluation, NIH Office of Biotechnology Activities, Gamma-Retroviral Vectors, Natural History
- Medical subject headings
- Leukemia, B-Cell, Multiple Myeloma, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1/Cohort 1 | Subjects who have received treatment on an NCI Surgery Branch CAR T-cell gene therapy protocols. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study start24 Sep 2015
- Primary completion1 Jul 2034 (estimated)
- Study completion1 Aug 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lyphoma, B-CellStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- James N Kochenderfer, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02473757
- Sponsor's protocol ID
- 150141
- Other IDs
- 15-C-0141
- Status last verified
- 20 Oct 2026
- First submitted
- 13 Jun 2015
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No