RecruitingPHASE2, PHASE3INTERVENTIONAL

Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells

This study is for people in the UK, both children and adults, who have previously had a special cancer treatment called gene-modified T-cell therapy. This therapy involves changing your own immune cells (T-cells) to better fight cancer. The main goal of this study is to carefully watch these participants over a long time. Researchers want to understand if the treatment is safe in the long run and how well it continues to work. If you've had this type of treatment in a past study sponsored by Celgene or a partner, you might be asked to join. It helps gather important information to make future treatments better and safer for everyone.

At a glance

Status

Recruiting

Phase

PHASE2, PHASE3

Sponsor

Celgene

Enrolment target

1,541

Start

19 Jul 2018

Estimated completion

30 Nov 2036

Neoplasms

What is this study about?

This study is all about understanding the long-term effects of a special type of cancer treatment called gene-modified T-cell therapy. Imagine your body's immune system as an army that fights off diseases. T-cells are like the soldiers in this army. In gene-modified T-cell therapy, doctors take some of your own T-cells, change them in a lab so they are better at finding and destroying cancer cells, and then put them back into your body.

The main reason for this study is to keep a close watch on people who have already received this treatment. This is really important because while we know a lot about how treatments work in the short term, we often need to learn more about what happens years down the line. By following participants over a long period, researchers can gather crucial information about how safe the treatment is and if it continues to be effective in keeping cancer away or managing it.

This kind of study helps doctors and scientists understand genetic treatments better. The information collected from people like you helps improve these treatments for future patients, ensuring they are as safe and effective as possible. It's a way of looking back to make sure we're always moving forward in cancer care.

Key takeaways

This study tracks the long-term safety and effectiveness of a past cancer treatment.
It's for people who previously received gene-modified T-cell therapy.
No new medication is given; it's an observation study.
Your participation helps improve future cancer care for others.
You can withdraw from the study at any time.
It helps gather vital information about this advanced therapy.

Who may be eligible?

This study is for adults and children who have already received a specific type of treatment called "gene-modified T-cell therapy." You would have received this treatment as part of a previous medical study sponsored by Celgene, Juno Therapeutics, or their related companies.

To be eligible, you must have either finished the follow-up period of your original treatment study or had to stop that study early. The most important thing is that you actually received at least one dose of the gene-modified T-cells.

Finally, if you are invited to join, you need to understand what the study involves and agree to take part by signing a consent form. There are no other major reasons listed that would prevent you from taking part, beyond what the researchers themselves might decide for specific individual cases.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I have already received gene-modified T-cell therapy.
My previous treatment was part of a Celgene or partner company study.
I have completed or stopped my original treatment study.
I am willing and able to sign a consent form to participate.

Answer every question to see your result.

What does participation involve?

If you join this study, it means you'll be part of a long-term follow-up plan. You won't be given any new medication as part of this study itself, as it's purely about observing the effects of the treatment you've already received. The study will involve regular check-ups, which might include things like blood tests or physical examinations. The exact schedule and types of assessments will be explained to you in detail if you are invited to participate. This follow-up will continue for a long period to monitor your health and the treatment's ongoing effects. The total duration of your participation could be many years.

Potential risks and benefits

The main benefit of taking part in this study is contributing valuable information that helps doctors understand the long-term safety and effectiveness of gene-modified T-cell therapy. This helps improve future treatments for others. As you have already received the treatment, this study itself does not involve new clinical risks from a new medication. However, any medical procedure, like blood tests, has very small, common risks such as bruising or discomfort. You are completely free to withdraw from the study at any time, for any reason, without it affecting your ongoing medical care.

Locations (205)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Alabama Birmingham
Verified postcode
Birmingham, United States· Recruiting
Banner MD Anderson Cancer Center
Verified postcode
Gilbert, United States· Recruiting
Mayo Clinic Phoenix
Verified postcode
Phoenix, United States· Recruiting
Local Institution - 01039
Verified postcode
Scottsdale, United States· Completed
Local Institution - 01021
Verified postcode
Tucson, United States· Withdrawn
City Of Hope
Verified postcode
Duarte, United States· Recruiting
University Of California San Diego Moores Cancer Center
Verified postcode
La Jolla, United States· Recruiting
Local Institution - 01206
Verified postcode
Los Angeles, United States· Withdrawn
Local Institution - 01043
Verified postcode
Sacramento, United States· Withdrawn
University of California, San Francisco- California
Verified postcode
San Francisco, United States· Recruiting
UCLA Medical Centre-Santa Monica
Verified postcode
Santa Monica, United States· Recruiting
Stanford Cancer Center
Verified postcode
Stanford, United States· Recruiting

Common questions

What is gene-modified T-cell therapy?

It's a special cancer treatment where your own immune cells are changed in a lab to better fight cancer, then put back into your body.

Will I get new medication in this study?

No, this study is just to observe the long-term effects of the treatment you've already received, not to give you new drugs.

Why is this study important?

It helps doctors understand how safe and effective the cancer treatment is over many years, which improves future care for others.

Who can join this study?

You can join if you've already had gene-modified T-cell therapy from a specific previous study and agree to participate.

How long will I be in this study?

This is a long-term follow-up study, so your participation could last for many years.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

clinical.trials@bms.com 855-907-3286 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.