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RecruitingPHASE3INTERVENTIONAL

CAR-T Long Term Follow Up (LTFU) Study

This study is looking at the long-term health of patients in the UK who have already received a specific cell therapy called CAR-T for cancer. Because CAR-T is a newer type of treatment, health authorities require us to carefully monitor patients for many years to ensure its safety and effectiveness. This study will follow participants for 15 years after their last CAR-T treatment. The main goals are to check for any delayed side effects, monitor for certain viruses, and see how well the treatment continues to work over time. This helps us gather important information to understand the full picture of CAR-T therapy and ensure patient safety.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Novartis Pharmaceuticals
Enrolment target
1,400
Start
02 Nov 2015
Estimated completion
22 Feb 2036

What is this study about?

This is a long-term follow-up study for patients who have already received a treatment called CAR-T therapy, which is a type of immunotherapy that uses your own modified immune cells to fight cancer. National health authorities require thorough monitoring of patients receiving these kinds of advanced treatments, especially because CAR-T therapy involves changes to your cells that can last a long time. The main goal of this study is to keep a close eye on the health of people who have had CAR-T therapy for 15 years after their treatment.

We want to understand if there are any side effects that might appear much later after the treatment. We will also check to see how well the CAR-T treatment continues to work over time to control the cancer, and monitor for any signs of particular viruses. Gathering this information is really important because it helps medical experts understand the full safety and effectiveness of CAR-T therapy in the long run. The more we know, the better we can understand how these innovative treatments help patients.

Essentially, this study helps build a more complete picture of CAR-T therapy. It allows us to track results that might not be obvious quickly and helps ensure that all aspects of the treatment are well-understood. This ongoing monitoring contributes to improving patient care and understanding for future patients who might receive CAR-T therapy.

Key takeaways

  • This study monitors the long-term health of patients who have already had CAR-T therapy.
  • It aims to understand side effects that might appear years after treatment.
  • Participation lasts for 15 years after your last CAR-T treatment.
  • No new treatments are given; it's purely for data collection.
  • Information gathered helps improve future CAR-T treatments and patient safety.
  • You can withdraw from the study at any time.

Who may be eligible?

To join this study, you must have already received a CAR-T cell therapy as part of a previous clinical trial sponsored or supported by Novartis, or a similar trial from the University of Pennsylvania where Novartis also had an agreement.

Critically, before starting this long-term study, you would also need to have given your informed consent, meaning you understand what's involved and agree to take part.

There are no specific reasons that would stop someone from joining this study, other than not meeting the above criteria.

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.

  1. Have I had CAR-T therapy in a previous study supported by Novartis or the University of Pennsylvania?
  2. Did I complete or leave my previous CAR-T study early?
  3. Am I willing to provide informed consent for this long-term follow-up study?
Answer every question to see your result.

What does participation involve?

If you join this study, you will be followed for 15 years after your last CAR-T treatment. This doesn't necessarily mean frequent hospital visits for 15 years. Instead, it involves collecting information about your health and any medical care you receive during this period. Much of this information might come from routine check-ups you already have with your doctor. You will be monitored for safety and how well the treatment works. The study aims to gather data that might become available through your standard medical appointments.

Potential risks and benefits

The main benefit of participating is that your health will be carefully monitored over a long period, which contributes valuable information to the medical community about CAR-T therapy. This helps others in the future. As this is a monitoring study for a treatment you've already received, there are no new medical treatments involved, so the direct medical risks to you are minimal. The main risk is the time and effort involved in providing your data. You are always free to withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (118)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Mayo Clinic Arizona
    Verified postcode
    Phoenix, United States· Completed
  • City of Hope National Medical Center
    Verified postcode
    Duarte, United States· Recruiting
  • Childrens Hospital Los Angeles
    Verified postcode
    Los Angeles, United States· Recruiting
  • UCLA Medical Center
    Verified postcode
    Los Angeles, United States· Recruiting
  • UCSF Medical Center
    Verified postcode
    San Francisco, United States· Recruiting
  • Stanford University Medical Center
    Verified postcode
    Stanford, United States· Recruiting
  • Emory University School of Medicine-Winship Cancer Institute
    Verified postcode
    Atlanta, United States· Recruiting
  • Emory University School of Medicine/Winship Cancer Institute
    Verified postcode
    Atlanta, United States· Recruiting
  • Childrens Healthcare of Atlanta
    Verified postcode
    Atlanta, United States· Recruiting
  • Uni of Chi Medi Ctr Hema and Onco
    Verified postcode
    Chicago, United States· Recruiting
  • University of Chicago Medical Center, Hematology & Oncology
    Verified postcode
    Chicago, United States· Recruiting
  • University of Kansas Cancer Center SC
    Verified postcode
    Westwood, United States· Recruiting

Common questions

What is CAR-T therapy?

CAR-T therapy is a type of cancer treatment where some of your immune cells are taken from your blood, specially changed in a lab to fight cancer, and then put back into your body.

Why is this study needed if I've already had CAR-T therapy?

This study is important because it helps us understand the long-term effects of CAR-T therapy, including any side effects that might appear over many years and how well the treatment keeps working. This information is required by health authorities and improves our knowledge for future patients.

How long will I be followed in this study?

You will be followed for 15 years from the time of your last CAR-T treatment.

Will I receive any new treatment in this study?

No, this study is purely for monitoring your health after you've already received CAR-T therapy. It does not involve any new treatments or medicines.

What kind of information will be collected about me?

The study will collect information about your general health, any medical conditions you experience, and how your CAR-T therapy has continued to affect your cancer over time. This data will usually come from your regular medical check-ups.

How to find out more

Novartis Pharmaceuticals

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

Interested in taking part?

Register your interest

Share your details and the research team for "CAR-T Long Term Follow Up (LTFU) Study…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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