A Phase II, single arm, multicenter open label trial to determine the efficacy and safety of tisagenlecleucel (CTL019) in adult patients with refractory or relapsed follicular lymphoma
This research study is looking into a new cell therapy called tisagenlecleucel for adults in the UK who have a type of cancer called follicular lymphoma. This specific type of lymphoma has either returned after initial treatment or hasn't improved with previous therapies. The main goal of the study is to find out how effective this new treatment is at shrinking or getting rid of the cancer, and to understand any potential side effects. Participants will receive the tisagenlecleucel treatment, and doctors will carefully monitor their response and well-being over time. This is a Phase II study, meaning it's an important step in determining if this therapy could become a new standard treatment option.
At a glance
What is this study about?
This study is looking at a new type of treatment called tisagenlecleucel for adults living with follicular lymphoma. Follicular lymphoma is a type of cancer that affects certain cells in your immune system, and it's called 'relapsed' if it comes back after being treated, or 'refractory' if it doesn't get better with treatment.
Tisagenlecleucel is a special kind of cell therapy. It involves taking some of your own immune cells, called T-cells, and changing them in a lab so they become better at finding and fighting cancer cells. These specially trained cells are then put back into your body. The main purpose of this study is to see how well these new cells work to treat follicular lymphoma that has not responded to other treatments or has returned, and to check for any side effects.
Doctors taking part in this study will carefully monitor all patients to understand how the treatment affects their cancer and their overall health. This information is key to deciding if tisagenlecleucel could be a helpful new treatment option for people with follicular lymphoma in the future.
Key takeaways
- This study is testing a new cell therapy for follicular lymphoma.
- It's for adults whose lymphoma has come back or hasn't responded to other treatments.
- The therapy uses your own immune cells to fight cancer.
- The study aims to see how effective and safe this new treatment is.
- Participation involves receiving the treatment and regular health check-ups.
- You can discuss with your doctor if this study might be suitable for you.
Who may be eligible?
This study is looking for adult patients, 18 years old and over, who have follicular lymphoma. Both men and women can take part.
To be eligible, your follicular lymphoma must have either returned after you've already had treatment for it, or it hasn't responded well to previous treatments you've received.
Your individual medical history will be reviewed by the study doctors to make sure this treatment is the right fit for you and that you meet all the necessary health requirements to participate safely.
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.
- Are you 18 years old or older?
- Do you have follicular lymphoma?
- Has your follicular lymphoma returned after treatment, or not responded to previous treatments?
- Are you willing to have regular hospital visits for check-ups and tests?
- Are you able to understand and sign the consent form?
What does participation involve?
If you decide to join this study, you will receive the tisagenlecleucel treatment. This involves several steps: first, some of your blood will be collected to get your T-cells. These cells will then be sent to a special lab to be modified. Before you receive the modified cells back, you might need some chemotherapy to prepare your body. Then, you will receive the tisagenlecleucel as an infusion, similar to a drip.
After getting the treatment, you will have regular medical check-ups, blood tests, and scans. These visits will help doctors see how well the treatment is working and monitor for any side effects. You will also be asked to complete questionnaires about your quality of life, which helps us understand how you feel day-to-day. The visits will be frequent at first and then become less often over time. The total duration of your participation in the study, including follow-up, will be discussed with you by the study team.
Potential risks and benefits
Locations (7)
- —UnverifiedItaly
- —UnverifiedBelgium
- —UnverifiedGermany
- —UnverifiedSpain
- —UnverifiedNetherlands
- —UnverifiedNorway
- —UnverifiedFrance
Common questions
What is follicular lymphoma?
Follicular lymphoma is a type of slow-growing cancer that affects white blood cells called lymphocytes, which are part of your immune system.
What does 'relapsed' or 'refractory' mean?
Relapsed means the cancer has come back after treatment. Refractory means the cancer did not get better or respond to previous treatments.
What is tisagenlecleucel?
It's a new type of cell therapy where your own immune cells are specially trained in a lab to fight your cancer and then given back to you.
Will I have to pay to participate?
No, you will not have to pay for the study treatment or the care directly related to the study.
Can I leave the study at any time?
Yes, you have the right to withdraw from the study at any point without needing to give a reason, and it will not affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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