A Study to Evaluate the Long-term Safety of Patients With Advanced Lymphoid Leukemia Who Have Been Previously Administered With UCART19
This research is looking at people with advanced lymphoid leukaemia who have already received a special cell treatment called UCART19. The main goal is to understand how safe this treatment is in the long run and how well it continues to work. By carefully observing these patients over time, doctors hope to learn more about the lasting effects of UCART19. This information is really important for making sure future treatments are as safe and effective as possible. It's a 'follow-up' study, meaning you would have already had the treatment and they want to keep checking on your health.
At a glance
What is this study about?
This study is about following up with people who have advanced lymphoid leukaemia and have already been treated with a special medicine called UCART19. Lymphoid leukaemia is a type of cancer that affects your blood and bone marrow, and 'advanced' means it's spread in a way that needs careful attention.
The main purpose of this study is to see how safe the UCART19 treatment is over a long period. Researchers want to make sure there are no unexpected problems or side effects that show up much later. They also want to understand how well the treatment continues to help patients in the long term, even after the main part of their treatment has finished.
By gathering this information from many patients, doctors can get a clearer picture of the overall safety and lasting benefits of UCART19. This helps improve future treatments for people with lymphoid leukaemia and makes sure that doctors have the best possible information when deciding on care. It's a bit like checking in on someone after they've had a big journey, just to make sure they're still doing well.
Key takeaways
- This study is for people who have already had UCART19 treatment for advanced lymphoid leukaemia.
- The main goal is to understand the long-term safety and effectiveness of the treatment.
- You won't receive new treatment, but will have regular health check-ups.
- It helps doctors learn to improve future care for patients.
- Your participation is about monitoring your health over time.
Who may be eligible?
To be part of this study, you must have already received the UCART19 treatment. This could have been as part of another research study, or if you received it through a special program like compassionate use.
Also, if you are able to have children, or if you are a man with a partner who can have children, you would need to agree to use effective birth control for 12 months after your last UCART19 treatment.
There are no other specific health reasons that would stop you from joining this particular follow-up study, as long as you meet the main criteria of having already had the UCART19 treatment.
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.
- Have I already received the UCART19 treatment?
- Am I willing to use effective birth control (if applicable) for 12 months after my last UCART19 dose?
- Am I happy to sign a consent form?
- Do I want to help doctors learn more about this treatment?
What does participation involve?
If you join this study, you won't be given new medication, as it's a follow-up to treatment you've already received. Your participation will mainly involve regular check-ups and assessments over a long period to monitor your health. This might include blood tests, physical examinations, and possibly imaging scans like X-rays or CT scans, as well as answering questions about how you're feeling. The total duration of your participation will depend on the study plan, but it's focused on long-term follow-up.
Potential risks and benefits
Locations (16)
- Children's Hospital Los AngelesVerified postcodeLos Angeles, United States
- Colorado Blood Cancer InstituteVerified postcodeDenver, United States
- Moffit Cancer CenterVerified postcodeTampa, United States
- Massachussetts General HospitalVerified postcodeCharlestown, United States
- Children's Hospital of PhiladelphiaVerified postcodePhiladelphia, United States
- University of Texas Southwestern Medical CenterVerified postcodeDallas, United States
- University of Texas MD Anderson Cancer CenterVerified postcodeHouston, United States
- Hôpital Saint-LouisVerified postcodeParis, France
- Hôpital Robert-DebréVerified postcodeParis, France
- Hôpital Saint-AntoineVerified postcodeParis, France
- Kyushyu University HospitalVerified postcodeFukuoka, Japan
- Hokkaido University HospitalVerified postcodeSapporo, Japan
Common questions
What is lymphoid leukaemia?
Lymphoid leukaemia is a type of cancer that affects your blood and bone marrow, specifically the white blood cells called lymphocytes.
What is UCART19?
UCART19 is a special cell-based treatment for lymphoid leukaemia that you would have already received.
Why is this study being done?
This study is being done to check the long-term safety and how well UCART19 continues to work for patients who have already had the treatment.
Do I get new treatment in this study?
No, this is a follow-up study. You would have already received the UCART19 treatment before joining this study.
How long will I be in this study?
The study involves long-term follow-up, so you would be monitored for an extended period, which could be several years.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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