A Phase 2, Open-Label, Multicenter, Basket Study Evaluating the Safety and Efficacy of Brexucabtagene Autoleucel in Adults with Rare B-cell Malignancies (ZUMA-25) – Substudy A – Relapsed/Refractory Waldenstrom Macroglobulinemia
This study is looking into a new treatment for adults in the UK who have a rare blood cancer called Waldenstrom Macroglobulinemia. This particular study is for people whose cancer has either returned after initial treatment or hasn't improved with other treatments. The new treatment, called Tecartus, is a special type of cell therapy that uses your own modified immune cells to fight the cancer. Researchers want to understand if Tecartus can help people go into remission (where the cancer signs disappear or reduce significantly) and how safe it is. They will also look at how long the treatment's effects last and how it impacts people's lives.
At a glance
What is this study about?
This clinical trial, called ZUMA-25, is exploring a new way to treat a specific type of blood cancer in adults called Waldenstrom Macroglobulinemia. This cancer affects certain white blood cells. The study is specifically for people whose cancer has either come back after previous treatments (relapsed) or hasn't responded to other treatments (refractory). This means that standard treatments haven't worked well for them.
The main treatment being tested is called Tecartus (which contains something called brexucabtagene autoleucel). This is a type of CAR T-cell therapy. In simple terms, it involves taking some of your own immune cells, sending them to a lab to be specially trained to find and destroy cancer cells, and then giving them back to you. The idea is to give your own body a stronger weapon against the cancer.
Researchers want to see how many people taking part will have a significant response to this treatment, meaning their cancer either disappears completely or improves a lot. They will also be closely monitoring for any side effects to understand how safe the treatment is. This study is important because it could offer a new option for patients with this rare and challenging type of blood cancer.
Key takeaways
- Tests a new cell therapy (Tecartus) for Waldenstrom Macroglobulinemia.
- For adults whose cancer has returned or not responded to other treatments.
- Aims to see how well the treatment works and if it's safe.
- Involves regular check-ups and close monitoring of your health.
- You can stop participating at any time.
- This is a Phase 2 study, which means it's still being carefully evaluated.
Who may be eligible?
To be able to join this study, you need to be an adult, at least 18 years old. The study is open to both men and women.
Importantly, you must have been diagnosed with Waldenstrom Macroglobulinemia, and your cancer must have either returned after you've had previous treatments, or it hasn't responded well to those treatments. This means your doctors have tried other ways to treat your cancer, but they haven't been successful enough.
There will be other medical checks and criteria that your doctor will need to review to make sure this study is safe and suitable for you. This might include looking at your general health, other medical conditions you have, and the types of treatments you've had before.
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?
- Have you been diagnosed with Waldenstrom Macroglobulinemia?
- Has your cancer come back after treatment, or has it not responded to previous treatments?
- Are you able to travel to a study center for regular appointments?
What does participation involve?
If you decide to take part in this study, you will first undergo a full health check-up to ensure that this treatment is right for you. If you are suitable, you will likely receive several medications, including Tecartus, which is the main study treatment. Tecartus is given as an infusion, similar to a drip.
Throughout the study, you will have regular visits to the hospital or clinic. During these visits, doctors and nurses will monitor your health very closely. This will involve blood tests, physical examinations, and potentially scans to see how the cancer is responding to the treatment and to check for any side effects. You might also be given other supportive medications like MESNA, CYCLOPHOSPHAMIDE, METHYLPREDNISOLONE, DEXAMETHASONE, or FLUDARABINE, depending on what the doctors decide is best for your care, and sometimes IMMBRUVICA (another medication).
Doctors will be carefully looking at how well the treatment works, how long any improvements last, and how you feel generally. The total duration of your active participation, including follow-up, will be decided by the study doctors, but monitoring your health and the treatment's effects can continue for a long time.
Potential risks and benefits
Locations (7)
- —UnverifiedNetherlands
- —UnverifiedSpain
- —UnverifiedGermany
- —UnverifiedSweden
- —UnverifiedFrance
- —UnverifiedAustria
- —UnverifiedItaly
Common questions
What is Waldenstrom Macroglobulinemia?
It's a rare type of cancer that affects certain white blood cells, usually in the bone marrow.
What does 'relapsed/refractory' mean?
It means your cancer has come back after treatment or didn't respond well to previous treatments.
What is Tecartus?
It's a type of cell therapy that uses your own specially modified immune cells to fight cancer.
Will I have to pay to be part of the study?
No, you will not have to pay for the study treatment or the care you receive as part of the trial.
Can I leave the study at any time?
Yes, you can choose to leave the study at any point, and it won't 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.
Discussion
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