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 D - Relapsed/Refractory Hairy Cell Leukemia (HCL)
This research study is for adults who have a rare type of blood cancer called hairy cell leukaemia, where the cancer has returned or hasn't improved with regular treatments. The study is testing a new type of treatment called Tecartus, which involves using your own specially modified immune cells to fight the cancer. Researchers want to find out how effective Tecartus is at shrinking or getting rid of the cancer, and also monitor its safety. This study is in an early stage (Phase 2), meaning it's still gathering information about this new treatment for this specific condition. We hope to learn if this could be a new option for patients in the future.
At a glance
What is this study about?
This study is investigating a new treatment called Tecartus for adults who have hairy cell leukaemia. Hairy cell leukaemia is a rare type of blood cancer that affects your white blood cells. This study is specifically for people whose hairy cell leukaemia has either come back after treatment (this is called 'relapsed') or hasn't gotten better with previous treatments (this is called 'refractory').
Tecartus is a special kind of treatment called CAR T-cell therapy. It involves taking some of your own immune cells, called T-cells, and sending them to a lab. There, they are specially changed to help them recognise and fight your cancer cells better. These modified cells are then given back to you as a one-time infusion. The aim is to see if these re-engineered cells can shrink or remove the cancer and how safe this process is for patients.
This is a Phase 2 study, which means it's an important step in understanding how well this new treatment works and what side effects it might have specifically for hairy cell leukaemia patients. The main goal is to measure how many patients have their cancer either completely or partially disappear after receiving Tecartus. They will also be looking at other factors like how long the treatment's effects last and how people's overall health changes.
Key takeaways
- This study is for adults with hairy cell leukaemia that has come back or not responded to other treatments.
- It tests a new type of cell therapy called Tecartus.
- Researchers want to see how well it works and if it's safe.
- This is an early-stage study, gathering important information.
- You'll receive preparations (like chemotherapy) before the main treatment.
Who may be eligible?
This study is looking for adult patients who have a specific type of blood cancer called hairy cell leukaemia. Your cancer must have either come back after previous treatments or not responded well to treatments you've already had.
You must be 18 years old or older to take part in this study. The study is open to both men and women.
There will be other health requirements that your doctor will check to make sure this study is safe and suitable for you. This might include recent blood tests, heart health, and how well your kidneys and liver are working.
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 hairy cell leukaemia?
- Has your hairy cell leukaemia come back after treatment, or not gotten better with treatment?
- Are you able to travel to study appointments?
- Do you have other significant health conditions that might prevent you from joining (your doctor will check this)?
What does participation involve?
If you join this study, you will undergo several steps. First, some of your immune cells (T-cells) will be collected – this process is called apheresis, similar to donating blood, but takes a bit longer. These cells will then be sent away to be specially prepared. Before you receive the Tecartus, you will likely get some chemotherapy medicines (like fludarabine and cyclophosphamide) to prepare your body. You might also receive other medicines like methylprednisolone, mesna, and dexamethasone to help manage side effects.
The prepared Tecartus cells will then be given back to you as a one-time infusion, similar to a blood transfusion. After the infusion, you will have regular check-ups, blood tests, and scans to monitor your health and how well the treatment is working. The study team will track your progress over time, and the total duration of your involvement will depend on how you respond to the treatment and the study follow-up plan. This could involve several months of close monitoring, followed by longer-term check-ups.
Potential risks and benefits
Locations (7)
- —UnverifiedNetherlands
- —UnverifiedSpain
- —UnverifiedSweden
- —UnverifiedGermany
- —UnverifiedAustria
- —UnverifiedItaly
- —UnverifiedFrance
Common questions
What is hairy cell leukaemia?
It's a rare and slow-growing cancer of the blood and bone marrow, affecting a type of white blood cell called B cells.
What does 'relapsed/refractory' mean?
It means your cancer has either come back after prior treatment or hasn't responded to previous treatments.
What is Tecartus?
It's a type of CAR T-cell therapy, which uses your own immune cells that have been specially trained to fight your cancer.
Will I have to stay in hospital?
After receiving the Tecartus infusion, you will likely need to stay in hospital for a period for close monitoring of potential side effects.
Is this treatment guaranteed to work?
No, there are no guarantees. This is a research study to find out more about the treatment's effectiveness and safety.
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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