Tisagenlecleucel versus standard of care in adult patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma: A randomized, open label, phase III trial (BELINDA)
The BELINDA study is looking at a new type of treatment called Tisagenlecleucel for adults with an aggressive form of B-cell non-Hodgkin lymphoma. This is for patients whose cancer has either returned after initial treatment or hasn't responded to standard therapies. The study compares Tisagenlecleucel to the usual treatments doctors give in these situations. Researchers are trying to find out which treatment is better at keeping the cancer from growing or spreading for longer. They are also checking how long people live, how many see their cancer shrink, and any side effects. This is a Phase III trial, which means it's a key step in seeing if this new treatment could become widely available.
At a glance
What is this study about?
This study, called BELINDA, is exploring a new way to treat an aggressive type of cancer called B-cell non-Hodgkin lymphoma in adults. Specifically, it's for people whose lymphoma has either come back after treatment (this is called 'relapsed') or hasn't responded to previous treatments at all (this is called 'refractory'). It's really important to find better ways to help patients in this situation.
At the heart of the study is a new treatment called Tisagenlecleucel. This is a very advanced type of therapy where a patient's own immune cells are specially trained in a lab to fight their cancer. In this study, we want to see how well Tisagenlecleucel works compared to the standard treatments currently used for this type of lymphoma. Standard treatments might include different chemotherapy drugs, or other targeted therapies like Rituximab or Ibrutinib.
The main goal is to find out if Tisagenlecleucel can stop the cancer from getting worse for longer than standard treatments. The study will also be looking at overall survival (how long people live), how many patients see their cancer shrink, and any side effects that occur. This research is a 'Phase III' trial, meaning it's a large, important step to confirm if this new treatment is better and safer than what is currently available.
Key takeaways
- The study compares a new cell therapy (Tisagenlecleucel) to standard treatments.
- It's for adults with aggressive lymphoma that has returned or not responded to past treatments.
- The main aim is to see which treatment stops cancer from growing for longer.
- Researchers will also look at overall survival, cancer shrinkage, and side effects.
- Participation involves random assignment to a treatment, regular hospital visits, and close monitoring.
Who may be eligible?
To join this study, you must be an adult aged 18 or over. The study is open to both men and women.
The specific condition for joining is that you have aggressive B-cell non-Hodgkin lymphoma, and your cancer has either returned after you've already had treatment, or it hasn't responded to the treatment you received. Your doctor will be able to confirm if your lymphoma fits these criteria.
There might be other health requirements or previous treatment history that your doctor will need to check to make sure the study is a safe and suitable option for you.
- Are you 18 years old or older?
- Have you been diagnosed with an aggressive type of B-cell non-Hodgkin lymphoma?
- Has your lymphoma either come back after past treatment, or not responded to previous treatments?
- Are you able to attend regular hospital appointments and tests?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you will be randomly assigned to receive either the new treatment (Tisagenlecleucel) or one of the standard treatments for your type of lymphoma. This is like flipping a coin – neither you nor your doctor will choose which group you are in.
You will have regular hospital visits for check-ups, blood tests, and scans to monitor your health and how your cancer is responding. The treatments themselves involve a range of medications, some given by infusion (into a vein) and others as tablets. The duration of your treatment and follow-up will vary, but researchers will monitor your progress closely over time. Your participation will involve ongoing assessments to track the cancer, potential side effects, and your overall well-being. The total duration of follow-up for this study can last for several years, even after active treatment has finished.
Potential risks and benefits
Locations (7)
- —Netherlands
- —Spain
- —Norway
- —Italy
- —Germany
- —France
- —Austria
Common questions
What is aggressive B-cell non-Hodgkin lymphoma?
It's a type of cancer that starts in white blood cells called lymphocytes, which are part of your immune system. 'Aggressive' means it can grow and spread quickly.
What does 'relapsed or refractory' mean?
'Relapsed' means your cancer came back after treatment. 'Refractory' means your cancer didn't respond to previous treatments at all.
What is Tisagenlecleucel?
It's a special type of cell therapy where your own immune cells are taken, reprogrammed to fight your cancer, and then given back to you.
Is this a new treatment?
Tisagenlecleucel is an advanced therapy. This study is aiming to confirm if it is better than existing standard treatments for your specific situation.
Will I know which treatment I'm getting?
No, you will be randomly assigned to either the new treatment or a standard therapy, similar to tossing a coin. This helps make the study fair and unbiased.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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