ME-401 combined with rituximab-bendamustine for high-risk and rituximab with a 1:1 randomization to ME-401 for low-risk follicular lymphoma as primary treatment: a phase II study – NLG-FL5 (Follicular lymphoma and ME-401: FLAME)
The FLAME study is a Phase II clinical trial investigating a new drug called ME-401 for people who have recently been diagnosed with follicular lymphoma. Follicular lymphoma is a type of slow-growing blood cancer. This study aims to see how effective and safe ME-401 is when given alongside standard treatments. For people with a more serious form of the disease (high-risk), ME-401 will be combined with rituximab and bendamustine. For those with a less serious form (low-risk), half of the participants will receive ME-401 in addition to rituximab, while the other half will receive only rituximab. This helps researchers understand the best way to use ME-401 as a first treatment option.
At a glance
What is this study about?
This study, known as FLAME, is a medical research project looking into a new treatment for a type of cancer called follicular lymphoma. Follicular lymphoma is a cancer that affects white blood cells, a key part of your body's immune system. While it's generally slow-growing, understanding the best way to treat it early is very important.
The main aim of this study is to test a new medicine called ME-401. Researchers want to see if adding ME-401 to existing treatments can work better as the very first treatment a person receives after being diagnosed with follicular lymphoma. This is a 'Phase II' study, which means it's one of the earlier stages of drug testing, focusing on whether a new treatment is effective and safe in a group of people.
Understanding how different treatments work together is crucial. For people with a more challenging form of follicular lymphoma (called 'high-risk'), the study will combine ME-401 with two established medicines, rituximab and bendamustine. For those with a less challenging form (called 'low-risk'), some people will get ME-401 plus rituximab, while others will just get rituximab. This comparison helps doctors learn if ME-401 improves the standard treatment without adding too many side effects.
Key takeaways
- This study is for adults with newly diagnosed follicular lymphoma.
- It's testing a new drug, ME-401, with standard treatments.
- The aim is to find out if ME-401 is effective and safe as a first treatment.
- Participants will receive either ME-401 plus standard treatment, or standard treatment alone (depending on risk level).
- Close medical monitoring will be part of taking part.
Who may be eligible?
To be considered for this study, you would need to be an adult, 18 years old or older. The study is open to both men and women.
Beyond these basic requirements, there will be other specific medical criteria that your doctor will need to check. These would include things like your specific diagnosis of follicular lymphoma, if you've had other treatments before, and your general health, to ensure the study is safe and appropriate for you.
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 follicular lymphoma?
- Could this be considered your first treatment for follicular lymphoma?
- Are you able to travel to study appointments?
What does participation involve?
If you decide to take part in this study, you would receive the study medication (ME-401, rituximab, and/or bendamustine) as prescribed by the study doctors. This would involve regular visits to the hospital or clinic for treatments, check-ups, and to monitor your health. These visits will likely include blood tests, physical examinations, and possibly scans to see how your body is responding to the treatment.
The study would involve a period of active treatment, followed by a time where you would continue to be monitored. The total length of your participation, including follow-up, would be fully explained by the study team. They will also tell you about any specific dietary or activity guidelines you might need to follow while taking part.
Potential risks and benefits
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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 is ME-401?
ME-401 is an investigational new drug being tested to see if it can help treat follicular lymphoma.
What does 'Phase II study' mean?
A Phase II study means researchers are testing a new treatment on a group of patients to see if it's effective and safe, following initial safety tests.
Will I definitely get the new drug ME-401?
It depends on the 'risk' level of your follicular lymphoma. For low-risk, some participants will receive ME-401 and some won't, to allow comparison.
Can I stop participating in the study if I change my mind?
Yes, you have the right to leave the study at any time without it affecting 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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