Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5
This research study is looking at a new way to treat a type of cancer called follicular lymphoma. It's called a 'Phase 3' study, which means it's one of the final steps before a treatment might be widely available. The study is comparing a new drug combination, mosunetuzumab and lenalidomide, to the usual chemotherapy treatments for people newly diagnosed with follicular lymphoma. Doctors want to find out if this new combination is more effective at treating the cancer and if it has fewer or different side effects compared to what’s currently used. Participants will be randomly assigned to receive either the new combination or standard treatment, and doctors will carefully monitor their health and progress.
At a glance
What is this study about?
This study is trying to find a better way to treat follicular lymphoma, a type of slow-growing blood cancer that affects certain white blood cells. If you've been diagnosed with follicular lymphoma and haven't had treatment for it yet, this study might be for you. The main goal is to compare a new drug combination – mosunetuzumab with lenalidomide – against the standard treatments that doctors usually give. They want to see if this new combination works better to control the cancer and if it has similar, fewer, or different side effects.
To make sure the results are fair and reliable, some participants will receive the new treatment, and others will receive a standard treatment. Which treatment you get will be decided randomly, like flipping a coin. This is common in studies like this. Neither you nor your doctor can choose. The study is also 'open-label,' which means both you and your doctor will know which treatment you are receiving.
This is a large, international study involving many hospitals, and it will run for quite a long time – about 10 years in total. This allows doctors to closely follow patients over several years to understand the long-term effects of the treatments. Your health will be carefully checked throughout the study and for many years after your treatment finishes.
Key takeaways
- Tests a new combination of drugs for follicular lymphoma.
- Compares it to standard chemotherapy for first-time treatment.
- Participation lasts about 2.5 years for treatment, with long-term follow-up.
- You will know which treatment you are receiving (open-label).
- Results will help doctors understand better treatment options.
- You can stop participating at any time.
Who may be eligible?
To be able to join this study, you must be an adult aged 18 or over. You need to have been diagnosed with follicular lymphoma, and it must be your first time receiving treatment for this condition. Your doctors will check if your lymphoma falls into a certain risk category (FLIPI 2-5) and if your cancer needs treatment based on specific signs, such as large tumours, certain symptoms like fevers or weight loss, or if it's causing problems with your blood counts.
You'll also need to have at least one measurable area of cancer that doctors can track. Your medical team will do tests to make sure you meet all the health requirements to take part safely. It's important to understand that if you have already had treatment for follicular lymphoma, or if your lymphoma doesn't meet the specific criteria mentioned above, you will not be able to join this particular study.
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?
- Has your doctor confirmed you need treatment for your lymphoma?
- Have you *not had* any previous treatment for follicular lymphoma?
- Do you have at least one measurable area of cancer?
What does participation involve?
If you decide to join, you'll first go through a screening period of up to 6 weeks. During this time, doctors will do tests to make sure the study is right for you. If you meet all the criteria, you'll be randomly assigned to either receive the new drug combination or a standard chemotherapy treatment.
The main treatment phase will last for about 30 months (2 and a half years). This includes regular doses of your assigned medication, which might involve a first cycle lasting 3 weeks, followed by 11 cycles of 4 weeks, and then potentially up to 9 more cycles every 8 weeks, depending on your treatment group. You will have regular hospital visits for these treatments and to have check-ups and tests.
You'll continue treatment unless your cancer doesn't respond, it gets worse, you decide to stop, or you experience side effects that are too severe. After the treatment period, your health will be monitored for about 3 months, and then, importantly, doctors will continue to check on your long-term health and survival for up to 7 years. The entire study, from start to finish for all patients, could last around 10 years.
Potential risks and benefits
Locations (116)
- Krankenhaus der Barmherzigen Brüder Graz - Abteilung Für Innere Medizin IVerified postcodeGraz, Austria· Recruiting
- Krems University Hospital - Abteilung Für Innere Medizin 2Verified postcodeKrems, Austria· Recruiting
- LKH HOCHSTEIERMARK - Department für Hämato-OnkologieVerified postcodeLeoben, Austria· Recruiting
- Kepler Universitaetsklinikum - Univ.-Klinik für Hämatologie und Internistische OnkologieVerified postcodeLinz, Austria· Recruiting
- Paracelsus Medical University - 3rd Medical DepartmentVerified postcodeSalzburg, Austria· Recruiting
- Univ. Klinikum ST.PÖLTEN - Klinische Abteilung Für Innere Medizin 1Verified postcodeSankt Pölten, Austria· Recruiting
- Medical University of Vienna - Department of Hematology and HemostaseologyVerified postcodeVienna, Austria· Recruiting
- Klinikum Wels-Grieskirchen GMBH - IVth Internal DepartmentVerified postcodeWels, Austria· Recruiting
- Universitätsklinikum Wiener Neustadt - Klinische Abteilung für Innere Medizin IIIVerified postcodeWiener Neustadt, Austria· Withdrawn
- AZ SINT-JAN BRUGGE - OOSTENDE AV - Service HématologieVerified postcodeBruges, Belgium· Recruiting
- INSTITUT JULES BORDET - Service HématologieVerified postcodeBrussels, Belgium· Recruiting
- UNIVERSITE CATHOLIQUE DE LOUVAIN SAINT-LUC - Service HématologieVerified postcodeBrussels, Belgium· Recruiting
Common questions
What is follicular lymphoma?
Follicular lymphoma is a common type of slow-growing blood cancer that affects white blood cells called lymphocytes.
What does 'Phase 3' mean for a study?
A Phase 3 study is one of the final steps of testing a new treatment. It usually involves a large number of people and compares the new treatment to standard care to see if it's better or safer.
Will I know which treatment I'm getting?
Yes, this is an 'open-label' study, which means both you and your doctor will know whether you are receiving the new drug combination or the standard treatment.
How long will I be involved in the study?
Your active treatment will be for about 30 months, followed by follow-up checks on your health and survival for up to 7 years after your treatment period.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time. This will not affect your relationship with your doctor or your future medical care.
How to find out more
Anne FAUGIER
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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