A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma
This UK clinical trial is looking at a new drug called glofitamab for adults with a type of blood cancer called mantle cell lymphoma. This is for people whose cancer has either come back after treatment (relapsed) or isn't responding to their current or past treatments (refractory). The main goal is to compare glofitamab to other common treatments, like a combination of rituximab and bendamustine, or lenalidomide with rituximab, to see which works best. Researchers want to understand if glofitamab can be a better option for these patients. Taking part means you would receive either the new drug or a standard treatment, and doctors would closely monitor your health and the cancer's progress.
At a glance
What is this study about?
This study is for adults in the UK who have a specific type of blood cancer called mantle cell lymphoma. This cancer affects white blood cells, and the trial is looking for people whose cancer has either returned after they've had treatment before (this is called 'relapsed') or hasn't responded to their previous treatments (this is called 'refractory'). It's important to find new and more effective ways to treat mantle cell lymphoma, especially for those whose cancer is proving difficult to control.
In this trial, doctors are comparing a new medicine called glofitamab with some standard treatments already used for mantle cell lymphoma. The standard treatments being looked at are often a combination of medicines like rituximab and bendamustine, or lenalidomide with rituximab. By comparing these, the researchers hope to understand if glofitamab works better or is safer for people in this situation.
The main aim is to see how well glofitamab helps to shrink or control the cancer compared to the standard treatments. They will also be looking at how safe glofitamab is and what side effects people might experience. Finding more effective treatments could offer new hope for those living with mantle cell lymphoma where other treatments haven't worked as well as hoped.
Key takeaways
- This study is testing a new drug for mantle cell lymphoma.
- It's for people whose cancer has returned or isn't responding to treatment.
- Participants will receive either the new drug or standard treatment.
- Regular hospital visits and tests will be needed.
- You can stop participating at any time.
Who may be eligible?
To join this study, your doctor will first check if you meet certain requirements. You need to have mantle cell lymphoma that has either come back or isn't responding to treatment, and you must have already tried at least one other treatment, including a type of drug called a BTK inhibitor.
You also need to be well enough to take part, meaning you can carry out most of your normal daily activities. Doctors will check this, along with some blood tests to make sure your body is working properly. They'll also need to see if your cancer can be measured on scans and confirm that you have a certain type of mantle cell lymphoma. You would need to be at least 18 years old.
There are also some reasons why you might not be able to join. For example, if you are pregnant or breastfeeding, or planning to become pregnant soon. If you've previously had similar medicines to glofitamab, or certain other types of cancer treatment like CAR-T cell therapy, you wouldn't be able to join. Also, if you have certain other serious health conditions, particularly affecting your brain or spine, or if you're allergic to specific medications, you might not be eligible. Your doctor will go through all of these points with you carefully.
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.
- Do I have mantle cell lymphoma that has come back or isn't responding to treatment?
- Have I already had at least one treatment, including a BTK inhibitor?
- Am I at least 18 years old?
- Am I generally well enough to do most daily activities?
- Am I not pregnant or breastfeeding, and not planning to be soon?
What does participation involve?
If you decide to take part in this study, you would either receive the new drug, glofitamab, or one of the standard treatment options. You wouldn't be able to choose which treatment you receive; this would be decided randomly, like flipping a coin, but your doctors won't know which one you're getting either.
Taking part would involve regular visits to the hospital or clinic. During these visits, doctors would give you your medication, and you'd have various tests, including blood tests and scans, to see how the treatment is working and to check for any side effects. These assessments are crucial for monitoring your health and the progress of your lymphoma. The exact number and frequency of visits will depend on the specific treatment you receive, but you should expect to be seen regularly for treatment cycles and follow-up checks.
After your treatment period, there would also be a follow-up phase where doctors would continue to monitor your health over time to see the long-term effects of the treatment. The total duration of your participation, including treatment and follow-up, could vary, but the study team will explain the full timeline to you in detail.
Potential risks and benefits
Locations (76)
- Alta Bates Summit Medical CenterVerified postcodeBerkeley, United States· Withdrawn
- City of Hope Cancer CenterVerified postcodeDuarte, United States· Recruiting
- University of California Los Angeles (UCLA) - Cancer Care - Santa MonicaVerified postcodeSanta Monica, United States· Recruiting
- Yale Cancer CenterVerified postcodeNew Haven, United States· Recruiting
- Georgetown UniversityVerified postcodeWashington D.C., United States· Recruiting
- University of MiamiVerified postcodeCoral Gables, United States· Recruiting
- Indiana UniversityVerified postcodeIndianapolis, United States· Withdrawn
- University of Michigan Health SystemVerified postcodeAnn Arbor, United States· Recruiting
- St. Luke's HospitalVerified postcodeChesterfield, United States· Recruiting
- Renown Regional Medical CenterVerified postcodeReno, United States· Recruiting
- Rutgers Cancer Institute of New JerseyVerified postcodeNew Brunswick, United States· Recruiting
- University of RochesterVerified postcodeRochester, United States· Recruiting
Common questions
What is mantle cell lymphoma?
Mantle cell lymphoma is a type of cancer that affects white blood cells called lymphocytes.
What does 'relapsed or refractory' mean?
It means your cancer has come back after treatment, or it hasn't responded to previous treatments.
What is glofitamab?
Glofitamab is a new medicine being tested in this study to see if it can help treat mantle cell lymphoma.
Will I definitely get the new drug?
No, you might get glofitamab or one of the standard treatments. Which one you get is chosen randomly.
Can I leave the study if I change my mind?
Yes, you can withdraw from the study at any time without affecting your medical care.
How to find out more
Reference Study ID Number: GO43878 https://forpatients.roche.com/
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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