Brentuximab Vedotin Plus Lenalidomide and Rituximab for the Treatment of Relapsed/Refractory DLBCL
This clinical trial in the UK is looking for people with a specific type of blood cancer called Diffuse Large B-cell Lymphoma (DLBCL). This is for those whose cancer has either returned after treatment or didn't get better with previous therapies. The main goal is to find out if a new combination of medicines is more effective. Participants will receive two standard drugs, rituximab and lenalidomide. Half of the participants will also receive an investigational drug called brentuximab vedotin, while the other half will receive a 'dummy' drug (placebo) that looks the same but contains no medicine. Neither the patient nor their doctor will know if they are receiving the investigational drug or the placebo. This setup helps researchers fairly compare the new combination against existing treatments to understand if it offers a better way forward.
At a glance
What is this study about?
This clinical study is designed for individuals in the UK who have Diffuse Large B-cell Lymphoma (DLBCL), a type of cancer that affects white blood cells. This trial is specifically for patients whose DLBCL has come back after treatment or hasn't improved with their previous therapies. We understand that finding effective treatments for cancer can be a challenging journey, and this study aims to explore a new potential option.
The main question this study hopes to answer is whether adding an additional medicine, brentuximab vedotin, to a combination of two already used drugs, rituximab and lenalidomide, is more effective in treating DLBCL than using just rituximab and lenalidomide on their own. By comparing these two approaches, researchers can learn if this new combination offers advantages like helping the treatment work better or for longer. This is important because it could lead to new ways to help people with DLBCL who need more treatment options.
To make sure the study is fair and unbiased, some participants will receive brentuximab vedotin while others will receive a placebo – a substance that looks exactly like the actual medicine but doesn't contain any active drug. All participants will also receive rituximab and lenalidomide. Neither you nor your doctors will know which treatment you are getting. This is known as a 'blinded' study, and it's a standard and important part of clinical trials to ensure the results are as accurate as possible.
Key takeaways
- This study is for adults with DLBCL that has returned or not responded to previous treatments.
- It aims to see if adding brentuximab vedotin to rituximab and lenalidomide is more effective.
- Participants will be randomly assigned to receive either brentuximab vedotin or a placebo, plus two other drugs.
- Neither you nor your doctor will know which specific treatment arm you are on.
- Regular hospital visits, blood tests, and scans will be part of your participation.
- You can withdraw from the study at any time without affecting your medical care.
Who may be eligible?
To join this study, you must be an adult aged 18 or older. You need to have Diffuse Large B-cell Lymphoma (DLBCL) that has either returned after treatment or didn't get better with at least two previous lines of therapy. This includes people whose DLBCL has changed from another type of lymphoma. Doctors will check your medical history to confirm the specific type of DLBCL you have.
Another important requirement is that you must not be a suitable candidate for a stem cell transplant or CAR-T cell therapy, which are other advanced treatments for DLBCL. This could be for various reasons, such as other health conditions affecting your heart, lungs, kidneys, or liver, or if these treatments have not worked for you before. It might also be if you can't access CAR-T therapy for practical reasons.
Also, your cancer needs to be visible on scans and measurable by doctors, and you should generally be well enough to take part in the study, meaning you are able to carry out most of your normal daily activities. You cannot join if you've had another cancer recently (within two years), or have a specific brain infection called PML, or active cancer in your brain or its coverings.
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?
- Do you have Diffuse Large B-cell Lymphoma (DLBCL) that has come back or not responded to at least two previous treatments?
- Are you considered unsuitable for stem cell transplant or CAR-T cell therapy by your doctor?
- Is your cancer visible and measurable on scans?
- Are you generally well enough to manage most daily activities?
- Have you not had another cancer diagnosis in the last two years?
What does participation involve?
If you decide to take part in this study, you'll be assigned to one of two groups by chance – like flipping a coin. You'll receive either the investigational drug brentuximab vedotin or a placebo (a dummy drug), along with rituximab and lenalidomide. You'll get these medicines through ongoing hospital visits.
During your time in the study, you'll have regular hospital visits for check-ups, blood tests, and scans (like PET and CT scans) to see how you're responding to the treatment and to monitor your general health. These appointments are important for your safety and to help the researchers understand the effects of the medicines. The study will continue as long as the treatment is helping and you are tolerating it well, or until a certain period has passed. Throughout the study, you'll have a team of medical professionals looking after you and explaining each step.
Potential risks and benefits
Locations (145)
- Central Alabama ResearchVerified postcodeBirmingham, United States
- University of California Davis Comprehensive Cancer CenterVerified postcodeSacramento, United States
- University of California Davis Medical CenterVerified postcodeSacramento, United States
- Florida Cancer SpecialistsVerified postcodeBonita Springs, United States
- Florida Cancer SpecialistsVerified postcodeBradenton, United States
- Florida Cancer SpecialistsVerified postcodeCape Coral, United States
- Florida Cancer SpecialistsVerified postcodeDaytona Beach, United States
- Florida Cancer SpecialistsVerified postcodeFort Myers, United States
- Florida Cancer SpecialistsVerified postcodeFort Myers, United States
- Florida Cancer SpecialistsVerified postcodeNaples, United States
- Florida Cancer SpecialistsVerified postcodePort Charlotte, United States
- Florida Cancer SpecialistsVerified postcodeSarasota, United States
Common questions
What is Diffuse Large B-cell Lymphoma (DLBCL)?
DLBCL is a fast-growing type of cancer that starts in white blood cells called lymphocytes.
What does 'relapsed/refractory' mean?
It means your DLBCL has either come back after treatment (relapsed) or hasn't responded to previous treatments (refractory).
Why am I getting a placebo?
Receiving a placebo helps researchers fairly compare the new drug combination against existing treatments to see if it truly makes a difference.
Will I know which treatment I'm getting?
No, neither you nor your doctor will know if you're getting brentuximab vedotin or the placebo. This is called a 'blinded' study.
What are rituximab and lenalidomide?
These are existing medications that are used to treat DLBCL and are part of the treatment for all participants in this study.
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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