A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Safety and Efficacy of Polatuzumab Vedotin in Combination with Rituximab Plus Gemcitabine Plus Oxaliplatin (R- GEMOX) Versus R- GEMOX Alone in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma
This research study is for adults whose diffuse large B-cell lymphoma (DLBCL) has returned or hasn't improved with earlier treatments. We are testing a new combination of medicines: Polivy (polatuzumab vedotin) with standard treatment (MabThera plus gemcitabine and oxaliplatin, known as R-GEMOX). The goal is to see if adding Polivy makes the treatment safer and more effective than R-GEMOX by itself. The study will carefully monitor any side effects, especially nerve issues (peripheral neuropathy), and look at how long people live after treatment. This is a Phase III study, which means it's a large, important step in determining if this new treatment could become a standard option for patients.
At a glance
What is this study about?
This study is for adults living with a specific type of cancer called diffuse large B-cell lymphoma (DLBCL). This particular study focuses on patients whose lymphoma has either come back after previous treatment, or hasn't responded well to the treatments they've already received. It's a common type of non-Hodgkin lymphoma.
We are investigating a new way to treat this condition. The study compares two treatment approaches: one group will receive a standard chemotherapy combination called R-GEMOX (which includes MabThera, gemcitabine, and oxaliplatin), and the other group will receive R-GEMOX plus an additional new medicine called Polivy. The main aim is to see if adding Polivy to the R-GEMOX treatment is more effective and safe for patients with relapsed/refractory DLBCL.
This is a 'Phase III' study, which is a key stage in medical research. It means that the treatments have already been tested in smaller groups, and now we need to confirm their safety and how well they work in a larger group of people. Researchers will be carefully monitoring participants for any side effects, particularly nerve problems (peripheral neuropathy), and will track how long people live, among other health measures. The hope is that this new combination could offer a better treatment option for those facing challenging forms of DLBCL.
Key takeaways
- This study evaluates a new drug combination for a type of lymphoma that has returned or not responded to previous treatments.
- It combines a new drug, Polivy, with a standard treatment called R-GEMOX.
- The main goals are to check the safety of the new combination and how well it helps patients.
- Researchers will pay close attention to side effects, especially nerve issues.
- It's a large-scale Phase III study, aiming to confirm if this new treatment is better than current options.
Who may be eligible?
To join this study, participants must be adults (18 years or older) and capable of giving their informed consent. Both men and women can take part.
Critically, the study is specifically for individuals diagnosed with diffuse large B-cell lymphoma (DLBCL) that has either returned after previous treatment or hasn't responded adequately to earlier treatments. There will be other specific medical criteria that your doctor will check to ensure it's safe and appropriate for you to participate.
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 diffuse large B-cell lymphoma (DLBCL)?
- Has your DLBCL either returned after treatment or not fully responded to previous treatments?
- Are you able to regularly attend hospital appointments for treatment and check-ups?
What does participation involve?
If you decide to take part in this study, you would be randomly assigned to one of two treatment groups: either the standard R-GEMOX treatment alone, or R-GEMOX combined with Polivy. This is similar to flipping a coin, ensuring a fair comparison between the two groups. You wouldn't be able to choose which group you're in.
You would receive treatment through infusions (drips) over several cycles. Throughout the study, you would have regular hospital visits for blood tests, physical examinations, and to discuss any side effects you might be experiencing. We would specifically monitor for nerve-related side effects, such as tingling or numbness.
The total duration of your participation would involve the treatment period, plus a follow-up period where your health would continue to be monitored for a longer time, even after your main treatment has finished. Your study doctor will explain the exact schedule of visits and treatments, and the overall length of your involvement.
Potential risks and benefits
Locations (5)
- —UnverifiedItaly
- —UnverifiedGermany
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedGreece
Common questions
What is diffuse large B-cell lymphoma (DLBCL)?
DLBCL is a type of fast-growing cancer that affects white blood cells called lymphocytes.
What does 'relapsed/refractory' mean?
It means the cancer has either returned after treatment ('relapsed') or it hasn't responded well to previous treatments ('refractory').
What is Polivy?
Polivy (polatuzumab vedotin) is a newer type of cancer drug that targets cancer cells specifically, while also delivering chemotherapy directly to them.
Will I know which treatment I'm getting?
Yes, this study is 'open-label,' meaning both you and your doctors will know which treatment you are receiving.
How long will I be in the study?
This involves a treatment period and a follow-up period, which your doctor will explain in detail, but it could be for an extended time to monitor your health.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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