An open-label, prospective Phase III clinical study to compare polatuzumab vedotin plus rituximab, ifosfamide, carboplatin and etoposide (Pola-R-ICE) with rituximab, ifosfamide, carboplatin and etoposide (R-ICE) alone as salvage therapy in patients with primary refractory or relapsed diffuse large B-cell lymphoma (DLBCL)
This research study is for adult patients diagnosed with a type of cancer called Diffuse Large B-cell Lymphoma (DLBCL). This is a fast-growing cancer of the immune system. The study focuses on people whose cancer has either returned after initial treatment (relapsed) or hasn't improved with standard treatment (primary refractory). The main goal is to compare two treatment approaches: a standard combination of medicines called R-ICE, and a new combination called Pola-R-ICE, which adds an extra drug called polatuzumab vedotin. Researchers want to see if the new combination can help prevent the cancer from growing or coming back for a longer time. They will also look at side effects, quality of life, and how well patients respond to the treatments.
At a glance
What is this study about?
This study is looking into new ways to treat a type of cancer called Diffuse Large B-cell Lymphoma (DLBCL). This is a cancer that starts in certain white blood cells called B-cells. For some people, DLBCL can be challenging to treat because it might come back after initial treatment or not respond to it very well. When this happens, doctors call it 'relapsed' or 'primary refractory' DLBCL.
The main aim of this study is to compare two treatment plans for these patients. One plan is a standard treatment called R-ICE. This involves a combination of several important medicines. The other plan, called Pola-R-ICE, adds an extra medicine called polatuzumab vedotin to the R-ICE combination. Researchers want to find out if adding polatuzumab vedotin can make the treatment more effective at stopping the cancer from growing or returning.
To see how well these treatments work, doctors will be carefully watching how long patients stay free from their cancer progressing. This is called 'event-free survival'. They will also be looking at other important things like how many patients’ cancers shrink or disappear, how long those improvements last, overall survival, and any side effects patients might experience. The study also considers how these treatments affect a patient's overall quality of life, which is very important.
Key takeaways
- This study evaluates a new treatment combination for challenging DLBCL.
- It compares standard R-ICE with a new Pola-R-ICE combination.
- The goal is to find out if the new treatment keeps cancer away longer.
- Participation involves receiving treatment and close medical monitoring.
- Quality of life is an important aspect being measured.
Who may be eligible?
This study is specifically designed for adults who have been diagnosed with Diffuse Large B-cell Lymphoma (DLBCL). This includes people whose lymphoma has either returned after they've had treatment before (this is called 'relapsed') or if their lymphoma didn't get better with their initial treatment (this is called 'primary refractory').
You must be 18 years old or older to take part in this study. The study is open to both men and women, and does not have an upper age limit. Doctors will check other specific health requirements to make sure it's safe 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 come back after treatment (relapsed)?
- Did your DLBCL not fully respond to your initial treatment (primary refractory)?
- Are you willing to discuss the study details with your doctor?
What does participation involve?
If you join this study, you will be assigned to receive either the standard R-ICE treatment or the Pola-R-ICE treatment. Both treatments involve receiving a combination of medicines through infusions, usually in a hospital setting. You will have regular visits with the study doctors and nurses to monitor your progress, manage any side effects, and undergo various assessments.
These assessments typically include physical exams, blood tests, and scans (like CT scans) to see how the treatment is affecting your lymphoma. The study team will also ask you to complete questionnaires to understand how you are feeling and how the treatment impacts your quality of life. The exact number of visits, tests, and the total length of your participation will depend on how you respond to the treatment and the study's specific schedule, but generally, these types of studies involve several cycles of treatment followed by ongoing monitoring.
Potential risks and benefits
Locations (3)
- —UnverifiedSpain
- —UnverifiedAustria
- —UnverifiedGermany
Common questions
What is Diffuse Large B-cell Lymphoma (DLBCL)?
DLBCL is a fast-growing cancer of a type of white blood cell called B-lymphocytes, which are part of your immune system.
What does 'relapsed' or 'primary refractory' mean?
Relapsed means the cancer has come back after treatment. Primary refractory means the cancer didn't respond well to the first treatment.
What is the main purpose of this study?
The study aims to see if adding an extra drug (polatuzumab vedotin) to a standard treatment (R-ICE) can better control DLBCL that has come back or hasn't responded to previous treatment.
Will I definitely get the new treatment?
No, you will be assigned randomly to receive either the standard R-ICE treatment or the new Pola-R-ICE treatment. It's like flipping a coin to decide.
What kind of tests will I have during the study?
You will have regular blood tests, physical examinations, and scans (like CT scans) to check how the treatment works and monitor your health.
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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