Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Efficacy of Polatuzumab, Bendamustine and Rituximab in patients with relapsed/refractory mantle cell lymphoma- A single center phase II trial

This study is a Phase II clinical trial investigating a new treatment approach for mantle cell lymphoma. This is a type of cancer that affects white blood cells. The study is for patients whose cancer has either returned after initial treatment or hasn't responded well to previous therapies. Researchers are testing a combination of three existing medicines: MabThera, Polivy, and Bendamustin. The main goal is to understand how safe this new combination is and how well it works in shrinking or controlling the cancer. They will also look at how long any positive effects last. This is an exploratory study, meaning it's an important step in finding better ways to treat this challenging condition.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Medical University Of Vienna

Enrolment target

Start

10 Dec 2024

Mantle cell lymphoma

What is this study about?

This study is called a clinical trial, which is a carefully planned research study involving volunteers. Its main purpose is to explore a new way of treating a specific type of blood cancer called mantle cell lymphoma. This cancer affects certain white blood cells in your body.

For some people, mantle cell lymphoma can come back after treatment, or it might not respond to the first treatments they receive. This study is for those very situations. Researchers are testing a combination of three medicines that are already known and used in other cancer treatments: MabThera, Polivy, and Bendamustin. By using them together, scientists hope to find a more effective way to fight this type of lymphoma.

The main things the researchers want to find out are how safe this new treatment combination is, how well it helps control or shrink the cancer, and how long any benefits from the treatment might last. This is an early-stage study (Phase II), which means it's an important step in learning more about this potential treatment before it can be widely used.

Key takeaways

This study is for adults with mantle cell lymphoma that has returned or not responded to other treatments.
It tests a new combination of three existing medicines: MabThera, Polivy, and Bendamustin.
The main goals are to check the treatment's safety and how well it controls the cancer.
Participants will receive treatments as infusions and have regular health checks.
It's a Phase II trial, an important step in exploring new treatment options.
You can discuss with your doctor if this study might be suitable for you.

Who may be eligible?

To be able to take part in this study, there are certain requirements you need to meet. These are put in place to make sure the study is safe for you and that the results are clear and reliable.

First, you must be at least 18 years old. There is no upper age limit, meaning older adults can also participate.

The study is open to both men and women. If you have been diagnosed with mantle cell lymphoma that has either returned after getting better, or if your cancer has not fully responded to your previous treatments, then you might be able to join this study. Your doctor will be able to tell you if you meet all the specific criteria.

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.

I am 18 years old or older.
I have been diagnosed with mantle cell lymphoma.
My mantle cell lymphoma has come back after treatment or isn't responding to my current treatment.
I am willing to follow the study's treatment and visit schedule.
My doctor has confirmed that I don't have other health conditions that would make taking part unsafe.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the three study medications (MabThera, Polivy, and Bendamustin) as infusions, which means they will be given directly into your bloodstream, usually through a drip. The study team will explain the exact schedule and how often these infusions will happen.

Throughout the study, you will have regular visits to the hospital or clinic. These visits will involve various tests and checks, such as blood tests, scans, and physical examinations. These are important for checking your general health, how you are responding to the treatment, and if you are experiencing any side effects. The study team will carefully monitor you during and after each treatment cycle. The overall length of your participation will depend on how you respond to the treatment and the study plan, but the team will discuss the expected duration with you.

Potential risks and benefits

Taking part in any clinical trial involves both potential benefits and potential risks. A possible benefit of joining this study is that you might have access to a new treatment combination that could help control your mantle cell lymphoma, especially if your current treatments aren’t working well. While this treatment combines existing drugs, their action together is still being studied. As with all medications, there's a risk of side effects, which can vary from mild to more serious; the study team will monitor you closely for these. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Austria

Common questions

What is mantle cell lymphoma?

It's a type of cancer that starts in your white blood cells, which are part of your immune system.

What does 'relapsed/refractory' mean?

It means the cancer has come back after treatment, or it didn't fully respond to previous treatments.

Are the medicines new?

The medicines themselves are known, but this study is testing them in a new combination for mantle cell lymphoma.

Why is it called a 'Phase II' trial?

Phase II trials are an early step to see how safe a new treatment is and how well it might work in a larger group of people.

Will I have to pay to be in the study?

No, you will not have to pay for the study treatments or any study-related tests.