Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

An Open-label, Phase 2 Study of ACP-196 in Subjects with Mantle Cell Lymphoma

This study is testing a new treatment called Calquence for adults who have Mantle Cell Lymphoma, a type of blood cancer. The main goal is to find out how many patients respond to the treatment, meaning their cancer either shrinks or disappears. Researchers will also look at how long this response lasts, how long people live without their cancer getting worse, and how long they live overall. They'll also carefully check for any side effects and see how the drug moves through the body. This is a Phase II study, meaning it's an earlier stage where researchers are trying to understand the drug's effectiveness and safety in more detail.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Acerta Pharma B.V.

Enrolment target

Start

04 Jun 2024

Mantle Cell Lymphoma

What is this study about?

This research study is about a new medicine called Calquence, which comes in two forms: capsules and tablets. It's being tested for adults who have a specific type of blood cancer called Mantle Cell Lymphoma. This is a cancer that affects certain white blood cells.

The main thing the researchers want to find out is how well this new drug works. They'll measure this by looking at how many patients have a 'response'. A response means that the cancer either gets smaller (a partial response) or completely disappears (a complete response). A group of experts unrelated to the study drug company will also check these responses to ensure accuracy.

Beyond just seeing if the cancer responds, the study will also track other important things. For example, they'll see how long the good effects of the treatment last, how long patients live without their cancer getting worse, and how long they live in total. They'll also pay close attention to any side effects the drug might cause, how often these happen, and if people need to stop taking the drug or change their dose because of them. Finally, they'll study how the drug behaves in the body.

Key takeaways

This study tests a new drug, Calquence, for Mantle Cell Lymphoma.
It aims to see how many patients respond to the treatment.
Researchers will also check for safety and side effects.
It's open to adults aged 18 and over, both men and women.
Participation involves regular clinic visits for checks and tests.

Who may be eligible?

To join this study, you must be an adult aged 18 or older. There is no upper age limit, so people of all adult ages can be considered. The study is open to both men and women.

More specific details about your health, medical history, and current cancer status would be checked by the study doctors to make sure the treatment is safe and suitable for you. This might include recent blood test results or how well other organs in your body are working. You would discuss all these details with the study team to see if you're a good fit.

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 a diagnosis of Mantle Cell Lymphoma?
Are you able to attend regular clinic appointments?
Are you comfortable taking a new study medication?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medicine, Calquence, either as a 100 mg capsule or a 100 mg tablet. You would have regular visits to the clinic where doctors and nurses would perform various checks. These check-ups would include blood tests to look at your general health, how the drug is affecting your blood cells and immune system, and to see how the drug is moving through your body. You would also have scans and other tests to see if your cancer is responding to the treatment. The study doctors will carefully monitor any side effects you might experience. The total duration of your participation would depend on how well you respond to the treatment and your overall health, but you would be followed regularly during and after treatment.

Potential risks and benefits

Taking part in a clinical study may offer you access to a new treatment before it's widely available, which could potentially help your condition. However, there's no guarantee the treatment will work for you, and it may not be better than standard treatments. All medications have potential side effects, and some side effects of Calquence might not be fully known yet. The study team will explain all known risks and carefully monitor you. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

—
Unverified
Poland
—
Unverified
France

Common questions

What is Mantle Cell Lymphoma?

It's a type of cancer that affects a certain kind of white blood cells (lymphocytes) in your body.

What is Calquence?

Calquence is the name of the new drug being tested in this study for Mantle Cell Lymphoma.

What does 'overall response rate' mean?

It's a way to measure how many people's cancer either shrinks or disappears after taking the study drug.

What is a Phase II study?

It's an earlier stage of research where doctors are trying to find out more about how well a new drug works and if it's safe.

Will I get the actual drug or a dummy pill?

This study is an 'open-label' study, which means everyone in the study will receive the active study drug, Calquence. There is no placebo.