AuthorisedTherapeutic exploratory (Phase II)Interventional

PirtobrUtinib as frontline Therapy for elderly unfit/frail patient with MAntle cell lymphoma: a phase II study of the Fondazione Italiana Linfomi (FIL)

This study, called "PirtobrUtinib as frontline Therapy for elderly unfit/frail patient with MAntle cell lymphoma," is investigating a new medication called pirtobrutinib. It's for older patients with a type of cancer called mantle cell lymphoma, especially those who may not be strong enough for usual treatments. The main goal is to find out how long patients stay free from their cancer getting worse after starting this drug. Researchers will also look at how many patients respond to the treatment, how long they live, their quality of life, and any side effects. This is a Phase II study, meaning it's exploring how well the treatment works and its safety in a group of people, building on earlier safety tests.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fondazione Italiana Linfomi Ets

Enrolment target

Start

26 Feb 2026

Mantle Cell Lymphoma

What is this study about?

This clinical trial is designed for people with a type of cancer called mantle cell lymphoma. Mantle cell lymphoma is a cancer that affects white blood cells, a part of your immune system. This study focuses on older patients who might be feeling frail or unwell, meaning standard aggressive treatments could be too hard on their bodies.

The main purpose of the study is to test a new drug called pirtobrutinib. Researchers want to see how effective this drug is at keeping the cancer from growing, coming back, or getting worse. This is often called "progression-free survival." They're also carefully watching for any side effects and how the drug affects patients' daily lives and general well-being.

This is a Phase II study, which means it's one of the steps in testing a new medication. It helps doctors understand if the drug works well enough to be considered for further, larger studies, and to get more information about its safety and side effects in a specific patient group.

Key takeaways

This study is for older or frail patients with mantle cell lymphoma.
It tests a new drug called pirtobrutinib.
The main goal is to see how long the cancer is kept from getting worse.
Researchers will also check for side effects and how patients feel overall.
Participation involves regular check-ups and taking the study drug.

Who may be eligible?

This study is looking for patients of any age who have mantle cell lymphoma. Because the study is specifically designed for those who might be elderly or not strong enough for more intensive treatments, your doctor will assess your overall health and fitness before you can join.

There aren't any specific age limits, but your medical team will carefully review your health records to make sure this study is the right fit for you. They will consider your general condition and if you have any other serious health problems that might make taking part unsafe or difficult.

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.

Do I have mantle cell lymphoma?
Has my doctor mentioned I might be considered 'elderly' or 'unfit/frail' for standard treatments?
Am I open to taking a new, experimental drug?
Am I able to attend regular hospital or clinic appointments for monitoring?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study drug, pirtobrutinib. You'll have regular appointments where doctors will monitor your health, check how you're responding to the treatment, and look for any side effects. These checks might include blood tests, scans, and questionnaires about how you're feeling and your quality of life.

The total duration of your participation will depend on how you respond to the treatment. You will continue to take the study drug for as long as it is working for you and as long as you are tolerating it well. After you stop taking the drug, you will still have follow-up appointments so doctors can continue to monitor your health and gather important information for the study.

Potential risks and benefits

Taking part in this study could offer some potential benefits, such as gaining early access to a new treatment that might help control your mantle cell lymphoma, especially if standard options aren't suitable. However, there are also potential risks, including side effects from the study drug, which could range from mild to more serious. Your doctors will monitor you closely for any issues. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your future 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
Italy

Common questions

What is mantle cell lymphoma?

It's a type of cancer that affects white blood cells, which are important for fighting infections in your body.

What is pirtobrutinib?

It's a new medication being tested to see if it can help stop mantle cell lymphoma from growing or getting worse.

Why is this study for 'elderly unfit/frail' patients?

It's specifically designed for older patients or those who might not be strong enough for the usual, more intensive cancer treatments.

What kind of tests will I have if I join?

You'll likely have regular check-ups, blood tests, and scans to see how the treatment is working and to monitor your health.

Can I stop taking part in the study if I want to?

Yes, you can choose to leave the study at any time, and it won't affect your ongoing medical care.