AuthorisedTherapeutic exploratory (Phase II)Interventional

Study PACIFIC: Fixed duration treatment with combined pirtobrutinib and short course immuno-chemotherapy in fit patients with previously untreated symptomatic chronic lymphocytic leukemia (CLL). A phase II FILO trial

This is a research study for people in the UK recently diagnosed with a type of blood cancer called chronic lymphocytic leukaemia (CLL) who haven't started treatment yet. The study is investigating a new medication called pirtobrutinib when given alongside a short course of standard combination therapy. The main goal is to see if this treatment can clear almost all leukaemia cells from the blood after a fixed treatment period, specifically checking at 24 months. Researchers will also look at how long people stay well, how long they live, and how long before they need different treatment. This is a Phase II trial, meaning it's testing if the treatment is effective and safe enough to potentially be studied in larger groups of people.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

French Innovative Leukemia Organization

Enrolment target

Start

05 Nov 2025

Patients with previously untreated symptomatic chronic lymphocytic leukemia.

What is this study about?

This research is looking into a new way to treat chronic lymphocytic leukaemia (CLL), a type of cancer that affects white blood cells. If you have CLL and haven't had treatment for it yet, this study might be for you. The study combines a new drug, pirtobrutinib, with a short course of a standard type of treatment that uses a mix of different medicines.

The main idea behind this study is to see if combining these treatments can get rid of the leukaemia cells very effectively. The researchers want to know if, after a set period of treatment, there are so few leukaemia cells left in the blood that they are almost undetectable. This is an important step because doctors hope that by getting rid of most of the cells, patients might stay healthier for longer.

This kind of study also helps doctors understand more about how well the treatment works in the long term. They will be checking things like how long people stay free from the disease, how long they live, and how long it is before they might need another type of treatment. All this information helps improve future care for people with CLL.

Key takeaways

This study is for people with untreated, symptomatic CLL.
It tests a new drug, pirtobrutinib, with standard therapy.
The treatment is for a fixed period, not ongoing.
Researchers aim to reduce leukaemia cells to very low levels.
It's a Phase II trial, checking effectiveness and safety.
You can stop participating at any time.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

The most important requirement is that you have chronic lymphocytic leukaemia (CLL) that is causing symptoms and you have not had any treatment for it yet. This means that if you've already started medication or other therapies for your CLL, this study might not be suitable for you.

Also, your doctors will need to make sure you are generally fit enough to take part. They will do some health checks to ensure the treatment is likely to be safe for you.

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 chronic lymphocytic leukaemia (CLL)?
Is your CLL currently causing symptoms?
Have you *not* started any treatment for your CLL yet?
Are you generally fit and well enough for medical treatments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given the study medication, pirtobrutinib, along with a short course of standard combination therapy. You'll have regular appointments at the hospital or clinic. During these visits, doctors and nurses will monitor your health closely.

This will involve blood tests to check your leukaemia cells and overall health at specific times, including month 9, 18, and 24. At month 24, you'll also have a bone marrow test. These tests help the researchers see how well the treatment is working.

The study treatment is given for a fixed period. After that, you'll continue to be followed up by the study team, even if you stop taking the main medication. The total duration of your involvement, including follow-up, will be explained by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from receiving a new treatment that could be more effective than existing options, or lead to a fixed treatment period. However, as with any medication, there's a chance of side effects and discomfort from tests like blood samples or bone marrow exams. Some side effects might be unknown or serious. Your doctor will discuss all known risks with you. Remember, joining is entirely voluntary, and you can withdraw from the study at any time without 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
France

Common questions

What is chronic lymphocytic leukaemia (CLL)?

CLL is a type of cancer that affects white blood cells called lymphocytes in your blood and bone marrow.

What is pirtobrutinib?

Pirtobrutinib is a new drug being tested in this study to see how it works against CLL cells.

Will I stop treatment if my leukaemia cells are undetectable?

The study involves a 'fixed duration' treatment, meaning you'll take the treatment for a set period, not indefinitely, regardless of undetectable cells.

What does 'Phase II' mean for a trial?

A Phase II trial means researchers are testing if a new treatment is effective and safe enough in a group of people before potentially moving to larger studies.

Will I have to pay to be part of this study?

No, you will not have to pay for the study treatment or any study-related tests. These are covered by the research study.