Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A PHASE 2 OPEN LABEL STUDY OF ORAL LORLATINIB (PF-06463922) IN PATIENTS WITH RELAPSED ALK POSITIVE LYMPHOMA PREVIOUSLY TREATED WITH ALK INHIBITORS

This research study is about a new medicine called Lorviqua (pronounced Lor-vee-kwa). It's for adults (18 and over) who have a specific type of cancer called Anaplastic Large Cell Lymphoma (ALCL) that has a special marker called ALK positive. This study is for people whose cancer has returned after they've already had other treatments for it. Researchers want to see how well Lorviqua works in shrinking the cancer. They will also look at side effects, how long people stay well, and their quality of life. This is a Phase 2 study, meaning it's still in the earlier stages of testing, but it's important for understanding if Lorviqua could be a helpful new treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Universita Degli Studi Di Milano Bicocca

Enrolment target

Start

31 Jan 2025

Anaplastic Large Cells Lymphoma (ALCL) ALK+

What is this study about?

This study is trying to find new ways to treat a specific type of cancer called Anaplastic Large Cell Lymphoma (ALCL). This cancer has a special feature called ALK positive, which means it responds to certain targeted medicines. The researchers are particularly interested in people whose ALCL has come back or worsened even after they've already tried other ALK inhibitor medicines. The goal is to see if a new drug called Lorviqua can help these patients.

Lorviqua is being tested to see if it can make the cancer shrink or disappear for a period of time. This is a 'Phase 2' study, which means it's one of the earlier steps in testing a new medicine. At this stage, doctors are looking closely at how effective the drug is and what side effects it might cause. They also want to understand if it improves how people feel and live their daily lives.

Finding new and effective treatments for ALCL that has come back is very important. Studies like this help doctors learn more about diseases and develop new medicines to offer patients more options and better care in the future. Your participation could help improve knowledge and treatment for others facing similar conditions.

Key takeaways

This study is testing a new drug, Lorviqua, for a specific type of ALCL.
It's for adults whose ALCL (ALK positive) has relapsed after other treatments.
The main goal is to see if Lorviqua can shrink the cancer.
The study will also look at safety and quality of life.
Participation means regular clinic visits, tests, and taking the study drug.

Who may be eligible?

This study is particularly for adults who have been diagnosed with a specific type of cancer called Anaplastic Large Cell Lymphoma, or ALCL for short. Importantly, your ALCL must have a special characteristic, which doctors call being 'ALK positive'.

Another key requirement is that your ALCL must have come back or worsened after you've already received other treatments that target this ALK positive feature. The study is open to both men and women who are 18 years old or older. There is no upper age limit for joining.

To see if you are a good fit for this study, a doctor will check all your medical information carefully. They will make sure that the study is safe and appropriate for your individual situation.

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 Anaplastic Large Cell Lymphoma (ALCL)?
Has your doctor confirmed your ALCL is 'ALK positive'?
Has your ALCL come back or worsened after previous treatments for it?

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, Lorviqua, in the form of tablets you swallow. You'll take these tablets as instructed by the study doctor. The doctors and nurses on the study team will ask you to visit the clinic regularly. During these visits, they will carry out different checks to see how you are responding to the medication and if you're experiencing any side effects.

These checks will likely include physical examinations, blood tests, and scans (like CT scans) to see if the cancer is shrinking or changing. You might also be asked to fill out questionnaires about how you are feeling and your quality of life. The study team will explain exactly what each visit involves and how often you'll need to come in. There will also be a follow-up period after you stop taking the study drug to monitor your health.

Potential risks and benefits

Participating in this study might offer a potential benefit for you by giving you access to a new treatment, Lorviqua, which isn't currently available outside of clinical trials for your condition. It could potentially help shrink your cancer. However, like all medicines, Lorviqua may have side effects, and some could be serious. The study team will carefully monitor you for any side effects and explain them to you. You are free 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
Italy

Common questions

What is an 'ALK positive' lymphoma?

It means your cancer cells have a specific change that doctors can target with certain medicines. It helps them choose the right treatment.

What does 'relapsed' mean in this study?

It means your cancer has come back or worsened after you've already had treatment for it.

How will I know if the treatment is working?

The study team will do regular scans and tests to check if the cancer is shrinking or stable.

What does a 'Phase 2' study mean?

It means this is an earlier stage of testing a new drug. Doctors are looking closely at how well it works and its safety.

Will I have to pay to be in the study?

No, you will not have to pay for the study medication or related medical procedures. Travel expenses may be covered, but you should ask the study team.