AuthorisedTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Multi-regional, Open-label, Randomized Study of Tirabrutinib vs Rituximab and Temozolomide in Participants with Relapsed/Refractory Primary Central Nervous System Lymphoma

This study is looking for people in the UK who have a specific type of cancer called primary central nervous system lymphoma (PCNSL). This is a cancer that starts in the brain or spinal cord. The study is for those whose cancer has either returned after initial treatment or hasn't responded well to previous treatments. Researchers want to compare a new drug called Tirabrutinib with existing treatments, Rituximab and Temozolomide. The main goal is to find out if Tirabrutinib is better at slowing down or stopping the cancer from growing. They will also look at how long people live, how many have a good response to treatment, and other measures of health and well-being. This is a Phase 3 study, meaning it's a key step in seeing if the new medicine should be widely used.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Deciphera Pharmaceuticals Inc.

Enrolment target

Start

14 May 2026

Relapsed/refractory primary central nervous system lymphoma

What is this study about?

This research study is about a type of cancer called primary central nervous system lymphoma (PCNSL). This cancer affects the brain and/or spinal cord. The study focuses on situations where the cancer has either returned after you've had treatment before (this is called 'relapsed') or when it hasn't responded well to previous treatments (this is called 'refractory'). It's a really important area of research because finding better ways to treat this condition can make a big difference for patients.

The study aims to compare a newer treatment, Tirabrutinib, against two established treatments, Rituximab and Temozolomide. Your doctors will want to see which treatment works best to stop the cancer from growing or spreading. They'll also be looking at other important things, like how long people live, how many see their cancer shrink or disappear, and how long the benefits of the treatment last. This is a 'Phase 3' study, which means it's one of the final steps in testing if a new medicine is safe and effective enough to be used more widely.

By taking part, you could be helping researchers understand more about PCNSL and potentially contribute to finding better treatments for future patients. It's a chance to receive closely monitored care and access to a potentially new treatment. The information gathered from this study will be carefully reviewed by a team of experts to ensure the results are accurate and reliable.

Key takeaways

This study is testing a new drug for a type of brain/spinal cord lymphoma.
It's for people whose cancer has come back or hasn't responded to previous treatments.
The study compares a new drug (Tirabrutinib) with standard treatments (Rituximab and Temozolomide).
It aims to find out which treatment is better at stopping the cancer from growing.
Participation involves regular clinic visits and close monitoring.
You have the right to leave the study at any time.

Who may be eligible?

To join this study, you must be at least 18 years old. Both men and women can take part. The main requirement is that you have primary central nervous system lymphoma (PCNSL) that has either come back after previous treatment or hasn't responded to the treatments you've already had.

There will be other medical checks to make sure the study is safe for you. For example, the study team will need to confirm your overall health is suitable for the treatments involved. They'll also check your past medical treatments and current medications to ensure there are no conflicts.

It's important to remember that these are just some of the main points. The study doctors and nurses will go through all the detailed requirements with you to see if this study is the right fit for your specific 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 primary central nervous system lymphoma (PCNSL)?
Has your PCNSL either returned after previous treatment or not responded well to past treatments?
Are you able to attend regular clinic appointments and follow study instructions?
Are you willing for your treatment to be decided by chance (randomly assigned)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to receive either the new drug Tirabrutinib or the standard treatments, Rituximab and Temozolomide. This is like flipping a coin, so neither you nor your doctor chooses which treatment you get. You will need to visit the study clinic regularly for appointments. During these visits, you will have various tests, such as blood tests, scans, and possibly other evaluations to check your health and how the treatment is working. The study team will explain how and when to take your medication, which might be in capsule form or given as an infusion (through a drip).

Your health will be closely monitored throughout the study. After your main treatment period, there will be a follow-up phase where the team will continue to check on your health and any long-term effects of the treatments. The total length of your participation will depend on how you respond to the treatment and the study's overall design, but it will involve regular contact and assessments for an extended period.

Potential risks and benefits

Taking part in any medical study comes with potential benefits and risks. A potential benefit of joining this study is that you would receive close medical attention and access to a possible new treatment (Tirabrutinib) that might be more effective than current options for your specific condition. However, there are also potential risks, as all medications can have side effects. These could range from mild to serious, and the study team will discuss all known potential side effects of each treatment with you in detail. It’s important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (8)

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

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Unverified
Czechia
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Unverified
Germany
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Unverified
Italy
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Unverified
Belgium
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Unverified
Spain
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Unverified
Poland
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Unverified
Austria
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Unverified
France

Common questions

What is primary central nervous system lymphoma (PCNSL)?

It's a type of cancer that starts in the brain or spinal cord, rather than spreading there from another part of the body.

What does 'relapsed/refractory' mean?

It means the cancer has either come back after previous treatment (relapsed) or hasn't responded well to past treatments (refractory).

What is Tirabrutinib?

Tirabrutinib is a new medication being tested in this study to see if it's an effective treatment for PCNSL.

What are Rituximab and Temozolomide?

These are existing treatments often used for PCNSL, and they are being used as a comparison against the new drug in this study.

Will I know which treatment I'm getting?

No, you will be randomly assigned to receive either Tirabrutinib or the combination of Rituximab and Temozolomide, like drawing lots, to ensure the comparison is fair.