AuthorisedTherapeutic exploratory (Phase II)Interventional

SAKK 38/19: Assessing a ctDNA and PET-oriented therapy in patients with DLBCL. A multicenter, open-label, phase II trial

This study, named SAKK 38/19, is investigating a new approach to treating a type of blood cancer affecting white blood cells, called diffused large B-cell lymphoma. Doctors are using a drug named Calquence (also known as acalabrutinib) and are closely monitoring patients using special tests like PET scans and ctDNA (which looks for cancer DNA in the blood). The main goals are to see how long patients remain free from their cancer progressing and how many achieve complete remission. This is a Phase II study, meaning it's exploring how well this new treatment works and its safety in a group of patients.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Swiss Group for Clinical Cancer Research

Enrolment target

104

Start

14 Oct 2024

Disseminated large B-cell lymphoma

What is this study about?

This study, called SAKK 38/19, is looking into new ways to treat a type of cancer that affects your white blood cells, specifically a kind called 'diffused large B-cell lymphoma'. This cancer starts in the cells that fight infection and can spread throughout the body.

The main aim of this study is to see how well a new treatment approach works. This approach involves a medication called Calquence (you might also hear it called acalabrutinib). Researchers will also be using advanced tests like CTDNA (which checks for tiny bits of cancer DNA in your blood) and PET scans (a special type of scan that can show where the cancer is active) to keep a close eye on the cancer and how you're responding to treatment.

They want to find out two main things: first, how long people stay free from their cancer getting worse (this is called 'progression-free survival'), and second, how many people see their cancer completely disappear (this is called 'complete remission'). Understanding these points will help doctors decide if this new way of treating diffused large B-cell lymphoma could be a good option for future patients.

Key takeaways

This study is testing a new treatment called Calquence for diffused large B-cell lymphoma.
It aims to see how well the treatment stops cancer growth and helps achieve complete remission.
Special tests like ctDNA and PET scans will be used to monitor progress.
Participation involves taking tablets and having regular clinic visits for tests and check-ups.
It's a Phase II study, meaning it's exploring the effectiveness and safety of a new treatment.

Who may be eligible?

To join this study, people generally need to be at least 18 years old. Both men and women are welcome to take part.

There will be other conditions that doctors will need to check to make sure the study is a good fit for you and that it's safe for you to participate. These might include things like your general health, other medical conditions you have, and if you've had certain treatments before.

It's important to have a detailed conversation with your doctor or the study team. They will go through all the requirements with you and answer any questions you have to help you decide if this study is right 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?
Do you have diffused large B-cell lymphoma?
Are you able to take medication by mouth (tablets)?
Are you willing and able to attend regular hospital visits for tests and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be taking a medication called Calquence. This comes as a tablet that you swallow. The study team will explain exactly how and when to take it.

You'll have regular visits to the clinic for check-ups. These visits will involve various tests, such as blood tests (including the special ctDNA test), and scans like PET scans, to monitor your health and how the treatment is working. The study team will tell you how often these visits and tests will be, but they are crucial for understanding the treatment's effects.

Overall, the study will involve ongoing treatment and monitoring for a period, and the team will keep track of your health and any side effects. They'll also follow up with you after your treatment phase to see how you're doing in the long term.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from a new treatment that isn't widely available yet, which could help your cancer. However, this drug, like all medications, can have side effects. These can range from mild to more serious, and the study team will carefully monitor you for any problems. You have the right 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 diffused large B-cell lymphoma?

It's a fast-growing cancer that affects a type of white blood cell called B-lymphocytes, which are part of your immune system.

What is Calquence (acalabrutinib)?

It's a medication that works by blocking a specific protein in cancer cells, which can help stop them from growing and spreading.

What is 'progression-free survival'?

This refers to the length of time a patient lives with the disease without it getting worse.

What does 'complete remission' mean?

It means that all signs of the cancer have disappeared from the body following treatment.

Will I receive special monitoring if I join?

Yes, you'll have regular checks, including blood tests looking for cancer DNA (ctDNA) and PET scans, to closely monitor your health and response.