Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

TRIANGLE - autologous Transplantation after a Rituximab/Ibrutinib/Ara-c containing iNduction in Generalized mantle cell Lymphoma – a randomized European mcl network trial

This study, called TRIANGLE, is for people with generalized mantle cell lymphoma. It's looking for the best way to treat this cancer. Researchers want to see if adding a new drug, ibrutinib, to the usual treatment makes a difference. They will compare a combination of treatments, including ibrutinib, against the standard approach. The main goal is to find out if the new treatment helps people stay well for longer without their cancer coming back or getting worse. They will also look at how long people live overall and check for any side effects. This is a Phase III study, which means it's one of the final steps before a new treatment might become widely available.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Klinikum der Universitaet Muenchen AöR

Enrolment target

832

Start

08 Nov 2024

Generalized mantle cell Lymphoma

What is this study about?

This important study, known as TRIANGLE, is focusing on an aggressive type of cancer called mantle cell lymphoma. When we talk about "generalized," it means the cancer has spread beyond just one area. The study aims to find the most effective treatment strategy for patients with this condition. Currently, there are established ways to treat mantle cell lymphoma, but doctors are always looking for improvements.

In this study, researchers are exploring if adding a specific drug called ibrutinib to the standard treatment plan makes a difference. Ibrutinib works by blocking signals that cancer cells need to grow and survive. The study will compare patients receiving the standard treatment against those receiving the standard treatment plus ibrutinib. By doing this comparison, the researchers hope to determine if the new approach is more successful at controlling the cancer and improving patients' health.

The main thing the doctors want to measure is how long patients live without their cancer getting worse or coming back, or sadly, if they pass away. This is often called 'failure-free survival'. They will also look at other important things, like how long people live in total, how well the treatments shrink the cancer, and any side effects patients might experience. The goal is to provide patients with the best possible treatment options for mantle cell lymphoma.

Key takeaways

This study is for adults with generalized mantle cell lymphoma.
It compares standard treatment for mantle cell lymphoma with a new approach including the drug ibrutinib.
The main goal is to see if the new treatment can help patients stay well for longer.
Patients will be monitored closely for treatment effectiveness and side effects.
Participation helps advance understanding and potential new treatments for this cancer.

Who may be eligible?

To be considered for this study, you must be an adult aged 18 years or older. There is no upper age limit, meaning older adults can also take part. The study is open to both men and women.

Crucially, you would need to have been diagnosed with 'generalized mantle cell lymphoma'. This means your doctors have confirmed you have this specific type of cancer and it has spread within your body.

Your medical team will also need to review your overall health, the exact stage of your cancer, and any other medical conditions you might have, to make sure this study is a safe and suitable option for you. Not everyone with mantle cell lymphoma will be able to join, as there are strict health guidelines to ensure safety.

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 generalized mantle cell lymphoma?
Are you comfortable with the possibility of receiving either standard treatment or standard treatment plus ibrutinib?
Are you able to attend regular hospital appointments for check-ups and treatment?

Answer every question to see your result.

What does participation involve?

If you decide to participate in this study, you would first go through a screening process to confirm you meet all the health requirements. Once accepted, you would be randomly assigned to one of the study treatment groups. This means you wouldn't choose which treatment you receive; it's decided by chance, like flipping a coin, to ensure a fair comparison.

Your treatment would involve a combination of medicines, which may include ibrutinib, delivered over a period of time. You would have regular visits to the hospital for checks, which include blood tests, scans, and physical examinations. These appointments are important for monitoring your health, how well the treatment is working, and checking for any side effects.

After your main course of treatment, you would continue to be monitored for a longer period. This 'follow-up' allows doctors to understand the long-term effects of the treatments. The total duration of your involvement could be several years, as doctors need to track outcomes over time. All medication directly related to the study would be provided.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as access to a new treatment like ibrutinib that might prove more effective for your condition than standard care. You also play a vital role in advancing medical knowledge for future patients. However, there are potential risks, as any medical treatment can cause side effects. These can range from mild to serious, and doctors will carefully monitor you for them. All known risks will be explained in detail before you decide to join. It is your right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (12)

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

—
Unverified
Norway
—
Unverified
Spain
—
Unverified
Poland
—
Unverified
Czechia
—
Unverified
Sweden
—
Unverified
Belgium
—
Unverified
Italy
—
Unverified
Portugal
—
Unverified
Finland
—
Unverified
Denmark
—
Unverified
Germany
—
Unverified
Netherlands

Common questions

What is mantle cell lymphoma?

Mantle cell lymphoma is a type of non-Hodgkin lymphoma, which is a cancer that starts in white blood cells called lymphocytes.

What is ibrutinib?

Ibrutinib is a targeted therapy drug that works by blocking a specific protein in cancer cells, helping to stop them from growing and spreading.

What does 'Phase III' mean for this study?

Phase III means the study is comparing the new treatment against the best available standard treatment to see which is more effective and safer on a larger group of patients.

Will I know which treatment I'm receiving?

In some 'randomized' studies, you might not know which specific treatment group you're in (standard or new treatment with ibrutinib) to ensure fair results.

What does 'failure-free survival' mean?

Failure-free survival is a measure of how long you live without your cancer getting worse, coming back, or sadly, passing away from any cause.