Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Rituximab, bendamustine and cytarabine followed by venetoclax (V-RBAC) in high-risk elderly patients with mantle cell lymphoma (MCL)

This research study is investigating a new and potentially more effective treatment for older patients diagnosed with mantle cell lymphoma, a type of blood cancer. The treatment involves a combination of medicines: rituximab, bendamustine, cytarabine, and venetoclax, often called V-RBAC. The main goal is to measure how many patients treated with V-RBAC remain free from their cancer progressing for at least two years after starting treatment. Researchers will also be looking at how long people live, if the treatment fully gets rid of the cancer, and the safety of the new treatment. This is a Phase II study, meaning it's still in the earlier stages of checking if the treatment works and is safe before it might become more widely available.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fondazione Italiana Linfomi Ets

Enrolment target

130

Start

02 Sep 2024

Mantle Cell Lymphoma

What is this study about?

This study is focused on a specific type of blood cancer called mantle cell lymphoma, which affects white blood cells. This particular study is for older patients who have a higher-risk form of this cancer. The researchers are testing a new combination of medicines, sometimes called V-RBAC, which includes rituximab, bendamustine, cytarabine, and venetoclax. The hope is that this new combination will be more effective than current treatments.

The main aim of this study is to see how successful this new treatment is at stopping the cancer from growing or coming back for a period of two years. If the treatment can keep the cancer under control for longer, it would be a significant step forward. The study will also look at other important things, like how long patients live after starting the treatment, how many patients achieve a complete remission (meaning no signs of cancer are detected), and the overall safety of the new drug combination.

This is a 'Phase II' study. This means that researchers are trying to see if this treatment works well enough and is safe enough to be tested in even larger groups of people later on. It’s an important step in finding better ways to treat mantle cell lymphoma.

Key takeaways

Tests a new treatment combo (V-RBAC) for mantle cell lymphoma.
Aims to stop cancer growth for at least two years.
Focuses on older patients with higher-risk cancer.
It's a Phase II study, checking effectiveness and safety.
Will monitor other outcomes like overall survival and remission.

Who may be eligible?

This study is looking for adult patients who have mantle cell lymphoma. If you are 18 years old or older, you might be able to take part. There is no upper age limit, meaning both younger adults and very elderly patients are considered.

Both men and women are welcome to participate. The study is specifically for those with a 'higher-risk' form of mantle cell lymphoma, which doctors will be able to determine based on medical tests. Your doctors will check if your specific health situation and cancer type match what the study is looking for.

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 a diagnosis of mantle cell lymphoma?
Has your doctor told you that your mantle cell lymphoma is considered 'higher-risk'?
Are you able to manage regular hospital visits for treatment 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 receive the new combination treatment, V-RBAC, which involves several different medications given over time. You will need to come to the hospital or clinic regularly for your treatments and to have check-ups. These check-ups will likely include blood tests, scans, and other medical assessments to see how you are responding to the treatment and to monitor for any side effects. Researchers will also take samples to check how the treatment affects your cancer at a molecular level. The study will follow your progress closely for at least two years to see how well the treatment works and how long its effects last. The exact number of visits and the full duration of your participation, including follow-up, will be clearly explained by the study team.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new and potentially more effective treatment for your mantle cell lymphoma, which might lead to better control of your cancer. However, as with any medical treatment, there are potential risks, including side effects from the medications. The research team will carefully monitor you for any side effects and manage them as best as possible. 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 mantle cell lymphoma?

It's a rare type of blood cancer that affects certain white blood cells called B-lymphocytes. It can be quite aggressive.

What does 'higher-risk' mean?

It means your doctor has identified specific features of your cancer that suggest it might be more challenging to treat with standard therapies.

What is a Phase II study?

It's an early stage of research to see if a new treatment works and is safe in a small group of people, before testing it more widely.

What is V-RBAC?

It's the name for the combination of different medicines being tested in this study: venetoclax, rituximab, bendamustine, and cytarabine.

Will I get this new treatment for free if I join?

Yes, all treatments and study-related care provided as part of the clinical trial are generally at no cost to you.