Active not recruitingPHASE3INTERVENTIONAL

A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL

This research study is investigating a new treatment approach for mantle cell lymphoma (MCL), a type of blood cancer, in people who haven't received treatment for it before. We're comparing two groups: one group will receive a new medicine called acalabrutinib in combination with the usual treatment (which is a mix of bendamustine and rituximab, often called BR). The other group will get the usual treatment (BR) along with a dummy drug, or placebo. The main goal is to find out if adding acalabrutinib to BR helps people live longer without their cancer getting worse, compared to just having BR and a placebo. This will help doctors understand if this new combination could be a better way to treat MCL.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Acerta Pharma BV

Enrolment target

635

Start

05 Apr 2017

Estimated completion

15 Feb 2027

Lymphoma, Mantle Cell

What is this study about?

This study is all about finding new ways to treat a type of cancer called mantle cell lymphoma (MCL). MCL is a cancer that affects white blood cells, and it's important to find the best possible treatments. If you've been diagnosed with MCL and haven't had any treatment for it yet, this study might be for you. We're especially interested in how a new medicine, acalabrutinib, might improve treatment.

Currently, a common treatment for MCL is a combination of two medicines called bendamustine and rituximab, often short-formed to BR. In this study, we want to see if adding acalabrutinib to this standard BR treatment makes it more effective. To do this, we'll compare two groups of people. One group will receive acalabrutinib along with BR. The other group will receive BR combined with a 'placebo', which looks like acalabrutinib but doesn't contain any active medicine. This comparison helps us understand if any benefits come from acalabrutinib itself.

The main thing we'll be looking at is whether people receiving the acalabrutinib combination live longer without their cancer getting worse. An independent group of experts will check scans and medical records to make this decision. By doing this research, we hope to discover if acalabrutinib could be a valuable addition to MCL treatment, potentially offering a better future for patients.

Key takeaways

This study evaluates a new treatment for previously untreated mantle cell lymphoma.
It compares acalabrutinib plus standard treatment (BR) to standard treatment plus a dummy medicine.
The main goal is to see if the new combination helps people live longer without their cancer worsening.
Only people aged 65 or older with specific MCL diagnoses can join.
Participation involves regular visits, tests, and taking study medicines, over several years.
You have the right to leave the study at any time.

Who may be eligible?

This study is looking for both men and women who are 65 years old or older. You would need to have a confirmed diagnosis of mantle cell lymphoma that hasn't been treated with any cancer medicines before, and your doctors would need to agree that treatment for your MCL is needed at this time. We'd also ask to see specific test results that confirm your type of lymphoma.

There are certain health conditions that might mean this study isn't right for you. For example, if you have severe heart problems, a condition that makes it hard for your body to absorb medicines properly, or an untreated infection, you might not be able to join. You also can't be taking part in another medical research study at the same time. If you use contraception, you'll need to agree to continue using highly effective methods during the study and for a certain time afterwards.

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 65 years old or older?
Have you been diagnosed with mantle cell lymphoma?
Have you never received any treatment for your mantle cell lymphoma before?
Do you have a general good health status for your age?
Are you willing and able to use effective contraception if needed?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be assigned to one of two treatment groups: either acalabrutinib plus bendamustine and rituximab, or a placebo (dummy medicine) plus bendamustine and rituximab. You won't know which group you're in, and neither will your doctor, which helps us get fair results. You will take the study medicine (acalabrutinib or placebo) by mouth, and receive bendamustine and rituximab as an infusion (into a vein).

Throughout the study, you'll have regular visits to the hospital for check-ups, blood tests, and scans (like CT scans) to see how you're responding to treatment and to monitor your general health. Your doctor will also ask about any side effects you might be experiencing. These visits will be more frequent at the beginning of the study and may become less so over time. The total length of your participation, including follow-up after your main treatment, could be quite long, potentially several years, to fully understand the long-term effects of the treatments.

Potential risks and benefits

Taking part in a clinical trial might offer potential benefits, such as receiving a new investigational treatment that could be more effective than existing options, and you'll receive very close medical monitoring throughout the study. However, there are also potential risks; you might experience side effects from the study drugs, or the new treatment might not work for you. The treatment you receive could also be the placebo. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (228)

Research Site
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Tucson, United States
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Downey, United States
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Santa Monica, United States
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New Haven, United States
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Washington D.C., United States
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Tallahassee, United States
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West Palm Beach, United States
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Marietta, United States
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Westwood, United States
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Louisville, United States
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Ann Arbor, United States
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Rochester, United States

Common questions

What is mantle cell lymphoma (MCL)?

It's a type of cancer that affects a specific kind of white blood cell, which are part of your immune system.

What is acalabrutinib?

Acalabrutinib is a newer medicine that targets specific signals within cancer cells to stop them from growing.

What is a placebo?

A placebo is a 'dummy' medicine that looks like the real drug but contains no active ingredients. It helps us compare the effects of the active treatment fairly.

Will I know which treatment I'm getting?

Neither you nor your study doctor will know if you're receiving acalabrutinib or the placebo. This is called 'blinding' and ensures the study results are unbiased.

How long will I be in the study?

The study involves initial treatment and then follow-up for a period that could be several years, to monitor your health and the long-term effects of the treatment.