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Active not recruitingPHASE3INTERVENTIONAL

A Study to Investigate the Efficacy of Zanubrutinib Plus Rituximab Compared With Bendamustine Plus Rituximab in Adults With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation

This study is for adults with a type of cancer called Mantle Cell Lymphoma. It specifically focuses on people who haven't had treatment for their lymphoma before and aren't able to have a stem cell transplant. Researchers want to compare two different ways of treating the lymphoma: a drug called zanubrutinib combined with rituximab, versus a combination of bendamustine and rituximab. The main goal is to find out which of these treatment combinations works best to control the lymphoma and which has fewer side effects. This kind of research helps doctors find better ways to treat cancer patients in the future.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
BeOne Medicines
Enrolment target
510
Start
20 Aug 2019
Estimated completion
30 Sep 2031

What is this study about?

Mantle Cell Lymphoma is a type of cancer that starts in white blood cells called lymphocytes. Most people with MCL are older, and the disease can be challenging to treat. For some patients, a stem cell transplant can be an effective treatment, but it's not suitable for everyone, especially older adults or those with other health problems. This study is designed specifically for people with previously untreated MCL who are not eligible for a stem cell transplant. The researchers want to find out which treatment combination, out of two options, is more effective and safer for these patients.

The study compares two different drug combinations. One combination uses a newer drug called zanubrutinib with rituximab. Rituximab is a common treatment for lymphoma. The other combination uses bendamustine, another chemotherapy drug, along with rituximab. Both combinations aim to shrink the cancer and stop it from growing.

By comparing these two treatments, doctors hope to learn which approach offers the best outcomes for patients with MCL who cannot have a stem cell transplant. This research is important because it could lead to new or improved standard treatments that help people live longer and have a better quality of life.

Key takeaways

  • This study is for adults with previously untreated Mantle Cell Lymphoma.
  • It's for people who are not suitable for a stem cell transplant.
  • It compares two different drug combinations: zanubrutinib plus rituximab vs. bendamustine plus rituximab.
  • The goal is to find out which treatment works best and is safest.
  • Participation involves regular clinic visits, tests, and taking study medication.
  • You can withdraw from the study at any time.

Who may be eligible?

This study is looking for adults aged 60 or older who have Mantle Cell Lymphoma that hasn't been treated before. If you're aged 60 to under 70, you'd only be considered if you have other health issues that prevent you from having a stem cell transplant. You also need to have lymphoma that can be measured, for example, on a scan, and you should generally feel well enough to participate.

There are also some reasons why you might not be able to join the study. For instance, if your lymphoma has spread to your brain or spinal cord, or if you have severe heart problems or a significant bleeding disorder. You also can't be in the study if you have active infections or if you need certain medications that could interfere with the study drugs. The treatment goal must also be to treat your lymphoma as a main therapy, not just to reduce it before a stem cell transplant.

The research team will review your full medical history to confirm if this study is suitable for you. This ensures your safety and that the study is right 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.

  1. Are you 60 years old or older with Mantle Cell Lymphoma?
  2. Have you *not* had any treatment for your Mantle Cell Lymphoma before?
  3. Has your doctor told you that you are not suitable for a stem cell transplant?
  4. Do you generally feel well enough and have no major heart problems or active infections?
  5. Can you swallow capsules and tablets without difficulty?
Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be randomly assigned to one of two treatment groups, like flipping a coin. This means neither you nor your doctor can choose which drug combination you receive. You will receive either zanubrutinib plus rituximab or bendamustine plus rituximab. The treatments will involve taking medication, likely in cycles, with regular visits to the clinic for check-ups, blood tests, and scans to see how you're responding to the treatment and to monitor for any side effects. You will be closely monitored throughout the study. The total duration of your participation, including regular follow-up after your main treatment, will be explained by the study team.

Potential risks and benefits

Taking part in this study could potentially offer you access to new treatments for your Mantle Cell Lymphoma. Both treatment combinations aim to improve your health. However, like all medications, they can cause side effects. These could range from mild to more serious, and the study team will monitor you closely for any issues. There's no guarantee that the treatment will work for you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (176)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Chao Family Comprehensive Cancer Center
    Verified postcode
    Orange, United States
  • Rush University Medical Center
    Verified postcode
    Chicago, United States
  • Beth Israel Deaconess Medical Center (Bidmc)
    Verified postcode
    Boston, United States
  • University of Michigan Health System
    Verified postcode
    Ann Arbor, United States
  • Comprehensive Cancer Centers of Nevada
    Verified postcode
    Las Vegas, United States
  • Icahn School of Medicine At Mount Sinai
    Verified postcode
    New York, United States
  • Clinical Research Alliance, Inc
    Verified postcode
    Westbury, United States
  • Providence Portland Medical Center
    Verified postcode
    Portland, United States
  • West Penn Hospital
    Verified postcode
    Pittsburgh, United States
  • The University of Texas Md Anderson Cancer Center
    Verified postcode
    Houston, United States
  • Joe Arrington Cancer Research and Treatment Center
    Verified postcode
    Lubbock, United States
  • Seattle Cancer Care Alliance
    Verified postcode
    Seattle, United States

Common questions

What is Mantle Cell Lymphoma?

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

What does 'untreated' mean in this study?

It means you haven't received any previous treatment specifically for your Mantle Cell Lymphoma.

What is a 'stem cell transplant'?

It's an intensive treatment for some cancers that involves replacing damaged blood cells with healthy ones. This study is for people who can't have this procedure.

Will I know which treatment I'm getting?

No, you will be randomly assigned to one of the two treatment groups, so you won't know which combination you are receiving at first.

What if I change my mind about participating?

You can leave the study at any time, for any reason, without it affecting your future medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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