Active not recruitingPHASE3INTERVENTIONAL

Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Participants With B-cell Malignancies

This research study is checking the long-term safety of a medicine called zanubrutinib. It's for people who have been diagnosed with a type of blood cancer called B-cell malignancy. To join this study, participants must have already taken zanubrutinib as part of an earlier research study run by BeiGene, the company making the drug. The main goal is to see how safe zanubrutinib remains when taken over a longer period. This helps doctors understand more about its effects and how well it's tolerated by patients when used for an extended time. It's part of ensuring that treatments are not only effective but also safe for patients in the long run.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

BeiGene

Enrolment target

955

Start

16 Jan 2020

Estimated completion

01 Dec 2028

B-cell Malignancies

What is this study about?

This study is called a 'long-term extension' study. Think of it as a continuation for people who have already been taking a specific medicine, zanubrutinib, as part of an earlier research project. Zanubrutinib is a drug designed to treat certain types of blood cancers, specifically those affecting a kind of white blood cell called B-cells.

The main purpose of this particular study is to keep a close eye on the safety of zanubrutinib when taken over a longer period. Doctors want to understand if there are any side effects that might appear or become more noticeable over time, even after people have finished the initial study. It's really important to gather this information so that healthcare professionals have a complete picture of the drug's long-term safety profile.

This study looks at general safety using different ways the drug might be given. It's an important step in making sure that new treatments for B-cell malignancies are not only effective but also safe and well-understood for long-term use. The information gathered will help doctors make the best treatment decisions for future patients.

Key takeaways

This study focuses on the long-term safety of the cancer drug zanubrutinib.
It's for adults with B-cell malignancies who previously took zanubrutinib in another study.
The goal is to understand how safe the drug is over an extended period.
Participation involves ongoing treatment with zanubrutinib and regular health check-ups.
You can stop participating at any time if you wish.

Who may be eligible?

This study is for adults, aged 18 and older, who have a type of blood cancer called B-cell malignancy. The key requirement is that you must have previously taken part in another study (called a 'parent study') where you received zanubrutinib, made by the company BeiGene.

You might be able to join if you're still on zanubrutinib from that parent study and are doing well on it, or if you were in the parent study but now need to restart or continue zanubrutinib. Even if your cancer has shown signs of progressing, you might still be considered if your doctor, you, and the study team all agree that continuing zanubrutinib is the best option for you.

However, you can't join if you had to stop zanubrutinib in the earlier study because of serious side effects, or if you didn't follow the study rules. You also can't join if you have a severe, uncontrolled infection or another serious health problem that the doctors think could make it unsafe for you to participate or affect the study results. If you haven't taken zanubrutinib before, there are some health checks you'd need to pass, like having healthy blood counts and good kidney and liver function.

Quick self-check

Are you 18 years old or older?
Do you have a type of blood cancer called B-cell malignancy?
Have you previously taken zanubrutinib as part of another BeiGene research study?
Are you currently feeling well enough to continue or restart treatment, as agreed with your doctor?
Do you have generally healthy organ function (like kidneys, liver, and blood counts)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will continue to receive zanubrutinib. The study team will regularly check in with you to monitor your health and how you're feeling. This will involve scheduled visits to the clinic, where you might have blood tests, physical examinations, and answer questions about any side effects or changes in your health. The medical team will be checking various aspects of your health, such as blood counts, liver and kidney function, and heart health.

The exact number and timing of visits will be explained by the study team, but they are designed to safely keep track of your well-being while you take zanubrutinib long-term. You'll receive the study medication (zanubrutinib) for the duration of your participation, as long as it continues to be beneficial for you and you're not experiencing unacceptable side effects. After you stop taking the study medication, there might be some final follow-up appointments to ensure your health is stable. The overall duration of your participation can vary, as the main goal is to follow participants long-term.

Potential risks and benefits

By taking part in this study, you might continue to benefit from zanubrutinib treatment for your B-cell malignancy, potentially keeping your condition stable or improving. The main aim is to gather more information about the long-term safety of zanubrutinib, which could help future patients. However, like all medicines, zanubrutinib can have side effects, which could include some that are not yet fully known or may become more noticeable with long-term use. The study team will monitor you closely for any side effects and will explain all known risks. You are always free to stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (152)

Banner Md Anderson Cancer Center
Gilbert, United States
Carti Cancer Center
Little Rock, United States
Rocky Mountain Cancer Centers Centennial
Centennial, United States
Colorado Blood Cancer Institute
Denver, United States
Florida Cancer Specialists Fort Myers
Fort Myers, United States
Scri Florida Cancer Specialists North
St. Petersburg, United States
Dana Farber Cancer Institute
Boston, United States
University of Michigan Health System
Ann Arbor, United States
Mayo Clinic Rochester
Rochester, United States
Forrest General Hospital Cancer Center
Hattiesburg, United States
University of Nebraska Medical Center
Omaha, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, United States

+140 more sites — see the official record for the full list.

Common questions

What is zanubrutinib?

Zanubrutinib is a medicine used to treat certain types of blood cancer, specifically B-cell malignancies.

Why is this study needed?

This study helps doctors understand the long-term safety of zanubrutinib, especially for people who have been taking it for a while.

Can I join if I've never taken zanubrutinib?

Generally no, this study is mainly for people who have already received zanubrutinib in a previous research study.

What kind of tests will I have?

You'll likely have blood tests, physical exams, and discussions about your health to monitor how you're doing on the medication.

What if I experience side effects?

The study team will closely monitor you for any side effects, and you should tell them immediately if you feel unwell.