Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

An International, Phase 2, Open-Label, Randomized Study of BGB-3111 Combined With Obinutuzumab Compared With Obinutuzumab Monotherapy in Relapsed/ Refractory Follicular Lymphoma

This study is for adults whose follicular lymphoma has either come back after treatment or hasn't responded to previous treatments. It's testing a new drug called zanubrutinib, given together with another drug called obinutuzumab. Some participants will receive the combination, while others will receive only obinutuzumab. The main goal is to see if the new combination treatment is more effective in shrinking the lymphoma or stopping its growth. Researchers will carefully track how well people respond to treatment, how long the response lasts, and their overall health. This is a Phase 2 study, meaning it's still in the earlier stages of looking at how safe and effective the new treatment is.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Beigene Ltd.

Enrolment target

Start

04 Apr 2024

Relapsed/Refractory Follicular Lymphoma

What is this study about?

This study is for people who have follicular lymphoma which has either returned after previous treatment or hasn't gotten better with treatment. This is sometimes called 'relapsed' or 'refractory' lymphoma.

The study aims to find out if a new combination of medicines is more effective than one of the medicines given alone. The new medicine being tested is called zanubrutinib. It will be given alongside a standard medicine called obinutuzumab. Some people in the study will receive both zanubrutinib and obinutuzumab, while others will just receive obinutuzumab.

The main thing the researchers want to find out is how many people respond to the treatments and how much their lymphoma shrinks or improves. They will also look at how long any improvements last, how long people live without their lymphoma getting worse, and how the treatments affect people's quality of life. Safety is also very important, so they will carefully monitor for any side effects.

Key takeaways

This study is for adults with follicular lymphoma that has returned or not responded to treatment.
It compares a new drug combination (zanubrutinib + obinutuzumab) with obinutuzumab alone.
The main goal is to see if the new combination is more effective at treating the lymphoma.
Participation involves regular hospital visits, tests, and taking study medication.
All potential benefits and risks will be thoroughly explained by the study team.
You have the right to withdraw from the study at any time.

Who may be eligible?

This study is open to adults aged 18 and over, both men and women. You must have follicular lymphoma that has either come back after previous treatment, or hasn't responded to previous treatments.

The research team will have other specific health requirements to make sure the study is safe for you and that the results are clear. For example, they might check your overall health, other medical conditions, and any other medications you are taking.

Only the study doctors can confirm if you are suitable to join. It's important to discuss all your health details with them.

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 follicular lymphoma?
Has your lymphoma come back after treatment, or not responded to previous treatments?
Are you able to attend regular hospital appointments?
Are you willing to potentially receive either the new drug combination or standard treatment?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to receive either the combination of zanubrutinib and obinutuzumab, or obinutuzumab on its own. Random assignment means it's like flipping a coin – you won't get to choose which group you're in. You'll have regular hospital visits for check-ups, blood tests, physical examinations, and scans to monitor your lymphoma and any side effects. You'll also fill out questionnaires about your quality of life. The medication will be given as prescribed by the study team, and they will explain how to take it. The total duration of your participation will depend on how you respond to the treatment and the study plan, but it will involve ongoing assessments and follow-up.

Potential risks and benefits

There's a chance that the new treatment combination might work better for your lymphoma than standard care, but there's no guarantee. Like all medicines, the study treatments can have side effects, which the research team will explain to you and monitor closely. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (5)

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

—
Unverified
France
—
Unverified
Czechia
—
Unverified
Italy
—
Unverified
Spain
—
Unverified
Poland

Common questions

What is follicular lymphoma?

It's a type of slow-growing blood cancer that affects certain white blood cells called lymphocytes.

What does 'relapsed/refractory' mean?

It means the lymphoma has either come back after treatment or didn't get better with previous treatments.

What is a Phase 2 study?

It's an early stage of research to see if a new treatment is safe and effective in a larger group of people, after being tested in a small group.

Will I know which treatment I'm getting?

Yes, this is an 'open-label' study, meaning you and the study team will know which treatment you are receiving.

What are 'endpoints' in a study?

These are the main things researchers measure to see if a treatment is working, such as how much the lymphoma shrinks or how long people respond to treatment.