RecruitingPHASE3INTERVENTIONAL

A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphoma

This study is looking at new ways to treat two types of cancer called follicular lymphoma and marginal zone lymphoma. These are types of non-Hodgkin lymphoma that affect white blood cells. The study is for people whose lymphoma has either returned after initial treatment or hasn't responded well to previous therapies. Researchers want to see if a combination of drugs including zanubrutinib works better than a common existing treatment, a combination of lenalidomide and rituximab. For follicular lymphoma, zanubrutinib is combined with obinutuzumab. For marginal zone lymphoma, it's combined with rituximab. The main goal is to find out which treatment keeps the lymphoma from growing or spreading for the longest time.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

BeiGene

Enrolment target

780

Start

10 Mar 2022

Estimated completion

01 Jun 2030

Relapsed/Refractory Follicular Lymphoma Marginal Zone Lymphoma

What is this study about?

This study is for people in the UK who have been diagnosed with either follicular lymphoma or marginal zone lymphoma. These are both types of slow-growing cancer that start in white blood cells called lymphocytes. Doctors often call these 'relapsed/refractory' because the cancer has either come back after previous treatment or didn't respond adequately to earlier therapies. When this happens, doctors need to explore new treatment options, and clinical trials like this are a way to do that.

The main aim of this study is to compare two different treatment approaches. For people with follicular lymphoma, it compares a newer drug called zanubrutinib, given alongside another medicine called obinutuzumab, against a standard treatment which is a combination of two drugs, lenalidomide and rituximab. For those with marginal zone lymphoma, the study compares zanubrutinib plus rituximab against the same standard treatment of lenalidomide plus rituximab.

At the end of the study, doctors will look at how long each treatment keeps the lymphoma from growing or spreading. This is often called 'progression-free survival' and is a key way to determine which treatment combination is more effective. The results will help doctors understand better treatment options for these types of lymphoma in the future.

Key takeaways

This study is for specific types of lymphoma that have returned or not responded well to previous treatment.
It aims to compare a new drug combination with an existing standard treatment.
The main goal is to find which treatment keeps the cancer under control for longer.
Your health would be closely monitored with regular tests and scans.
Participation could offer access to new treatments and contribute to medical research.

Who may be eligible?

To join this study, you would typically need to have been diagnosed with either follicular lymphoma (grades 1-3a) or marginal zone lymphoma, and your lymphoma must have returned or not responded well to at least one previous course of treatment that included a specific type of anti-cancer drug (an anti-CD20 agent). Doctors would also need to see clear signs of the disease on scans, and your general health, specifically your blood counts, liver, and kidney function, would need to be suitable for taking part.

However, there are also reasons why you might not be able to join. For example, if your lymphoma has changed into a faster-growing type of cancer, you wouldn't be eligible. Also, if you need to take steroids regularly, have certain heart problems, or have had another cancer in the past two years, you might not be able to participate. If you have an active infection that needs treatment or have previously had lenalidomide without a good response or only for a very short time, you would also be excluded.

Quick self-check

Have I been diagnosed with follicular lymphoma (grades 1-3a) or marginal zone lymphoma?
Has my lymphoma come back or not responded well after at least one previous treatment?
Is my lymphoma visible on scans?
Do I have overall good health, including normal blood, liver, and kidney function?
Have I either not had previous lenalidomide treatment or had a good, lasting response to it?

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

What does participation involve?

Taking part in this study would involve regular hospital visits for check-ups and to receive your study medication. You would be assigned to one of the treatment groups (either zanubrutinib with another drug, or lenalidomide with rituximab). Your health would be carefully monitored throughout the study, including blood tests, scans (such as PET/CT scans), and physical exams to see how you are responding to the treatment and to check for any side effects. The exact number and frequency of visits, as well as the total duration of your participation, would be explained in detail by the study team.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as access to new and potentially more effective treatments before they become widely available. It also contributes to medical knowledge that can help future patients. However, there are also potential risks; the new treatments might have side effects that are not fully known, or they might not work for you. The study team will explain all known side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (277)

Ucsf Fresno University of California San Francisco Fresno
Fresno, United States· Active not recruiting
Kaiser Permanente Southern California
Irvine, United States· Completed
Cancer and Blood Specialty Clinic
Los Alamitos, United States· Active not recruiting
Los Angeles Cancer Network
Los Angeles, United States· Active not recruiting
Valkyrie Clinical Trials
Los Angeles, United States· Active not recruiting
UCLA Hematologyoncology
Los Angeles, United States· Completed
Scripps Health
San Diego, United States· Completed
Sharp Healthcare Sharp Memorial Hospital
San Diego, United States· Active not recruiting
Baptist Md Anderson Cancer Center
Jacksonville, United States· Completed
Ascension Sacred Heart
Pensacola, United States· Completed
Northwest Georgia Oncology Centers Marietta
Marietta, United States· Active not recruiting
Cancer Care Specialists of Illinois
Decatur, United States· Completed

+265 more sites — see the official record for the full list.

Common questions

What is 'relapsed/refractory' lymphoma?

It means your lymphoma has come back after treatment, or it didn't fully respond to previous treatments.

What are zanubrutinib, rituximab, lenalidomide, and obinutuzumab?

These are all different types of medicines used to treat lymphoma. The study is comparing combinations of them.

What does 'progression-free survival' mean?

It's the length of time you live with the disease without it getting worse or spreading.

Will I know which treatment I'm getting?

In some studies, participants are randomly assigned to a group, and you might not know which specific treatment you're receiving at first, though this will be explained beforehand.

Are there any costs involved for me?

Generally, study-related treatments and tests are provided free of charge, but you should discuss any potential costs like travel with the study team.

How to find out more

Study Director BeiGene

clinicaltrials@beigene.com 1-877-828-5568 Official trial record

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