Clinical Trial Goal
To find out if zanubrutinib or lenalidomide, in combination with rituximab, is safe and works well to treat marginal zone lymphoma (MZL) that has relapsed or is refractory
You may be able to join this trial if you:
- Are 18 years old or older
- Have MZL that has relapsed or is refractory
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Lenalidomide is a drug that blocks growth of cancer cells.
Obinutuzumab is a monoclonal antibody that targets CD20 on certain cells.
Rituximab is a monoclonal antibody that targets CD20 on certain cells.
Zanubrutinib is a small molecule inhibitor that blocks BTK in certain cells.
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you’ll be told what group you’re in:
Obinutuzumab is a monoclonal antibody that targets CD20 on certain cells.
Rituximab is a monoclonal antibody that targets CD20 on certain cells.
Zanubrutinib is a small molecule inhibitor that blocks BTK in certain cells.
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you’ll be told what group you’re in:
- Group 1 – Lenalidomide plus rituximab
- Group 2 – Zanubrutinib plus rituximab
- Group 3 - Zanubrutinib plus obinutuzumab
Randomized means doctors will use a computer to assign you to either group. A computer assigns you by chance, like flipping a coin or drawing a name out of a hat. You, your doctor or the clinical trial doctor won’t have any control over which group you’ll be assigned. This means you won’t be able to choose your group.
You’ll get treatment in cycles that last 1 month. In each cycle, you'll get:
- Lenalidomide – Group 1 only - A pill that you take by mouth 1 time each day for 3 weeks
- Obinutuzumab - Group 3 only - Given as intravenous (IV) infusions up to 3 times
- Rituximab - Given as IV infusions 1 to 4 times
- Zanubrutinib - Group 2 and 3 only - Two pills that you take by mouth 1-2 times each day
You may continue treatment for up to 1 year. You'll have scans to see how well the treatment is working. The clinical trial doctors will check your health for about 7 years.
The Food and Drug Administration (FDA) has approved all of the drugs used in this trial. Using them in this way to treat MCL is new and unproven.
Locations
Sponsors
lead: BeiGene
