Clinical Trial Goal
To find out if the combination of sonrotoclax and zanubrutinib is safe and works well to treat MCL that has relapsed or is refractory
You may be able to join this trial if you:
- Are 18 years old or older
- Have MCL that has relapsed or is refractory
- Do not have lymphoma in your brain or spinal cord
- Have not been treated with a bcl2 inhibitor like venetoclax. Your doctor can tell you this
- Have not had an autologous (your own cells) blood or marrow transplant (BMT) or CAR T-cell therapy in the last 3 months
- Have not had an allogeneic (cells from a donor) BMT in the last 6 months
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Sonrotoclax and zanubrutinib are small molecule inhibitors that block BTK in certain cells.
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you and the clinical trial doctors won’t know which group you’re in until after the trial is finished:
In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you and the clinical trial doctors won’t know which group you’re in until after the trial is finished:
- Group 1 – Zanubrutinib plus sonrotoclax
- Group 2 – Zanubrutinib plus placebo
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:
- Sonrotoclax - Group 1 only - A pill that you take by mouth
- Zanubrutinib - A pill that you take by mouth
You may continue treatment for as long as the clinical trial doctors think it’s best for your health. You'll have scans to see how well the treatment is working. The clinical trial doctors will check your health for up to 5.5 years.
The Food and Drug Administration (FDA) has approved zanubrutinib for the treatment of relapsed or refractory MCL. The FDA has not yet approved sonrotoclax.
Locations
Sponsors
lead: BeiGene
