Clinical Trial Goal
To find out if the combination of sonrotoclax and obinutuzumab or sonrotoclax and rituximab is safe and works well to treat CLL or SLL that has relapsed or is refractory
You may be able to join this trial if you:
- Are 18 years old or older
- Have CLL or SLL that has relapsed or is refractory
- Do not have any of the following:
- Acute prolymphocytic leukemia
- Richter's transformation
- Do not have lymphoma in your brain or spinal cord
- Have not had autologous (your own cells) blood or marrow transplant (BMT) in the last 3 months
- Have not had CAR T-cell therapy in the last 3 months
- Do not have graft-versus-host-disease (GVHD)
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Obinutuzumab is a monoclonal antibody that targets CD20 on certain cells.
Rituximab is a monoclonal antibody that targets CD20 on certain cells.
Sonrotoclax is a small molecule inhibitor that blocks BTK in certain cells.
Venetoclax is a small molecule inhibitor that blocks BCL2 in certain cells.
In this trial, you’ll be randomized to 1 of 3 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:
Rituximab is a monoclonal antibody that targets CD20 on certain cells.
Sonrotoclax is a small molecule inhibitor that blocks BTK in certain cells.
Venetoclax is a small molecule inhibitor that blocks BCL2 in certain cells.
In this trial, you’ll be randomized to 1 of 3 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 –Obinutuzumab plus sonrotoclax
- Group 2 – Rituximab plus sonrotoclax
- Group 3 - Rituximab plus venetoclax
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:
- Obinutuzumab - Group 1 only - Given as intravenous (IV) infusions. The dose you'll get depends on when you start the trial and how safe it has been
- Rituximab - Group 2 & 3 only - Given as IV infusions. The dose you'll get depends on when you start the trial and how safe it has been
- Sonrotoclax - Group 1 & 2 only - A pill that you take by mouth. The dose you'll get depends on when you start the trial and how safe it has been
- Venetoclax - Group 3 only - A pill that you take by mouth. The dose you'll get depends on when you start the trial and how safe it has been
You may continue treatment for as long as the clinical trial doctors think it’s best for your health. You'll have biopsies and/or scans to see how well the treatment is working. The clinical trial doctors will check your health for up to 7 years.
The Food and Drug Administration (FDA) has not yet approved sonrotoclax.
Locations
Sponsors
collaborator: German CLL Study Group, lead: BeOne Medicines
