Clinical Trial Goal
To find out:
- The highest dose of roginolisib that's safe to give with rituximab and venetoclax
- If the combination of rituximab, roginolisib and venetoclax is safe and works well to treat CLL that has relapsed or is refractory
You may be able to join this trial if you:
- Are 18 years old or older
- Have CLL that has relapsed or is refractory
- Have not been treated with venetoclax or a drug that targets P13K in the last 6 months. Your doctor can tell you this
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Rituximab is a monoclonal antibody that targets CD20 on certain cells.
Roginolisib is a small molecule inhibitor that blocks PI3-kinase delta 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 2 groups. Once you’re randomized, you’ll be told what group you’re in:
Roginolisib is a small molecule inhibitor that blocks PI3-kinase delta 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 2 groups. Once you’re randomized, you’ll be told what group you’re in:
- Group 1 – Rituximab plus roginolisib plus venetoclax
- Group 2 – 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 treatment in cycles that last 1 month. In each cycle, you'll get:
- Rituximab – Given as intravenous (IV) infusions. The dose you'll get depends on when you start the trial and how safe it has been
- Roginolisib – Group 1 only - A pill that you take by mouth 1 time each day
- Venetoclax – A pill that you take by mouth 1 time each day
You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for up to 5 years.
The Food and Drug Administration (FDA) has not yet approved roginolisib.
Locations
Dana-Farber Cancer InstituteRECRUITING
Boston, Massachusetts
Jennifer Brown, MD, PhD, 617-632-5847, Jennifer_brown@dfci.harvard.edu
Sponsors
collaborator: United States Department of Defense, lead: Jennifer R. Brown, MD, PhD
