Clinical Trial Goal
To find out if the combination of vemurafenib and obinutuzumab, compared to standard care, is safe and works well to treat HCL that has not yet been treated
You may be able to join this trial if you:
- Are 18 years old or older
- Have HCL and have had no treatment
- Have cancer cells with a BRAF mutation. 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
Cladribine is a chemotherapy (chemo) drug that blocks the 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.
Vemurafenib is a drug that blocks BRAF mutations on 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.
Vemurafenib is a drug that blocks BRAF mutations on 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 – Obinutuzumab and vemurafenib
- Group 2 – Cladribine and rituximab (standard care)
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:
- Cladribine – Group 2 only - Given as an intravenous (IV) infusion 1 time each day for 5 days
- Obinutuzumab – Group 1 only - Given as an IV infusion 1 or 3 times starting on the second month of treatment
- Rituximab - Group 2 only - Given as an IV infusion 1 time each day for 5 days
- Vemurafenib - Group 1 only - A pill that you take by mouth 2 times each day
You may continue treatment for up to 4 months. You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for 2 years.
The Food and Drug Administration (FDA) has approved all of the drugs used in this trial.
Locations
Sponsors
collaborator: Genentech, Inc., lead: Memorial Sloan Kettering Cancer Center
