Full Title
A Randomized, Multi-Center, Phase II Study of Vemurafenib plus Obinutuzumab vs. Cladribine plus Rituximab in Patients with Previously Untreated Hairy Cell Leukemia (HCL)Purpose
Researchers in this study are comparing two different treatments for hairy cell leukemia. The people in this study have hairy cell leukemia that has not yet been treated. In addition, their leukemia has a genetic mutation (change) called BRAF V600E.
The standard treatment for hairy cell leukemia is chemotherapy with cladribine plus rituximab. The study treatment is vemurafenib plus obinutuzumab. Vemurafenib and obinutuzumab (non-chemotherapy drugs) have been used to treat hairy cell leukemia. They may cause fewer side effects than the standard chemotherapy drugs, including a lower risk of infections and need for transfusions.
If you join this study, you will be randomly assigned to get one of these treatments:
- Vemurafenib (taken by mouth) plus obinutuzumab (given by vein)
- Cladribine plus rituximab (both given by vein)
Who Can Join
To join this study, there are a few conditions. You must:
- Have hairy cell leukemia that has not yet been treated and has a BRAF V600E gene mutation.
- Be able to walk and do routine activities for more than half the time you are awake.
- Be age 18 or older.
Contact
For more information or to see if you can join this study, please call Dr. Jae Park’s office at 646-608-3743.