The researchers are doing this study to compare the safety of vemurafenib in combination with obinutuzumab to the standard of approach of cladribine in combination with rituximab. The researchers will look at which treatment causes fewer or milder side effects. Researchers think vemurafenib and obinutuzumab (non-chemotherapy drugs) may cause fewer side effects compared with the usual approach of chemotherapy drugs. They will also compare the two approaches to see which approach is more effective at eliminating cancer cells.
Patients must be ≥ 18 years of age
Histologically confirmed classical HCL by the enrolling institution
Presence of BRAF V600E mutation as confirmed by PCR, NGS or immunohistochemistry. If patient is known to have negative BRAF mutation, repeat testing is advisable as well as discussion with the main study principal investigator.
Has not received any prior therapy for the disease
Have had previous treatment for HCL, including purine analogs, vemurafenib, rituximab, obinutuzumab, and other investigational agents. Previous treatment with transfusions and other supportive care such as G-CSF and erythropoietin are allowed.
Known hypersensitivity to any of the study drugs.
Patients with known long QT syndrome or uncorrectable electrolyte abnormalities
Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis.
Memorial Sloan Kettering Cancer Center
Lead sponsor
Genentech, Inc.
Collaborator