Memorial Sloan Kettering Cancer Center
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.
Inclusion Criteria: * 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 * Patients who meet the standard treatment initiation criteria, as defined by ANC ≤1.0, Hgb ≤ 10.0 or PLT ≤100K * ECOG performance status of 0 - 2 * Acceptable pre-study organ function duri…
Vemurafenib orally twice daily (b.i.d.) continuously in cycles of 4 weeks (28 days) for a total of 4 cycles.
Obinutuzumab will be administered concomitantly with vemurafenib starting at cycle 2 of treatment in cycles of 4 weeks.
Cladribine IV on days 1-5 concurrently with rituximab.
Rituximab on days 1-5 concurrently with rituximab.