Phase II Study of Vemurafenib and Obinutuzumab for Untreated Classical Hairy Cell Leukemia

Inclusion Criteria

• Must be 18 years or older.
• Have a confirmed diagnosis of classical hairy cell leukemia (HCL).
• Have not received any previous treatment for HCL.
• Meet specific blood count criteria, such as low white blood cells, hemoglobin, or platelets.
• Be in good overall health with an ECOG performance status of 0 to 2.
• Have acceptable organ function based on specific blood tests.
• Have a normal heart rhythm and function as shown by an ECG.
• Women of childbearing potential must agree to use two forms of birth control during the study and for 6 months after.
• Men must agree to use a condom and ensure their female partners use an additional form of birth control during the study and for 6 months after.
• Women of childbearing potential must have a negative pregnancy test before starting treatment.

Exclusion Criteria

• Have received previous treatment for HCL, except for supportive care like transfusions.
• Have allergies to any of the study drugs.
• Have a significant history of liver disease or current alcohol abuse.
• Have uncorrectable electrolyte imbalances.
• Have active and uncontrolled infections.
• Test positive for hepatitis B or C, unless specific conditions are met.
• Have an HIV or HTLV-1 infection.
• Have another invasive cancer requiring treatment that could interfere with the study drugs.
• Have a condition that prevents taking medication by mouth.
• Have a variant of HCL that lacks a specific marker (CD25).
• Are pregnant, breastfeeding, or planning to become pregnant during the study.