Study Comparing Vemurafenib and Obinutuzumab with Cladribine and Rituximab for Hairy Cell Leukemia

Inclusion Criteria

• Must be 18 years or older.
• Have a confirmed diagnosis of classical Hairy Cell Leukemia (HCL).
• Have a specific genetic mutation called BRAF V600E.
• Have not received any previous treatment for HCL.
• Meet certain health criteria, such as low blood cell counts.
• Be in good general 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 based on an ECG test.
• Women of childbearing potential must agree to use two forms of birth control during the study and for a period after treatment ends.
• Men must agree to use a condom and ensure their female partners use an additional form of birth control during the study and for a period after treatment ends.
• Women of childbearing potential must have a negative pregnancy test before starting treatment.

Exclusion Criteria

• Have had previous treatment for HCL, except for supportive care like blood transfusions.
• Have allergies to any of the study drugs.
• Have a history of heart rhythm problems or uncorrectable electrolyte imbalances.
• Have significant liver disease or current alcohol abuse.
• Test positive for hepatitis B or C, unless certain conditions are met.
• Have an HIV or HTLV-1 infection.
• Have an active, uncontrolled infection.
• Have received a live vaccine within 28 days before starting the study.
• Have another active cancer, except for certain skin cancers or early-stage cancers that have been treated and are in remission.
• Have a condition that affects the absorption of oral medications.
• Have a variant of HCL that lacks a specific marker (CD25).
• Are pregnant, breastfeeding, or planning to become pregnant during the study.