A Phase II study of the BRAF inhibitor, Vemurafenib (Zelboraf), in patients with relapsed or refractory hairy cell leukemia.
Be = 18 years of age.
Have histologically confirmed classical HCL with one of the following: intolerance to purine analogs, failure to achieve any response (CR or PR) to the initial purine analog-based therapy, relapse = 2 years of purine analog-based therapy, = 2 relapses.
Have histology confirmation of diagnosis will be performed at MSKCC or a participating site.
Meet the standard treatment initiation criteria, as defined by ANC =1.0, Hgb = 10.0 or PLT =100K
Have ECOG performance status of 0-2.
Have acceptable pre-study organ function during screening as defined as: total bilirubin = 1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5x ULN, and serum creatinine = 1.5x ULN.
Have an Electrocardiogram (ECG) without evidence of clinically significant ventricular arrhythmias or ischemia as determined by the investigator and a rate-corrected QT interval (QTc, Bazett's formula) of < 480 msec.
For women o
Be pregnant or breast-feeding.
Have had chemotherapy (including purine analogs, rituximab, and other investigational agents) within six weeks prior to entering the study.
Have had major surgery within 4 weeks prior to entering the study.
Have invasive malignancy within the past 2 years prior to first study drug administration, except for adequately treated (with curative intent) basal or squamous cell carcinoma, melanoma, in situ carcinoma of the cervix, in situ ductal adenocarcinoma of the breast, in situ prostate cancer, or limited stage bladder cancer or other cancers from which the patient has been disease-free for at least 2 years.
Have refractory nausea or vomiting, malabsorption, external biliary shunt, or history of any type of gastrointestinal surgery that would preclude adequate absorption of study drug.
Have prior treatment with MEK or BRAF inhibitors.
Have active HIV, hepatitis B and hepatitis C.
Be HCL variant (as defined by absence of expression of
The inclusion and exclusion criterias listed here are not all inclusive.