Phase II Eltrombopag in Chronic Lymphocytic Leukemia (CLL)

Inclusion Criteria

• Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
• Age >/= 18 years
• PLT transfusion-dependent, defined as need for transfusion to maintain PLT count >/=20K/µL, or the average of two (non-transfused) PLT counts taken within 2 weeks of the screening period 55K/µL
• Patients with ITP must have failed at least 1 prior treatment for ITP including one of the following: corticosteroids, rituximab, splenectomy, cyclosporine
• At least 3 weeks must have elapsed since the last chemotherapy treatment for CLL
• ECOG performance status (PS) </=2
• Adequate liver function (total bilirubin </=2* upper limit normal (ULN); ALT </=2.5* ULN)
• Adequate renal function (serum creatinine Cr </=2.2 mg/dL)
• For patients with ITP on corticosteroids or cyclosporine, dose of corticosteroids or cyclosporine must be stable for 2 weeks prior to enrollment and planned to be tapered in patients responding to eltrombopag
• Able to provide informed consent

Exclusion Criteria

• Concurrent chemotherapy for CLL
• Diagnosis of Richter's transformation
• Uncontrolled autoimmune hemolytic anemia i.e. patients with AIHA that is not controlled with treatment such as corticosteroids or cyclosporine. This would include patients who require PBRC transfusions or who do not have a stable hemoglobin (HGB) due to ongoing hemolysis.
• Concurrent treatment for ITP (except for corticosteroids and cyclosporine)
• Diagnosis of myelodysplastic syndrome or acute myeloid leukemia
• Active infection or significant medical illness as determined by the treating physician
• Treatment with thrombomimetic agents in the past 3 months (rTPO, PEG-rHuMGDF, Nplate or Promacta)
• Pregnant or breast feeding subjects and subjects not willing to use adequate contraceptive precautions