Eltrombopag Olamine in Treating Thrombocytopenia in Patients With Chronic Myeloid Leukemia or Myelofibrosis Receiving Tyrosine Kinase Therapy

Inclusion Criteria

• CML patients in chronic phase receiving treatment with any Food and Drug Administration (FDA) approved TKI; or CML patients in accelerated or blastic phase who are considered to be in this phase because of thrombocytopenia or because of clonal evolution and with no other criteria for accelerated/blastic phase or patients with myelofibrosis receiving treatment with FDA approved TKI and with peripheral blood and/or bone marrow blasts = = 3 thrombocytopenia (platelets = 3 months
• Total bilirubin = = 10% blasts in peripheral blood and/or in bone marrow
• Thrombocytopenia that is considered to be unrelated to treatment with TKI or accelerated phase as defined above
• Stem cell transplantation within preceding 60 days prior to registration
• Patients with documented active hepatitis B or C infection
• Patients with known bone marrow reticulin fibrosis (>= grade 2) (only applicable to patients with CML)
• Patients with palpable splenomegaly >= 16 cm below coastal margin (only applicable to patients with CML)
• Female subjects who are pregnant or breastfeeding
• Women of childbearing potential are required to have a beta human chorionic gonadotropin (BHCG) serum or urine pregnancy test performed within 7 days prior to first study drug dose; a female of childbearing potential is a sexually mature woman who:
• Has not undergone a hysterectomy or bilateral oophorectomy
• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
• Women of child-bearing potential and men must agree to use contraception prior to study entry and for the duration of study participation
• Patients with known risk factors for thromboembolism (e.g. Factor V Leiden mutation, antithrombin III (ATIII) deficiency, Protein C and S deficiency, antiphospholipid syndrome, portal hypertension, etc.)