Eltrombopag for the Management of Thrombocytopenia Associated With Tyrosine Kinase Therapy in Patients With Chronic Myeloid Leukemia (CML) and Myelofibrosis (MF)

Inclusion Criteria:

1. CML patients in chronic phase receiving treatment with any 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
2. Grade >/= 3 thrombocytopenia (platelets < 50 x 10^9/L) after the first 3 months of
therapy with the TKI for patients with CML and platelets <100 x 10^9/L for patients
with MF after the first 3 months of therapy. Thrombocytopenia must be either recurrent
(i.e., second or greater episode of thrombocytopenia) or having required dose
reductions of the TKI.

3. Subject is anticipated to have therapy with TKI continued for >/= 3 months

4. Adequate organ function: Total bilirubin (except for Gilbert's Syndrome) ULN; ALT and AST < 3 x ULN; Creatinine
Exclusion Criteria:

1. CML patients in accelerated or blastic phase except for those 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 myelofibrosis patients who have
transformed to acute leukemia or have >/= 10% blasts in peripheral blood and/or in
bone marrow.

2. Thrombocytopenia that is considered to be unrelated to treatment with TKI or
accelerated phase as defined above;

3. Age < 18 years;

4. Stem cell transplantation within preceding 60 days prior to registration;

5. Patients with documented active hepatitis B or C infection;

6. Patients with known bone marrow reticulin fibrosis (>/= grade 2) (only applicable to
patients with CML);

7. Patients with palpable splenomegaly >/= 16cm below coastal margin (only applicable to
patients with CML).

8. Female subjects who are pregnant or breastfeeding. Women of childbearing potential are
required to have a 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: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) 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.

9. Patients with known risk factors for thromboembolism (e.g. Factor V Leiden mutation,
ATIII deficiency, Protein C and S deficiency, antiphospholipid syndrome, portal
hypertension, etc.)