Open Label Study of Subcutaneous Homoharringtonine (Omacetaxine Mepesuccinate) in Patients With Advanced CML

This will be an open label, multicenter study of subcutaneous HHT (omacetaxine mepesuccinate)
therapy of patients with chronic myeloid leukemia (CML) in chronic, accelerated, or blast
phase who have failed or are intolerant to tyrosine kinase inhibitor therapy. Patients will
be treated with induction course cycles consisting of subcutaneous (SC) HHT 1.25 mg/m² twice
daily for 14 consecutive days every 28 days. Patients will be evaluated every 7 days with
complete blood and platelet counts while undergoing induction therapy; the number of
consecutive doses of HHT or intervals between subsequent cycles may be adjusted, as
clinically indicated, according to guidelines provided in the treatment plan.

Inclusion Criteria:

- Male or female patients, age 18 years or older

- Philadelphia chromosome (Ph) positive chronic myelogenous leukemia in either chronic,
accelerated, or blast phase

- Patients will have either failed, demonstrated intolerance, or a combination of prior
failure and intolerance, to prior treatments with at least two tyrosine kinase
inhibitors (TKI's). Failure of TKI treatment may either be primary (never achieved a
response) or secondary resistance (loss of response).

- Acceptable Renal and Liver Function

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

- Sexually active patients and their partners must use an effective double barrier
method of contraception

Exclusion Criteria:

- New York Heart Association classification (NYHA) class III or IV heart disease, active
ischemia or any other uncontrolled cardiac condition

- Myocardial infarction in the previous 12 weeks.

- Other concurrent illness which would preclude study conduct and assessment

- uncontrolled and active infection, and positive HIV or positive HTLV I/II status,
whether on treatment or not.

- Pregnant or lactating.

- Any medical or psychiatric condition, which may compromise the ability to give written
informed consent or to comply with the study protocol.

- Lymphoid Ph+ blast crisis

- Patient is enrolled in another clinical investigation within 30 days of enrollment or
is receiving another investigational agent