Phase 1 Study of CPX-351(Cytarabine:Daunorubicin) Liposome Injection in Patients With Advanced Hematologic Malignancies.

Inclusion Criteria:

- Ability to understand and voluntarily sign an informed consent form

- Age > 18 years at the time of signing the informed consent form

- Pathological confirmation of leukemia or myelodysplastic syndrome.

- AML according to WHO criteria; except for core-binding factor AMLs (t(8;21), inv(16)
or t(16;16)) and APL

- ALL

- MDS

- Patients with AML include the following:

- Patients in 2nd or greater relapse

- Patients in first relapse with initial CR duration lasting <6 months

- Patients in first relapse refractory to induction therapy

- Patients with primary refractory AML

- Patients with ALL include the following

- Patients with T-cell ALL refractory or in relapse following nelarabine

- Patients with other ALL that is refractory or in relapse.

- Patients with MDS include the following:

- The subset of RAEB-2 patients with >10% blasts with at least 1 prior therapy that
includes a hypomethylating agent.

- Previously untreated chemotherapy induced AML

- Eastern Cooperative Oncology Group (ECOG) performance status score of 0,1 or 2

- Able to adhere to the study visit schedule and other protocol requirements

- Life expectancy of at least 12 weeks

- Laboratory values fulfilling the following:

- Serum creatinine < 1.5 mg/dL

- Serum total bilirubin < 1.5 mg/dL

- Serum alanine aminotransferase or aspartate aminotransferase < 150 IU/liter Note: If
elevated liver enzymes are related to disease; contact medical monitor to discuss.

- Cardiac ejection fraction > 50% by MUGA scan or echocardiography

- All men and women must agree to practice effective contraception during the study
period if not otherwise documented to be infertile.

Exclusion Criteria:

- Any serious medical condition, laboratory abnormality or psychiatric illness that
would prevent the patient from signing the informed consent form

- Chemotherapy or other investigational anticancer therapeutic drugs in the two weeks
prior to study entry; in the event of rapidly proliferative disease, however, the use
of hydroxyurea is permitted up to 24 hours before study entry

- Clinical evidence of active CNS leukemic involvement

- Pregnant or lactating women

- Clinically significant cardiac disease (New York Heart Association Class III or IV)

- Severe debilitating pulmonary disease

- Active and uncontrolled infection. Patients with an infection under active treatment
with antibiotics and whose infection is controlled may be entered into the study

- Current evidence of invasive fungal infection (blood or tissue culture); HIV or
hepatitis C infection

- Hypersensitivity to cytarabine, daunorubicin or liposomal products

- History of Wilson's disease or other copper-related disorder