A phase I-II open label study of PTX-200 in combination with cytarabine in the treatment of relapsed or refractory acute leukemia.

Study design: Phase I/II study The Phase I study is open-label with four increasing dose levels for up to four 21-day cycles. Safety and activity will be evaluated at the end of each cycle.

The Phase II study is open label with administration of the recommended phase dose of PTX-200 for up to four 21-day cycles. PTX-200 will be co-administered with cytarabine in both the Phase I and Phase II parts of the study.

Inclusion Criteria:

• Pathologic confirmation of the diagnosis of AML, ALL (acute lymphoblastic leukemia), or blast-phase CML (chronic myelogenous leukemia)
• Age ≥ 18 years
• ECOG Performance Status 0-2
• Patients must be able to give adequate informed consent

Exclusion Criteria:

• Hyperleukocytosis with ≥ 30,000 leukemic blasts/µL blood (hydroxyurea permitted up to 24 hours prior to beginning study drugs)
• Uncontrolled Disseminated Intravascular Coagulation (DIC)
• Uncontrolled diabetes mellitus
• Active, uncontrolled infection

Open Label