A Study of PTX-200 (Triciribine) Plus Cytarabine in Refractory or Relapsed Acute Leukemia

Status: complete

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

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

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

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.

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