A Study of PTX-200 (Triciribine) Plus Cytarabine in Refractory or Relapsed 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.
Trial Phase Phase I/II
Trial Type Treatment
Prescient Therapeutics, Ltd.
- Primary ID PTX-200-AML-015
- Secondary IDs NCI-2016-01755
- Clinicaltrials.gov ID NCT02930109