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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prescient Therapeutics, Ltd.
• Treatments: Cytarabine

Criteria

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