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

Trial Status: Active

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

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

Connecticut

New Haven
Yale University
Status: APPROVED

Florida

Tampa
Moffitt Cancer Center
Status: ACTIVE

Kansas

Fairway
University of Kansas Clinical Research Center
Status: ACTIVE
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: ACTIVE

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

Lead Organization
Prescient Therapeutics, Ltd.

  • Primary ID PTX-200-AML-015
  • Secondary IDs NCI-2016-01755
  • Clinicaltrials.gov ID NCT02930109