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

  • STATUS
    Recruiting
  • days left to enroll
    18
  • participants needed
    40
  • sponsor
    Prescient Therapeutics, Ltd.
Updated on 17 February 2021
chronic myeloid leukemia
myeloid leukemia
cytarabine
lymphocytic leukemia

Summary

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

Description

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.

Details
Condition Acute Leukemia, acute leukemias
Treatment cytarabine, PTX-200
Clinical Study IdentifierNCT02930109
SponsorPrescient Therapeutics, Ltd.
Last Modified on17 February 2021

Eligibility

Yes No Not Sure

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/L blood (hydroxyurea permitted up to 24 hours prior to beginning study drugs)
Uncontrolled Disseminated Intravascular Coagulation (DIC)
Uncontrolled diabetes mellitus
Active, uncontrolled infection
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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