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AML-02: Omacetaxine With Standard-of-Care Induction With Cytarabine & Idarubicin in Newly-Diagnosed AML Patients

NCT02440568 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2021-07-06

Study results available
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Summary

This is a dose escalation study to evaluate Omacetaxine when given in combination with a standard induction regimen of "7+3" (cytarabine for Days 1-7 and Idarubicin for Days 1-3) in patients with newly diagnosed acute myelogenous leukemia (AML).

Conditions

Interventions

DRUG

Cytarabine

Cytarabine (100mg/m\^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days.

DRUG

Idarubicin

Idarubicin (12 mg/m\^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3.

DRUG

Omacetaxine mepesuccinate

Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Dose level 0.625mg/m\^2

DRUG

Omacetaxine mepesuccinate

Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Dose level 1.25mg/m\^2

DRUG

Omacetaxine mepesuccinate

Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Dose level 2.0mg/m\^2

DRUG

Omacetaxine mepesuccinate

Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Dose level 3.0mg/m\^2

Sponsors & Collaborators

  • Teva Pharmaceuticals USA

    collaborator INDUSTRY

  • University of Illinois at Chicago

    lead OTHER

Principal Investigators

  • John Quigley, MD · University of Illinois at Chicago

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-05
Primary Completion
2018-11-30
Completion
2018-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02440568 on ClinicalTrials.gov