NCT02440568

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

AML-02: Study of the Activity and Safety of the Addition of Omacetaxine to the Standard-of-Care Induction Therapy Regimen of Cytarabine and Idarubicin in Newly-Diagnosed AML Patients

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: University of Illinois at Chicago · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Detailed description

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). Omacetaxine will be given subcutaneously Q12 hours on Days 1-7. The optimally safe and active dose (OD) will be determined using the EffTox design. EffTox is a Bayesian adaptive design that seeks to determine the optimal dose for further study in Phase II by considering a trade-off between efficacy and toxicity. The EffTox design begins by treating a cohort of three patients at dose level 1. These patients' efficacy and toxicity outcomes are used to update the posterior distributions for the probability of efficacy and toxicity and identify acceptable dose levels. The study terminates if no dose levels are acceptable. Otherwise, the acceptable doses are ranked using the Euclidean distance from (1.0, 0.0) and the next cohort is treated at the dose with the minimum distance under the restriction that we may only escalate or deescalate by one dose level at a time (e.g., the second cohort can only escalate to dose level 2 or deescalate to dose level -1). The second cohort is treated at the dose with the minimum distance and posterior distributions, and the list of acceptable doses and distances are updated as before. This process continues until at least 20 subjects are enrolled in the study. The dose with the minimum distance at study completion is considered the optimal dose for further investigation. If none of the dose levels are acceptable at study completion, an optimal dose level will not be identified and the drug does not warrant further investigation. Post induction therapy will consist of standard cytarabine consolidation chemotherapy or allogeneic stem cell transplantation based on pretreatment risk assessment.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-06-05
• Primary completion: 2018-11-30
• Completion: 2018-11-30
• First posted: 2015-05-12
• Last updated: 2021-07-06
• Results posted: 2021-07-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study