NCT01873495

Omacetaxine for Consolidation and Maintenance

Omacetaxine for Consolidation and Maintenance in Patients Age ≥ 55 With AML in First Remission: A Pilot Study

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this pilot study is to assess the safety and tolerability of omacetaxine for consolidation in patients age 55 and older with acute myelogenous leukemia (AML) in first complete remission following induction with cytarabine and an anthracycline, and also to assess the safety and tolerability of omacetaxine for maintenance in patients age 55 and older with acute AML in first complete remission following 3 consolidation courses with omacetaxine.

Conditions

• Acute Myelogenous Leukemia (AML)

Interventions

Type	Name	Description
DRUG	Omacetaxine	Omacetaxine 1.25 mg/m² sub-cutaneously twice daily for 5 consecutive days every 28 (± 8) days for 3 cycles. Patients in continuous remission after 3 cycles of consolidation will receive maintenance omacetaxine 1.25 mg/m² twice daily for 3 days, every 28 days for up to 6 cycles

Timeline

• Start date: 2013-05-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2013-06-10
• Last updated: 2019-09-24
• Results posted: 2019-09-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study