CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
Omacetaxine +1 moredrug
Likely dose
Omacetaxine 1.25 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01272245
NCT01272245Phase 2Completed
CompareCT.gov

A Phase II Study of Omacetaxine (OM) and Low Dose Cytarabine (LDAC) in Older Patients With Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)

M.D. Anderson Cancer Center·interventional·Posted Jan 7, 2011·Updated May 30, 2018

In Brief

A Phase 2 clinical trial evaluating Omacetaxine and Cytarabine for Leukemia. Completed, enrolled 36 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if omacetaxine given with cytarabine can help to control the disease in patients with AML or high-risk MDS. The safety of the study drugs will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia
CountriesUnited States
CollaboratorsCephalon

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 7, 2011
Enrollment StartJul 1, 2011
Primary CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 15.5 years ago

Interventions

Omacetaxinedrug

1.25 mg/m2 subcutaneously (SQ) every 12 hours (+/- 3 hours) for 3 days (Days 1-3). Each cycle will be 4-7 weeks.

Cytarabinedrug

20 mg subcutaneously every 12 hours (+/- 3 hours) for 7 days (Days 1-7). Each cycle will be 4-7 weeks.