At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 10 enrolled
Drug / intervention
Decitabinedrug
Likely dose
Decitabine 20 mgfrom 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.
An Expanded Access Protocol to Administer Decitabine to Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
In Brief
A Phase 2 clinical trial evaluating Decitabine for Acute Myelogenous Leukemia and Myelodysplastic Syndrome. Completed, enrolled 10 participants across 1 site.
Detailed Summary
The purpose of this study is to provide decitabine to patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) who have completed participation per protocol in the DACO-018 study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJul 2005
Primary CompletionSep 2005
Study CompletionFeb 2008
First PostedSep 2008
TodayJul 2026
First PostedSep 25, 2008
Enrollment StartJul 1, 2005
Primary CompletionSep 1, 2005
Study CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.8 years ago
Interventions
Decitabinedrug
Decitabine is administered at a dose of 20 mg/m² over a 1-hour intravenous infusion for 5 consecutive days every 4 weeks in patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML; ≥ 30% blasts).