CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 71 enrolled
Drug / intervention
Decitabine +1 moredrug
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.

Search/NCT00968071
NCT00968071Phase 2Completed
CompareCT.gov

A Phase II Study of Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)

M.D. Anderson Cancer Center·interventional·Posted Aug 28, 2009·Updated Mar 8, 2013

In Brief

A Phase 2 clinical trial evaluating Decitabine and Gemtuzumab Ozogamicin for Acute Myelogenous Leukemia and Myelodysplastic Syndrome. Completed, enrolled 71 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if giving 5-aza-2 deoxycytidine (decitabine) in combination with Mylotarg (gemtuzumab ozogamicin) can help to control AML or high-risk MDS. The safety of this drug combination will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myelogenous Leukemia, Myelodysplastic Syndrome
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 28, 2009
Enrollment StartFeb 1, 2008
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 16.8 years ago

Interventions

Decitabinedrug

20 mg/m\^2 IV over an hour and half daily for 5 days.

Gemtuzumab Ozogamicindrug

3 mg/m\^2 IV on day 5.