CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 43 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/NCT00882102
NCT00882102Phase 2Completed
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Phase II Study of Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome

M.D. Anderson Cancer Center·interventional·Posted Apr 16, 2009·Updated Sep 13, 2013

In Brief

A Phase 2 clinical trial evaluating Decitabine and Gemtuzumab ozogamicin for Acute Myelogenous Leukemia and Myelodysplastic Syndrome. Completed, enrolled 43 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if 5-aza-2 deoxycytidine (decitabine) given in combination with Mylotarg (gemtuzumab ozogamicin) can help to control Acute myeloid leukemia (AML), high-risk myelodysplastic syndromes (MDS) or Myelofibrosis (MF). 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
CollaboratorsEisai Inc.

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 16, 2009
Enrollment StartApr 1, 2009
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 17.2 years ago

Interventions

Decitabinedrug

Decitabine 20 mg/m\^2 IV over 1-1/2 hours daily for 5 days.

Gemtuzumab ozogamicindrug

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