CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 50 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.

Search/NCT00398983
NCT00398983Phase 3Completed
CompareCT.gov

Randomized Study of Decitabine Versus Observation or Continued Standard Chemotherapy as Maintenance Therapy for Adults With Unfavorable Risk AML in First Complete Remission (CR) or Adults With Relapsed AML in Second or Greater CR

M.D. Anderson Cancer Center·interventional·Posted Nov 14, 2006·Updated Mar 4, 2013

In Brief

A Phase 3 clinical trial evaluating Decitabine for Acute Myelogenous Leukemia. Completed, enrolled 50 participants across 1 site.

Detailed Summary

The goal of this clinical study is to find out whether continued therapy with decitabine after achieving a remission in acute myeloid leukemia (AML) patients can help prolong the remission and prevent relapse of the disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myelogenous Leukemia
CountriesUnited States
CollaboratorsEisai Inc.

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 14, 2006
Enrollment StartAug 1, 2006
Primary CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 19.6 years ago

Interventions

Decitabinedrug

20 mg/m\^2 IV over 1 hour daily for 5 days