CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 55 enrolled
Drug / intervention
decitabine +8 moredrug
Likely dose
Not stated in 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/NCT00492401
NCT00492401Phase 2Completed
CompareCT.gov

Phase II Study of Decitabine in Acute Myeloid Leukemia

National Cancer Institute (NCI)·interventional·Posted Jun 27, 2007·Updated Jun 27, 2016

In Brief

A Phase 2 clinical trial evaluating decitabine, laboratory biomarker analysis, and 7 other interventions for Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and 7 related conditions. Completed, enrolled 55 participants across 1 site.

Detailed Summary

This phase II trial is studying how well decitabine works in treating patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Secondary Acute Myeloid Leukemia, Untreated Adult Acute Myeloid Leukemia
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 27, 2007
Enrollment StartMay 1, 2007
Primary CompletionDec 1, 2010
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 19.0 years ago

Interventions

decitabinedrug

Given IV

laboratory biomarker analysisother

Correlative studies

pharmacological studyother

Correlative studies

high performance liquid chromatographyother

Correlative studies

microarray analysisgenetic

Correlative studies

RNA analysisgenetic

Correlative studies

mass spectrometryother

Correlative studies

DNA methylation analysisgenetic

Correlative studies

matrix-assisted laser desorption/ionization time of flight mass spectrometryother

Correlative studies