CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 153 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/NCT00414310
NCT00414310Phase 2Completed
CompareCT.gov

Phase II Randomized Study of Low-Dose Decitabine (5-AZA-2'-Deoxycytidine) With or Without Valproic Acid in Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia -"SPORE"

M.D. Anderson Cancer Center·interventional·Posted Dec 21, 2006·Updated May 21, 2019

In Brief

A Phase 2 clinical trial evaluating Decitabine and Valproic Acid for Myelodysplastic Syndrome and Acute Myelogenous Leukemia. Completed, enrolled 153 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to find out if decitabine, given with or without valproic acid, can help to control AML or MDS. The safety of both treatments will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelodysplastic Syndrome, Acute Myelogenous Leukemia
CountriesUnited States
CollaboratorsEisai Inc.

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 21, 2006
Enrollment StartDec 1, 2006
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8.4 yearsPosted 19.5 years ago

Interventions

Decitabinedrug

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

Valproic Aciddrug

50 mg/kg orally daily for 7 days