CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 135 enrolled
Drug / intervention
Decitabine at 15 mg/m2 +1 moredrug
Likely dose
Decitabine at 15 mg/m2from 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/NCT01751867
NCT01751867Phase 3Completed
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An Open-label, Multi-center, Phase IIIb Study for Decitabine in Patients With Myelodysplastic Syndrome (MDS)

Xian-Janssen Pharmaceutical Ltd.·interventional·Posted Dec 18, 2012·Updated Apr 5, 2016

In Brief

A Phase 3 clinical trial evaluating Decitabine at 15 mg/m2 and Decitabine at 20 mg/m2 for Myelodysplastic Syndrome. Completed, enrolled 135 participants across 8 sites.

Detailed Summary

The purpose of this study is to evaluate the effectiveness and safety of decitabine in the treatment of myelodysplastic syndrome (name of a group of conditions that occur when the blood-forming cells in the bone marrow are damaged) in Chinese patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelodysplastic Syndrome
CountriesChina
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 18, 2012
Enrollment StartAug 1, 2009
Primary CompletionMay 1, 2011
Study CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.5 years ago

Interventions

Decitabine at 15 mg/m2drug

Decitabine will be given at a dose of 15 mg/m2 as a continuous intravenous infusion within a 3-hour intravenous infusion, repeated every 8 hours for 3 consecutive days.The total dose per day is 45 mg/m2; The total dose per course is 135 mg/m2. Cycles will be repeated every 6 weeks.

Decitabine at 20 mg/m2drug

Decitabine will be given at a dose of 20 mg/m2 as 1-hour IV infusion once daily on Days 1 through 5, of a 4-week treatment cycle.