Head to Head Comparison of Azacitidine and Decitabine in Myelodysplastic Syndrome (H-1012-015-342)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Inho Kim, Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT01409070

First received: July 28, 2011

Last updated: October 13, 2012

Last verified: October 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	July 28, 2011
Last Updated Date	October 13, 2012
Start Date ^ICMJE	January 2011
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 2, 2011)	Response rate [ Time Frame: 6 months ] [ Designated as safety issue: No ] Compare Azacitidine and Decitabine's treatment response rate in MDS patients
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01409070 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: August 2, 2011)	Efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ] To compare hematologic improvement between Azacitidine and decitabine Survival rate [ Time Frame: 6 months ] [ Designated as safety issue: No ] To compare survival rate between Azacitidine and decitabine Number of participants with non-hematologic toxicities [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] To compare toxicity between Azacitidine and decitabine infection rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] To compare infection rate between Azacitidine and decitabine
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Head to Head Comparison of Azacitidine and Decitabine in Myelodysplastic Syndrome
Official Title ^ICMJE	Head to Head Comparison of Azacitidine and Decitabine in Myelodysplastic Syndrome: Retrospective, Multicenter Study
Brief Summary	In Myelodysplastic syndrome, epigenetic treatments such as Azacitidine and Decitabine have been highlighted in phase 3 studies. However, as the 1st line treatment, it has not been evaluated the head to head comparison of two drugs. This study is a retrospective study to compare the efficacy of two drugs.
Detailed Description	Among 300 MDS patient, 200 of them have been taking Azacitidine and 100 of them have been taking Decitabine. Medical chart of these patients will be reviewed to assess the efficacy and safety between two agents.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	MDS patients who are diagnosed at SNUH
Condition ^ICMJE	Myelodysplastic Syndromes
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Azacitidine 200 MDS patients taking Azacitidine will be assessed Decitabine 100 MDS patients taking Decitabine will be assessed
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	300
Completion Date	December 2011
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Confirmed MDS by bone marrow examination Receiving azacitidine and decitabine as a first line chemotherapy Adequate hepatic, cardiac, and renal function Exclusion Criteria: Previously treated with another anti-cancer therapy due to MDS Not available for clinical information
Gender	Both
Ages	18 Years to 80 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01409070
Other Study ID Numbers ^ICMJE	H-1012-015-342
Has Data Monitoring Committee	Not Provided
Responsible Party	Inho Kim, Seoul National University Hospital
Study Sponsor ^ICMJE	Seoul National University Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Seoul National University Hospital
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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