NCT01409070

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 3, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

October 16, 2012

Status Verified

October 1, 2012

Enrollment Period

11 months

First QC Date

July 28, 2011

Last Update Submit

October 13, 2012

Conditions

Myelodysplastic Syndromes

Keywords

MDS

Outcome Measures

Primary Outcomes (1)

  • Response rate

    Compare Azacitidine and Decitabine's treatment response rate in MDS patients

    6 months

Secondary Outcomes (4)

  • Efficacy

    6 months

  • Survival rate

    6 months

  • Number of participants with non-hematologic toxicities

    6 months

  • infection rate

    6 months

Study Arms (2)

Azacitidine

200 MDS patients taking Azacitidine will be assessed

Decitabine

100 MDS patients taking Decitabine will be assessed

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

MDS patients who are diagnosed at SNUH

You may qualify if:

  • Confirmed MDS by bone marrow examination
  • Receiving azacitidine and decitabine as a first line chemotherapy
  • Adequate hepatic, cardiac, and renal function

You may not qualify if:

  • Previously treated with another anti-cancer therapy due to MDS
  • Not available for clinical information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SNUH

Seoul, South Korea

Location

Related Publications (1)

  • Lee YG, Kim I, Yoon SS, Park S, Cheong JW, Min YH, Lee JO, Bang SM, Yi HG, Kim CS, Park Y, Kim BS, Mun YC, Seong CM, Park J, Lee JH, Kim SY, Lee HG, Kim YK, Kim HJ; Korean Society of Haematology AML/MDS working party. Comparative analysis between azacitidine and decitabine for the treatment of myelodysplastic syndromes. Br J Haematol. 2013 May;161(3):339-47. doi: 10.1111/bjh.12256. Epub 2013 Feb 21.

    PMID: 23432512DERIVED

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 28, 2011

First Posted

August 3, 2011

Study Start

January 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

October 16, 2012

Record last verified: 2012-10

Locations

KR(1)