Head to Head Comparison of Azacitidine and Decitabine in Myelodysplastic Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Myelodysplastic Syndromes

Keywords

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MDS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Azacitidine

200 MDS patients taking Azacitidine will be assessed

No interventions assigned to this group

Decitabine

100 MDS patients taking Decitabine will be assessed

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Inho Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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SNUH

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED

PMID: 23432512 (View on PubMed)

Other Identifiers

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H-1012-015-342

Identifier Type: -

Identifier Source: org_study_id