Head to Head Comparison of Azacitidine and Decitabine in Myelodysplastic Syndrome

Completed

• Conditions: Myelodysplastic Syndromes

• Registration Number: NCT01409070
• Lead Sponsor: Seoul National University Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-07-28
• Study First Submitted QC: 2011-08-02
• Study First Posted: 2011-08-03
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-13
• Last Update Posted: 2012-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate	6 months	Compare Azacitidine and Decitabine's treatment response rate in MDS patients

Secondary Outcome Measures

Name	Time	Method
Efficacy	6 months	To compare hematologic improvement between Azacitidine and decitabine
Survival rate	6 months	To compare survival rate between Azacitidine and decitabine
Number of participants with non-hematologic toxicities	6 months	To compare toxicity between Azacitidine and decitabine
infection rate	6 months	To compare infection rate between Azacitidine and decitabine

Trial Locations

Locations (1)

SNUH; 🇰🇷 Seoul, Korea, Republic of