Platelet Response During the Second Cycle of Decitabine Can Predict Response and Survival for Myelodysplastic Syndrome

• Conditions: Myelodysplastic Syndrome

• Registration Number: NCT02045654
• Lead Sponsor: Samsung Medical Center

Brief Summary

To assess the efficacy of decitabine and identify predictors for response to decitabine therapy.

Detailed Description

* Histologically confirmed Myelodysplastic syndrome Diagnosed with MDS (de novo or secondary) based on the World Health Organization (WHO) classifications

* Survival and response Analysis

* Response rate

* Overall survival

* Leukemia free survival

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2014-01
• Study Start: 2014-01
• Study First Submitted: 2014-01-15
• Study First Submitted QC: 2014-01-23
• Last Update Submitted: 2014-01-23
• Study First Posted: 2014-01-27
• Last Update Posted: 2014-01-27
• Primary Completion: 2014-02
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Histologically confirmed Myelodysplastic syndrome Diagnosed with MDS (de novo or secondary) based on the World Health Organization (WHO) classifications

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate	1 year	International Working Group (IWG) response criteria

Secondary Outcome Measures

Name	Time	Method
Overall survival	1 year	measured from the date of decitabine therapy to the date of death or the last follow-up visit
Leukemia free survival	1 year	the date of decitabine therapy to the date of death or leukemic transformation

Trial Locations

Locations (1)

Division of Hematology Oncology, Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of