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Completed

NCT Number: NCT01409070

Head to Head Comparison of Azacitidine and Decitabine in Myelodysplastic Syndrome

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.

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Key information

Conditions

Myelodysplastic Syndromes Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

SNUH

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Response rate

    Time frame: 6 months

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

Secondary outcomes

  1. Efficacy

    Time frame: 6 months

    To compare hematologic improvement between Azacitidine and decitabine

  2. Survival rate

    Time frame: 6 months

    To compare survival rate between Azacitidine and decitabine

  3. Number of participants with non-hematologic toxicities

    Time frame: 6 months

    To compare toxicity between Azacitidine and decitabine

  4. infection rate

    Time frame: 6 months

    To compare infection rate between Azacitidine and decitabine

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Head to Head Comparison of Azacitidine and Decitabine in Myelodysplastic Syndrome: Retrospective, Multicenter Study

Acronym: H-1012-015-342

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 3, 2011
Registry last updated
Oct 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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