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Head to Head Comparison of Azacitidine and Decitabine in Myelodysplastic Syndrome (H-1012-015-342)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01409070
First Posted: August 3, 2011
Last Update Posted: October 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Inho Kim, Seoul National University Hospital
  Purpose
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.

Condition Phase
Myelodysplastic Syndromes Phase 3

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Head to Head Comparison of Azacitidine and Decitabine in Myelodysplastic Syndrome: Retrospective, Multicenter Study

Resource links provided by NLM:


Further study details as provided by Inho Kim, Seoul National University Hospital:

Primary Outcome Measures:
  • Response rate [ Time Frame: 6 months ]
    Compare Azacitidine and Decitabine's treatment response rate in MDS patients


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 6 months ]
    To compare hematologic improvement between Azacitidine and decitabine

  • Survival rate [ Time Frame: 6 months ]
    To compare survival rate between Azacitidine and decitabine

  • Number of participants with non-hematologic toxicities [ Time Frame: 6 months ]
    To compare toxicity between Azacitidine and decitabine

  • infection rate [ Time Frame: 6 months ]
    To compare infection rate between Azacitidine and decitabine


Enrollment: 300
Study Start Date: January 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Azacitidine
200 MDS patients taking Azacitidine will be assessed
Decitabine
100 MDS patients taking Decitabine will be assessed

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
MDS patients who are diagnosed at SNUH
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01409070


Locations
Korea, Republic of
SNUH
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Inho Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01409070     History of Changes
Other Study ID Numbers: H-1012-015-342
First Submitted: July 28, 2011
First Posted: August 3, 2011
Last Update Posted: October 16, 2012
Last Verified: October 2012

Keywords provided by Inho Kim, Seoul National University Hospital:
MDS

Additional relevant MeSH terms:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Azacitidine
Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors