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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Inho Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01409070
First received: July 28, 2011
Last updated: October 13, 2012
Last verified: October 2012
  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 Seoul National University Hospital:

Primary Outcome Measures:
  • Response rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Compare Azacitidine and Decitabine's treatment response rate in MDS patients


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To compare hematologic improvement between Azacitidine and decitabine

  • Survival rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To compare survival rate between Azacitidine and decitabine

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

  • infection rate [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01409070

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

No publications provided by Seoul National University Hospital

Additional 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
Study First Received: July 28, 2011
Last Updated: October 13, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
MDS

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

ClinicalTrials.gov processed this record on October 29, 2014