Head to Head Comparison of Azacitidine and Decitabine in Myelodysplastic Syndrome (H-1012-015-342)
This study has been completed.
Sponsor:
Seoul National University Hospital
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
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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.
| 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 More Information
No publications provided
| 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 Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Neoplasms Azacitidine Decitabine |
Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013