Head to Head Comparison of Azacitidine and Decitabine in Myelodysplastic Syndrome

Myelodysplastic Syndromes Clinical Trial

— H-1012-015-342  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01409070
• Other study ID #: H-1012-015-342
• Status: Completed
• Phase: Phase 3
• First received: July 28, 2011
• Last updated: October 13, 2012
• Start date: January 2011
• Est. completion date: December 2011

Study information

• Verified date: October 2012
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Locations

Country	Name	City	State
Korea, Republic of	SNUH	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	Compare Azacitidine and Decitabine's treatment response rate in MDS patients	6 months	No
Secondary	Efficacy	To compare hematologic improvement between Azacitidine and decitabine	6 months	No
Secondary	Survival rate	To compare survival rate between Azacitidine and decitabine	6 months	No
Secondary	Number of participants with non-hematologic toxicities	To compare toxicity between Azacitidine and decitabine	6 months	Yes
Secondary	infection rate	To compare infection rate between Azacitidine and decitabine	6 months	Yes