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

Seoul National University

Status: Completed

Conditions: Myelodysplastic Syndromes

Study type: Observational

Funder types: Other

Identifiers

NCT01409070

H-1012-015-342

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

Azacitidine

Description:

200 MDS patients taking Azacitidine will be assessed

Decitabine

Description:

100 MDS patients taking Decitabine will be assessed