Status:
COMPLETED
An Observational Study for Dacogen Long-Term Treatment in Patients With Myelodysplastic Syndrome
Lead Sponsor:
Janssen Korea, Ltd., Korea
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
20+ years
Brief Summary
The purpose of this study is to investigate the overall response rate (ORR) and safety when treating patients with myelodysplastic syndrome with decitabine. Decitabine is to be administered as long as...
Detailed Description
This study is a prospective (the study follows a group of individuals over time), open label (all people involved know the identity of the intervention), multicenter, single arm (one group of patients...
Eligibility Criteria
Inclusion
- Patients diagnosed with (primary or secondary) Myelodysplastic Syndrome including Chronic Myelomonocytic Leukemia (CMML)
- Patients with an International Prognostic Scoring System \>= Int-1
- Patients who were never treated with hypomethylating agent (azacitidine and decitabine)
- Female patients who are postmenopausal or received contraceptive operation or refrain from sexual relations. Women of childbearing potential should conduct an effective method of birth control (oral contraceptives, injections, intrauterine device, double barrier method, contraceptive patch and male partner's sterilization), in case of male patients who will not have a baby within 2 months after the completion of decitabine therapy
- Patients who signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Exclusion
- Patients diagnosed with Acute Myelogenous Leukemia (AML, bone marrow stem cell counts exceeding 20%) or other progressive malignant diseases
- Patients with active infection of virus or bacteria
- Patients who used to be treated with azacitidine or decitabine
- Patients who are hypersensitive to excipients of decitabine
- Patients who are pregnant or breast-feeding.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT01400633
Start Date
December 1 2010
End Date
March 1 2014
Last Update
May 25 2015
Active Locations (16)
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1
Ansan, South Korea
2
Anyang, South Korea
3
Busan, South Korea
4
Cheonan, South Korea