An Observational Study for Dacogen Long-Term Treatment in Patients With Myelodysplastic Syndrome
A Prospective Multicenter Observational Study for Dacogen Long-Term Treatment in Patients With Myelodysplastic Syndrome
3 other identifiers
observational
156
1 country
16
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 there is evidence of clinical benefit.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2010
Typical duration for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 14, 2011
CompletedFirst Posted
Study publicly available on registry
July 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedMay 25, 2015
May 1, 2015
3.2 years
July 14, 2011
May 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall response rate
every 28 days up to approximately 5 years
Secondary Outcomes (3)
The change of transfusion requirements
every 4 weeks up to approximately 5 years
Overall survival
every 3 months up to approximately 5 years
Adverse events
every 4 weeks up to approximately 5 years
Study Arms (1)
001
decitabine injection decitabine intravenous injection 20mg/m2 once a day for 5 consecutive days every 4 weeks
Interventions
decitabine intravenous injection 20mg/m2 once a day for 5 consecutive days every 4 weeks
Eligibility Criteria
Secondary or tertiary hospitals in South Korea
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Unknown Facility
Ansan, South Korea
Unknown Facility
Anyang, South Korea
Unknown Facility
Busan, South Korea
Unknown Facility
Cheonan, South Korea
Unknown Facility
Chungcheongbuk-Do, South Korea
Unknown Facility
Daegu, South Korea
Unknown Facility
Daejeon, South Korea
Unknown Facility
Gyeonggi-do, South Korea
Unknown Facility
Hwasun Gun, South Korea
Unknown Facility
Incheon, South Korea
Unknown Facility
Jinju, South Korea
Unknown Facility
Jungnam, South Korea
Unknown Facility
Kwanju, South Korea
Unknown Facility
Pusan, South Korea
Unknown Facility
Seoul, South Korea
Unknown Facility
Suwon, South Korea
Related Publications (1)
Jung KS, Kim YJ, Kim YK, Park SK, Kim HG, Kim SJ, Park J, Choi CW, Do YR, Kim I, Park S, Mun YC, Jeong SH, Kim MK, Yi HG, Chang MH, Kim SY, Lee JH, Jang JH. Clinical Outcomes of Decitabine Treatment for Patients With Lower-Risk Myelodysplastic Syndrome on the Basis of the International Prognostic Scoring System. Clin Lymphoma Myeloma Leuk. 2019 Oct;19(10):656-664. doi: 10.1016/j.clml.2019.06.003. Epub 2019 Jun 27.
PMID: 31375393DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Korea, Ltd. Clinical Trial
Janssen Korea, Ltd.
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2011
First Posted
July 22, 2011
Study Start
December 1, 2010
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
May 25, 2015
Record last verified: 2015-05