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NCT02045654 Clinical Trial

Platelet Response During the Second Cycle of Decitabine Can Predict Response and Survival for Myelodysplastic Syndrome

Myelodysplastic Syndrome Clinical Trial

Official title:
Retrospective Study for Predictive Marker for Decitabine Treament in MDS Patients

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02045654
Other study ID # 2014-01-086
Secondary ID
Status Recruiting
Phase N/A
First received January 15, 2014
Last updated January 23, 2014
Start date January 2014
Est. completion date March 2015

Study information
Verified date January 2014
Source Samsung Medical Center
Contact Jun Ho Jang, Pf
Email jh21.jang@samsung.com
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational

Clinical Trial Summary

To assess the efficacy of decitabine and identify predictors for response to decitabine therapy.

Description:

- Histologically confirmed Myelodysplastic syndrome Diagnosed with MDS (de novo or secondary) based on the World Health Organization (WHO) classifications

- Survival and response Analysis

- Response rate

- Overall survival

- Leukemia free survival

Recruitment information / eligibility
Status Recruiting
Enrollment 1
Est. completion date March 2015
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Histologically confirmed Myelodysplastic syndrome Diagnosed with MDS (de novo or secondary) based on the World Health Organization (WHO) classifications

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Division of Hematology Oncology, Samsung Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Response rate International Working Group (IWG) response criteria 1 year No
Secondary Overall survival measured from the date of decitabine therapy to the date of death or the last follow-up visit 1 year No
Secondary Leukemia free survival the date of decitabine therapy to the date of death or leukemic transformation 1 year No
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