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

January 23, 2014 updated by: Jun Ho Jang, Samsung Medical Center

Retrospective Study for Predictive Marker for Decitabine Treament in MDS Patients

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

Study Overview

Status

Unknown

Conditions

Detailed 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

Study Type

Observational

Enrollment (Anticipated)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 135-710
        • Recruiting
        • Division of Hematology Oncology, Samsung Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
MDS patients
MDS patients who were treated with decitabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: 1 year
International Working Group (IWG) response criteria
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 1 year
measured from the date of decitabine therapy to the date of death or the last follow-up visit
1 year
Leukemia free survival
Time Frame: 1 year
the date of decitabine therapy to the date of death or leukemic transformation
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Jun Ho Jang, Pf, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

February 1, 2014

Study Completion (Anticipated)

March 1, 2015

Study Registration Dates

First Submitted

January 15, 2014

First Submitted That Met QC Criteria

January 23, 2014

First Posted (Estimate)

January 27, 2014

Study Record Updates

Last Update Posted (Estimate)

January 27, 2014

Last Update Submitted That Met QC Criteria

January 23, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-01-086

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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