NCT02045654

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2014

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 27, 2014

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

January 27, 2014

Status Verified

January 1, 2014

Enrollment Period

1 month

First QC Date

January 15, 2014

Last Update Submit

January 23, 2014

Conditions

Myelodysplastic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Response rate

    International Working Group (IWG) response criteria

    1 year

Secondary Outcomes (2)

  • Overall survival

    1 year

  • Leukemia free survival

    1 year

Study Arms (1)

MDS patients

MDS patients who were treated with decitabine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Hematology Oncology, Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Jun Ho Jang, Pf

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Ho Jang, Pf

CONTACT

jh21.jang@samsung.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 15, 2014

First Posted

January 27, 2014

Study Start

January 1, 2014

Primary Completion

February 1, 2014

Study Completion

March 1, 2015

Last Updated

January 27, 2014

Record last verified: 2014-01

Locations

KR(1)