Skip to main content
OpenTrials
Completed

NCT Number: NCT00260065

A Study of Decitabine Given to Adults With Advanced-Stage Myelodysplastic Syndromes

The purpose of this study is to determine the overall response rate in patients with myelodysplastic syndromes (MDS) given a daily dosing schedule of decitabine.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Myelodysplastic Syndrome Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myelodysplastic Syndromes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Toronto, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must sign an Institutional Review Board (IRB) -approved informed consent form.
  • Must be 18 years of age or older.
  • Must have a diagnosis for MDS fitting any of the recognized French-American-British (FAB) classifications and International Prognostic Scoring System (IPSS) greater than or equal to 0.5 as determined by Complete Blood Count (CBC), bone marrow assessment, and cytogenetics within 28 days of receiving study drug. If FAB classification is Refractory anemia (RA) or Refractory anemia with ringed sideroblasts (RARS), then must be red cell transfusion dependent, defined as needing red cells more frequently than once every 4 weeks.
  • If receiving erythropoietin(Procrit), must have been on a stable dose for at least 8 weeks before first dose of study drug.
  • If receiving darbepoetin(Aranesp), must have been on a stable dose for at least 12 weeks before first dose of study drug.

Exclusion criteria

  • Must not have a diagnosis of Acute Myeloid Leukemia (AML) or other progressive malignant disease.
  • Must not have received any investigational agent within the 30 days preceding the first dose of study drug.
  • Must not have uncontrolled cardiac disease or uncontrolled congestive heart failure.
  • Must not have an active viral or bacterial infection.

Treatment and study plan

decitabine

Drug

20mg/m^2, IV on days 1-5 of each 28 day cycle; until progression, death or unacceptable toxicity develops.

Other names: Dacogen

Primary outcomes

  1. Number of Participants Who Achieved Overall Response

    Time frame: 1 year

    Overall Response = complete remission (disappearance of all target lesions) + partial remission (at least 30% decrease in the sum of the longest diameters of target lesions)

Secondary outcomes

  1. Best Response and Overall Improvement

    Time frame: 1 year

    Overall Improvement = complete remission + marrow complete remission + partial remission + hematologic improvement (CR+mCR+PR+HI)

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study title

A Phase 2 Study of Decitabine Administered Daily for 5 Days Every 4 Weeks to Adults With Advanced-Stage Myelodysplastic Syndromes

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Dec 1, 2005
Registry last updated
May 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.