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

Phase 2

Completed

• Conditions: Myelodysplastic Syndrome
• Interventions: Drug: Decitabine

• Registration Number: NCT00260065
• Lead Sponsor: Eisai Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-11-28
• Study First Submitted QC: 2005-11-28
• Study First Posted: 2005-12-01
• Primary Completion: 2008-06
• Study Completion: 2008-12
• Results First Submitted: 2009-04-13
• Results First Submitted QC: 2009-07-28
• Results First Posted: 2009-09-04
• Status Verified: 2010-06
• Last Update Submitted: 2013-05-13
• Last Update Posted: 2013-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

1. Must sign an Institutional Review Board (IRB) -approved informed consent form.
2. Must be 18 years of age or older.
3. 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.
4. If receiving erythropoietin(Procrit), must have been on a stable dose for at least 8 weeks before first dose of study drug.
5. If receiving darbepoetin(Aranesp), must have been on a stable dose for at least 12 weeks before first dose of study drug.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Decitabine	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Achieved Overall Response	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 Outcome Measures

Name	Time	Method
Best Response and Overall Improvement	1 year	Overall Improvement = complete remission + marrow complete remission + partial remission + hematologic improvement (CR+mCR+PR+HI)