Back to resultsA Study of Decitabine Given to Adults With Advanced-Stage Myelodysplastic Syndromes
Primary Purpose
Myelodysplastic Syndrome
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Decitabine
Sponsored by
About this trial
This is an interventional treatment trial for Myelodysplastic Syndrome focused on measuring Myelodysplastic Syndrome, Decitabine, Dacogen, MGI Pharma
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants Who Achieved Overall Response
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
Best Response and Overall Improvement
Overall Improvement = complete remission + marrow complete remission + partial remission + hematologic improvement (CR+mCR+PR+HI)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00260065
Brief Title
A Study of Decitabine Given to Adults With Advanced-Stage Myelodysplastic Syndromes
Official Title
A Phase 2 Study of Decitabine Administered Daily for 5 Days Every 4 Weeks to Adults With Advanced-Stage Myelodysplastic Syndromes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndrome
Keywords
Myelodysplastic Syndrome, Decitabine, Dacogen, MGI Pharma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Decitabine
Other Intervention Name(s)
Dacogen
Intervention Description
20mg/m^2, IV on days 1-5 of each 28 day cycle; until progression, death or unacceptable toxicity develops.
Primary Outcome Measure Information:
Title
Number of Participants Who Achieved Overall Response
Description
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)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Best Response and Overall Improvement
Description
Overall Improvement = complete remission + marrow complete remission + partial remission + hematologic improvement (CR+mCR+PR+HI)
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eisai US Medical Services
Organizational Affiliation
Eisai Inc.
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
City
Fort Myers
State/Province
Florida
Country
United States
City
Jacksonville
State/Province
Florida
Country
United States
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
City
Griffin
State/Province
Georgia
ZIP/Postal Code
30224
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Midland
State/Province
Texas
ZIP/Postal Code
79701
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
23790798
Citation
Jabbour E, Kantarjian H, O'Brien S, Kadia T, Malik A, Welch MA, Teng A, Cortes J, Ravandi F, Garcia-Manero G. Retrospective analysis of prognostic factors associated with response and overall survival by baseline marrow blast percentage in patients with myelodysplastic syndromes treated with decitabine. Clin Lymphoma Myeloma Leuk. 2013 Oct;13(5):592-6. doi: 10.1016/j.clml.2013.05.004. Epub 2013 Jun 20.
Results Reference
derived
PubMed Identifier
23260600
Citation
Jabbour E, Garcia-Manero G, Ravandi F, Faderl S, O'Brien S, Fullmer A, Cortes JE, Wierda W, Kantarjian H. Prognostic factors associated with disease progression and overall survival in patients with myelodysplastic syndromes treated with decitabine. Clin Lymphoma Myeloma Leuk. 2013 Apr;13(2):131-8. doi: 10.1016/j.clml.2012.11.001. Epub 2012 Dec 21.
Results Reference
derived
Links:
URL
http://www.mgipharma.com
Description
MGI Pharma's website
Learn more about this trial
A Study of Decitabine Given to Adults With Advanced-Stage Myelodysplastic Syndromes
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