Study Stopped
The study was stopped due to insufficient enrollment.
To Demonstrate Superiority of Decitabine Over Azacitidine in Subjects With Intermediate- or High-risk MDS.
A Randomized, Open-label, Parallel-Group Study Comparing the Efficacy and Safety of DACOGEN (Decitabine) for Injection and VIDAZA (Azacitidine) for Injection In Subjects With Intermediate or High Risk Myelodysplastic Syndromes (MDS)
1 other identifier
interventional
26
1 country
19
Brief Summary
The purpose of this study is to compare the response of patients with Intermediate or High Risk myelodysplastic syndromes (MDS) following treatment with decitabine or azacitidine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
19 active sites
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
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 5, 2009
CompletedFirst Posted
Study publicly available on registry
November 11, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedResults Posted
Study results publicly available
September 18, 2013
CompletedOctober 29, 2014
October 1, 2014
1.2 years
November 5, 2009
July 14, 2013
October 21, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (ORR), Defined as Proportion of Patients Having Complete Response (CR) and Marrow Complete Response (mCR) After Completion of 3 Cycles of Study Drug.
Based on Modified International Working Group Response Criteria for Altering Natural History of Myelodysplastic Syndromes. Complete Response: Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Peripheral blood Hgb ≥ 11 g/dL; Platelets ≥ 100 X 10\^9/L; Neutrophils ≥ 1.0 X 10\^9/Lb; Blasts 0%. Marrow Complete Response: Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment. Peripheral blood: if hematological improvement responses, they will be noted in addition to marrow CR.
13 Weeks
Secondary Outcomes (1)
Overall Response Rate (ORR), Defined as Proportion of Patients Having Complete Response (CR) and Marrow Complete Response (mCR) After Completion of 6 Cycles of Study Drug.
36 Weeks
Study Arms (2)
1
ACTIVE COMPARATOR2
ACTIVE COMPARATORInterventions
decitabine 20 mg/m\^2 /day intravenous (IV) infusion for 5 days every 28 days
azacitidine 75 mg/m\^2 /day subcutaneous (SC) injection for 7 days every 28 days
Eligibility Criteria
You may qualify if:
- Subjects who meet all of the following criteria may be included in the study:
- Must have a diagnosis of primary myelodysplastic syndromes (MDS) of Intermediate-1 transfusion dependent, Intermediate-2, or High-risk \[defined by International Prognostic Scoring System (IPSS) score of ≥0.5\] and recognized French-American-British (FAB) classifications
- Male or female, 18 years of age or older with signed informed consent
- Adequate renal function
- Demonstrated normal liver function
- Female subjects of childbearing age must have negative pregnancy test within 1 week of study entry and agree to use adequate contraception for the duration of the trial and for a minimum of six months after last dose of decitabine or azacitidine received.
- Male subjects must agree to use adequate contraception for the duration of the trial and for a minimum of six months after last dose of decitabine or azacitidine received.
You may not qualify if:
- Subjects who meet any of the following criteria will be excluded from participation in the study:
- Current use of radiotherapy for extramedullary disease for 2 weeks prior to entering study (permitted if \> 2 weeks from study entry and if recovered from toxic effects of therapy)
- Systemic fungal, bacterial, or viral infection which is not controlled (i.e., ongoing signs or symptoms of infection and without improvement despite appropriate treatment)
- Pregnancy or current lactation
- Significant concurrent disease, illness, or psychiatric disorder
- Treatment with an investigational agent 30 days prior to the first dose of decitabine or azacitidine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
Study Sites (19)
Birmingham Hematology and Oncology Associates
Birmingham, Alabama, 35205, United States
Stanford University Cancer Center
Stanford, California, 94305, United States
Stockton Hematology Oncology
Stockton, California, 95204, United States
Florida Cancer Specialists
Fort Myers, Florida, 33619, United States
Pasco Pinellas Cancer Center
New Port Richey, Florida, 34652, United States
Gulf Coast Oncology
St. Petersburg, Florida, 33705, United States
University of Chicago
Chicago, Illinois, 60637, United States
Siouxland Haeatology - Oncology Associates
Sioux City, Iowa, 51101, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, 20817, United States
Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Cornell Medical Center
New York, New York, 10021, United States
Carolinas Medical Center NorthEast NorthEast Oncology Associates
Concord, North Carolina, 28025, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Oncology and Hematology Care
Cincinnati, Ohio, 45242, United States
University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15232, United States
Charleston Hematology Oncology Associates
Charleston, South Carolina, 29403, United States
Sarah Cannon Cancer Center
Nashville, Tennessee, 37203, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
Gunderson Clinic Ltd.
La Crosse, Wisconsin, 54601, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Erhan Berrack, M.D.
- Organization
- Eisai Inc.
Study Officials
- STUDY DIRECTOR
Karen Stein
Eisai Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2009
First Posted
November 11, 2009
Study Start
November 1, 2009
Primary Completion
January 1, 2011
Last Updated
October 29, 2014
Results First Posted
September 18, 2013
Record last verified: 2014-10