To Demonstrate Superiority of Decitabine Over Azacitidine in Subjects With Intermediate- or High-risk MDS.
- Registration Number
- NCT01011283
- Lead Sponsor
- Eisai Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 26
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 azacitidine - 1 decitabine -
- Primary Outcome Measures
Name Time Method 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. 13 Weeks 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.
- Secondary Outcome Measures
Name Time Method 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 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.
Trial Locations
- Locations (19)
Stanford University Cancer Center
🇺🇸Stanford, California, United States
Birmingham Hematology and Oncology Associates
🇺🇸Birmingham, Alabama, United States
Florida Cancer Specialists
🇺🇸Fort Myers, Florida, United States
Gulf Coast Oncology
🇺🇸St. Petersburg, Florida, United States
Center for Cancer and Blood Disorders
🇺🇸Bethesda, Maryland, United States
Charleston Hematology Oncology Associates
🇺🇸Charleston, South Carolina, United States
Gunderson Clinic Ltd.
🇺🇸La Crosse, Wisconsin, United States
Sletten Cancer Institute
🇺🇸Great Falls, Montana, United States
Utah Cancer Specialists
🇺🇸Salt Lake City, Utah, United States
Stockton Hematology Oncology
🇺🇸Stockton, California, United States
University of Pittsburgh School of Medicine
🇺🇸Pittsburgh, Pennsylvania, United States
Pasco Pinellas Cancer Center
🇺🇸New Port Richey, Florida, United States
Cornell Medical Center
🇺🇸New York, New York, United States
Siouxland Haeatology - Oncology Associates
🇺🇸Sioux City, Iowa, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Gabrail Cancer Center
🇺🇸Canton, Ohio, United States
Oncology and Hematology Care
🇺🇸Cincinnati, Ohio, United States
Carolinas Medical Center NorthEast NorthEast Oncology Associates
🇺🇸Concord, North Carolina, United States
Sarah Cannon Cancer Center
🇺🇸Nashville, Tennessee, United States