To Demonstrate Superiority of Decitabine Over Azacitidine in Subjects With Intermediate- or High-risk MDS.

Phase 4

Terminated

• Conditions: Myelodysplastic Syndromes
• Interventions: Drug: azacitidine; Drug: decitabine

• 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

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-05
• Study First Submitted QC: 2009-11-10
• Study First Posted: 2009-11-11
• Primary Completion: 2011-01
• Results First Submitted: 2013-07-14
• Results First Submitted QC: 2013-07-14
• Results First Posted: 2013-09-18
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-21
• Last Update Posted: 2014-10-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

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)

Birmingham Hematology and Oncology Associates; 🇺🇸 Birmingham, Alabama, United States

Stanford University Cancer Center; 🇺🇸 Stanford, California, United States

Stockton Hematology Oncology; 🇺🇸 Stockton, California, United States

Florida Cancer Specialists; 🇺🇸 Fort Myers, Florida, United States

Pasco Pinellas Cancer Center; 🇺🇸 New Port Richey, Florida, United States

Gulf Coast Oncology; 🇺🇸 St. Petersburg, Florida, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Siouxland Haeatology - Oncology Associates; 🇺🇸 Sioux City, Iowa, United States

Center for Cancer and Blood Disorders; 🇺🇸 Bethesda, Maryland, United States

Sletten Cancer Institute; 🇺🇸 Great Falls, Montana, United States

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