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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
26
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
Birmingham Hematology and Oncology Associates
Birmingham, Alabama, United States
Stanford University Cancer Center
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.
Time frame: 13 Weeks
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.
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.
Time frame: 36 Weeks
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