An Effectiveness and Safety Study of Decitabine in Patients With Myelodysplastic Syndrome
Condition: Myelodysplastic Syndrome
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: Decitabine at 15 mg/m2; Decitabine at 20 mg/m2
Intervention description: Decitabine will be given at a dose of 15 mg/m2 as a continuous intravenous infusion within a 3-hour intravenous infusion, repeated every 8 hours for 3 consecutive days.The total dose per day is 45 mg/m2; The total dose per course is 135 mg/m2. Cycles will be repeated every 6 weeks.; Decitabine will be given at a dose of 20 mg/m2 as 1-hour IV infusion once daily on Days 1 through 5, of a 4-week treatment cycle.
Intervention MeSH terms: Decitabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 135.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Myelodysplastic Syndrome; Dacogen; Oncology; Decitabine; Bone marrow disorders

Summary:

      The purpose of this study is to evaluate the effectiveness and safety of decitabine in the
      treatment of myelodysplastic syndrome (name of a group of conditions that occur when the
      blood-forming cells in the bone marrow are damaged) in Chinese patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have diagnosed with Myelodysplastic Syndrome (MDS) denovo (previously not
             present) or secondary as per the classification of French-American-British (FAB) and
             International Prognostic Scoring System (IPSS) greater than or eaul to 0.5 as
             determined by complete blood count (CBC), bone marrow assessment and bone marrow
             cytogenetics

          -  Must have an Eastern Oncology Cooperative Group (ECOG) performance status of 0-2

          -  Must have adequate hepatic and renal function as measured by the aspartate
             transaminase (AST), alanine transaminase (ALT), total bilirubin and serum creatinine,
             respectively

          -  Must have recovered from all toxic effects of prior therapy and not received any
             chemotherapy for a minimum of 4 weeks (6 weeks if the patient has been treated with a
             nitrosoureas) prior to the first dose of study drug - Woman must be postmenopausal, or
             surgically sterile, or abstinent, or, if sexually active, be practicing an effective
             method of birth control (eg, oral contraceptives, contraceptive injections,
             intrauterine device, double-barrier method, contraceptive patch, male partner
             sterilization)

        Exclusion Criteria:

          -  Must not have a diagnosis of acute myeloid leukemia (greater than 30% bone marrow
             blasts) - Must not have received radiotherapy within 14 days before the first dose of
             study drug - Must not have any other prior cancer, other than superficial bladder
             cancer, basal cell skin and cervical cancer - Must not have associated autoimmune
             hemolytic anemia or immune thrombocytopenia and inaspirable bone marrow - Must not
             have a mental illness or any other condition (eg, uncontrolled cardiac or pulmonary
             disease, diabetes), that could prevent full cooperation with the study requirements.