The purpose of this study is to evaluate of the safety and efficacy of decitabine treatment of Myelodysplastic Syndrome.
Total subjects: 240, doseⅠgroup of 120 patients, doseⅡgroup of 120 patients. Subjects are stratified randomize. If necessary, participants accepted best supportive therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
Decitabine Injection 20mg/m2/d\*5d, IV\> 1h, one cycles per 4 weeks; Decitabine Injection 12mg/m2/d\*8d, IV\> 1h, one cycles per 4 weeks.
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGThe safety and efficacy of decitabine treatment of Myelodysplastic Syndrome.
The primary efficacy evaluation: ORR The secondary efficacy evaluation: CR,mCR,PR,HI, PFS in one year, Cytogenetic response, transfusion requirements, et al.
Time frame: 2-4 months
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