ow Dose of Decitabine in Intermediate-1 Risk Group Myelodysplastic Syndrome: Multicenter, prospective, and open-label study

Pusan National University Hospital0 个研究点目标入组 48 人开始时间: 待定最近更新: 2019年3月11日

试验速览

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•In order to be enrolled in this trial, the study subject must meet the following criteria:
•Patients who were diagnosed with Myelodysplastic syndromes (MDS) and did not receive chemotherapy
•Patients who MDS were defined by the World Health Organization (WHO) Diagnosnostic criteria as a intermediate-1 risk group with International Prostate Symptom Score (IPSS) classification and at least one of the following:
•(1)If anemia does not respond to erythropoietin or Anti-thymocyte globulin (ATG)
•(2)If there is neutropenia with an absolute neutrophil count of less than 1,800/?
•(3)If there is thrombocytopenia with platelet count below 100,000/?
•18 years or older, 80 years or younger
•ECOG performance status is 2 or less
•Life expectancy is more than 12 months
•Serum creatinine is less than 1.5 times the upper limit of normal (ULN)
•Serum bilirubin is less than 2.0 times ULN
•AST, ALT and Alkaline Phosphatase are less than 3 times ULN
•Patients who can sign their consent and sign the consent form
•Male patients with fertile female partners should agree to use at least two effective methods of contraception during the trial and 30 days after the last administration.
•A woman who is pregnant should meet the following criteria: During the clinical trial and three months after the last administration, she must agree to the use of a doctor-approved contraceptive method and the serum pregnancy test within 72 hours do.

•Patients with any of the following will be excluded from clinical trial registration.
•Patient who MDS were defined by the WHO Diagnostic Act and classified as an IPSS classification except for the intermediate-1 risk group
•Secondary or therapeutic MDS, del5q syndrome
•Chronic myelomonocytic leukemia (CMML)
•Autoimmune diseases or blood diseases such as idiopathic thrombocytopenic purpura (ITP)
•Major diseases in heart, kidney or lung, and accompanied by organ failure
•human immunodeficiency virus (HIV)-positive or active hepatitis virus (type B or type C)
•Uncontrolled acute infection
•Uncontrolled bleeding
•Pregnancy or lactation
•Sensitization to known or suspected decitabine
•Diagnosed as a malignant disease other than MDS within the past 12 months (excepted with basal cell carcinoma without complication, intraepithelial carcinoma of the neck or breast, other local malignant tumors highly likely to be treated after surgical removal or radiation therapy)

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