Myelodysplastic Syndrome (MDS)
Conditions
Interventions
Sponsors
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Subjects must satisfy the following criteria to be enrolled in the study: 1. Must have a diagnosis of MDS (de novo or secondary) fitting Refractory Anemia With Excess Blasts in transformation (RAEB-T) of the recognized FAB classifications, or Refractory Anemia With Excess Blasts(RAEB) of the recognized WHO(2008) classifications and IPSS intermediate-2 and high risk as determined by CBC, bone marrow assessment, and cytogenetics within 30 days of receiving study drug; 2. Male or female, 18 years of age or older; 3. Has an Eastern Oncology Cooperative Group (ECOG) performance status of 0-2; 4. Adequate hepatic and renal function as measured by the following pretreatment laboratory criteria: 5. Aspartate transaminase (AST): <2X the upper limit of normal (ULN); 6. Alanine transaminase (ALT): <2 X the ULN; 7. Total bilirubin: <1.5 X the ULN;?Serum Creatinine: <1.5 X the ULN; 8. Female subjects must be practicing an effective method of birth control before entry and throughout the study; have a negative serum or urine pregnancy test at screening; 9. Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
Exclusion criteria
Exclusion criteria: Potential subjects who meet any of the following criteria will be excluded from participating in the study: 1. Has received an investigational drug within 30 days preceding the first dose of study drug; 2. Is pregnant or breast-feeding; 3. A history of tumor and accept any the treatment for the tumor in the past three years; 4. Has active viral or bacterial infection, and has uncontrolled infection by using appropriate anti-infection; 5. Has known positive serology for HIV; 6. Has a mental illness or any other condition that could prevent full cooperation with the treatment and monitoring requirements of the study; 7. Has inaspirable bone marrow; 8. Has known hypersensitivity to any of the excipients of Decitabine; 9. Has previously been treated with Vidaza or Decitabine, or received hematopoietic stem cell transplantation in the past year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone marrow complete respondence;cytogenetic response rates;transfusion requirements;hospitalizations; | — |
Countries
China
Contacts
Public ContactZhijian Xiao
Institute of Hematology and Blood Diseases Hospital , Chinese Academy of Medical Sciences
Outcome results
None listed