Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukaemia(CMML)
Conditions
Interventions
B:Decitabine combined with arsenic trioxide and Ascorbic acid
Sponsors
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male or female aged 18 to 75 years old; 2. Must have a diagnosis of Refractory Anemia With Excess Blasts(RAEB) of the recognized WHO(2008) classifications or Chronic Myelomonocytic Leukaemia (CMML) as determined by CBC, bone marrow assessment, and cytogenetics within 30 days of receiving study drug; 3. QT interval of ECG <460ms; 4. Has an Eastern Oncology Cooperative Group (ECOG) performance status 0-2; 5. Adequate hepatic and renal function as measured by the following pretreatment laboratory criteria: Aspartate transaminase (AST) <2 upper limit of normal (ULN). Alanine transaminase (ALT) <2 ULN; Total bilirubin <1.5 ULN; Serum Creatinine: <1.5 ULN. 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; 6. 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 a plan to hematopoietic stem cell transplantation recently; 2. Has received an investigational drug within 30 days preceding the first dose of study drug; 3. Is pregnant or breast-feeding; 4. A history of tumor and accept any the treatment for the tumor in the past three years; 5. Has active viral or bacterial infection, and has uncontrolled infection by using appropriate anti-infection; 6. Has known positive serology for HIV; 7. has uncontrolledheart trouble; 8. Has a mental illness or any other condition that could prevent full cooperation with the treatment and monitoring requirements of the study; 9. Has inaspirable bone marrow; 10. Has known hypersensitivity to any of the excipients of Decitabine; 11. 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; | — |
Countries
China
Contacts
Public ContactZhijian Xiao
Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed