myelodysplastic syndromes(MDS) RAEB
Conditions
Interventions
A:Subjects will receive up to 2 treatment cycles of HAG(homoharringtonine, low-dose cytarabine and granulocyte colony-stimulating factor (G-CSF)). Subjects who achieve a CR should continue therapy. Su
B:Subjects will receive up to 2 treatment cycles of HAG (homoharringtonine, low-dose cytarabine and granulocyte colony-stimulating factor (G-CSF)). Subjects who achieve a CR should continue therapy. S
Sponsors
Institute of Hematology and Blood Diseases Hospital (IH), Chinese Academy of Medical Sciences (CAMS)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female, 18 years of age or older; 2. Must have a diagnosis of MDS RAEB-1 or RAEB-2 fitting any of the recognized WHO classifications as determined by CBC, bone marrow assessment; 3. Has an Eastern Oncology Cooperative Group (ECOG) performance status of 0-2; 4. Has no aspiration to accept hematopoietic stem cell transplantation; 5. Adequate hepatic and renal function as measured by the following pretreatment laboratory criteria: (1) Aspartate transaminase (AST): <2.5 X the upper limit of normal (ULN); (2) Alanine transaminase (ALT): <2.5*ULN; (3) Total bilirubin: <1.5*ULN; (4) Serum Creatinine: <1.5*ULN; 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; 7. Willing to adhere to the prohibitions and restrictions specified in this protocol.
Exclusion criteria
Exclusion criteria: 1. Has a diagnosis of AML (>20% bone marrow blasts) or other progressive malignant disease; 2. Has received an investigational drug within 30 days preceding the first dose of study drug; 3. Has arrhythmia and myocardial ischemia; 4. Has history of prior malignancy and received any treatment for this prior malignancy within the last 3 years, except for superficial bladder cancer, basal cell or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia(CIN) or prostate intraepithlial neoplasia(PIN); 5. Has active viral or bacterial infection; 6. Has previously been treated with Vidaza? or Decitabine or received stem cell transplant within the last 1 year; 7. Has known positive serology for HIV, hepatitis B(surface antigen-positive) or active hepatitis C; 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. Is pregnant or breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hematologic Response Rate (complete remission (CR), partial remission (PR) hematologic improve (HI); | — |
Secondary
| Measure | Time frame |
|---|---|
| safety and tolerance; | — |
Countries
China
Contacts
Public ContactZhijian Xiao
Outcome results
None listed