Myelodysplastic Syndrome-Refractory Anemia with Excess Blasts (MDS-RAEB) and Chronic Myelomonocytic Leukaemia (CMML)
Conditions
Interventions
study group:Realgar-Indigo natualis Formula
study group:Decitabine
Sponsors
Department of Hematology, The First Affiliated Hospital, Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. At least 18 years old; 2. Diagnosed as MDS 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 screening; 3. QT interval of ECG <460ms; 4. ECOG performance status 0-2; 5. Adequate hepatic and renal function as following: SGPT =2Xupper limit of normal (ULN). Serum Creatinine=1.5MG/DL.BUN=1.5MG/DL; 6. Must sign informed consent form.
Exclusion criteria
Exclusion criteria: 1. Subject who plans to receive hematopoietic stem cell transplantation in near future; 2. Has received an investigational drug within 30 days prior to this trial; 3. Has a prevoius malignancy history and accepted treatment for it within 3 years, except for superficial bladder cancer, basal cell carcinoma of the skin or squamous carcinoma of the skin, cervical intraepithelial carcinoma or intraepithelial carcinoma of prostate; 4. Has active viral or bacterial infection, and has uncontrolled infection under anti-infection treatment; 5. Positive blood tests of AIDS or HCV; 6. Subject who has mental illness or other disease can't adhere to the study requirements; 7. Has uncontolled heart disease; 8. Pregnant patient or women who can't take contraceptive measures; 9. Bone marrow dry tap; 10. Allergic to decitabine or RIF; 11. Subject who once received treatment with azacitidine or decitabine, or received stem cell transplantation within one year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety;bone marrow complete remission rate;cytogenetic response rate;transfusion requirements;duration of hospitalization;quality of life;correlationship between gene mutations and efficacy; | — |
Countries
China
Contacts
Public ContactHongyan Tong
Department of Hematology, The First Affiliated Hospital, Zhejiang University
Outcome results
None listed