myelodysplastic syndrome, acute myelocytic leukemia
Conditions
Interventions
MDS group1:Combination chemotherapy regimen Decitabine +VP16+Ara-C
MDS group 2:Decitabine +aclacinomycin+Ara-C
AML group 1:Decitabine +VP16+aclacinomycin+Ara-C
AML group 2:Decitabine + aclacinomycin+Ara-C
Sponsors
Huadong Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 30 days before the entry, diagnosis of myelodysplastic syndrome (primary or secondary, including t-AML and MPN/MDS)above RAEB-I subtypes according to WHO classification system (WHO2016) by blood test, bone marrow examination and cytogenetic examination, the international prognostic scoring system (IPSS score= 0.5; 30 days before the entry, diagnosis of acute myeloid leukemia according to WHO classification system (WHO2016) by blood test, bone marrow examination and cytogenetic examination; 2. Aged elder than 55 years; 3. the ECOG score 0 to 3; 4. with normal liver and renal function(Creatinine is less than or equal to 1.5 times of the benchmark value, BUN is less than or equal to 1.5 times of the benchmark value, SGPT is less than or equal to 2 times of the benchmark value); 5. Women of childbearing age need to be nonpregnant before treatment, and must agree to take effective contraceptive measures during the treatment period; 6. The subject must sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. enter other clinical trials in 30 days; 2. patients under pregnancy and lactation; 3. receive treatment for other tumors in the last 3 years, but exclusion superficial bladder cancer, skin squamous cell carcinoma of the basal layer cells or squamous cell carcinoma, cervical intraepithelial (CIN) or prostate cancer (PIN); 4. active and un controlable virus and bacteria infection; 5. positive serological reaction of HIV and active hepatitis C; 6. uncontrolable mental disorders which affect chemotherapy or study monitor; 7. bone marrow dry tap; 8. sensitive to the drug in the regimen; 9. received azacitidine and decitabine or stem cell transplantation in the last year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete remission rate;overall survival;pregression free survival;toxicity; | — |
Countries
China
Contacts
Public ContactYanhui Xie
Huadong Hospital
Outcome results
None listed