Acute myeloid leukemia/Myelodysplastic syndrome
Conditions
Interventions
Group 1:Demethylation drugs + targeted drugs
Group 2:Demethylation drug + placebo
Sponsors
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. According to the diagnosis criteria of MDS (2008), the IPSS international prognostic score is divided into intermediate-risk 2 and high-risk MDS patients; high-risk MDS patients who are relapsed and refractory; according to the AML (2008) diagnosis criteria, they are diagnosed as elderly AML or relapsed and refractory AML patients; 2. Aged between 18 and 80 years; 3. No differentiation inducing drugs were used within the first three months of inclusion, such as all-transretinoic acid, valproic acid and arsenic trioxide in the past three months; 4. ECOG score 0-2; 5. Creatinine <=1.5 ULN, BUN<=1.5 ULN, ALT<=2 ULN, AST<=2 ULN, Tbil<=1.5 ULN; 6. Patients were treated by cell stimulating factor therapy in the past, Stop using cell stimulating factor therapy at least a month before joining the study; 7. Accurate past history and treatment history (including blood transfusion, and hemoglobin measure) in the past 8 weeks before joining the study; 8. The patient or family members understand and voluntarily signed informed consent.
Exclusion criteria
Exclusion criteria: 1) In recent 30 days, patients received other study drug therapy; 2) 5q-syndromes; 3) Patients with a history of tumor and received treatment for tumor in the past three years; 4) Patients have active viral or bacterial infections, and failure to use appropriate anti-infection treatment; 5) Patients with mental disorders or other condition and cannot cooperate research treatment and monitoring requirements; 6) Pregnancy (Women of childbearing age need to undergo pregnancy tests) and lactation; 7) Known HIV, active hepatitis and positive serology; 8) Researchers think unfavorable patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate;Complete bone marrow remission rate;cytogenetic remission rate; | — |
Countries
China
Contacts
Public ContactZhang Zheng
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
Outcome results
None listed