Myelodysplastic syndrome
Conditions
Interventions
Experimental group:DCEG or DCAG regimen was applied according to gene stratification
control group:Decitabine monotherapy
Sponsors
Huadong Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants aged 55-80 years old; 2. After blood cell count, bone marrow examination and cytogenetic examination, the diagnosis was as follows: (1) Myelodysplastic syndrome (MDS) in WHO classification system (who 2016) or myelodysplastic syndrome in FAB classification, and IPSS score >=0.5; (2) According to WHO classification system (who 2016), MDS secondary to AML, and the number of white blood cells in peripheral blood is less than or equal to 10*10^9/L; (3) ECOG score 0-3; (4) Liver and kidney function must meet the following requirements: Alanine aminotransferase (ALT) < 3 ULN; Aspartate aminotransferase (AST) <3 ULN; Serum total bilirubin was less than 1.5 ULN; Serum creatinine (SCR) < 1.5 ULN; Urea nitrogen (BUN) < 1.5 ULN; 5. Before treatment, women of childbearing age should undergo pregnancy examination and agree to take effective contraceptive measures during the treatment; male subjects should take effective contraceptive measures within 6 months after receiving or completing the treatment; 6. Subjects must sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Participants in other clinical trials within 30 days; 2. Pregnant and lactating patients; 3. Active viral or bacterial infections are not controlled by appropriate anti infective therapy; 4. The serological reaction of HIV, hepatitis B virus or active hepatitis C virus is known to be positive; 5. Suffering from mental disorders or other conditions and unable to meet the requirements of research, treatment and monitoring; 6. Bone marrow aspiration was performed; 7. Those who are known to be allergic to any component of the protocol; 8. Have received azacytidine or decitabine treatment, or received allogeneic hematopoietic stem cell transplantation in the past year; 9. Patients with severe liver and kidney function damage without improvement after treatment, or liver cirrhosis or malignant liver tumor 10. Severe congestive heart failure is known; 11. Chronic obstructive pulmonary disease with severe restrictive ventilation dysfunction; 12. Severe and / or uncontrolled other medical conditions (such as uncontrolled diabetes, hypertension, solid tumors, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| routine blood test;Bone marrow cytologic examination;Molecular genetic examination; | — |
Countries
China
Contacts
Public ContactYanhui Xie
Huadong Hospital Affiliated to Fudan University
Outcome results
None listed