Myelodysplastic Syndrome
Conditions
Interventions
Experimental group:conventional chemotherapy
Sponsors
The First Affiliated Hospital,College of Medicine,Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Patients with myelodysplastic syndrome diagnosed according to WHO criteria, according to the revised International Prognostic Scoring System (IPSS-R) score > 3.5 (intermediate risk, high risk or very high risk); 2) The patient has been treated with demethylating drugs for 6 courses in the past, that is, the patient has not achieved remission for 6 months or relapsed after remission; 3) The age of the subjects must be =18 years old, male or non-pregnant, non-lactating female; 4) Eastern Cooperative Oncology Group (ECOG) physical status =3; 5) Healthy liver and kidney function (creatinine?3xULN, BUN?3xULN, ALT?3xULN, AST?3xULN, total bilirubin?3xULN); 6) Able to comply with the study visit schedule, and understand and comply with all trial protocol requirements; 7) Able to take oral drugs; able and willing to sign informed consent; 8) Peripheral blood total white blood cell (WBC) count = 25,000/µL (Note: hydroxyurea treatment is allowed to reduce white blood cells to meet the inclusion criteria).
Exclusion criteria
Exclusion criteria: 1) Receive any trial drug treatment within 28 days before the first day; 2) Those who have used Veneclair in the past are ineffective; 3) Any active malignancy, except focal non-metastatic squamous cell or basal cell skin cancer or carcinoma in situ; patients with a history of malignancy but have been cured (eg, no evidence of malignancy for at least 2 years) can join the group; 4) There are other clinically significant, poorly controlled systemic infections (viral, bacterial or fungal) that require treatment; 5) Life expectancy < 6 months; 6) Severe heart disease, including New York Heart Association (NYHA) class III or IV congestive heart failure, uncontrolled hypertension or hypotension, severe valve or endocardial disease, or significant renal, neurological, history of mental, endocrine, metabolic, immune, liver, cardiovascular and cerebrovascular diseases, or any other medical diseases that the investigator believes may have an adverse effect on the subjects participating in the study; 7) The subject has malabsorption syndrome or other adverse conditions that hinder the intestinal route of administration; 8) Known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection; Current alcohol and/or drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response rate;overall survival time;Incidence of disease progression; | — |
Countries
China
Contacts
Public ContactTong Hongyan
Outcome results
None listed