Myelodysplastic syndromes
Conditions
Interventions
experimental group:Selinexor combined with azacytidine
Sponsors
The First Affiliated Hospital of Zhejiang University
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1)Patients diagnosed as myelodysplastic syndrome with EB1 or EB2 according to WHO criteria; 2)=18 years old; 3) ECOG score = 2; 4) Life expectancy > 6 months; 5) Good liver and kidney function (ALT=2*ULN, AST=2* ULN, total bilirubin=1.5 * ULN; creatinine<176µmol/l) 6) Patients who are not suitable or willing to undergo hematopoietic stem cell transplantation; 7) Signed informed consent.
Exclusion criteria
Exclusion criteria: 1)Receiving any investigational drug treatment within 28 days before enrollment; 2)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 who have been cured (e.g., no evidence of malignancy for at least 2 years) can be enrolled; 3)There are other clinically significant, poorly controlled systemic infections (viral, bacterial or fungal) that require treatment; 4)Pregnant or lactating women; 5)There are serious heart diseases, including class III or IV congestive heart failure of the New York Heart Association (NYHA), uncontrollable hypertension or hypotension, or serious valve or endocardial disease, or significant history of kidney, nervous system, mental, endocrine, metabolism, immunity, liver, cardio cerebrovascular disease, or any other medical disease that the investigator believes may have adverse effects on the subject's participation in the study; 6)The subject has malabsorption syndrome or other adverse conditions that hinder the route of intestinal administration; 7)Human immunodeficiency virus (HIV), active hepatitis B or hepatitis C infection; 8)Current abuse of alcohol and or drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maximum tolerable dose;Recommended dose for phase II;Overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety or tolerability;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactHongyan Tong
The First Affiliated Hospital of Zhejiang University
Outcome results
None listed