Myelodysplastic syndrome
Conditions
Interventions
Case series:Decitabine: 0.1 to 0.2 mg/kg Subcutaneous injection 2 times a week x 4 weeks Compound Huangqi Tablets: 60mg/kg/d, divided into three oral doses
Sponsors
Henan Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18-70 years, male or female; 2) MDS patients diagnosed according to the 2008 World Health Organization (WHO) diagnosis of myeloid malignant disease; 3) MDS International Prognostic Points System (IPSS or IPSS-R) or WPSS scores for patients with moderate to high risk MDS; 4) The ECOG behavior status score is 0-2 points; 5) Expected survival time = 3 months; 6) No serious heart, lung, liver or kidney disease; 7) No treatment such as radiotherapy, chemotherapy, targeted therapy or hematopoietic stem cell transplantation was performed within 2 weeks before enrollment; 8) Bridged treatment before allogeneic hematopoietic stem cell transplantation (allo-ASCT) or allo-ASCT is not possible for various reasons; 9) Ability to understand and be willing to sign the informed consent form of this trial.
Exclusion criteria
Exclusion criteria: 1) Used to be allergic to the drugs contained in the protocol or to drugs similar in chemical structure to the test drug; 2) Pregnant, lactating women and women of childbearing age who are unwilling to take contraceptive measures; 3) There are serious active infections; 4) Patients who use drugs and long-term alcohol abuse to influence the evaluation of test results; 5) Inability to obtain informed consent for mental illness or other conditions cannot be combined with the requirements for completing the trial treatment and examination procedures; 6) Patients with clinically significant QTc interval prolongation (male > 450ms, female > 470ms), ventricular tachycardia (VT), atrial fibrillation (AF), grade II or higher heart block, myocardial infarction (MI) Patients with coronary heart disease who have congestive heart failure (CHF) and who are symptomatic for medical treatment within 1 year; 7) Cardiac B-ultrasound shows patients with end-diastolic pericardial cavity dark area width =10mm; 8) Patients undergoing organ transplantation; 9) Patients with active bleeding; 10) Patients with new diseases such as thrombosis, embolism, and cerebral hemorrhage in the past half year; 11) less than 6 weeks after major organ surgery; 12) Abnormal liver function (total bilirubin > 1.5 times the upper limit of normal value, 2.5 times the upper limit of ALT / AST > normal value or 5 times the upper limit of ALT / AST > normal value of liver-infested patients), abnormal renal function (serum Creatinine > 1.5 times the upper limit of normal); 13) The investigator determined that it was not suitable for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Countries
China
Contacts
Public ContactWei Xudong
He'nan Cancer Hospital
Outcome results
None listed