Myelodysplastic Syndromes,Acute Myeloid Leukemia Clinical Trial
Official title:
An Randomized Controlled Study of Azacitidine Combined With Homoharringtonine Compared With Azacitidine for Patients With Int/High -Risk MDS and AML-MRC
evaluate the clinical efficacy and safety of azacitidine combined with HAG regimen for patients with int/high -risk MDS and AML-MRC with less than 30% blasts compared with azacitidine
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2022 |
Est. primary completion date | June 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Aged between 18-75 years old, male or female; 2. Int/high risk MDS AND AML patients (non-AML-M3) diagnosed according to the 2008 World Health Organization (WHO) diagnosis of myeloid malignant disease; 3. The ECOG behavior status score is 0-3 points; 4. The expected survival time is = 3 months; 5. Ability to understand and be willing to sign the informed consent form of this trial. Exclusion Criteria: 1. In the past, allergy to the drug contained in the test protocol or to a drug similar to the chemical structure of the test drug; 2. There are serious active infections; 3. 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) within 1 year and who are symptomatic for medical treatment; 4. Heart B-ultrasound shows patients with end-diastolic pericardial cavity dark area width = 10mm; 5. Patients with active bleeding; 6. Patients with new diseases such as thrombosis, embolism and cerebral hemorrhage in the past six months; 7. 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 in patients with liver invasion), abnormal renal function (serum Creatinine > 1.5 times the upper limit of normal); 8. The investigator determined that it was not suitable for the participants. |
Country | Name | City | State |
---|---|---|---|
China | Shandong Provincial Hospital | Jinan | Shandong |
Lead Sponsor | Collaborator |
---|---|
Shandong Provincial Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease free survival | 3 years |