A Study of Azacitidine for Patients With Int/High -Risk MDS and AML-MRC

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shandong Provincial Hospital
• Treatments: Azacitidine

Criteria

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.