New treatment approach for newly diagnosed Acute Myeloid Leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates a new treatment regimen combining mitoxantrone liposome, cytarabine, and azacitidine (MA+AZA) for patients with newly diagnosed Acute Myeloid Leukemia (AML). Patients are randomly assigned to receive either the MA+AZA regimen or a traditional chemotherapy regimen (DA+AZA). The study aims to evaluate the efficacy and safety of the MA+AZA combination compared to the standard treatment, providing high-quality clinical evidence to improve outcomes for AML patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with primary AML with morphologically and immunologically confirmed diagnosis of bone marrow;
2. Age 18-75 years old;
3. Liver and renal function: serum total bilirubin ≤1.5 × upper limit of normal (ULN), AST/ALT \<2 × ULN, serum creatinine \<1.5 × ULN, 80 ml/min ≤ creatinine clearance ≤120 ml/min;
4. Cardiac function: ejection fraction EF ≥50%, ultrasensitive troponin and natriuretic peptide \<1.5 × ULN;
5. Physical condition: ECOG score 0-2;
6. Obtained informed consent signed by the patient or family.

Exclusion Criteria:

1. Allergy or significant contraindication to any of the drugs involved in the protocol;
2. Patients with concomitant myelofibrosis;
3. Severe cardiac disease, including myocardial infarction and cardiac insufficiency;
4. Concomitant malignant tumours of other organs;
5. Patients with active tuberculosis and HIV-positive patients;
6. Other blood system diseases at the same time;
7. Pregnant or breastfeeding women;
8. Inability to understand or comply with the study protocol;
9. Previous intolerance or allergy to similar drugs;
10. Concurrent participation in other clinical studies;
11. Any other condition that prevents the study from proceeding.

Where it's running

• Zhongnan Hospital of Wuhan University
  Wuhan, Hubei, China Recruiting
• The First Affiliated Hospital of Zhengzhou University
  Zhengzhou, Henan, China Not yet recruiting
• The Central Hospital of Huanggang
  Huanggang, Hubei, China Not yet recruiting
• The First People's Hospital of Jingzhou
  Jingzhou, Hubei, China Not yet recruiting
• Jingzhou Central Hospital
  Jingzhou, Hubei, China Not yet recruiting
• Shiyan Taihe Hospital
  Shiyan, Hubei, China Not yet recruiting

Study contacts

• Study coordinator: Fuling Zhou, Doctor
• Email: zhoufuling@whu.edu.cn
• Phone: 027-67813137

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.