MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)

Launched by ZHONGNAN HOSPITAL · Mar 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients with newly diagnosed Acute Myeloid Leukemia (AML), which is a type of blood cancer. The researchers are testing a combination of a special form of a drug called mitoxantrone liposome, along with two other medications, cytarabine and azacitidine. This new treatment, known as the MA+AZA regimen, will be compared to a traditional chemotherapy treatment called DA+AZA to see which is more effective in helping patients with AML.

To be eligible for the trial, participants need to be between 18 and 75 years old and have a confirmed diagnosis of AML. They should also have good liver and kidney function and be in decent physical shape. The trial is currently looking for volunteers, and those who join will receive the new treatment and be monitored closely for its effects. It’s important to note that certain conditions, like severe heart issues or other active cancers, may prevent someone from participating. Overall, this trial aims to find a potentially better treatment option for patients dealing with this challenging disease.

Gender

ALL

Eligibility criteria

• 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.