New treatment approach for newly diagnosed Acute Myeloid Leukemia

A Prospective, Multicenter, Randomized Controlled Study on the MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)

This study is testing a new combination treatment for people with newly diagnosed Acute Myeloid Leukemia to see if it works better than the usual chemotherapy.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 154 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zhongnan Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 11 sites (Zhengzhou, Henan and 10 other locations)
• Trial ID: NCT06345365 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with a confirmed diagnosis of primary AML and adequate organ function.

Not a fit: Patients with significant contraindications to the drugs involved, severe cardiac disease, or other serious health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could lead to improved induction therapy and better clinical outcomes for patients with primary AML.

How similar studies have performed: Other studies have shown promise with similar combination therapies in AML, but this specific regimen is being explored for the first time.

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.

Where this trial is running

Zhengzhou, Henan and 10 other locations

• 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)
• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)
• Xianning Central Hospital — Xianning, Hubei, China (Not_yet_recruiting)
• The Central Hospital of Xiaogan — Xiaogan, Hubei, China (Not_yet_recruiting)
• Yichang Central Hospital — Yichang, Hubei, China (Not_yet_recruiting)
• Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Wuxi, Jiangsu, China (Not_yet_recruiting)
• Shanxi Cancer Hospital — Taiyuan, Shanxi, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Fuling Zhou, Doctor

Conditions Acute Myeloid Leukaemia; Mitoxantrone liposome; Newly diagnosed AML patients; Ara-Cytarabine; Azacytidine