Clinical trial NCT06345365: MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)
Official title: A Prospective, Multicenter, Randomized Controlled Study on the MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Acute Myeloid Leukaemia
Keywords: Mitoxantrone liposome
Newly diagnosed AML patients
Ara-Cytarabine
Azacytidine
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
Collaborators: name: Ruijin Hospital
name: Shanxi Province Cancer Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: Jingzhou Central Hospital
name: Yichang Central People's Hospital
name: Taihe Hospital
name: Central Hospital of Xiaogan
name: Xianning Central Hospital
name: The First People's Hospital of Jingzhou
First posted: 2024-04-03
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigator proposed to apply the new dosage form of mitoxantrone hydrochloride liposomes to the clinical treatment of AML, while combining with cytarabine and azacitidine to form the MA+AZA treatment regimen(Mitoxantrone liposome +Ara-Cytarabine+Azacitidine), which would provide an optimal induction treatment regimen for patients with primary AML by comparing with the traditional chemotherapy regimen, DA+AZA (Daunorubicin+Ara-Cytarabine+Azacitidine).

Detailed description: In this study, AML patients were randomly divided into MA+AZA treatment group and DA+AZA treatment group by conducting a prospective, multicentre, exploratory, randomised controlled study. By observing the efficacy and safety of the MA+AZA combination regimen in the treatment of primary AML, and comparing the superiority of the traditional regimen, high-quality clinical evidence was obtained, providing practical evidence to support the improvement of the intervention effect and clinical prognosis of primary AML.

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.

Primary outcomes:
measure: Complete remission rate
timeFrame: Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)
measure: Compound CR rate
timeFrame: Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)
measure: Objective remission rate
timeFrame: Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)
measure: No remission rate
timeFrame: Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)
measure: Event-free survival
timeFrame: Assessment of up to 100 months from the date of randomisation to the date of first recorded progress or the date of death from any caus)
measure: Disease-free survival
timeFrame: From date of achieving remission to date of relapse or death from any cause (Assessment of up to 100 months from the date of randomisation to the date of first recorded progress or the date of death from any cause, whichever comes first)
measure: Overall survival
timeFrame: Time from the patient's first dose of medication to death from any cause (Assessment of up to 100 months from the date of randomisation to the date of first recorded progress or the date of death from any cause, whichever comes first)
measure: Mortality rate
timeFrame: 30 days, 60 days after starting treatment; Assessment of up to 100 months from the date of randomisation to the date of first recorded progress or the date of death from any cause, whichever comes first
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Huanggang
country: China
facility: The Central Hospital of Huanggang
state: Hubei
city: Jingzhou
country: China
facility: The First People's Hospital of Jingzhou
state: Hubei
city: Jingzhou
country: China
facility: Jingzhou Central Hospital
state: Hubei
city: Shiyan
country: China
facility: Shiyan Taihe Hospital
state: Hubei
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Xianning
country: China
facility: Xianning Central Hospital
state: Hubei
city: Xiaogan
country: China
facility: The Central Hospital of Xiaogan
state: Hubei
city: Yichang
country: China
facility: Yichang Central Hospital
state: Hubei
city: Wuxi
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Jiangsu
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital
state: Shanxi
Study officials:
affiliation: Wuhan University
name: Fuling Zhou
role: STUDY_DIRECTOR
References: