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)

Overview

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.

Interventions

• Drug mitoxantrone liposome, Ara-Cytarabine and azacitidine
  Mitoxantrone hydrochloride liposome 24 mg/m2, IV every 4 weeks, day 1; Ara-Cytarabine 100 mg/m2, IV every 12 h, days 1-7; Azacitidine 100 mg, subcutaneous, once daily, days 1 to 7
• Drug Daunorubicin,Ara-Cytarabine, azacitidine
  Daunorubicin 60 mg/m2, intravenously, once daily, days 1 to 3; Ara-Cytarabine 100 mg/m2, IV drip, every 12h, days 1 to 7; Azacitidine 100 mg, subcutaneous, once daily, days 1 to 7;

Primary outcome measures

• Complete remission rate [Time frame: Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)]

Secondary outcome measures (8)

• Incidence of adverse events [Time frame: Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)]
• Compound CR rate [Time frame: Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)]
• Objective remission rate [Time frame: Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)]
• No remission rate [Time frame: Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)]
• Event-free survival [Time frame: 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)]
• Disease-free survival [Time frame: 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)]
• Overall survival [Time frame: 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)]
• Mortality rate [Time frame: 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]

Eligibility criteria

Inclusion criteria

• Patients with primary AML with morphologically and immunologically confirmed diagnosis of bone marrow;
• Age 18-75 years old;
• 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;
• Cardiac function: ejection fraction EF ≥50%, ultrasensitive troponin and natriuretic peptide <1.5 × ULN;
• Physical condition: ECOG score 0-2;
• Obtained informed consent signed by the patient or family.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 11 centers

• The First Affiliated Hospital of Zhengzhou University — Zhengzhou
• The Central Hospital of Huanggang — Huanggang
• The First People's Hospital of Jingzhou — Jingzhou
• Jingzhou Central Hospital — Jingzhou
• Shiyan Taihe Hospital — Shiyan
• Zhongnan Hospital of Wuhan University — Wuhan
• Xianning Central Hospital — Xianning
• The Central Hospital of Xiaogan — Xiaogan
• … and 3 more centers

Identifiers

NCT: NCT06345365 · 09

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗