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NCT Number: NCT06345365

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

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).

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Key information

Conditions

Acute Myeloid Leukaemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mitoxantrone liposome, Ara-Cytarabine and azacitidine

Drug

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

Daunorubicin,Ara-Cytarabine, azacitidine

Drug

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 outcomes

  1. Complete remission rate

    Time frame: Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)

    Bone marrow primitive cells <5%, no primitive cells with Auer vesicles, no primitive cells in the peripheral blood, no extramedullary leukaemia, neutrophil count ≥1.0×109/L, platelet count ≥100×109/L.

Secondary outcomes

  1. Incidence of adverse events

    Time frame: Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)

    Incidence of adverse events, e.g., GI adverse reactions, cardiotoxicity, etc.

  2. Compound CR rate

    Time frame: Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)

    CR+ CRi

  3. Objective remission rate

    Time frame: Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)

    CR+CRi+MLFS+PR

  4. No remission rate

    Time frame: Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)

    Patients not meeting criteria for CR, CRi, MLFS or PR

  5. 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)

    From the date of the patient's first dose to the date of treatment failure,haematological relapse after CR/CRi or all-cause mortality, whichever occurs first

  6. 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)

    For patients achieving CR or CRi only, from the date of achieving remission to the date of relapse or death from any cause

  7. 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)

    The time from the patient's first dose of medication to the time of death from any cause.

  8. 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

    Early deaths: all-cause deaths within the timeframe associated with study treatment (e.g., 30 days, 60 days after starting treatment); Cumulative deaths: deaths within the period from the date of achieving remission to the date of no prior relapse for patients achieving CR or CRi only.

Study contacts

Contact information is provided by the study sponsor or research team.

Fuling Zhou, Doctor

CONTACT

[email protected]

027-67813137

Sponsors and collaborators

Lead sponsor

Zhongnan Hospital

Other

Collaborators

  • Central Hospital of Xiaogan
  • Jingzhou Central Hospital
  • Ruijin Hospital
  • Shanxi Province Cancer Hospital
  • Taihe Hospital
  • The First Affiliated Hospital of Zhengzhou University
  • The First People's Hospital of Jingzhou
  • Xianning Central Hospital
  • Yichang Central People's Hospital

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Apr 3, 2024
Registry last updated
Apr 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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