Acute Myeloid Leukaemia
Conditions
Keywords
Mitoxantrone liposome, Newly diagnosed AML patients, Ara-Cytarabine, Azacytidine
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.
Interventions
DRUGmitoxantrone 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
DRUGDaunorubicin,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;
Sponsors
Ruijin Hospital
Shanxi Province Cancer Hospital
The First Affiliated Hospital of Zhengzhou University
Jingzhou Central Hospital
Yichang Central People's Hospital
Taihe Hospital
Central Hospital of Xiaogan
Xianning Central Hospital
The First People's Hospital of Jingzhou
Zhongnan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete remission rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Objective remission rate | Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days) | CR+CRi+MLFS+PR |
| Incidence of adverse events | 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. |
| No remission rate | 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 |
| Compound CR rate | Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days) | CR+ CRi |
| Disease-free survival | 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 |
| Overall survival | 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. |
| Mortality rate | 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. |
| Event-free survival | 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 |
Countries
China
Contacts
Primary ContactFuling Zhou, Doctor
Outcome results
None listed