A Phase 3 interventional study of mitoxantrone liposome, Ara-Cytarabine and azacitidine and Daunorubicin,Ara-Cytarabine, azacitidine in Acute Myeloid Leukaemia, sponsored by Zhongnan Hospital. Recruiting at 11 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-10.
Sponsored by Zhongnan Hospital · Phase 3, Interventional, and Treatment
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).
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 154 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Zhongnan Hospital is the lead sponsor of 103 studies on the registry; 48 are open to participants now.
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Exclusion Criteria:
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: mitoxantrone liposome, Ara-Cytarabine and 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;
Drug: Daunorubicin,Ara-Cytarabine, 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
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;
Complete remission rate
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.
Time frame: Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)
Incidence of adverse events
Incidence of adverse events, e.g., GI adverse reactions, cardiotoxicity, etc.
Time frame: Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)
Compound CR rate
CR+ CRi
Time frame: Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)
Objective remission rate
CR+CRi+MLFS+PR
Time frame: Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)
No remission rate
Patients not meeting criteria for CR, CRi, MLFS or PR
Time frame: Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)
Event-free survival
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
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
For patients achieving CR or CRi only, from the date of achieving remission to the date of relapse or death from any cause
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
The time from the patient's first dose of medication to the time of death from any cause.
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
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.
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
Plan to share: No
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Zhongnan Hospital