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

Acute Myeloid Leukaemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06345365
• Other study ID #: 09
• Status: Recruiting
• Phase: Phase 3
• Start date: January 18, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: January 2024
• Source: Zhongnan Hospital
• Contact: Fuling Zhou, Doctor
• Phone: 027-67813137
• Email: zhoufuling[@]whu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 154
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukaemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

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
• 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;

Locations

Country	Name	City	State
China	The Central Hospital of Huanggang	Huanggang	Hubei
China	Jingzhou Central Hospital	Jingzhou	Hubei
China	The First People's Hospital of Jingzhou	Jingzhou	Hubei
China	Shiyan Taihe Hospital	Shiyan	Hubei
China	Shanxi Cancer Hospital	Taiyuan	Shanxi
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Wuxi	Jiangsu
China	Xianning Central Hospital	Xianning	Hubei
China	The Central Hospital of Xiaogan	Xiaogan	Hubei
China	Yichang Central Hospital	Yichang	Hubei
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (10)

Lead Sponsor	Collaborator
Zhongnan Hospital	Jingzhou Central Hospital, Ruijin Hospital, Shanxi Province Cancer Hospital, Taihe Hospital, The Central Hospital of Xiaogan, The First Affiliated Hospital of Zhengzhou University, The First People's Hospital of Jingzhou, Xianning Central Hospital, Yichang Central People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)
Secondary	Incidence of adverse events	Incidence of adverse events, e.g., GI adverse reactions, cardiotoxicity, etc.	Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)
Secondary	Compound CR rate	CR+ CRi	Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)
Secondary	Objective remission rate	CR+CRi+MLFS+PR	Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)
Secondary	No remission rate	Patients not meeting criteria for CR, CRi, MLFS or PR	Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days)
Secondary	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	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)
Secondary	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	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)
Secondary	Overall survival	The time from the patient's first dose of medication to the time of death from any cause.	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)
Secondary	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.	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