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

NCT06345365 · Zhongnan Hospital
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Official title
A Prospective, Multicenter, Randomized Controlled Study on the MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)
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.
Eligibility criteria
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.
Study design
Enrollment target: 154 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2024-01-18
Estimated completion: 2028-12-31
Last updated: 2024-04-10
Interventions
Drug: mitoxantrone liposome, Ara-Cytarabine and azacitidineDrug: Daunorubicin,Ara-Cytarabine, azacitidine
Primary outcomes
  • Complete remission rate (Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days))
Sponsor
Zhongnan Hospital · other
With: 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
Contacts & investigators
ContactFuling Zhou, Doctor · contact · zhoufuling@whu.edu.cn · 027-67813137
InvestigatorFuling Zhou · study_director, Wuhan University
All locations (11)
The First Affiliated Hospital of Zhengzhou UniversityNot Yet Recruiting
Zhengzhou, Henan, China
The Central Hospital of HuanggangNot Yet Recruiting
Huanggang, Hubei, China
The First People's Hospital of JingzhouNot Yet Recruiting
Jingzhou, Hubei, China
Jingzhou Central HospitalNot Yet Recruiting
Jingzhou, Hubei, China
Shiyan Taihe HospitalNot Yet Recruiting
Shiyan, Hubei, China
Zhongnan Hospital of Wuhan UniversityRecruiting
Wuhan, Hubei, China
Xianning Central HospitalNot Yet Recruiting
Xianning, Hubei, China
The Central Hospital of XiaoganNot Yet Recruiting
Xiaogan, Hubei, China
Yichang Central HospitalNot Yet Recruiting
Yichang, Hubei, China
Ruijin Hospital, Shanghai Jiaotong University School of MedicineNot Yet Recruiting
Wuxi, Jiangsu, China
Shanxi Cancer HospitalNot Yet Recruiting
Taiyuan, Shanxi, China