Compares two drug combinations for newly diagnosed acute myeloid leukemia
Tests a liposome mitoxantrone combination against standard chemotherapy in adults with leukemia.
Plain-language title generated from the registry record
Registry title: MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)
Key facts
- Where
- Huanggang, Jingzhou, Shiyan, Taiyuan, Wuhan, Wuxi, Xianning, Xiaogan, Yichang, and Zhengzhou, ChinaSee the 11 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with newly diagnosed acute myeloid leukemia (AML) who have not been treated before, to compare two chemotherapy combinations.
- Age
- 18 to 75 years old
- Sex
- All sexes can join
- Disease stage
- Primary AML, confirmed by bone marrow tests; physical condition (ECOG score) 0-2
Main reasons for not taking part
- Myelofibrosis at the same time
- Severe heart disease, such as a heart attack or heart failure
- Another cancer in a different organ
- Active tuberculosis or HIV-positive
- Pregnant or breastfeeding women
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06345365, who can take part
Where in China
- The Central Hospital of HuanggangHuanggang, ChinaContact: Fuling Zhou, DoctorNot yet recruiting
- Jingzhou Central HospitalJingzhou, ChinaContact: Fuling Zhou, DoctorNot yet recruiting
- The First People's Hospital of JingzhouJingzhou, ChinaContact: Fuling Zhou, DoctorNot yet recruiting
- Shiyan Taihe HospitalShiyan, ChinaContact: Fuling Zhou, DoctorNot yet recruiting
- Shanxi Cancer hospitalTaiyuan, ChinaContact: Fuling Zhou, DoctorNot yet recruiting
- Zhongnan Hospital of Wuhan UniversityWuhan, ChinaContact: Zhou Fuling, directorTaking people
- Ruijin Hospital, Shanghai Jiaotong University School of MedicineWuxi, ChinaContact: Fuling Zhou, DoctorNot yet recruiting
- Xianning Central HospitalXianning, ChinaContact: Fuling Zhou, DoctorNot yet recruiting
- The Central Hospital of XiaoganXiaogan, ChinaContact: Fuling Zhou, DoctorNot yet recruiting
- Yichang Central HospitalYichang, ChinaContact: Fuling Zhou, DoctorNot yet recruiting
- The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaContact: Fuling Zhou, DoctorNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Zhongnan Hospital
- Trial code
- NCT06345365
- Record updated
- 10 April 2024
- Original description
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).Read full original descriptionShow less
A Prospective, Multicenter, Randomized Controlled Study on the 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).
Inclusion: 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: Patients with concomitant myelofibrosis; Concomitant malignant tumours of other organs; Previous intolerance or allergy to similar drugs; Concurrent participation in other clinical studies; Allergy or significant contraindication to any of the drugs involved in the protocol; Severe cardiac disease, including myocardial infarction and cardiac insufficiency; Patients with active tuberculosis and HIV-positive patients; Other blood system diseases at the same time; Any other condition that prevents the study from proceeding; Pregnant or breastfeeding women; Inability to understand or comply with the study protocol.