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| Name | Class |
|---|---|
| Ruijin Hospital | OTHER |
| Shanxi Province Cancer Hospital | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| Jingzhou Central Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mitoxantrone liposome, Ara-Cytarabine and azacitidine | Experimental | 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 and azacitidine | Active Comparator | 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; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mitoxantrone liposome, Ara-Cytarabine and azacitidine | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Compound CR rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fuling Zhou, Doctor | Contact | 027-67813137 | zhoufuling@whu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Fuling Zhou | Wuhan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | Zhengzhou | Henan | 450052 | China | |
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| OTHER |
| Yichang Central People's Hospital | OTHER |
| Taihe Hospital | OTHER |
| Central Hospital of Xiaogan | OTHER |
| Xianning Central Hospital | OTHER |
| The First People's Hospital of Jingzhou | OTHER |
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| Daunorubicin,Ara-Cytarabine, azacitidine | Drug | 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; |
|
CR+ CRi
| Efficacy evaluation at 2-3 weeks after the first cycle (each cycle is 28 days) |
| Objective remission rate | CR+CRi+MLFS+PR | 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 | 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 | 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 | 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 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. | 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 |
| The Central Hospital of Huanggang |
| Not yet recruiting |
| Huanggang |
| Hubei |
| 438000 |
| China |
| The First People's Hospital of Jingzhou | Not yet recruiting | Jingzhou | Hubei | 434000 | China |
| Jingzhou Central Hospital | Not yet recruiting | Jingzhou | Hubei | 434020 | China |
| Shiyan Taihe Hospital | Not yet recruiting | Shiyan | Hubei | 442000 | China |
| Zhongnan Hospital of Wuhan University | Recruiting | Wuhan | Hubei | 430071 | China |
|
| Xianning Central Hospital | Not yet recruiting | Xianning | Hubei | 437100 | China |
| The Central Hospital of Xiaogan | Not yet recruiting | Xiaogan | Hubei | 432100 | China |
| Yichang Central Hospital | Not yet recruiting | Yichang | Hubei | 443003 | China |
| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Not yet recruiting | Wuxi | Jiangsu | 214028 | China |
| Shanxi Cancer Hospital | Not yet recruiting | Taiyuan | Shanxi | 030009 | China |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D001374 | Azacitidine |
| ID | Term |
|---|---|
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
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