Trial Title:
MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)
NCT ID:
NCT06345365
Condition:
Acute Myeloid Leukaemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Cytarabine
Azacitidine
Daunorubicin
Mitoxantrone
Conditions: Keywords:
Mitoxantrone liposome
Newly diagnosed AML patients
Ara-Cytarabine
Azacytidine
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
mitoxantrone liposome, Ara-Cytarabine and azacitidine
Description:
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
Arm group label:
mitoxantrone liposome, Ara-Cytarabine and azacitidine
Intervention type:
Drug
Intervention name:
Daunorubicin,Ara-Cytarabine, azacitidine
Description:
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;
Arm group label:
Daunorubicin, Ara-Cytarabine and azacitidine
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).
Detailed 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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Zip:
450052
Country:
China
Status:
Not yet recruiting
Facility:
Name:
The Central Hospital of Huanggang
Address:
City:
Huanggang
Zip:
438000
Country:
China
Status:
Not yet recruiting
Facility:
Name:
The First People's Hospital of Jingzhou
Address:
City:
Jingzhou
Zip:
434000
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Jingzhou Central Hospital
Address:
City:
Jingzhou
Zip:
434020
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Shiyan Taihe Hospital
Address:
City:
Shiyan
Zip:
442000
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Zhongnan Hospital of Wuhan University
Address:
City:
Wuhan
Zip:
430071
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhou Fuling, director
Phone:
+86-02767813137
Email:
zhoufuling@163.com
Facility:
Name:
Xianning Central Hospital
Address:
City:
Xianning
Zip:
437100
Country:
China
Status:
Not yet recruiting
Facility:
Name:
The Central Hospital of Xiaogan
Address:
City:
Xiaogan
Zip:
432100
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Yichang Central Hospital
Address:
City:
Yichang
Zip:
443003
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Address:
City:
Wuxi
Zip:
214028
Country:
China
Status:
Not yet recruiting
Facility:
Name:
Shanxi Cancer Hospital
Address:
City:
Taiyuan
Zip:
030009
Country:
China
Status:
Not yet recruiting
Start date:
January 18, 2024
Completion date:
December 31, 2028
Lead sponsor:
Agency:
Zhongnan Hospital
Agency class:
Other
Collaborator:
Agency:
Ruijin Hospital
Agency class:
Other
Collaborator:
Agency:
Shanxi Province Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
The First Affiliated Hospital of Zhengzhou University
Agency class:
Other
Collaborator:
Agency:
Jingzhou Central Hospital
Agency class:
Other
Collaborator:
Agency:
Yichang Central People's Hospital
Agency class:
Other
Collaborator:
Agency:
Taihe Hospital
Agency class:
Other
Collaborator:
Agency:
The Central Hospital of Xiaogan
Agency class:
Other
Collaborator:
Agency:
Xianning Central Hospital
Agency class:
Other
Collaborator:
Agency:
The First People's Hospital of Jingzhou
Agency class:
Other
Source:
Zhongnan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06345365
