Actively Recruiting
MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)
Led by Zhongnan Hospital · Updated on 2024-04-10
154
Participants Needed
11
Research Sites
258 weeks
Total Duration
On this page
Sponsors
Z
Zhongnan Hospital
Lead Sponsor
R
Ruijin Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with primary AML confirmed by bone marrow morphology and immunology
- Age between 18 and 75 years
- Liver function: total bilirubin ≤1.5 times upper limit of normal (ULN), AST/ALT <2 times ULN
- Kidney function: serum creatinine <1.5 times ULN, creatinine clearance between 80 and 120 ml/min
- Cardiac function: ejection fraction ≥50%, ultrasensitive troponin and natriuretic peptide <1.5 times ULN
- Physical condition with ECOG score 0 to 2
- Signed informed consent obtained from patient or family
You will not qualify if you...
- Allergy or significant contraindication to any study drugs
- Presence of myelofibrosis
- Severe cardiac disease including myocardial infarction or cardiac insufficiency
- Other malignant tumors in different organs
- Active tuberculosis or HIV-positive status
- Other blood system diseases concurrently
- Pregnant or breastfeeding women
- Inability to understand or follow the study protocol
- Previous intolerance or allergy to similar drugs
- Participation in other clinical studies concurrently
- Any other condition preventing study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Not Yet Recruiting
2
The Central Hospital of Huanggang
Huanggang, Hubei, China, 438000
Not Yet Recruiting
3
The First People's Hospital of Jingzhou
Jingzhou, Hubei, China, 434000
Not Yet Recruiting
4
Jingzhou Central Hospital
Jingzhou, Hubei, China, 434020
Not Yet Recruiting
5
Shiyan Taihe Hospital
Shiyan, Hubei, China, 442000
Not Yet Recruiting
6
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430071
Actively Recruiting
7
Xianning Central Hospital
Xianning, Hubei, China, 437100
Not Yet Recruiting
8
The Central Hospital of Xiaogan
Xiaogan, Hubei, China, 432100
Not Yet Recruiting
9
Yichang Central Hospital
Yichang, Hubei, China, 443003
Not Yet Recruiting
10
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Wuxi, Jiangsu, China, 214028
Not Yet Recruiting
11
Shanxi Cancer Hospital
Taiyuan, Shanxi, China, 030009
Not Yet Recruiting
Research Team
F
Fuling Zhou, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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