Actively Recruiting
A Prospective, Multicenter, Randomized Controlled Study on the 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
104 weeks
Total Duration
On this page
Sponsors
Z
Zhongnan Hospital
Lead Sponsor
R
Ruijin Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment regimen called MA+AZA, which combines mitoxantrone hydrochloride liposomes with cytarabine and azacitidine, for adults newly diagnosed with primary Acute Myeloid Leukemia (AML). This study compares the MA+AZA regimen with the traditional DA+AZA chemotherapy regimen to assess their effectiveness and safety in improving treatment outcomes for AML patients. The trial is a prospective, multicenter, randomized controlled study aiming to provide high-quality clinical evidence to improve AML treatment and prognosis. Participants are randomly assigned to one of two treatment groups. The MA+AZA group receives mitoxantrone hydrochloride liposome 24 mg/m2 intravenously on day 1 every 4 weeks, cytarabine 100 mg/m2 intravenously every 12 hours for 7 days, and azacitidine 100 mg subcutaneously once daily for 7 days. The comparison group receives daunorubicin 60 mg/m2 intravenously once daily for 3 days, cytarabine 100 mg/m2 intravenously every 12 hours for 7 days, and azacitidine 100 mg subcutaneously once daily for 7 days. Each treatment cycle lasts 28 days. During the study, participants undergo evaluations including complete remission rates 2 to 3 weeks after the first treatment cycle. Researchers also monitor adverse events, remission rates, survival times, and mortality up to 100 months after randomization. Regular assessments include blood tests and physical health evaluations. The study lasts for multiple cycles and includes long-term follow-up to assess the overall impact of the treatments on patient survival and disease progression.
CONDITIONS
Brief 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 old
- Liver and kidney function within specified normal limits (bilirubin, AST/ALT, creatinine, creatinine clearance)
- Cardiac function with ejection fraction 50% or higher and specific heart biomarkers within limits
- Physical condition with ECOG score between 0 and 2
- Signed informed consent by patient or family
You will not qualify if you...
- Allergy or significant contraindication to any study drugs
- Presence of myelofibrosis
- Severe heart disease including myocardial infarction or heart failure
- Other active malignant tumors
- Active tuberculosis or HIV infection
- Other blood system diseases
- Pregnant or breastfeeding women
- Unable to understand or follow the study protocol
- Previous intolerance or allergy to similar drugs
- Participation in other clinical studies
- Any other condition preventing study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Each treatment cycle is 28 days
Participants receive either the MA+AZA regimen or the DA+AZA regimen, which includes intravenous and subcutaneous drug administration over a treatment cycle.
1 visit for drug administration on Day 1; drug administration on days 1 to 7 as scheduled during the 28-day cycle
Duration - Up to 100 months
Participants are evaluated for remission, survival, and adverse events up to 100 months after randomization to monitor long-term outcomes.
Periodic visits for assessments during follow-up
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
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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