Actively Recruiting
Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Based DCMG Regimen for R/R AML
Led by Beijing 302 Hospital · Updated on 2024-12-27
20
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The DCMG regimen includes decitabine or azacitidine (hypomethylating agents), mitoxantrone liposome, cytarabine, and granulocyte colony-stimulating factor (G-CSF), comprising four medications. This project initiates a prospective and exploratory clinical study on the DCMG chemotherapy regimen for the treatment of relapsed/refractory AML (Acute Myeloid Leukemia). The study aims to evaluate the efficacy and safety of the DCMG combination chemotherapy regimen in treating relapsed/refractory AML.
CONDITIONS
Official Title
Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Based DCMG Regimen for R/R AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has fully understood the study and voluntarily agrees to participate with signed informed consent
- Age between 18 and 75 years, any gender
- Diagnosed with relapsed or refractory Acute Myeloid Leukemia (AML), including minimal residual disease positivity
- Serum total bilirubin no more than 1.5 times the upper limit of normal
- Serum ALT and AST no more than 2.5 times the upper limit of normal
- Serum creatinine no more than 1.5 times the upper limit of normal
- Left ventricular ejection fraction (LVEF) of 50% or higher
- Estimated survival time of at least 3 months
- ECOG performance status score between 0 and 2
You will not qualify if you...
- Previously received mitoxantrone or mitoxantrone liposome injection
- Previously received doxorubicin or other anthracyclines with a total dose over 360 mg/m2 (or equivalent)
- Long QTc syndrome or QTc interval over 480 ms
- Complete left bundle branch block or second- or third-degree atrioventricular block
- Severe uncontrolled arrhythmia requiring medication
- NYHA heart failure class II or higher
- Ejection fraction below 50% or below normal lab limits
- History of recent heart attack, unstable angina, severe arrhythmias, significant pericardial disease, or recent ECG abnormalities within 6 months
- Major surgery, radiotherapy, chemotherapy, biological therapy, immunotherapy, or experimental treatment within 2 weeks before study drug
- Uncontrolled systemic diseases such as infections, hypertension, or diabetes
- Previous or current other malignancies except certain controlled skin or carcinoma in situ cancers
- Active hepatitis B or C infection with high viral load
- HIV infection
- Pregnant or breastfeeding women or those refusing contraception during the study
- Significant neurological or psychiatric history
- Investigator deems patient unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, China
Actively Recruiting
Research Team
D
Dr. Gao Xiaoning, Chief Physician, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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