Actively Recruiting
Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Based DCMG Chemotherapy Regimen for Relapsed or Refractory Acute Myeloid Leukemia
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
Researchers are investigating the safety and effectiveness of the DCMG chemotherapy regimen, which includes decitabine or azacitidine (hypomethylating agents), mitoxantrone liposome, cytarabine, and granulocyte colony-stimulating factor (G-CSF), for treating adults with relapsed or refractory Acute Myeloid Leukemia (AML). This is a Phase 2 exploratory clinical study focusing on patients who have AML that has returned or not responded to previous treatment. The DCMG regimen is given in cycles lasting 4 weeks each. Mitoxantrone hydrochloride liposome is administered intravenously on Day 1 at 15 mg/m². Decitabine is given intravenously at 20 mg/m² on Days 1 to 5, or azacitidine at 75 mg/m² on Days 1 to 7. Cytarabine is injected intravenously every 12 hours on Days 1 to 5, with a lower dose for patients with hypoplastic bone marrow. G-CSF or pegylated recombinant human granulocyte stimulating factor is given by subcutaneous injection starting on Day 0 until white blood cell counts exceed a set threshold. Participants may receive one or two cycles of this treatment. During the study, participants will be monitored to assess the complete remission rate at the end of the second cycle. Evaluations will include safety checks and effectiveness measures. The study involves detailed laboratory tests, heart function assessments, and regular monitoring of blood counts and overall health to ensure safety and track responses to treatment. The total age range for participants is 18 to 75 years, with follow-up throughout the treatment period.
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
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Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, China
Actively Recruiting
Research Team
D
Dr. Gao Xiaoning, Chief Physician, Professor
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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