Tests a drug combination in adults with relapsed or hard-to-treat acute myeloid leukemia
Tests a combination chemotherapy regimen in adults with relapsed or refractory acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Based DCMG Regimen for R/R AML
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 75 whose acute myeloid leukemia (AML) has come back, has not responded to treatment, or still shows traces of disease (MRD positive).
- Age
- 18 to 75 years
- Sex
- All sexes can join.
- Disease stage
- Relapsed or refractory acute myeloid leukemia (AML), or AML with minimal residual disease (MRD) positivity, confirmed by pathology.
- Earlier treatment
- People who had mitoxantrone or mitoxantrone hydrochloride liposome before cannot join. Doxorubicin or other anthracyclines above a total of 360 mg/m² (doxorubicin equivalent) are not allowed. No major surgery, radiotherapy, chemotherapy, biological therapy, immunotherapy or experimental treatment within 2 weeks before the first dose.
Main reasons for not taking part
- Serious heart problems, such as QTc over 480 ms, heart block, NYHA class II or higher, or ejection fraction under 50%
- Heart attack, unstable angina or other heart events within 6 months before enrolment
- Another cancer now or before (with a few exceptions)
- Active hepatitis B or C infection, or HIV infection
- Pregnant or breastfeeding women, or refusing effective contraception
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06741722, who can take part
Where in China
- Chinese PLA General HospitalBeijing, ChinaContact: Lei XuTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Beijing 302 Hospital
- Trial code
- NCT06741722
- Record updated
- 27 December 2024
- Original description
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.Read full original descriptionShow less
Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Based DCMG Regimen for Relapsed/refractory Acute Myeloid Leukemia
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.
Inclusion: The patient has fully understood the study, voluntarily agrees to participate, and has signed the Informed Consent Form (ICF); Age between 18 and 75 years, with no gender restrictions; Confirmed diagnosis of relapsed/refractory AML (Acute Myeloid Leukemia) by pathology (meeting any one of the following criteria):; Patients who meet the diagnostic criteria for acute myeloid leukemia (AML) with minimal residual disease (MRD) positivity; Or patients who meet the diagnostic criteria for recurrent AML, or refractory AML; Serum total bilirubin ≤ 1.5 times the upper limit of normal, serum ALT and AST both ≤ 2.5 times the upper limit of the normal range, serum creatinine ≤ 1.5 times the upper limit of normal; Echocardiogram showing left ventricular ejection fraction (LVEF) ≥ 50%; Estimated survival time ≥ 3 months; ECOG performance status score of 0-2.
Exclusion: The subject's prior anti-tumor treatment history meets one of the following conditions:; Previously received mitoxantrone or mitoxantrone hydrochloride liposome injection; Previously received doxorubicin or other anthracyclines, with a total cumulative dose of doxorubicin > 360 mg/m² (other anthracycline drugs are converted at a ratio of 1 mg doxorubicin equivalent to 2 mg daunorubicin or 0.5 mg idarubicin); Underwent any major surgery, radiotherapy, chemotherapy, biological therapy, immunotherapy, or experimental treatment within 2 weeks before the first administration of the study drug; Previous or current diagnosis of other malignancies (excluding adequately controlled basal cell carcinoma of the skin that is non-melanoma, breast/cervical carcinoma in situ, or other malignancies that have been adequately controlled without treatment in the past five years); Uncontrolled systemic diseases (such as progressive infections, uncontrolled hypertension, diabetes, etc.); Active hepatitis B or C infection during the viremic phase (Hepatitis B testing: if either HBsAg or core antibody is positive, add HBV-DNA testing; viral DNA levels exceeding 1x10\^3 copies/mL; Hepatitis C testing: if HCV antibody is positive, add HCV-RNA testing; viral RNA levels exceeding 1x10\^3 copies/mL); Human Immunodeficiency Virus (HIV) infection (HIV antibody positive); Significant neurological or psychiatric history; Cardiac function and disease meet any of the following conditions:; Long QTc syndrome or QTc interval > 480 ms; Complete left bundle branch block, second-degree or third-degree atrioventricular block; Severe, uncontrolled arrhythmia requiring medication; New York Heart Association (NYHA) classification ≥ Class II; Ejection fraction (EF) < 50% or below the lower limit of normal for the study center's laboratory; History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmias, or any other arrhythmia requiring treatment, clinically significant pericardial disease, or evidence on electrocardiogram of acute ischemia or active conduction system abnormalities within 6 months prior to enrollment; Pregnant women, breastfeeding women, patients who refuse to use effective contraception during the study period; Patients deemed unsuitable for participation in this study by the investigator.