Safety and Efficacy of Mitoxantrone Hydrochloride Liposome Based DCMG Regimen for R/R AML
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing 302 Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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;
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;
Disqualifiers
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);
Long QTc syndrome or QTc interval > 480 ms;
Complete left bundle branch block, second-degree or third-degree atrioventricular block;
Trial design
Treatments tested in this trial
- Decitabine, Azacitidine, Mitoxantrone liposome, Cytarabine, G-CSF
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov