Acute myeloid leukemia
Conditions
Interventions
Experimental group:Mitoxantrone hydrochloride liposome: 24mg/m^2, i.v.drip, d1
Cytarabine: 100mg/m^2, civ, d1-7
Every 4 weeks is a cycle, totaling 2 cycles.
Sponsors
Sun Yat-Sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients fully understand the study, voluntarily participate and sign an informed consent form (ICF); 2. Aged 18 -75 years (including the boundary values 18 and 75), and fit for intensive chemotherapy; 3. Patients with newly diagnosed AML or MDS/AML confirmed by the 2022 International Consensus Classification (ICC) or World Health Organization (WHO) criteria, and meeting any of the following criteria: (1) Treatment-related AML; (2) Have a history of MDS; (3) Accompanied by MDS-related gene/chromosome abnormalities; (4) Previous history of CMML; 4. ECOG PS score: 0~2 points; 5. Expected survival time >= 3 months; 6. Liver and kidney function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3 times the upper limit of normal (ULN) (<= 5 times the upper limit of normal for patients with liver infiltration); Total bilirubin <= 1.5 times the upper limit of normal (<= 3 times the upper limit of normal for patients with hepatic infiltration); Serum creatinine <= 1.5 times the upper limit of normal value; 7. Treatment for MDS (other than blood transfusion) must be completed 2 weeks before the start of study therapy; In the case of rapidly proliferating diseases, hydroxyurea is permitted until 24 hours before the start of the investigatory treatment. Toxicity associated with previous MDS treatment must return to grade 2 or below before study treatment can begin.
Exclusion criteria
Exclusion criteria: 1. Acute promyelocytic leukemia (APL); 2. The subject's previous history of anti-tumor therapy meets one of the following conditions: (1) Previously received mitoxantrone or mitoxantrone liposomes; (2) Had previously received doxorubicin or anthracycline treatment, and the total cumulative dose of doxorubicin was > 360mg/m2 (1 mg of doxorubicin was equivalent to 2 mg of daunorubicin or 0.5 mg of daunorubicin for other anthracyclines); (3) Within 4 weeks before the first use of the drug in this study or within 5 half-lives of the drug, have received anti-tumor therapy including surgery, chemotherapy, targeted therapy, etc., or participated in other clinical trials and received clinical trial drugs; 3. Heart function and disease meet one of the following conditions: (1) Long QTc syndrome or QTc interphase > 480 ms; (2) Complete left bundle branch block, degree II or III atrioventricular block; (3) Severe, uncontrolled arrhythmias requiring medical treatment; (4) New York College of Cardiology Grade >= II; (5) Cardiac ejection fraction (LVEF) less than 50%; (6) A history of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically serious pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities within the 6 months prior to recruitment; 4. Concurrent with other uncontrolled malignancies (except for non-melanoma basal cell carcinoma of the skin that is effectively controlled, breast/cervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment in the past 6 months or more, and in patients receiving long-term non-chemotherapy therapy such as hormone therapy); 5. Uncontrollable systemic diseases (such as advanced infections, uncontrolled hypertension, diabetes, etc.); 6. Suffering from central nervous system leukemia; 7. In addition to CMML, there is a myeloproliferative tumor (MPN) (defined as a history of primary thrombocythemia or polycythemia realis or idiopathic myelofibrosis prior to the diagnosis of AML) or a combined history of MDS/MPN; 8. Persons infected with human immunodeficiency virus (HIV) (HIV antibody positive); 9. Hepatitis B, hepatitis C active stage infection (hepatitis B surface antigen or core antibody positive, add HBV-DNA test, HBV-DNA more than 1x103 copies /mL excluded; HCV RNA was tested for positive hepatitis C antibody, and HCV RNA exceeding 1x103 copies /mL was excluded; 10. A known history of immediate or delayed hypersensitivity to similar drugs and excipients of the investigational drug; 11. Accompanied by a serious neurological or psychiatric history; 12. The researcher judged that there were some patients who were not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Response; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate, ORR;Overall survival;Recurrent free survival;Evaluatable residual lesion negative conversion rate;Safety: Hematological and non hematological toxicity;Evaluation of exploratory biomarkers;Event free survival; | — |
Countries
China
Contacts
Public ContactLiang Yang
Sun Yat-Sen University Cancer Center
Outcome results
None listed