acute myeloid leukemia
Conditions
Interventions
Treatment group:Mitoxantroquinone hydrochloride liposomes+cytarabine+vineclavone
Sponsors
Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. The patient fully understands this study and voluntarily participates and signs an informed consent form (ICF). 2. 18-60 years old with ECOG score = 2 points 3. Primary and relapsed refractory AML diagnosed clinically, except for acute promyelocytic leukemia; 1) Recurrent AML: After complete remission (CR), leukemia cells reappear in the peripheral blood or primitive cells in the bone marrow>5% (excluding other reasons such as bone marrow regeneration after consolidation chemotherapy), or leukemia cell infiltration appears outside the marrow; 2) Recurrent/refractory AML (meeting one of the following criteria is sufficient): a) Newly treated cases that have been treated with standard regimens for 2 courses but are ineffective; b) Patients who undergo consolidation and intensified treatment after CR and experience recurrence within 12 months; c) Two or more relapses; d) Individuals with persistent extramedullary leukemia; 4. Expected survival time = 3 months; 5. Liver and kidney function: alanine aminotransferase (AST) and aspartate aminotransferase (ALT) = 2.5 times the upper limit of normal value (ULN) (= 5 times the upper limit of normal value for patients with liver infiltration); Total bilirubin = 1.5 times the upper limit of normal value (= 3 times the upper limit of normal value for patients with liver infiltration); Serum creatinine = 1.5 times the upper limit of normal value;
Exclusion criteria
Exclusion criteria: 1. The subject's previous history of anti-tumor treatment meets one of the following conditions: a) Individuals who have previously received mitoxantrone or mitoxantrone liposomes; b) Previously received treatment with doxorubicin or other anthracyclines, with a total cumulative dose of doxorubicin>360 mg/m2 (1 mg of doxorubicin is equivalent to 2 mg of doxorubicin or 0.5 mg of doxorubicin); c) Within 2 weeks prior to the first use of the investigational drug, have received anti-tumor therapy (including chemotherapy, targeted therapy, etc.) or participated in other clinical trials and received clinical trial medication; 2. Heart function and disease meet one of the following conditions: a) Long QTc syndrome or QTc interval>480 ms; b) Complete left bundle branch block, II or III degree atrioventricular block; c) Severe and uncontrolled arrhythmias that require medication treatment; d) The New York College of Cardiology has a classification of = Grade II; e) The ejection fraction (EF) of the heart is less than 50%; f) A history of myocardial infarction, unstable angina, severe unstable ventricular arrhythmias, or any other arrhythmias requiring treatment, a history of clinically severe pericardial disease, or evidence of acute ischemic or active conduction system abnormalities on electrocardiogram within the 6 months prior to enrollment. 3. Has previously or currently suffered from other malignant tumors (except for effectively controlled non melanoma skin basal cell carcinoma, breast/cervical carcinoma in situ, and other malignant tumors that have not been treated and have been effectively controlled within the past five years); 4. Uncontrollable systemic diseases; (such as progressive infection, uncontrollable hypertension, diabetes, etc.); 5. Suffering from central nervous system leukemia; 6. Human immunodeficiency virus (HIV) infected individuals (HIV antibody positive); 7. Active infection of hepatitis B and hepatitis C (hepatitis B B virus surface antigen is positive and hepatitis B B virus DNA exceeds 1x103 copies/mL; hepatitis C virus RNA exceeds 1x103 copies/mL); 8. Have a known history of immediate or delayed hypersensitivity reactions to similar drugs and excipients in the study drug; Pregnant women, lactating women, and patients who refuse to take effective contraceptive measures during the study period; 10. Accompanied by a history of severe neurological or mental illness; 11. The researchers determined that patients who are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete remission rate(CRc);Objective response rate (ORR); Overall survival (OS);Disease free survival (DFS); | — |
Countries
china
Contacts
Public ContactHui Li
Sichuan Provincial People's Hospital
Outcome results
None listed