acute myeloid leukemia
Conditions
Interventions
test group:Liposomal mitoxantrone combined with venetoclax and azacitidine
control group:venetoclax combined with azacitidine.
Sponsors
Tongji Hospital Affiliated to Tongji Medical College Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Patients fully understand this study, voluntarily participate and sign the informed consent form (ICF); 2) Age = 18 years old; 3) Relapsed and refractory acute myeloid leukemia (non-APL) confirmed by clinical diagnosis; definition of relapsed and refractory As follows: a) Relapsed AML: Leukemia cells reappear in peripheral blood after complete remission (CR) or blast cells in the bone marrow are >5% (except for other reasons such as bone marrow regeneration after consolidation chemotherapy) or leukemia cells infiltrate outside the marrow; b) Difficult to Curative AML (sufficient to meet one of the following): Initially treated cases that failed to respond to 2 courses of standard treatment; Those who relapsed within 12 months after undergoing consolidation and intensive treatment after CR; Relapsed after 12 months but after routine treatment Those who are ineffective with chemotherapy; Those who have relapsed twice or more; Those who have persistent extramedullary leukemia; 4) Normal heart function, cardiac ejection fraction =50%; 5) Liver and kidney function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5 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; serum creatinine =1.5 times normal The upper limit of the value; 6) Eastern Cooperative Oncology Group (ECOG) physical status score: 0-2 points.
Exclusion criteria
Exclusion criteria: Subjects with any of the following conditions will not be allowed to enter the study: 1) Patients who have been treated with venetoclax or mitoxantrone preparations in the past; 2) Patients who have previously received autologous or allogeneic hematopoietic stem cell transplantation; 3) Past or present Those who also suffer from other malignant tumors and need treatment; 4) Uncontrollable systemic diseases (such as advanced active infection, uncontrollable hypertension, etc.); 5) Suffering from central nervous system leukemia; 6) Those who are interested in the same type of research drugs Drugs and excipients with a known history of immediate or delayed hypersensitivity reactions; 7) Pregnant women, lactating women, and patients who refuse to take effective contraceptive measures during the study; 8) Associated with a history of severe neurological or mental illness; 9) Other serious Diseases such as: myocardial infarction, severe or unstable angina, severe arrhythmia 10) Cerebrovascular events (including transient cerebral ischemia), etc.; 11) Known infection with human immunodeficiency virus (HIV); active infection with hepatitis B and hepatitis C ; Subjects with inactive hepatitis carriers or subjects with low viral hepatitis virus titers after treatment with non-banned antiviral drugs will not be excluded. 12) Subjects who received treatment with strong or moderate CYP3A inducers/inhibitors or strong P-gp inhibitors or related foods within 7 days before starting study treatment. 13) Patients who are unable to take oral medications or have malabsorption syndrome. 14) Patients who have been or are currently taking any leukemia treatment drugs (except those that can be used according to the protocol) or participating in clinical studies. 15) The researcher determines that there are patients who are not suitable to participate in this study. 16) Patients who are allergic to study drugs or to allopurinol that may need to be used, or who are unable to take uric acid-lowering drugs. 17) Unable to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compound remission rate of one course of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Composite remission rate of two courses of treatment.;MRD;Disease-free survival rate;Relapse-free survival;overall survival;safety; | — |
Countries
China
Contacts
Public ContactDengJu LI
Huazhong University of Science Tongji Hospital, Tongji Medical College.
Outcome results
None listed