Acute Myeloid Leukemia
Conditions
Interventions
case series:mitoxantrone hydrochloride liposome
Sponsors
Institute of Hematology & Oncology, Harbin First Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age: =18 years old; 2. Subjects with histologically confirmed diagnosis of AML except acute promyelocytic leukemia: 1) Initial AML; 2) AML not reaching CR/CRI after one course of induction treatment; 3) Relapsed/refractory AML (refer to ELN standard 2022) Refractory AML: patients who fail to reach CR/CRI after 2 courses of intensive induction treatment or the specified evaluation response time (such as 180 days of low-intensity treatment); Relapsed AML: the patient's bone marrow primordial cells after CR or CRi are = 5%, or primordial cells appear again in the blood of at least 2 peripheral blood samples at least one week apart, or extramedullary leukemia occurs; MRD relapses AML: patients who have changed from MRD negative to MRD positive; 3. Subjects receiving mitoxantrone liposome monotherapy or combination regimen; 4. ECOG Performance Status: 0-2; 5. Expected survival = 3 months; 6. Liver and kidney function: serum creatinine = 1.5×ULN (upper limit of normal); AST and ALT = 2.5×ULN (= 5×ULN for subjects with liver metastases); total bilirubin = 1.5×ULN (= 3×ULN for subjects with liver metastases). 7. Complete at least one efficacy evaluation; 8. Subjects fully understand and voluntarily participate in this study and sign the informed consent form (ICF);
Exclusion criteria
Exclusion criteria: 1. Uncontrolled systemic diseases (such as unstable angina, myocardial infarction, congestive heart failure, severe unstable ventricular arrhythmia, severe pericardial disease history and other cardiovascular diseases; uncontrollable hypertension, diabetes, etc.); 2. Have a known history of immediate or delayed hypersensitivity reaction to the same drugs and excipients of the study drug; 3. Subjects unwilling to take effective contraceptive measures during the study period; 4. Subjects participated in other interventional clinical studies at the same time; 5. Subjects with other malignant tumors requiring treatment; 6. Unsuitable subjects for this study determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate;Minimal Residual Disease negativity rate;Relapse free survival;Overall survival;Safety; | — |
Countries
China
Contacts
Public ContactJun Ma, Jianxiang Wang
Outcome results
None listed