Relapsed or Refractory Acute Myeloid Leukemia
Conditions
Interventions
Sponsors
The Second Affiliated Hospital of the Army Medical University of the PLA
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Patients fully understand the study, voluntarily participate and sign the informed consent (ICF); 2. Aged 18-60 years (including boundary values 18 and 60); 3. Clinically diagnosed AML other than acute promyelocytic leukemia; 1) Patients who fail to achieve CR/CRi after 1 course of initial induction therapy 2) Recurrent AML: reoccurrence of leukemia cells in peripheral blood or more than 5% of bone marrow primitive cells after complete response (except for other causes such as bone marrow regeneration after consolidation chemotherapy) or extramedullary leukemia cell infiltration after complete response (CR); 3) Refractory AML (one of the following criteria is acceptable) : a) Initial treatment cases that failed after 2 courses of treatment with standard regimen; b) Patients with relapse within 12 months after CR consolidation and intensive therapy; c) Patients who relapsed 12 months later but failed conventional chemotherapy; d) Patients with two or more relapses; e) Persistence of extramedullary leukemia; 4. Physical status score of Eastern Oncology Collaboration Group (ECOG) : 0-2; 5. Expected survival time >=3 months; 6. 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 (=3 times the upper limit of normal for patients with hepatic infiltration); Serum creatinine =1.5 times the upper limit of normal.
Exclusion criteria
Exclusion criteria: 1. The patient's previous history of antitumor therapy meets one of the following conditions: a) Patients previously received mitoxantrone or mitoxantrone liposome; b) Patients previously received CLAG/FLAG regimen; c) Prior treatment with doxorubicin or anthracycline with a cumulative dose of doxorubicin > 360 mg/m^2 (1 mg of doxorubicin was equivalent to 2 mg of daunorubicin or 0.5 mg of daunorubicin with other anthracyclines); d) Within 2 weeks prior to the first use of the investigational drug or within 5 half-lives of the drug (whichever occurs first), the patient has received anti-tumor treatment (including chemotherapy, targeted therapy, hormone therapy, and the use of anti-tumor active traditional Chinese medicine, except for those determined by the researcher to not affect the therapeutic effect of the study) or participated in other clinical trials and received clinical trial medication; 2. Cardiac function and disease conform to one of the following conditions: a) Long QTc syndrome or QTc interval >480 ms; b) Complete left bundle branch block, degree II or III atrioventricular block; c) Severe, uncontrolled arrhythmia requiring medical treatment; d) New York College of Cardiology grade >= ?; e) Cardiac ejection fraction (EF) was less than 50%; f) A history of myocardial infarction, unstable angina pectoris, severely unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically severe pericardial disease, or electrocardiogram evidence of acute ischemic or active conduction abnormalities within 6 months prior to enrollment; 3. Past or present co-existing malignancies (excluding cured skin basal cell carcinoma, cervical carcinoma in situ, and other malignant tumors that have not been treated and effectively controlled within the past five years); 4. Uncontrolled systemic diseases (such as advanced infections, uncontrolled hypertension, diabetes, etc.); 5. Suffering from central nervous system leukemia; 6. Human immunodeficiency virus (HIV) infection (HIV antibody positive); 7. Hepatitis B and hepatitis C active infection (If the surface antigen or core antibody of hepatitis B is positive, additional HBV-DNA test will be performed. If the HBV-DNA exceeds 1x10^3 copies/mL, it will be excluded; Hepatitis C antibody positive additional test for HCV-RNA, excluding hepatitis C virus RNA exceeding 1x10^3 copies/mL); 8. A known history of immediate or delayed hypersensitivity to similar drugs and excipients of the investigational drug; 9. Pregnant patients, lactating patients, and patients who refused to take effective contraceptive measures during the study; 10. A history of severe neurological or psychiatric illness; 11. The researchers judged that patients were not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate;Relapsed-free survival;Event-free survival;Overall survival;Minimal residual disease negative (MRD ? ) rate;Safety;Median duration of neutrophils<0.5x10^9/L and platelets<25x10^9/L; | — |
Countries
China
Contacts
Public ContactZhang Xi/ Wen Qin
The Second Affiliated Hospital of the Army Medical University of the PLA
Outcome results
None listed