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 relapsed refractory AML other than acute promyelocytic leukemia; (1) 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); (2) Recurrent/refractory AML (one of the following criteria is acceptable) : 1) Initial treatment cases that failed after 2 courses of treatment with standard regimen; 2) Patients with relapse within 12 months after CR consolidation and intensive therapy; 3) Patients who relapsed 12 months later but failed conventional chemotherapy; 4) Patients with two or more relapses; 5) Persistence of extramedullary leukemia; 4. Physical status score of Eastern Oncology Collaboration Group (ECOG) : 0-1; 5. Expected survival time >=3 months; 6. Liver and kidney function: alanine aminotransferase (AST) and aspartate aminotransferase (ALT) <=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: (1) Patients previously received mitoxantrone or mitoxantrone liposome; (2) 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); (3) Received anti-tumor therapy (including chemotherapy, targeted therapy, etc.) or participated in other clinical trials and received clinical trial drugs within 2 weeks before the first use of the drug in this study; 2. Cardiac function and disease conform to one of the following conditions: (1) Long QTc syndrome or QTc interval >480 ms; (2) Complete left bundle branch block, degree II or III atrioventricular block; (3) Severe, uncontrolled arrhythmia requiring medical treatment; (4) New York College of Cardiology grade >= ?; (5) Cardiac ejection fraction (EF) was less than 50%; (6) 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 (in addition to non-melanoma basal cell carcinoma of the skin, carcinoma in situ of the breast/cervix, and other malignancies that have been effectively controlled without treatment in 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 (hepatitis B virus surface antigen positive and hepatitis B virus DNA more than 1x10^3 copies /mL; HCV RNA in excess of 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 |
|---|---|
| Maximum tolerated dose of mitoxantrone liposomes; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety;Complete remission rate (CR);Composite complete response rate (CRc);Objective response rate (ORR);Time to response (TTR);Disease free survival (DFS);Overall survival (OS); | — |
Countries
China
Contacts
Public ContactWen Qin
The Second Affiliated Hospital of the Army Medical University of the PLA
Outcome results
None listed