Acute Myeloid Leukemia
Conditions
Interventions
Experimental group:mitoxantrone hydrochloride liposome+cytarabine
Sponsors
Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects fully understand and voluntarily participate in this study and sign the informed consent form (ICF); 2. Age: 60-75 years old (including boundary values of 60 and 75); 3. Subjects with histologically confirmed diagnosis of newly treated AML except acute promyelocytic leukemia (APL) , which is one of the following subtypes: a. Treatment-related AML b. A history of MDS c. With MDS related gene/chromosome abnormality d. A history of CMML 4. Elderly patients in the comprehensive assessment as Fit group: ECOG < 3, no major concomitant diseases, and MMSE and SPPB meet the standards (refer to Appendix 8-11); 5. Expected survival time =3 months; 6. Liver and kidney function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =3 times upper limit of normal value (ULN) (=5 times upper limit of normal value 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 value; 7. Treatment for MDS (except blood transfusion) must be completed 2 weeks before the study treatment begins; In the case of rapidly proliferating disease, hydroxyurea is permitted until 24 hours before the study treatment begins. Toxicity associated with prior MDS treatment must return to grade 2 or below before the study treatment begin.
Exclusion criteria
Exclusion criteria: 1. The subject had previously received any of the following anti-tumor treatments: a) Subjects who have been treated with mitoxantrone or mitoxantrone liposomes; b) Previously received doxorubicin or other anthracycline treatment, and the total cumulative dose of doxorubicin was more than 360 mg/m2 (1 mg doxorubicin equivalent to 2 mg daunorubicin or 0.5 mg idarubicin); c) Subjects who received anti-tumor treatment including surgery, chemotherapy, targeted therapy or participated in other clinical trials and received trial drugs within 4 weeks before the first use of the drug in this study or within 5 half-lives of the drug;; 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, grade II or III atrioventricular block; c) Serious and uncontrolled arrhythmias requiring drug treatment; d) New York Heart Association grade = II; e) Cardiac ejection fraction (LVEF)< 50%; f) A history of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically serious pericardial disease, or ECG evidence of acute ischemia or active conduction system abnormalities within 6 months before recruitment. 3. Subjects with other malignant tumors past or present (except for non-melanoma skin basal cell carcinoma, breast/cervical carcinoma in control, and other malignant tumors that have been effectively controlled without treatment within the past 6 months or more, and long-term non-chemotherapy treatment such as hormone therapy); 4. Uncontrolled systemic diseases (such as active infection, uncontrolled hypertension, diabetes, etc.); 5. Suffering from central nervous system leukemia; 6. In addition to CMML, there is a history of myeloproliferative tumor (MPN) (defined as a history of essential thrombocythemia or polycythemia realis or idiopathic myelofibrosis prior to the diagnosis of AML) or a combined history of MDS/MPN; 7. Combined with good prognosis (8; 21)(q22; q22.1)RUNX1::RUNX1T1, inv(16)(p13.1q22)CBFB::MYH11; 8. Human immunodeficiency virus (HIV) infection (HIV antibody positive); 9. Hepatitis B and hepatitis C active infection (plus HBV DNA if one positive for hepatitis B surface antigen or core antibody and HBV DNA more than 1×103 copy/mL excluded; plus HCV RNA if hepatitis C antibody positive and HCV RNA more than 1×103 copy/mL exclude); 10. A known history of immediate or delayed hypersensitivity to similar drugs and excipients of the investigational drug; 11. A history of severe neurological or psychiatric illness; 12. Unsuitable subjects for this study determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite complete remission; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate;Overall survival;Relapse free survival;Minimal Residual Disease;Safety: hematological and non-hematological toxicity;Biomarker evaluation; | — |
Countries
China
Contacts
Public ContactJunmin Li
Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
Outcome results
None listed