Acute Myeloid Leukemia
Conditions
Interventions
Experimental group:mitoxantrone hydrochloride liposome+venetoclax+azacitidine
Sponsors
General Hospital of Chinese People's Liberation Army Northern Theater Command
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. 2. Age =18. 3. Clinically diagnosed as newly diagnosed and relapsed/refractory acute myeloid leukemia (AML), excluding acute promyelocytic leukemia. Relapsed/refractory AML were defined as: a. Bone marrow blasts=5% after CR (except for other reasons such as bone marrow regeneration after consolidation chemotherapy) or leukemia cell infiltration appeared in extramedullary. b. Refractory AML: Initial patients who failed to achieve CR after 2 courses of standard treatment; Relapsed within 12 months; Relapsed after 12 months but failed to conventional chemotherapy; 2 or more relapses; Extramedullary leukemia persists. 4. Normal cardiac function: Cardiac ejection fraction (EF) =50%. 5. AST/ALT =2.5 ULN (for subjects with hepatic infiltration =5 ULN); Total bilirubin =1.5 ULN; Serum creatinine =1.5 ULN. 6. Eastern Oncology Collaboration Group (ECOG) 0-2.
Exclusion criteria
Exclusion criteria: 1. Previous or current occurrence of other malignancies in need of treatment. 2. Subjects are suffering from any other uncontrollable disease (including but not limited to: uncontrolled hypertension, and advanced infection). 3. Central nervous system leukemia. 4. A history of immediate or delayed allergy to similar drug and excipients of the investigate drug. 5. Pregnant, lactating female or subjects who refuse to use effective contraception during the study. 6. With a history of severe neurological or psychiatric illness. 7. With other serious diseases, including but not limited to: Myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia. 8. Cerebrovascular events (including transient cerebral ischemia). 9. HIV infection; HBV and HCV active infection. Non-active hepatitis carriers with low hepatitis virus titers after treatment with non-prohibited antivirals are not excluded. 10. Subjects who received strong or moderate CYP3A inducers/inhibitors or P-glycoprotein (P-gp) inhibitors or food within 7 days before starting study treatment. 11. Subjects who are unable to take oral medications or have malabsorption syndrome. 12. Have received other anti-tumor therapy (except for drugs that may be used as specified in the protocol) or participated in other clinical trials. 13. Not suitable for this study as decided by the investigator. 14. Patients who are allergic to the investigational drug or to allopurinol that may be needed or who are unable to take urico-lowering drugs. 15. Unable to sign informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| composite complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| event-free survival;relapse-free survival;overall survival;safety; | — |
Countries
China
Contacts
Public ContactJinghua Liu
General Hospital of Chinese People's Liberation Army Northern Theater Command
Outcome results
None listed