Acute myeloid leukemia
Conditions
Interventions
Experimental Group:Mitoxantrone hydrochloride liposome injection combined with azacitidine and venetoclax (MAV)
Sponsors
The First Affiliated Hospital of Army Medical University
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 years old; 3.Clinically diagnosed relapsed/refractory AML after standard induction therapy, excluding acute promyelocytic leukemia (APL): (1)Treatment-naïve patients who achieved no response (NR) after one cycle or failed to achieve CR/CRh/CRi after >=2 cycles of standard induction therapy; (2)Patients who relapsed after achieving complete remission (CR) [reappearance of leukemia cells in peripheral blood, or bone marrow blasts >5% (excluding causes such as bone marrow regeneration post-consolidation chemotherapy), or extramedullary leukemia infiltration]; 4.ECOG PS 0-2; 5.Life expectancy >= 3 months; 6.Hepatic and Renal Function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=2.5×upper limit of normal (ULN) (<=5×ULN in patients with liver infiltration); Total bilirubin <=1.5×ULN (<=3×ULN in patients with liver infiltration); Serum creatinine <=1.5×ULN.
Exclusion criteria
Exclusion criteria: 1.Previous anti-tumor therapy meets one of the following criteria: a)Prior therapy with venetoclax; b)Prior therapy with mitoxantrone or mitoxantrone liposome; c)Prior therapy with doxorubicin or anthracyclines, and the cumulative dose of doxorubicin > 360 mg/m^2 (1 mg doxorubicin was equivalent to 2 mg daunorubicin or 0.5 mg idarubicin); d)Have received other anti-tumor therapy (including chemotherapy, targeted therapy, hormone therapy, Chinese medicines with anti-tumor activity, except those that do not affect the efficacy of the study as determined by the investigator) or participated in other clinical trials and received clinical trial drugs within 4 weeks or 5 half-lives of the drug before the study (whichever is shorter). 2.Cardiovascular diseases, including but not limited to: a)QTc interval >480 ms or long QTc syndrome in screening; b)Complete left bundle branch block, 2 or 3 grade atrioventricular block; c) Requiring treatment of serious and uncontrolled arrhythmia; d)New York Heart Association (NYHA>=grade II); e) Cardiac ejection fraction (EF) was less than 50% or below the lower limit of the examined range in the study center laboratory; f)Myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other history of arrhythmia or clinically serious pericardial disease that requires treatment within the first 6 months of enrollment, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities. 3.Previous or current occurrence of other malignancies (in addition to non-melanoma basal cell carcinoma of the skin that is effectively controlled, breast/cervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment within the past five years); 4.Use of potent or moderate CYP3A inducers/inhibitors or P-glycoprotein (P-gp) inhibitors within 7 days prior to initiation of study treatment; 5.Inability to take oral medications or diagnosis of malabsorption syndrome; 6.Central nervous system leukemia; 7.Subjects are suffering from any other uncontrollable disease (including but not limited to: uncontrolled diabetes and hypertension, and advanced infection); 8.Human immunodeficiency virus (HIV) infection (positive HIV antibodies); 9.Active hepatitis B or C infection: a) HBsAg positive with detectable HBV-DNA (> lower limit of quantification); b) Anti-HCV positive with detectable HCV-RNA (> lower limit of quantification); 10.History of known immediate or delayed hypersensitivity to drugs of the same class as the investigational product or to any of its excipients; 11.Pregnant, lactating female or subjects who refuse to use effective contraception during the study; 12.With a history of severe neurological or psychiatric illness; 13.Not suitable for this study as decided by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of composite complete response; | — |
Secondary
| Measure | Time frame |
|---|---|
| Event-free survival;Objective Response Rate;The rate of MRD negativity;Relapse-free survival;Safety;Overall survival; | — |
Countries
China
Contacts
Public ContactShuangnnian Xu
The First Affiliated Hospital of Army Medical University
Outcome results
None listed