The goal of this study is to evaluate the efficacy and safety of a combination regimen of mitoxantrone hydrochloride liposome injection, cytarabine and venetoclax (MAV) in the treatment of relapsed or refractory (R/R) AML. It will also tentatively explore the correlation between different biological characteristics and therapeutic efficacy. The main questions it aims to answer are:Dose the combination regimen of MAV enhanced the composite complete remission in R/R AML? Participants will receive laboratory tests of bone marrow and blood specimens at regular times after MAV treatment.
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.
Age ≥18.
Clinically diagnosed relapsed/refractory AML, excluding acute promyelocytic leukemia.
Initial treatment patients who failed after 2 courses of treatment with standard regimen.
Prior therapy with mitoxantrone or mitoxantrone liposome;
Prior therapy with doxorubicin or anthracyclines, and the cumulative dose of doxorubicin > 360 mg/m² (1 mg doxorubicin was equivalent to 2 mg daunorubicin or 0.5 mg idarubicin);
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;
QTc interval >480 ms or long QTc syndrome in screening;
Single group
mitoxantrone hydrochloride liposome
DrugMitoxantrone hydrochloride liposome (24 mg/m\^2) on day 1, every 4 weeks
Cytarabine
DrugCytarabine (1.0 g/m\^2, q12h ) on day 1,3,5, every 4 weeks
Venetoclax
DrugVenetoclax 100 mg on day 2，200 mg on day 3，400 mg on day 4-10, every 4 weeks
Composite complete remission (CRc) rate
Blast rate lower than 5% with or without peripheral blood cell recover
Overall response rate (ORR)
Response is assessed according to the the European LeukemiaNet (ELN) 2022 criteria
Relapsed free survival (RFS)
Defined only for patients achieving CR or CRi; measured from the date of achievement of remission until the date of hematologic relapse or death from any cause;
Event free survival (EFS)
Defined for all patients in a trial; measured from day 1 of treatment to the date of treatment failure, hematologic relapse from CR/CRi or death from any cause, whichever occurs first;
overall survival (OS)
Defined for all patients in a trial; measured from day 1 of treatment to the date of death from any cause;
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First Affiliated Hospital of Zhejiang University
Lead sponsor
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Collaborator
