The purpose of this prospective, multi-center, single-arm, phase 2 study is to evaluate the efficacy and safety of a combination regimen of mitoxantrone hydrochloride liposome injection, standard-dose of cytarabine and venetoclax (MAV) in the treatment of relapsed or refractory (R/R) AML. The study plan to enroll 72 R/R AML patients who are expected to 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.
Patients who failed after at least 1 courses of initial induction therapy.
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;
Subjects who received strong or moderate CYP3A inducers/inhibitors or P-glycoprotein (P-gp) inhibitors within 7 days before starting study treatment;
Single group
mitoxantrone hydrochloride liposome
DrugMitoxantrone hydrochloride liposome (30 mg/m\^2) on day 1, every 4 weeks
Cytarabine
DrugCytarabine (100 mg/m\^2 ) on day 1-7, every 4 weeks
Venetoclax
DrugVenetoclax 100 mg on day 2，200 mg on day 3，400 mg on day 4-8, every 4 weeks
Composite complete remission (CRc) rate
Complete remission plus complete remission with incomplete hematologic recovery (CR+CRi). Response is assessed according to the the European LeukemiaNet (ELN) 2022 criteria.
Overall response rate (ORR)
CR+CRi+morphologic leukemia-free state+partial remission (CR+CRi+MLFS+PR). 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 the study. 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 the study. Measured from day 1 of treatment to the date of death from any cause.
Click on the lead sponsor to view all of their trials.
First Affiliated Hospital of Zhejiang University
Lead sponsor
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Collaborator
