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;
First Affiliated Hospital of Zhejiang University
Lead sponsor
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
Collaborator