OncoMatch/Clinical Trials/NCT06434662
Mitoxantrone Hydrochloride Liposome Injection, Cytarabine Combined With Venetoclax in the Treatment of R/R AML
Is NCT06434662 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including mitoxantrone hydrochloride liposome and Cytarabine for relapsed/refractory acute myeloid leukaemia.
Treatment: mitoxantrone hydrochloride liposome · Cytarabine · Venetoclax — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard regimen
Initial treatment patients who failed after 2 courses of treatment with standard regimen
Cannot have received: mitoxantrone or mitoxantrone liposome (mitoxantrone, mitoxantrone liposome)
Prior therapy with mitoxantrone or mitoxantrone liposome
Cannot have received: anthracycline (doxorubicin, daunorubicin, idarubicin)
Exception: cumulative dose of doxorubicin > 360 mg/m^2 (1 mg doxorubicin = 2 mg daunorubicin or 0.5 mg idarubicin)
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)
Cannot have received: other anti-tumor therapy
Exception: except those that do not affect the efficacy of the study as determined by the investigator
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
Lab requirements
Kidney function
Serum creatinine≤1.5 ULN
Liver function
AST/ALT≤2.5 ULN (for subjects with hepatic infiltration≤5 ULN); Total bilirubin≤1.5 ULN (for subjects with hepatic infiltration≤3 ULN)
Cardiac function
QTc interval >480 ms or long QTc syndrome; complete left bundle branch block, 2 or 3 grade atrioventricular block; requiring treatment of serious and uncontrolled arrhythmia; NYHA≥3; cardiac ejection fraction (EF) <50%; 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
AST/ALT≤2.5 ULN (for subjects with hepatic infiltration≤5 ULN); Total bilirubin≤1.5 ULN (for subjects with hepatic infiltration≤3 ULN); Serum creatinine≤1.5 ULN. Cardiovascular diseases, including but not limited to: ...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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