OncoMatch/Clinical Trials/NCT06621212
Mitoxantrone Hydrochloride Liposome, Standard-dose of Cytarabine and Venetoclax in the Treatment of R/R AML
Is NCT06621212 recruiting? Yes, currently enrolling (Jun 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 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Other
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Myeloproliferative Neoplasm
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: induction therapy — initial
Patients who failed after at least 1 courses of initial induction therapy.
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≥2; 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: QTc interval >480 ms or long QTc syndrome in screening; Complete left bundle branch block, 2 or 3 grade atrioventricular block; Requiring treatment of serious and uncontrolled arrhythmia; NYHA≥2; Cardiac ejection fraction (EF) was less than 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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06621212 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior mitoxantrone or mitoxantrone liposome, anthracycline, other anti-tumor therapy disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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