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OncoMatch/Clinical Trials/NCT06621199

Mitoxantrone Hydrochloride Liposome in Combination With Cytarabine and Venetoclax Regimen in Newly Diagnosed Elderly AML

Is NCT06621199 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Mitoxantrone hydrochloride liposome and Cytarabine for acute myeloid leukemia.

Phase 2RecruitingFirst Affiliated Hospital of Zhejiang UniversityNCT06621199Data as of May 2026

Treatment: Mitoxantrone hydrochloride liposome · Cytarabine · VenetoclaxThis is a phase 2 study to evaluate the efficacy and safety of mitoxantrone hydrochloride liposome in combination with cytarabine and venetoclax (MAV) regimen in newly diagnosed elderly AML. To account, conservatively, for a 10% dropout rate before study completion, we planned to include 42 patients. The primary endpoint is 2-year event free survival(EFS).

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: anthracycline

Subjects who have received anthracycline pretreatment

Cannot have received: anti-AML treatments

Exception: except for hydroxyurea, leukapheresis and other leukocyte-lowering treatments

Subjects who have received...other anti-AML treatments (except for hydroxyurea, leukapheresis and other leukocyte-lowering treatments)

Lab requirements

Kidney function

Serum creatinine≤1.5 ULN

Liver function

ALT/AST≤2.5 ULN (for subjects with hepatic infiltration≤5 ULN); Total bilirubin≤1.5 ULN (for subjects with hepatic infiltration≤3 ULN)

Cardiac function

Long QTc syndrome or QTc interval >480 ms; Complete left bundle branch block, degree II or III atrioventricular block; Severe, uncontrolled arrhythmia requiring medical treatment; NYHA classification ≥ grade II; Cardiac ejection fraction (EF) <50%; History of myocardial infarction, unstable angina, severely unstable ventricular arrhythmia or any other arrhythmia requiring treatment, clinically severe pericardial disease, or ECG evidence of acute ischemic or active conduction abnormalities within 6 months prior to enrollment

ALT/AST≤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. Cardiac function and disease conform to one of the following conditions: Long QTc syndrome or QTc interval >480 ms; Complete left bundle branch block, degree II or III atrioventricular block; Severe, uncontrolled arrhythmia requiring medical treatment; NYHA classification ≥ grade II; Cardiac ejection fraction (EF) <50%; History of myocardial infarction, unstable angina, severely unstable ventricular arrhythmia or any other arrhythmia requiring treatment, clinically severe pericardial disease, or ECG evidence of acute ischemic or active conduction abnormalities within 6 months prior to enrollment

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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