OncoMatch/Clinical Trials/NCT05522192

Clinical Study of Mitoxantrone Hydrochloride Liposome Injection in Subjects With Acute Myeloid Leukemia

Is NCT05522192 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Mitoxantrone liposome and Venetoclax for relapsed or refractory acute myeloid leukemia.

Phase 1/2RecruitingHui ZengNCT05522192Data as of May 2026

Treatment: Mitoxantrone liposome · Venetoclax — This study is an open-label, single-arm, phase I/II clinical study. Phase I is a multi-center, dose-escalation study, aiming to explore the maximum tolerated dose (MTD) of venetoclax combined with mitoxantrone liposome in the treatment of relapsed or refractory acute myeloid leukemia (AML), and determine the recommended dose for phase II (RP2D); Phase II is a multi-center, exploratory study, aiming to explore efficacy of venetoclax combined with mitoxantrone liposome in the treatment of relapsed and refractory AML patients, and to explore the differences in the efficacy of this combination therapy with different gene mutations.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Performance status

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

Prior therapy

Cannot have received: mitoxantrone or mitoxantrone liposome (mitoxantrone, mitoxantrone liposome)

Those who have previously received mitoxantrone or mitoxantrone liposome

Cannot have received: anthracycline (doxorubicin, daunorubicin, idarubicin)

Exception: total cumulative dose of doxorubicin is more than 360 mg/m^2 (1 mg doxorubicin converted from other anthracycline drugs is equivalent to 2 mg daunorubicin or 0.5 mg idarubicin)

Previously received doxorubicin or other anthracycline treatment, and the total cumulative dose of doxorubicin is more than 360 mg/m^2 (1 mg doxorubicin converted from other anthracycline drugs is equivalent to 2 mg daunorubicin or 0.5 mg idarubicin)

Cannot have received: anti-tumor treatment

Have received anti-tumor treatment (including chemotherapy, targeted therapy, hormone therapy, taking traditional Chinese medicine with anti-tumor activity, etc.) or participated in other clinical trials and received clinical trial drugs within 4 weeks before the first use of the study drugs

Lab requirements

Kidney function

Serum creatinine ≤1.5 x ULN

Liver function

AST and ALT ≤2.5 x ULN (≤5 x ULN for patients with liver infiltrates); Total bilirubin ≤1.5 x ULN (≤3 x ULN for patients with liver infiltration)

Cardiac function

Normal cardiac function: LVEF ≥ 45% assessed by echocardiography or radionuclide active angiography (MUGA)

Liver and kidney function: Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) ≤2.5 x upper limit of normal (ULN) (≤5 x ULN for patients with liver infiltrates); Total bilirubin ≤1.5 x ULN (≤3 x ULN for patients with liver infiltration); Serum creatinine ≤1.5 x ULN; Normal cardiac function: left ventricular ejection fraction (LVEF) ≥ 45% assessed by echocardiography or radionuclide active angiography (MUGA)

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

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