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OncoMatch/Clinical Trials/NCT06429449

Mitoxantrone for Venetoclax Resistant Acute Myeloid Leukemia

Is NCT06429449 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Venetoclax and Azacitidine for leukemia.

Phase 1RecruitingUniversity of Colorado, DenverNCT06429449Data as of May 2026

Treatment: Venetoclax · Azacitidine · MitoxantroneThis is an open label, phase 1 study for AML subjects with relapsed or refractory disease or subjects in morphologic remission with MRD+ after first line therapy with venetoclax+HMA. A preliminary dose-finding cohort will be followed by 3 expansion cohorts.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Performance status

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

Prior therapy

Min 1 prior line

Must have received: venetoclax plus hypomethylating agent (venetoclax, azacitidine, decitabine) — first-line

treated with first-line venetoclax/HMA (azacitidine or decitabine)

Cannot have received: anthracycline

Any prior exposure to an anthracycline

Cannot have received: anthracenedione

Any prior exposure to an ... anthracenedione

Lab requirements

Kidney function

creatinine clearance ≥ 60 mL/min, CKD-EPI Creatinine Equation

Liver function

AST ≤ 3.0 × ULN; ALT ≤ 3.0 × ULN; bilirubin ≤ 1.5 × ULN, unless due to Gilbert's syndrome or leukemic organ involvement

Cardiac function

LVEF >50% by MUGA or ECHO within 1 month prior to study day 1

adequate renal function as demonstrated by a calculated creatinine clearance ≥ 60 mL/min, calculated using the formula CKD-EPI Creatinine Equation; adequate heart function as measured by left ventricular ejection fraction (LVEF) >50%, assessed by multigated acquisition (MUGA) or echocardiogram (ECHO) within 1 month prior to study day 1; adequate liver function as demonstrated by: AST ≤ 3.0 × ULN; ALT ≤ 3.0 × ULN; bilirubin ≤ 1.5 × ULN, unless due to Gilbert's syndrome or leukemic organ involvement

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

US trial sites

  • University of Colorado Hospital · Aurora, Colorado

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