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OncoMatch/Clinical Trials/NCT06429449

Mitoxantrone for Venetoclax Resistant Acute Myeloid Leukemia

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

Phase 1RecruitingUniversity of Colorado, DenverNCT06429449Data as of Jun 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

Treatments studied

Targeted therapy

Venetoclax

Chemotherapy

AzacitidineMitoxantrone

Cancer type

Acute Myeloid Leukemia

Performance status

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

Demographics

Ages ≤ 80

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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Frequently asked questions

Is NCT06429449 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior anthracycline, anthracenedione disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 80 years or younger.

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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