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OncoMatch/Clinical Trials/NCT06769490

Dose Escalation and Expansion of Ziftomenib in Combination With Quizartinib in Acute Myeloid Leukemia

Is NCT06769490 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including Ziftomenib and Quizartinib for acute myeloid leukemia.

Phase 1RecruitingM.D. Anderson Cancer CenterNCT06769490Data as of Jun 2026

Treatment: Ziftomenib · QuizartinibThe goal of this all-oral combination is to deliver safe and effective therapy for the largest portion of AML subtypes (NPM1mt, KMT2Ar, NUP98r \~ 40-45%).

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Extracted eligibility criteria

Treatments studied

Targeted therapy

ZiftomenibQuizartinib

Cancer type

Acute Myeloid Leukemia

Biomarker criteria

Required: KMT2A (MLL) rearrangement

Required: NPM1 mutation

Required: NUP98 rearrangement

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Cannot have received: menin inhibitor

Prior treatment with a menin inhibitor

Lab requirements

Kidney function

estimated glomerular filtration rate > 50 mL/min (using Cockcroft-Gault) unless related to disease

Liver function

total bilirubin < 2x ULN unless increase is due leukemic involvement (<2.5 ULN), unless due to ongoing hemolysis or Gilbert's syndrome and AST and/or ALT < 3x ULN unless considered due to leukemic involvement, in which case direct bilirubin or AST and/or ALT < 5x ULN will be considered eligible

Cardiac function

Baseline ejection fraction must be > 40%

Adequate hepatic function (total bilirubin < 2x upper limit of normal (ULN) unless increase is due leukemic involvement (<2.5 ULN), unless due to ongoing hemolysis or Gilbert's syndrome and AST and/or ALT < 3x ULN unless considered due to leukemic involvement, in which case direct bilirubin or AST and/or ALT < 5x ULN will be considered eligible). Adequate renal function with an estimated glomerular filtration rate > 50 mL/min (using Cockcroft-Gault) unless related to disease. Baseline ejection fraction must be > 40%.

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

US trial sites

  • The University of Texas M. D. Anderson Cancer Center · Houston, Texas

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Frequently asked questions

Is NCT06769490 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior menin inhibitor disqualifies patients from enrollment.

Does this trial require KMT2A?

Yes, KMT2A rearrangement is a required biomarker for enrollment.

Does this trial require NPM1?

Yes, NPM1 mutation is a required biomarker for enrollment.

Does this trial require NUP98?

Yes, NUP98 rearrangement is a required biomarker for 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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