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OncoMatch/Clinical Trials/NCT06229912

A Phase II Study of the Menin Inhibitor Revumenib in Leukemia Associated With Upregulation of HOX Genes

Is NCT06229912 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Revumenib for leukemia.

Phase 2RecruitingM.D. Anderson Cancer CenterNCT06229912Data as of Jun 2026

Treatment: RevumenibTo learn if revumenib (also known as SNDX-5613) can help to control leukemias associated with an increase in expression of HOX genes.

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Revumenib

Biomarker criteria

Required: KMT2A (MLL) partial tandem duplication

KMT2A-PTD = Normal karyotype

Required: NPM1 NPM1-MLF1 fusion

NPM1-MLF1 = t(3;5)(q25;q34)

Required: NUP98 rearrangement

NUP98r = 11p15 rearrangements

Required: SET SET-NUP214 fusion

SET-NUP214 = t(9;9)(q34;q34)

Required: RUNX1 RUNX1-EVI1 fusion

RUNX1-EVI1 = t(3;21)(q26;q22)

Required: KAT6A MYST3-CREBBP fusion

MYST3-CREBBP = t(8;16)(p11;p13)

Required: CDX2 CDX2-ETV6 fusion

CDX2-ETV6 = t(12;13)(p13;q12)

Required: PICALM CALM-AF10 fusion

CALM-AF10 = t(10;11)(p13;q14-21)

Required: MN1 MN1-ETV6 fusion

MN1-ETV6 = t(12;22)(p13;q12)

Required: UBTF UBTF-TD

UBTF-TD = Normal karyotype

Performance status

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

Demographics

Ages ≥ 12

Prior therapy

Min 1 prior line

Must have received: any prior therapy — relapsed or refractory

Relapsed or refractory acute leukemia

Lab requirements

Blood counts

wbc must be below 25,000/ ul at time of enrollment

Kidney function

estimated glomerular filtration rate ≥ 60 ml/min based on local institutional practice for age-appropriate determination

Liver function

direct bilirubin < 1.5x uln unless increase is due leukemic involvement, 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%

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

US trial sites

  • Memorial Sloan Kettering Cancer Center · New York, New York
  • MD Anderson Cancer Center · Houston, Texas

Showing up to 5 US sites.

See all sites on ClinicalTrials.gov →

Frequently asked questions

Is NCT06229912 currently recruiting?

Yes, this trial is currently recruiting patients.

Is prior treatment required for enrollment?

Yes. Patients must have previously received any prior therapy.

Does this trial require KMT2A?

Yes, KMT2A partial tandem duplication is a required biomarker for enrollment.

Does this trial require NPM1?

Yes, NPM1 NPM1-MLF1 fusion 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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