OncoMatch/Clinical Trials/NCT07356154
A Study of Revumenib and Mezigdomide in People With Leukemia
Is NCT07356154 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including Revumenib and Mezigdomide for leukemia.
Treatment: Revumenib · Mezigdomide — The purpose of this study is to find out whether the combination of mezigdomide and revumenib is a safe treatment for people with relapsed or refractory KMT2A-r, NUP98-r, and NPM1-m acute leukemias.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Biomarker criteria
Required: NPM1 NPM1c exon 12 variant
Eligible patients must have an NPM1c (nucleophosmin) exon 12 variant as determined by these assays.
Required: KMT2A (MLL) translocation
Eligible patients must have a KMT2A ... translocation as determined by these assays
Required: NUP98 translocation
Eligible patients must have a ... NUP98 translocation as determined by these assays
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: any anti-leukemia therapy
failure of at least 1 prior line of therapy (can be either primary refractory disease or progression during or after treatment)
Cannot have received: menin inhibitor
Exception: Phase 1: no requirement; Phase 2, cohort 1: menin inhibitor naïve required; Phase 2, cohort 2: menin inhibitor exposed required
Regarding prior treatment with a menin inhibitor: Participants enrolled in Phase 1 have no requirements regarding prior treatment with a menin inhibitor; Participants enrolled in Phase 2, cohort 1, are required to be menin inhibitor naïve; Participants enrolled in Phase 2, cohort 2, are required to be menin inhibitor exposed
Cannot have received: mezigdomide (mezigdomide)
Participants who have previously received mezigdomide [excluded]
Lab requirements
Blood counts
WBC count <25,000/μL at time of initiation of study drug (leukapheresis and/or hydroxyurea permitted to decrease WBC)
Kidney function
serum creatinine < 2 x ULN or estimated GFR ≥ 60 mL/min (age-appropriate formula)
Liver function
AST/SGOT and ALT/SGPT ≤ 3 x ULN, unless considered due to leukemic organ involvement; serum total bilirubin < 1.5 x ULN (higher if due to ineffective erythropoiesis, leukemia organ involvement or Gilbert's syndrome)
Cardiac function
ejection fraction ≥ 50% by echocardiogram or MUGA; no significant active cardiac disease within 6 months prior to start (NYHA class III/IV CHF, ACS, stroke); QTcF < 450 ms (exceptions for bundle branch block or pacemaker with PI approval)
adequate organ function defined as: AST/SGOT and ALT/SGPT ≤ 3 x ULN, unless considered due to leukemic organ involvement; serum total bilirubin < 1.5 x ULN (higher if due to ineffective erythropoiesis, leukemia organ involvement or Gilbert's syndrome); serum creatinine < 2 x ULN or estimated GFR ≥ 60 mL/min; ejection fraction ≥ 50% by echocardiogram or MUGA
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope Cancer Center (Data collection only) · Duarte, California
- Memorial Sloan Kettering at Basking Ridge (All Protocol Activities) · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (All Protocol Activities) · Middletown, New Jersey
- Memorial Sloan Kettering Bergen (All Protocol Activities) · Montvale, New Jersey
- Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities) · Commack, New York
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07356154 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior menin inhibitor, mezigdomide disqualifies patients from enrollment.
Does this trial require NPM1?
Yes, NPM1 NPM1c exon 12 variant is a required biomarker for enrollment.
Does this trial require KMT2A?
Yes, KMT2A translocation is a required biomarker for enrollment.
Does this trial require NUP98?
Yes, NUP98 translocation 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.
Check if I qualify