OncoMatch/Clinical Trials/NCT07356154
A Study of Revumenib and Mezigdomide in People With Leukemia
Is NCT07356154 recruiting? Yes, currently enrolling (May 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
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic 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)
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 →
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