OncoMatch/Clinical Trials/NCT07356154
A Study of Revumenib and Mezigdomide in People With Leukemia
Official title: A Phase 1/2 Study of the Menin Inhibitor Revumenib With the CELMod Mezigdomide in Relapsed/Refractory KMT2A-rearanged, NPM1-mutant, and NUP98-rearranged Acute Leukemias
Is NCT07356154 recruiting? Yes, currently enrolling (Oct 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: KMT2A (MLL) translocation
Required: NPM1 exon 12 variant
Required: NUP98 translocation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: systemic 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 2, cohort 1: menin inhibitor naïve required; Phase 2, cohort 2: menin inhibitor exposed required; Phase 1: no requirement
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 (no previous treatment with a menin inhibitor); Participants enrolled in Phase 2, cohort 2, are required to be menin inhibitor exposed (previous treatment received a menin inhibitor)
Cannot have received: mezigdomide (mezigdomide)
Participants who have previously received mezigdomide
Lab requirements
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; total bilirubin < 1.5 x ULN (higher if attributed to ineffective erythropoiesis, leukemia organ involvement or Gilbert's syndrome)
Cardiac function
Ejection fraction ≥ 50% by echocardiogram or MUGA scan
adequate organ function defined as: AST/SGOT and ALT/SGPT ≤ 3 x ULN, unless considered due to leukemic organ involvement; total bilirubin < 1.5 x ULN (higher if attributed to ineffective erythropoiesis, leukemia organ involvement or Gilbert's syndrome); Serum creatinine < 2 x ULN or estimated GFR ≥ 60 mL/min (age-appropriate formula); Ejection fraction ≥ 50% by echocardiogram or MUGA scan; WBC count <25,000/μL at time of initiation of study drug (leukapheresis or hydroxyurea permitted to decrease WBC)
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 KMT2A?
Yes, KMT2A translocation is a required biomarker for enrollment.
Does this trial require NPM1?
Yes, NPM1 exon 12 variant 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