A Study of Revumenib and Mezigdomide in People With Leukemia
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
Sponsor: Memorial Sloan Kettering Cancer Center
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Phase I: Maximum Tolerated Dose
Time frame: 1 year
Eligibility Criteria
Inclusion Criteria: * Participant must be ≥ 12 years of age at the time of signing the informed consent form (ICF). * Participant must weigh at least 40 kg * Participant is willing and able to adhere to the study visit schedule and other protocol requirements. * Participant has relapsed/refractory acute leukemia defined acute myeloid leukemia, acute lymphoblastic leukemia, or mixed phenotype acute leukemia after as failure of at least 1 prior line of therapy (can be either primary refractory disease or progression during or after treatment) * Participant has confirmed acute leukemia with detectable NPM1c, KMT2A translocation, or NUP98 translocation. 1. At MSK, NPM1 testing utilizes MSK-REACT, a rapid multi-gene NGS panel used in all new AML diagnoses that is clinically validated by the Laboratory of Diagnostic Molecular Pathology pursuant to the requirements of CLIA'88 and approved by New York State, or MSK-IMPACT, a multi-gene NGS panel, which is authorized by the FDA. At non-MSK …
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