About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Participants with acute promyelocytic leukemia
Participants with isolated myeloid sarcoma
Participants who have previously received mezigdomide.
Participants with immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, disseminated intravascular coagulation, or uncontrolled tumor lysis syndrome.
Trial design
Sequential
Treatments tested in this trial
Revumenib
DrugRevumenib is a novel menin inhibitor
Mezigdomide
DrugMezigdomide (CC-92480) is an investigational CELMoD.
Treatment groups
Trial outcomes
Primary outcomes
Phase I: Maximum Tolerated Dose
Maximum Tolerated Dose/MTD is defined as the highest dose level in which 6 participantshave been treated with at most 1 instance of dose limiting toxicities/DLT.
Sponsors and contacts
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