A Study of Revumenib and Mezigdomide in People With Leukemia

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age12+
SponsorMemorial Sloan Kettering Cancer Center

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 volunteers

Qualifiers

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

Design model

Sequential

Treatments tested in this trial

  • Revumenib

    Drug

    Revumenib is a novel menin inhibitor

  • Mezigdomide

    Drug

    Mezigdomide (CC-92480) is an investigational CELMoD.

Treatment groups

52 Participants
are divided into 5 treatment groups
Group A: Phase 1AExperimental treatment 2 interventions
Group B: Phase 1BExperimental treatment 2 interventions
Group C: Phase 1CExperimental treatment 2 interventions
Group D: Phase 2: Menin Inhibitor Naive CohortExperimental treatment 2 interventions
Group E: Phase 2: Menin Inhibitor Exposed CohortExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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