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

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

Treatments tested in this trial

  • Revumenib
  • Mezigdomide

Treatment groups

52 Participants
are divided into 5 treatment groups

Locations

10
City of Hope Cancer Center (Data collection only)91010, DuarteCalifornia, United States
Memorial Sloan Kettering at Basking Ridge (All Protocol Activities)07920, Basking RidgeNew Jersey, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)07748, MiddletownNew Jersey, United States
Memorial Sloan Kettering Bergen (All Protocol Activities)07645, MontvaleNew Jersey, United States

Sponsors and collaborators

Memorial Sloan Kettering Cancer Center

Lead sponsor