About this trial
To learn if revumenib (also known as SNDX-5613) can help to control leukemias associated with an increase in expression of HOX genes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 12 years with weight ≥ 40Kg.
ECOG performance status of ≤ 2.
WBC must be below 25,000/ uL at time of enrollment. Participants may receive cytoreduction prior to enrollment.
Baseline ejection fraction must be > 40%.
Disqualifiers
Participants with any concurrent uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the participant at unacceptable risk of study treatment.
The use of other chemotherapeutic agents or anti-leukemic agents is not permitted during study with the following exceptions (1) intrathecal chemotherapy for prophylactic use or for controlled CNS leukemia. (2) use of hydroxyurea for participants with rapidly proliferative disease or for control of counts during differentiation syndrome. (3) use of steroids for treatment of differentiation syndrome.
Participants with any severe gastrointestinal or metabolic condition which could interfere with the absorption of oral study medications.
Participants with concurrent active malignancy under treatment.
Trial design
Single group
Treatments tested in this trial
Revumenib
DrugGiven by PO
Treatment groups
Trial outcomes
Primary outcomes
Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Sponsors and contacts
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M.D. Anderson Cancer Center
Lead sponsor
Syndax Pharmaceuticals
Collaborator