A Phase II Study of the Menin Inhibitor Revumenib in Leukemia Associated With Upregulation of HOX Genes
M.D. Anderson Cancer Center
Summary
To learn if revumenib (also known as SNDX-5613) can help to control leukemias associated with an increase in expression of HOX genes.
Description
Primary Objectives • To assess the efficacy of revumenib in leukemias associated with upregulation of HOX genes. Secondary Objectives * To assess rates of measurable residual disease (MRD) clearance, as assessed by multiparameter flow cytometry in participants who respond to treatment. * To assess rates of cytogenetic remissions in participants with baseline cytogenetic abnormalities at diagnosis. * To assess event-free survival (EFS), duration of response (DOR), and overall survival (OS) in participants with leukemia associated with upregulation of HOX following treatment with revumenib.…
Eligibility
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥ 12 years with weight ≥ 40Kg. 2. ECOG performance status of ≤ 2. 3. Relapsed or refractory acute leukemia, of either myeloid, lymphoid or mixed lineages, with genetic alterations associated with upregulation of HOX, as specified below: Alteration/Mutation - Cytogenetics KMT2A-PTD = Normal karyotype; NPM1-MLF1 = t(3;5)(q25;q34); NUP98r = 11p15 rearrangements; SET-NUP214 = t(9;9)(q34;q34); RUNX1-EVI1 = t(3;21)(q26;q22); MYST3-CREBBP = t(8;16)(p11;p13); CDX2-ETV6 = t(12;13)(p13;q12); CALM-AF10 = t(10;11)(p13;q14-21); MN1-ETV6 = t(12;22)(p13;q12); UBTF-TD = Normal…
Interventions
- DrugRevumenib
Given by PO
Locations (2)
- Memorial Sloan Kettering Cancer CenterNew York, New York
- MD Anderson Cancer CenterHouston, Texas