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Overview 
AUGMENT-102/NCT05326516: A Phase 1, open-label, dose-escalation study to evaluate safety, tolerability, and preliminary anti-leukemic activity of revumenib (SNDX-5613) in combination with chemotherapy3 in patients with relapsed/refractory leukemias harboring a KMT2A/MLL gene rearrangement or nucleophosmin 1 mutation (NPM1m).1

About Revumenib (SNDX-5613) 
Revumenib (SNDX-5613) is an investigational, novel, orally available Menin-KMT2A inhibitor.2 The interaction of Menin and KMT2A has been demonstrated to play an essential role in the leukemic transformation for acute leukemia patients with a KMT2A rearrangement or NPM1 mutation.4, 5

Prevalence
KMT2A rearrangements are found in 5% to 10% of adult AML and B-ALL cases and >70% of infant leukemias6

NPM1 mutations are found in about 25% to 30% of all adult AML6

References

  1. A Study of SNDX-5613 in Combination With Chemotherapy in Participants With Leukemia (AUGMENT-102). ClinicalTrials.gov identifier: NCT05326516. https://clinicaltrials.gov/ct2/show/NCT05326516. Updated April 13, 2022. Accessed April 13, 2022.

  2. Data on file. Syndax Pharmaceuticals, Inc.

  3. For ALL/MPAL: 1. 4-drug regimen (vincristine, prednisone, pegaspargase, daunorubicin) followed by etoposide+cyclophosphamide or 2. fludarabine + cytarabine. For AML: fludarabine+cytarabine.

  4. Kuhn MW, Armstrong SA. Designed to kill: novel menin-MLL inhibitors target MLL-rearranged leukemia. Cancer Cell. 2015;27(4):431-433.

  5. Kuhn MW, Song E, Feng Z, et al. Targeting chromatin regulators inhibits leukemogenic gene expression in NPM1 mutant leukemia. Cancer Discov. 2016;6(10):1166–1181.

  6. Ley TJ, Miller C, Ding L, et al. Genomic and epigenomic landscapes of adult de novo acute myeloid leukemia. N Engl J Med. 2013;368(22):2059–2074.