AUGMENT-102 (chemotherapy combination)

AUGMENT-102
CLINICAL TRIAL NOW RECRUITING

A Phase 1 trial investigating orally administered revumenib in combination with chemotherapy in patients with MLLr or mNPM1 acute leukemias1,2

INTERVENTION:

Revumenib capsules orally and pre-specified chemotherapy regimens1,3


ENROLL:

If you are interested in learning more about enrolling your adult and pediatric relapsed/refractory patients in AUGMENT-102, contact us directly at clinicaltrials@syndax.com.

INTERVENTION:

Revumenib capsules orally and pre-specified chemotherapy regimens1,3


ENROLL:

If you are interested in learning more about enrolling your adult and pediatric relapsed/refractory patients in AUGMENT-102, contact us directly at clinicaltrials@syndax.com.

Revumenib/SNDX-5613 is an investigational, novel, orally available Menin-MLL1 inhibitor.2 The interaction of Menin and MLL1 has been demonstrated to play an essential role in the leukemic transformation for acute leukemia patients with MLLr or NPM1 mutation.4,5
Prevalence6
  • MLL rearrangements are found in 5% to 10% of adult AML and B-ALL cases and >70% of infant leukemias
  • NPM1 mutations are found in about 25% to 30% of all adult AML
AUGMENT-102/NCT05326516: A Phase 1, Open-Label, Dose-escalation study to Evlaulate Safety, Tolerability, and Preliminary Anti-Leukemic Activity of SNDX-5613 in Combination with Chemotherapy3 in Patients with Relapsed/Refractory Leukemias harboring a KMT2A/MLL Gene Rearrangement or Nucleophosmin 1 Mutation (mNPM1).1
This trial is actively recruiting
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.