Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX-5613 in Patients With Relapsed/Refractory Leukemias, Including Those Harboring an MLL/KMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation

Next Previous
Trial Profile

A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX-5613 in Patients With Relapsed/Refractory Leukemias, Including Those Harboring an MLL/KMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 10 Jul 2025

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Revumenib (Primary) ; Cobicistat; Fluconazole; Isavuconazole; Itraconazole; Ketoconazole; Posaconazole; Voriconazole
  • Indications Acute biphenotypic leukaemia; Acute myeloid leukaemia; Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Adverse reactions; First in man; Pharmacokinetics; Registrational; Therapeutic Use
  • Acronyms AUGMENT-101
  • Sponsors Syndax Pharmaceuticals

Most Recent Events

  • 24 Jun 2025 According to a Syndax Pharmaceuticals media release, FDA has granted Priority Review for sNDA of Revumenib in R/R NMP1 mutant AML under the RTOR program. The PDUFA action date is 25 Oct 2025. This sNDA is based on the AUGMENT-101 trial data and if approved, would expand the indication for Revuforj to include patients with R/R AML who have an NPM1 mutation, the most common genetic mutation in AML.
  • 12 Jun 2025 According to a Syndax Pharmaceuticals media release, company will present data from this study as poster presentation at the 30th European Hematology Association (EHA) Annual Congress Meeting being held June 12-15, 2025, in Milan, Italy and virtually.
  • 12 Jun 2025 Results presented in the Syndax Pharmaceuticals Media Release.

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top