๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-03-17

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation (NCT04065399)

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

๐ŸŸข Recruiting Phase1 / Phase2 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Syndax Pharmaceuticals

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

Phase 1 dose escalation will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of revumenib in participants with acute leukemia. In Phase 2, participants will be enrolled in 4 indication-specific expansion cohorts to determine the efficacy, short- and long-term safety, and tolerability of revumenib.

Who can join: Review the eligibility criteria below.

Location: City of Hope Comprehensive Cancer Center โ€” Duarte, California

Age range: 30 Days

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (57 Sites)

Showing the first 25 of 57 sites.

  • City of Hope Comprehensive Cancer Center โ€” Duarte, California
  • University Of California Care Medical Group - Norris Comprehensive Cancer Center And Hospital โ€” Los Angeles, California
  • Stanford Cancer Institute โ€” Palo Alto, California
  • University of Colorado โ€” Aurora, Colorado
  • Florida Cancer Specialists and Research Institute โ€” Sarasota, Florida
  • Moffitt Cancer Center โ€” Tampa, Florida
  • Emory Winship Cancer Institute โ€” Atlanta, Georgia
  • Children's Healthcare of Atlanta โ€” Atlanta, Georgia
  • The University of Chicago Medical Center โ€” Chicago, Illinois
  • University of Iowa Hospital โ€” Iowa City, Iowa
  • Dana Farber Cancer Institute โ€” Boston, Massachusetts
  • Washington University in St. Louis School of Medicine โ€” St Louis, Missouri
  • Hackensack University Medical Center โ€” Hackensack, New Jersey
  • Memorial Sloan Kettering Cancer Center โ€” New York, New York
  • Montefiore Medical Center โ€” New York, New York
  • Duke University Medical Center โ€” Durham, North Carolina
  • University of Cincinnati โ€” Cincinnati, Ohio
  • Ohio State University โ€” Columbus, Ohio
  • Oregon Health & Science University โ€” Portland, Oregon
  • University of Pennsylvania โ€” Philadelphia, Pennsylvania
  • The University of Texas MD Anderson Cancer Center โ€” Houston, Texas
  • Huntsman Cancer Institute at the University of Utah โ€” Salt Lake City, Utah
  • Peter MacCallum Cancer Centre (PMCC) โ€” Melbourne, Victoria
  • Royal Melbourne Hospital (RMH) โ€” Parkville, Victoria
  • Alfred Hospital โ€” Melbourne,

๐Ÿ“ž Contact the Study Coordinator

Phone: (781) 419-1400

Email: clinicaltrials@syndax.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—