🏛️ Verified NIH Record • Updated 2026-08-27

A Study of Bleximenib in Combination With Acute Myeloid Leukemia (AML) Directed Therapies (NCT05453903)

A Phase 1b Study of Bleximenib in Combination With AML-Directed Therapies for Participants With Acute Myeloid Leukemia Harboring KMT2A or NPM1 Alterations

🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Janssen Research & Development, LLC

🩺 Plain-English Summary (8th-Grade Level)

The purpose of this study is to determine the recommended Phase 2 dose (RP2D) candidate(s) of bleximenib in combination with AML directed therapies (dose selection) and further to evaluate safety and tolerability of bleximenib in combination with AML directed therapies at the RP2D(s) (dose expansion).

Who can join: Review the eligibility criteria below.

Location: The University of Alabama at Birmingham — Birmingham, Alabama

Age range: 12 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (32 Sites)

Showing the first 25 of 32 sites.

  • The University of Alabama at Birmingham — Birmingham, Alabama
  • City of Hope — Duarte, California
  • Massachusetts General Hospital — Boston, Massachusetts
  • Albert Einstein College Of Medicine — New York, New York
  • Novant Health — Charlotte, North Carolina
  • Novant Health Forsyth Medical Center — Winston-Salem, North Carolina
  • MD Anderson — Houston, Texas
  • Monash Medical Centre — Clayton,
  • Peter MacCallum Cancer Centre — Melbourne,
  • Westmead Hospital — Westmead,
  • Princess Margaret Cancer Centre University Health Network — Toronto, Ontario
  • Institut Paoli Calmettes — Marseille,
  • Chu Rennes Hopital Pontchaillou — Rennes,
  • Institut Universitaire du Cancer Toulouse Oncopole — Toulouse,
  • CHU de Tours - Hôpital de Bretonneau — Tours,
  • Charite Universitaetsmedizin Berlin — Berlin,
  • Universitatsklinikum Carl Gustav Carus Dresden — Dresden,
  • Universitaetsklinikum Heidelberg — Heidelberg,
  • Universitaetsklinikum Leipzig — Leipzig,
  • Universitatsklinikum Ulm — Ulm,
  • Azienda Opedaliero-Universitaria Policlinico Sant'orsola Malpighi di Bologna — Bologna,
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori — Meldola,
  • ASST Grande Ospedale Metropolitano Niguarda — Milan,
  • IRCCS Istituto Clinico Humanitas — Rozzano,
  • Hosp Clinic de Barcelona — Barcelona,

💰 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 § 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.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  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.
🏛️ View Official NIH Record ↗