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NCT05453903 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Leukemia, Myeloid, Acute, sponsored by Janssen Research & Development.

Active
Registry status
Phase 1
Development phase
196
Enrollment target
20
Study locations

NCT05453903: Active Phase 1 study of Leukemia, Myeloid, Acute, sponsored by Janssen Research & Development.

NCT05453903 is a Phase 1 study of Leukemia, Myeloid, Acute that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 196 participants, above the 109-participant average among 30 other Leukemia, Myeloid, Acute trials with a reported enrollment target (80% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05453903, a Phase 1 study of Leukemia, Myeloid, Acute, is active but no longer recruiting, sponsored by Janssen Research & Development.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
196 participants
Enrollment target
20
Study locations

Study Summary

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).

Primary Outcome

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

Conditions Studied

Leukemia, Myeloid, Acute

Interventions

  • DRUG Cytarabine
  • DRUG Bleximenib
  • DRUG Venetoclax (VEN)
  • DRUG Azacitidine (AZA)
  • DRUG Daunorubicin or Idarubicin

Study Locations (20)

Other

  • Monash Medical Centre - Clayton
  • Peter MacCallum Cancer Centre - Melbourne
  • Westmead Hospital - Westmead
  • 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

North Carolina

  • Novant Health - Charlotte
  • Novant Health Forsyth Medical Center - Winston-Salem

Alabama

  • The University of Alabama at Birmingham - Birmingham

California

  • City of Hope - Duarte

Massachusetts

  • Massachusetts General Hospital - Boston

New York

  • Albert Einstein College Of Medicine - New York

Texas

  • MD Anderson - Houston

Ontario

  • Princess Margaret Cancer Centre University Health Network - Toronto

Trial Details

FieldValue
Enrollment Target 196 participants
Start Date 2022-10-04
Est. Completion 2027-03-19
Phase Phase 1
Janssen Research & Development

593 total trials

What the registry record for NCT05453903 still lists

NCT05453903 is an interventional study that assigns participants to a tested intervention. The registered 196 participants enrollment target is mid-sized for trials with a published cap, above the 109-participant average among 30 other Leukemia, Myeloid, Acute trials with a reported enrollment target (80% higher).

The record links to 1 condition, with Leukemia, Myeloid, Acute appearing as the primary indexed condition, and to 5 interventions - of which Cytarabine is the first listed.

NCT05453903 names 20 study sites across 8 states, led by Other, North Carolina, Alabama.

Frequently Asked Questions

What is clinical trial NCT05453903 about?

NCT05453903 is a clinical study titled "A Study of Bleximenib in Combination With Acute Myeloid Leukemia (AML) Directed Therapies". 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...

What is the current status of trial NCT05453903?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 196 participants. The study started on 2022-10-04. Estimated completion is 2027-03-19.

What conditions does trial NCT05453903 study?

This clinical trial studies the following conditions: Leukemia, Myeloid, Acute.

What interventions are being tested in trial NCT05453903?

The interventions under investigation include: Cytarabine (DRUG), Bleximenib (DRUG), Venetoclax (VEN) (DRUG), Azacitidine (AZA) (DRUG), Daunorubicin or Idarubicin (DRUG).

Who is sponsoring clinical trial NCT05453903?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05453903 being conducted?

This trial has 20 study locations across Alabama, California, Massachusetts, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Leukemia, Myeloid, Acute

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05453903's enrollment target sits among peer trials

196 5th of 30 higher than 26 of 30 other Leukemia, Myeloid, Acute trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Leukemia, Myeloid, Acute trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT05453903, the US trial registry maintained by the National Library of Medicine. NCT05453903 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.