Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 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.

View on ClinicalTrials.gov ↗

View your shortlist →

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).

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

Sponsor

Janssen Research & Development

593 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05453903

The ClinicalTrials.gov registry entry for NCT05453903 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 196 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 109-participant average among 30 other Leukemia, Myeloid, Acute trials with a reported enrollment target (80% higher). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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.

Explore more on PlainTrial

Leukemia, Myeloid, Acute

All registered trials for this condition

Alabama

All trials with a study site in Alabama

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.