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ACTIVE NOT RECRUITING Phase 1

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

NCT05453903 · View on ClinicalTrials.gov ↗

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

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

442 total trials

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 196 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05453903 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, North Carolina, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05453903?

This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial