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NCT05546580 · ClinicalTrials.gov registry record · Phase 1

Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)

A Phase 1 study of Acute Myeloid Leukemia, in Relapse and Acute Myeloid Leukemia Refractory, sponsored by Oryzon Genomics S.A..

Recruiting
Registry status
Phase 1
Development phase
50
Enrollment target
13
Study locations

NCT05546580 is a Phase 1 study of Acute Myeloid Leukemia, in Relapse and Acute Myeloid Leukemia Refractory that is actively recruiting participants, run by Oryzon Genomics S.A.. The registered enrollment target is 50 participants, below the 57-participant average among 16 other Acute Myeloid Leukemia, in Relapse trials with a reported enrollment target (12% lower). The trial reports 13 study locations across 11 states.

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The verdict

NCT05546580, a Phase 1 study of Acute Myeloid Leukemia, in Relapse and Acute Myeloid Leukemia Refractory, is actively recruiting participants, sponsored by Oryzon Genomics S.A..

RECRUITING
Registry status
Phase 1
Development phase
50 participants
Enrollment target
13
Study locations

Study Summary

Iadademstat is being studied as a treatment for subjects with Relapsed or Refractory Acute Myeloid Leukemia (R/R AML) with FMS-like tyrosine kinase mutation (FLT3 mut+). During the trial, iadademstat will be given in combination with gilteritinib, a drug that is already approved to treat patients with FLT3-mutated R/R AML.

Conditions Studied

Acute Myeloid Leukemia, in Relapse Acute Myeloid Leukemia Refractory

Interventions

  • DRUG Iadademstat
  • DRUG Gilteritinib Oral Tablet

Study Locations (13)

Arizona

  • Banner MD Anderson Cancer Center - Gilbert
  • The University of Arizona Cancer Center - North Campus - Tucson

Florida

  • Sylvester Comprehensive Cancer Center - Miami
  • Miami Cancer Institute - Miami

Maryland

  • The John Hopkins University School of Medicine - Baltimore

Massachusetts

  • Massachusetts General Hospital (MGH) - Boston

New Jersey

  • Rutgers, The State University - Piscataway

New York

  • Icahn School of Medicine at Mount Sinai and Mount Sinai Hospital - New York

North Carolina

  • Duke University Medical Center - Durham

Oregon

  • Oregon Health & Science University - Portland

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2022-11-14
Est. Completion 2025-11-30
Phase Phase 1

Sponsor

Oryzon Genomics S.A.

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05546580

The ClinicalTrials.gov registry entry for NCT05546580 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 57-participant average among 16 other Acute Myeloid Leukemia, in Relapse trials with a reported enrollment target (12% lower). The listed sponsor is Oryzon Genomics S.A., which has 3 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Acute Myeloid Leukemia, in Relapse appearing as the primary indexed condition, and to 2 interventions - of which Iadademstat is the first listed.

NCT05546580 reports 13 study locations spanning 11 distinct geographic areas - top geographies include Arizona, Florida, Maryland.

Frequently Asked Questions

What is clinical trial NCT05546580 about?

NCT05546580 is a clinical study titled "Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)". Iadademstat is being studied as a treatment for subjects with Relapsed or Refractory Acute Myeloid Leukemia (R/R AML) with FMS-like tyrosine kinase mutation (FLT3 mut+). During the trial, iadademstat will be given in combination with gilteritinib, a drug that is already approved to treat patients wi...

What is the current status of trial NCT05546580?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2022-11-14. Estimated completion is 2025-11-30.

What conditions does trial NCT05546580 study?

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

What interventions are being tested in trial NCT05546580?

The interventions under investigation include: Iadademstat (DRUG), Gilteritinib Oral Tablet (DRUG).

Who is sponsoring clinical trial NCT05546580?

This trial is sponsored by Oryzon Genomics S.A., which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05546580 being conducted?

This trial has 13 study locations across Arizona, Florida, Maryland, Massachusetts, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.