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NCT05304377 · ClinicalTrials.gov registry record · Phase 1

A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia

A Phase 1 study of Chronic Myeloid Leukemia and CML, sponsored by Enliven Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
200
Enrollment target
20
Study locations

NCT05304377 is a Phase 1 study of Chronic Myeloid Leukemia and CML that is actively recruiting participants, run by Enliven Therapeutics. The registered enrollment target is 200 participants, roughly in line with the 204-participant average among 35 other Chronic Myeloid Leukemia trials with a reported enrollment target. The trial reports 20 study locations across 5 states.

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The verdict

NCT05304377, a Phase 1 study of Chronic Myeloid Leukemia and CML, is actively recruiting participants, sponsored by Enliven Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
200 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of ELVN-001 in patients with chronic myeloid leukemia with and without T315I mutations in patients who are relapsed, refractory or intolerant to TKIs.

Interventions

  • DRUG ELVN-001

Study Locations (20)

Other

  • Royal Adelaide Hospital - Adelaide
  • UZ Gent - Ghent
  • UZ Leuven - Leuven
  • CHU Liege - Liège
  • CHU Amiens Picardie Site Sud - Amiens
  • Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest - Bordeaux
  • Centre Hospitalier de Versailles (CHV) - Le Chesnay
  • CHRU de Lille - Hopital Calmette-Boulevard du Pr Leclercq CHRU Lille - Lille
  • Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren - Limoges
  • Centre Leon Berard - Lyon
  • Centre Hospitalier Lyon Sud - Pierre-Bénite
  • Uniklinik RWTH Aachen Medizinische - Aachen
  • Charite Campus Virchow - Berlin
  • Klinikum der Goethe Universitat - Frankfurt
  • Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes - Homburg

New York

  • Memorial Sloan Kettering Cancer Center - New York
  • Montefiore Medical Center - The Bronx

Oregon

  • Oregon Health & Science University-Knight Cardiovascular Institute - Portland

Texas

  • The University of Texas MD Anderson Cancer Center - Houston

Ontario

  • University Health Network (UHN) - Princess Margaret Cancer Centre - Toronto

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2022-05-22
Est. Completion 2026-12
Phase Phase 1

Sponsor

Enliven Therapeutics

3 total trials

What the Registry Record Tells You About NCT05304377

The ClinicalTrials.gov registry entry for NCT05304377 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 204-participant average among 35 other Chronic Myeloid Leukemia trials with a reported enrollment target. The listed sponsor is Enliven Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Chronic Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which ELVN-001 is the first listed.

NCT05304377 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Other, New York, Oregon.

Frequently Asked Questions

What is clinical trial NCT05304377 about?

NCT05304377 is a clinical study titled "A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia". The purpose of this study is to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of ELVN-001 in patients with chronic myeloid leukemia with and without T315I mutations in patients who are relapsed, refractory or intolerant to TKIs.

What is the current status of trial NCT05304377?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 200 participants. The study started on 2022-05-22. Estimated completion is 2026-12.

What conditions does trial NCT05304377 study?

This clinical trial studies the following conditions: Chronic Myeloid Leukemia, CML, Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive.

What interventions are being tested in trial NCT05304377?

The interventions under investigation include: ELVN-001 (DRUG).

Who is sponsoring clinical trial NCT05304377?

This trial is sponsored by Enliven Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05304377 being conducted?

This trial has 20 study locations across New York, Oregon, Texas, Ontario. 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

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