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New hope for leukemia patients Who've run out of options

NCT ID NCT05304377

Disease control Sponsor: Enliven Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests a new drug called ELVN-001 in people with chronic myeloid leukemia (CML) whose cancer has not responded to or who cannot tolerate other treatments. The main goals are to check the drug's safety and find the best dose. About 250 adults with CML will take part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2022

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * BCR-ABL1 positive CML in chronic phase, with or without T315I mutation. * US: The patient has failed or is intolerant to at least one prior second-generation tyrosine kinase inhibitor (TKI) or asciminib. Rest of World: The patient has failed, is intolerant to, or not a candidate for, available therapies known to be active for treatment of their CML (country-specific criteria may vary). * ECOG performance status of 0 to 2. * Adequate hematologic, hepatic and renal function. * Prior bone marrow transplant allowed if ≥ 6 months prior to the first dose of ELVN-001. Exclusion Criteria: * Treatment with anti-cancer or anti-CML therapy within 7 days or 5 half-lives, whichever is longer. * History of acute tyrosine kinase inhibitor (TKI)-related pancreatitis within 6 months of study entry. Active chronic pancreatitis, or pancreatic disease due to any cause. * QTc \>470 ms.

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Conditions

The condition(s) this trial relates to.

chronic myelogenous leukemia, BCR-ABL1 positive Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Chronic-Phase

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic myeloid leukemia Chronic phase chronic myeloid leukemia, BCR-ABL1 positive CML

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    38 sites in 14 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Azienda Ospedaliero Universitaria Delle Marche

    RECRUITING

    Ancona, 60126, Italy

  • Beatson West of Scotland Cancer Centre, Gartnavel General Hospital

    RECRUITING

    Glasgow, G12 0YN, United Kingdom

  • CHRU de Lille - Hopital Calmette-Boulevard du Pr Leclercq CHRU Lille

    RECRUITING

    Lille, 59000, France

  • CHU Amiens Picardie Site Sud

    RECRUITING

    Amiens, 80054, France

  • CHU Liege

    RECRUITING

    Liège, 4000, Belgium

  • Centre Hospitalier Lyon Sud

    WITHDRAWN

    Pierre-Bénite, 69495, France

  • Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren

    RECRUITING

    Limoges, 87000, France

  • Centre Leon Berard

    RECRUITING

    Lyon, 69008, France

  • Charite Campus Virchow

    RECRUITING

    Berlin, 13353, Germany

  • Chonbuk National University Hospital

    WITHDRAWN

    Jeonju, Jeollabuk-do, 54907, South Korea

  • Chonnam National University Hwasun Hospital

    WITHDRAWN

    Hwasun, 58128, South Korea

  • Complejo Hospitalario de Toledo - Hospital Virgen de la Salud

    TERMINATED

    Toledo, 45007, Spain

  • Hadassah Medical Center

    RECRUITING

    Jerusalem, 9112001, Israel

  • Hammersmith Hospital Imperial College Healthcare NHS Trust

    RECRUITING

    London, W12 0HS, United Kingdom

  • Hospital Del Mar

    RECRUITING

    Barcelona, 08003, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario de Gran Canaria Dr. Negrin, Servicio Canario e Salud (SCS)

    WITHDRAWN

    Las Palmas de Gran Canaria, 35010, Spain

  • Institut Bergonie - Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

    RECRUITING

    Bordeaux, 33076, France

  • Instytut Hematologii I Transfuzjologii

    RECRUITING

    Warsaw, 02-776, Poland

  • Keimyung University Dongsan Hospital

    WITHDRAWN

    Daegu, 42601, South Korea

  • Klinikum der Goethe Universitat

    RECRUITING

    Frankfurt, 60596, Germany

  • MICS Centrum Medyczne Torun

    RECRUITING

    Torun, 87-100, Poland

  • Medizinische Universitatsklinik Mannheim der Universitat Heidelberg

    RECRUITING

    Mannheim, 68167, Germany

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Montefiore Medical Center

    RECRUITING

    The Bronx, New York, 10461, United States

  • Oregon Health & Science University-Knight Cardiovascular Institute

    RECRUITING

    Portland, Oregon, 97239, United States

  • Pecsi Tudomanyegyetem Klinikai Kozpont (University of Pecs, Clinical Centre)

    RECRUITING

    Pécs, 7624, Hungary

  • Rabin Medical Center

    RECRUITING

    Petah Tikva, 4941492, Israel

  • Radboud University Medical Center

    RECRUITING

    Nijmegen, 6525, Netherlands

  • Royal Adelaide Hospital

    RECRUITING

    Adelaide, SA 5000, Australia

  • Samsung Medical Center

    WITHDRAWN

    Seoul, 06351, South Korea

  • Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika

    RECRUITING

    Budapest, 1083, Hungary

  • Szpital Specjalistycnzy im. Jedrzeja Sniadeckiego w Nowym Saczu

    RECRUITING

    Nowy Sącz, 33-300, Poland

  • The Christie NHS Foundation Trust

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • The Galilee Medical Center

    RECRUITING

    Nahariya, 2210001, Israel

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • UZ Gent

    RECRUITING

    Ghent, 9000, Belgium

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • Uijeongbu Eulji Medical Center

    RECRUITING

    Gyeonggi-do, 11749, South Korea

  • Uniklinik RWTH Aachen Medizinische

    RECRUITING

    Aachen, 52074, Germany

  • Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes

    RECRUITING

    Homburg, 66421, Germany

  • Universitaetsklinikum Jena

    RECRUITING

    Jena, 07747, Germany

  • Universitaetsmedizin Rostock

    RECRUITING

    Rostock, 18057, Germany

  • Universitat de Valencia - Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)

    RECRUITING

    Valencia, 46026, Spain

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

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

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