RecruitingPhase 1NCT05304377

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

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

Sponsor

Enliven Therapeutics

Enrollment

250 participants

Start Date

May 22, 2022

Study Type

INTERVENTIONAL

Conditions

Chronic Myeloid Leukemia Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1 trial tests a new drug called ELVN-001 for chronic myeloid leukemia (CML) — a blood cancer driven by a specific gene abnormality called BCR-ABL1. ELVN-001 is designed to work even when the cancer has a mutation (T315I) that makes it resistant to other CML drugs. **You may be eligible if...** - You have CML in the chronic phase (not blast crisis), with or without the T315I resistance mutation - Your CML has failed or you cannot tolerate at least one prior second-generation TKI drug (e.g., dasatinib or nilotinib) or asciminib - You have good enough blood counts and organ function (ECOG 0–2) **You may NOT be eligible if...** - You received cancer treatment within the past 7 days or 5 half-lives - Your CML is in blast crisis or accelerated phase (in some criteria) - You have other active cancers or serious health problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGELVN-001

orally once or twice daily

Locations(45)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Oregon Health & Science University-Knight Cardiovascular Institute

Portland, Oregon, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Royal Adelaide Hospital

Adelaide, Australia

UZ Gent

Ghent, Belgium

UZ Leuven

Leuven, Belgium

CHU Liege

Liège, Belgium

University Health Network (UHN) - Princess Margaret Cancer Centre

Toronto, Ontario, Canada

CHU Amiens Picardie Site Sud

Amiens, France

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

Bordeaux, France

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

Lille, France

Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren

Limoges, France

Centre Leon Berard

Lyon, France

Centre Hospitalier Lyon Sud

Pierre-Bénite, France

Uniklinik RWTH Aachen Medizinische

Aachen, Germany

Charite Campus Virchow

Berlin, Germany

Klinikum der Goethe Universitat

Frankfurt, Germany

Universitaetsklinikum Des Saarlandes Und Medizinische Fakultaet Der Universitaet Des Saarlandes

Homburg, Germany

Universitaetsklinikum Jena

Jena, Germany

Medizinische Universitatsklinik Mannheim der Universitat Heidelberg

Mannheim, Germany

Universitaetsmedizin Rostock

Rostock, Germany

Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika

Budapest, Hungary

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

Pécs, Hungary

Hadassah Medical Center

Jerusalem, Israel

The Galilee Medical Center

Nahariya, Israel

Rabin Medical Center

Petah Tikva, Israel

Azienda Ospedaliero Universitaria Delle Marche

Ancona, Italy

Radboud University Medical Center

Nijmegen, Netherlands

Szpital Specjalistycnzy im. Jedrzeja Sniadeckiego w Nowym Saczu

Nowy Sącz, Poland

MICS Centrum Medyczne Torun

Torun, Poland

Instytut Hematologii I Transfuzjologii

Warsaw, Poland

Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Keimyung University Dongsan Hospital

Daegu, South Korea

Uijeongbu Eulji Medical Center

Gyeonggi-do, South Korea

Chonnam National University Hwasun Hospital

Hwasun, South Korea

Samsung Medical Center

Seoul, South Korea

Hospital Del Mar

Barcelona, Spain

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

Las Palmas de Gran Canaria, Spain

Hospital Universitario La Paz

Madrid, Spain

Complejo Hospitalario de Toledo - Hospital Virgen de la Salud

Toledo, Spain

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

Valencia, Spain

Beatson West of Scotland Cancer Centre, Gartnavel General Hospital

Glasgow, United Kingdom

Hammersmith Hospital Imperial College Healthcare NHS Trust

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05304377

Related Trials

Asciminib RMP Study

NCT0594352217 locations

Phase II Study Assessing the Efficacy and Toxicity of Olverembatinib Monotherapy in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

NCT068177201 location

Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

NCT05334069745 locations

A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity and the Prevention of CMV Viremia in Patients Undergoing Haploidentical Hematopoietic Stem Cell Transplant

NCT070205333 locations

Expanded/Activated Gamma Delta T-cell Infusion Following Hematopoietic Stem Cell Transplantation and Post-transplant Cyclophosphamide

NCT035338162 locations