ENABLE (ELVN-001-101) = ELVN-001 for the Treatment of Chronic Myeloid Leukemia [Australia, Canada, Europe, Israel, Republic of Korea, USA]

What is the purpose of the study

This is a study to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of ELVN-001 in patients with CML with or without T315I mutations who are relapsed, refractory or intolerant to tyrosine kinase inhibitors (TKIs).

What will happen during the study

This is the first trial to investigate ELVN-001 in humans.

ELVN-001 is a new drug under investigation for the treatment of CML. ELVN-001 will be given orally once or twice daily. The dose will be increased stepwise to determine the recommended dose for further studies in patients with chronic phase or accelerated phase CML with and without T315I mutations. There will be four treatment groups.

Key inclusion criteria

This study includes patients of all sexes who:

• are aged 18 years or older
• have been diagnosed with BCR-ABL1 positive CML in chronic phase (CP), with or without T315I mutation
• United States: have failed or are intolerant to at least one prior second-generation tyrosine kinase inhibitor (TKI) or asciminib
• Rest of World: have failed, are intolerant to, or not a candidate for, available therapies known to be active for treatment of their CML (country-specific criteria may vary)
• have an Eastern Co-Operative Group (ECOG) status of 0, 1 or 2
• have adequate hematologic, liver and kidney function.

Further criteria may apply. Please discuss these with your doctor or study staff.

Key exclusion criteria

This study does not include patients who:

• have been treated with anti-cancer or anti-CML therapy within 7 days or 5 half-lives, whichever is longer
• have had acute TKI-related pancreatitis within 6 months of study entry, or have active pancreatitis or pancreatic disease due to any cause

Further criteria may apply. Please discuss these with your doctor or study staff.

Estimated primary completion date

Where can I find additional information

You can find a study description in the US register ClinicalTrials.gov. This is a database provided by the U. S. National Institutes of Health.

Study centers / principal investigators

Australia

Royal Adelaide Hospital
Adelaide, SA 5000
Contact: Naranie Shanmuganathan Naranie

Belgium

UZ Gent
Gent, 9000
Contact: Dr. Dominiek Mazure

UZ Leuven
Leuven, 3000
Contact: Dr. Peter Vandenberghe

CHU Liège
Liège, 4000
Contact: Dr. Marie Lejeune

Canada

University Health Network (UHN)
Princess Margaret Cancer Center
Toronto, M5G 2M9
Contact: Dr. Dong Hwan Dennis Kim

France

CHU Amiens Picardie Site Sud
Amiens, 80054
Contact: Dr. Amandine Charbonnier

Institut Bergonie, Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Bordeaux, 33076
Contact: Dr. Gabriel Etienne

CHRU de Lille, Hopital Calmette-Boulevard du Pr Leclercq CHRU Lille
Lille, 59000
Contact: Dr. Valerie Coiteux

Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren
Limoges, 87000
Contact: Dr. Pascal Turlure

Centre Hospitalier Berard
Lyon, 69008
Contact: Dr. Franck Nicolini

Centre Hospitalier Lyon Sud
Pierre Benite Cedex, 69495
Contact: Dr. Marie Balsat

Germany

Uniklinik RWTH Aachen Medizinische Klinik III
Aachen, 52074
Contact: Dr. Martina Crysandt

Charite Campus Virchow
Berlin, 13353
Contact: Dr. Philipp Le Coutre

Klinikum der Goethe Universität
Frankfurt, 60596
Contact: Dr. Fabian Lang

Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes
Homburg, 66421
Contact: Dr. Sarah Altmeyer

Universitätsklinikum Jena
Jena, 07747
Contact: Prof. Dr. Andreas Hochhaus

Medizinische Universitätsklinik Mannheim der Universität Heidelberg
Mannheim, 68167
Contact: Prof. Dr. Susanne Saussele

Universitätsmedizin Rostock
Rostock, 18057
Contact: Dr. Christian Junghans

Israel

Hadassah Medical Center
Jerusalem, 9112001
Contact: Dr. David Lavie

The Galilee Medical Center
Nahariya, 2210001
Contact: Dr Galia Stemer

Rabin Medical Center
Petah Tikva, 4941492
Contact: Dr. Adi Shacham-Abulafia

Hungary

Semmelweis Egyetem, Belgyogyaszati es Onkologiai Klinika
Budapest, 1083
Contact: Istvan Tackas, MD

Pecsi Tudomanyegyetem Klinikai Kozpont (University of Pecs, Clinical Centre)
Pécs, 7624
Contact: Dr. Hussain Alizadeh

Italy

Azienda Ospedaliero Universitaria Delle Marche
Ancona, 60126
Contact: Dr. Erika Morsia

Korea, Republic of

Uijeongbu Eulji Medical Center
Gyeonggi-do, 11749
Contact: Dr. Dong-Wook Kim

Netherlands

Radboud University Medical Center
Nijmegen, 6525
Contact: Dr. . N.M.A. Blijlevens

Poland

Szpital Specjalistycnzy im. Jedrzeja Sniadeckiego w Nowym Saczu
Nowy Sącz, 33-300
Contact: Dr. Szymon Fornagiel

MICS Centrum Medyczne Torun
Toruń, 87-100
Contact: Dr. Dominik Chraniuk

Instytut Hematologii I Transfuzjologii
Warszawa, 02-776
Contact: Dr. Ewa Lech-Maranda

Spain

Hospital Del Mar
Barcelona, 08003
Contact: Dr. Patricia Velez Tenza

Hospital Universitario La Paz
Madrid, 28046
Contact: Dr. Maria Raquel de Paz Arias

Complejo Hospitaliario de Toledo – Hospital Virgen de la Salud – Terminated
Toledo, 45007
Contact: Dr. Jorge Cuesta Tovar

Universitat de Valencia, Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
Valencia, 46026
Contact: Dr. Elvira Mora Castera

United Kingdom

Beatson West of Scotland Cancer Centre, Gartnavel General Hospital
Glasgow, G12 0YN
Contact: Dr. Mhairi Copland

Hammersmith Hospital Imperial College Healthcare NHS Trust
London, W12 0HS
Contact: Dr. Dragana Milojkovic

The Christie NHS Foundation Trust
Manchester, M20 4BX
Contact: Dr. John Chadwick

United States

New York

Montefiori Medical Center
Bronx, New York, 10461
Contact: David Levitz, MD

Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Contact: Michael Mauro, MD

Oregon

Oregon Health & Science University-Knight Cardiovascular Institute
Portland, Oregon, 97239
Contact: Michael Heinrich, MD

Texas

The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Contact: Koji Sasaki, MD