ELVN-001-101 = ELVN-001 for the Treatment of Chronic Myeloid Leukemia [Australia, Canada, France, Germany, Israel, Republic of Korea, Spain, 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 escalated to determine the recommended dose for further evaluation in patients with chronic phase or accelerated phase CML with and without T315I mutations. There will be four treatment groups.

The safety, tolerability and pharmacokinetic profile of ELVN-001 will be assessed. Changes in BCR-ABL1 transcript will be evaluated.

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
• who are resistant and/or intolerant to a previous therapy for treatment of their CML, or who are ineligble to receive an available therapy for their CML.
• 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

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
Principal Investigator: Dr. Amandine Charbonnier

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

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

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

Centre Hospitalier Berard
Lyon, 69008
Principal Investigator: Dr. Franck Nicolini

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

Germany

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

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

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

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

Universitätsklinikum Jena
Jena, 07747
Principal Investigator: Prof. Dr. Andreas Hochhaus

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

Universitätsmedizin Rostock
Rostock, 18057
Principal Investigator: Dr. Christian Junghans

Israel

Hadassah Medical Center
Jerusalem, 9112001
Principal Investigator: Dr. David Lavie

The Galilee Medical Center
Nahariya, 2210001
Principal Investigator: Dr Galia Stemer

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

Korea, Republic of

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

Spain

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

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

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

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

United Kingdom

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

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

United States

New York

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

Oregon

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

Texas

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