ELVN-001 for the Treatment Chronic Myeloid Leukemia [Australia, France, Germany, Republic of Korea, Spain, United States]

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 inhibibitors (TKIs).

What will happen during the study

This is a first-in-human trial with ELVN-001, a new drug under investigation for the treatment of CML. ELVN-001 will be given orally once 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 CML in chronic phase (CP) or CML in accelerated phase (AP), with or without T315I mutation,
  who are resistant and/or intolerant to a previous therapy for treatment of their CML
• have an Eastern Co-Operative Group (ECOG) status of 0, 1 or 2
• have adequate hematologic, liver and kidney function

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 an active infection or whose heart, liver or pancreas function is impaired

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

Estimated primary completion date

Where can I find additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health

Study description in the EU Clinical Trials Register which is hosted by the European Medicines Agency (EMA)

Study centers / principal investigators

Australia

Adelaide, SA 5000 – Recruiting
Royal Adelaide Hospital
Principal Investigator: Timothy Hughes

France

Bordeaux, 33076 – Not yet recruiting
Institut Bergonie – Centre Regional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest
Principal Investigator: Dr. Gabriel Etienne

Le Chesnay, 78157 – Not yet recruiting
Centre Hospitalier de Versailles (CHV)
Principal Investigator: Prof. Philippe Rousselot

Lille, 59000 – Not yet recruiting
CHRU de Lille – Hopital Calmette-Boulevard du Pr Leclercq CHRU Lille
Principal Investigator: Dr. Valerie Coiteux

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

Germany

Aachen, 52074 – Not yet recruiting
Uniklinik RWTH Aachen Medizinische Klinik III
Principal Investigator: Dr. Martina Crysandt

Berlin, 13353 – Not yet recruiting
Charite Campus Virchow
Principal Investigator: Dr. Philipp Le Coutre

Frankfurt, 60596 – Not yet recruiting
Klinikum der Goethe Universität
Principal Investigator: Dr. Fabian Lang

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

Mannheim, 68167 – Not yet recruiting
Medizinische Universitätsklinik Mannheim der Universitat Heidelberg
Principal Investigator: Prof. Dr. Susanne Saussele

Korea, Republic of

Jeonju, Jeollabuk-do, 54907 – Recruiting
Chonbuk National University Hospital
Principal Investigator: Prof. Jae-Yong Kwak

Daegu, 42601 – Not yet recruiting
Keimyung University Dongsan Hospital
Principal Investigator: Prof. Dr. Young Rok Do

Gyeonggi-do, 11749 – Not yet recruiting
Uijeongbu Eulji Medical Center
Principal Investigator: Dr. Dong-Wook Kim

Hwasun, 58128 – Not yet recruiting
Chonnam National University Hwasun Hospital
Principal Investigator: Dr. Hyeoung-Joon Kim

Seoul, 06351 – Not yet recruiting
Samsung Medical Center
Principal Investigator: Dr. Chul Won Jung

Spain

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

Las Palmas De Gran Canaria, 35010 – Not yet recruiting
Hospital Universitario de Gran Canaria Dr. Negrin, Servicio Canario de Salud (SCS)
Principal Investigator: Dr. Maria Teresa Gomez-Casares

Madrid, 28046 – Not yet recruiting
Hospital Universitario La Paz
Principal Investigator: Dr. Maria Raquel de Paz Arias

Toledo, 45007 – Not yet recruiting
Hospital Virgen de la Salud
Principal Investigator: Dr. Luis Felipe Casado Montero

Valencia, 46026 – Not yet recruiting
Universitat de Valencia – Hospital Universitari i Politecnic La Fe de Valencia (Hospital La Fe Bulevar Sur)
Principal Investigator: Dr. Elvira Mora Castera

United States

New York

New York, New York, 10065 – Not yet recruiting
Memorial Sloan Kettering Cancer Center
Principal Investigator: Dr. Michael Mauro

Oregon

Portland, Oregon, 97239 – Not yet recruiting
Oregon Health & Science University-Knight Cardiovascular Institute
Principal Investigator: Dr. Michael Heinrich

Texas

Houston, Texas, 77030 – Not yet recruiting
The University of Texas MD Anderson Cancer Center
Principal Investigator: Dr. Koji Sasaki