OPTIC = Ponatinib in resistant chronic phase CML [Africa, Asia, Australia, Europe, North- and South America]

What is the purpose of the study

To characterize the efficacy of ponatinib administered in three starting doses (45mg, 30mg, and 15mg daily) in patients with CP-CML who are resistant to at least two TKIs, as measured by major cytogenetic response (MCyR) by 12 months.

Key inclusion criteria

This study includes patients who:
– have chronic myeloid leukemia in chronic phase (CP-CML) and are resistant to at least two prior tyrosine kinase inhibitors (TKI)
– are at least 18 years old, have an Eastern Co-Operative Group (ECOG) status of 0-2, have given written informed consent and comply with scheduled visits and study procedures
– have fully recovered from the acute effects of prior cancer therapy before initiation of study drug
– have adequate kidney, liver and pancreas function
– have a negative pregnancy test, use a highly effective form of contraception from randomization through at least 4 months after the end of treatment (for female and male patients who are fertile)

Additional criteria apply.

Key exclusion criteria

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 centers / principal investigators

Argentina

Buenos Aires, Argentina, 1221
Hospital Ramos Mejia (Site 826)
Contact: Claudio Merlo
Principal Investigator: Elena B Moiraghi, MD

Caba, Buenos Aires, C1114AAN
Fundaleu (Site 825)
Contact: Miguel Frau
Principal Investigator: Carolina Pavlovsky, M.D.

La Plata, Buenos Aires, B1900AXI
Hospital Italiano La Plata

Australia

New South Wales
St. Leonards, New South Wales, 2065
Royal North Shore Hospital (Site 941)
Contact: Vicki Katsioulas
Principal Investigator: Christopher K Arthur, MD

Adelaide, 5000
Royal Adelaide Hospital, Haematology Clinical Trials (Site 951)
Principal Investigator: Professor Timothy Peter Hughes

Canada

Ontario
Toronto, Ontario, M5G2M9
Princess Margaret Cancer Centre (Site 083)
Principal Investigator: Jeffrey Howard Lipton

Quebec
Montreal, Quebec, H3T IE2
Jewish General Hospital (Site 129)
Contact: Marie Pascale Guay
Principal Investigator: Sarit Assouline, MD

Saskatchewan
Regina, Saskatchewan, S4T 1A5
Pasqua Hospital (Site 227)
Principal Investigator: Haji Chalchal, MD

Chile

Providencia, Santiago, 7500922
Hospital del Salvador (Site 829)
Contact: Maria Gianna Capurro
Principal Investigator: Maria Soledad Undurraga Sutton, MD

Vina del Mar, Valparaiso, 254-0364
Centro de Investigaciones Clínicas Viña del Mar (Site 828)
Contact: Gina Castagneto
Principal Investigator: Christine Rojas Hopkins, MD

Czech Republic
Olomouc, 77520
Fakultni nemocnice Olomoue (Site 515)
Principal Investigator: prof. Karel Indrak, MD, PhD

Praha 2, 128 20
Ustav Hematologie a Krevni Transfuze Praha (UHKT) (Site 516)
Contact: Jana Vedrova
Principal Investigator: Hana Klamova

Denmark

Aarhus C, 8000
Haematologisk Afdeling, Arahus Universitehospital (Site 683)
Principal Investigator: Prof. Jesper Stentoft, M.D.

France

Angers Cedex 9, 44993 CHU Angers
Service Maladies du Sang (Site 685)
Principal Investigator: Dr. Martine Gardembas

Bordeaux, 33076
Centre de Lutte Contre le Cancer – Institut Bergonie (Site 772)
Principal Investigator: Dr. Gabriel Etienne

Lille, Nord, 59037 CEDEX Hopital Claude Huriez CHRU (Site 952)
Contact: Sylvie Brice
Principal Investigator: Valerie Coiteux, MD

Nantes Cedex, 44093
CHU Hotel-Dieu, Service d’Hematologie Clinique (Site 521)
Principal Investigator: Dr. Viviane Dubruille

Nice Cedex 3, 06202
Centre Hospitalier Universitaire de Nice Hopital l’Archet (Site 509)
Contact: Marie-Christine Rigualt
Principal Investigator: Laurence Legros

Poitiers, B.p. 577, 86021
CHRU de Poitiers, Department of Oncology-Hematology and Cell Therapy (Site 954)
Principal Investigator: Prof. Francois Guilhot

Toulouse Cedex 9, Midi-pyrenees, 31059
Institut Universitaire du Cancer de Toulouse Oncopole

Vandoeuvre-les-Nancy Cedex, 54511
University Teaching Hospital – CHU Brabois (Site 953)
Principal Investigator: Dr. Agnes-Paule Guerci-Bresler

Germany

Aachen, 52074
Universitätsklinikum Aachen, AOR (Site 513)
Contact: Sabrina Holst
Principal Investigator: Martina Crysandt, MD

Berlin, 13353
Universitätsmedizin Berlin – Charité (CVK) (Site 701)
Contact: Peggy Grill
Principal Investigator: Philipp Le Coutre, MD

Essen, 45147
Essen University Hospital (Site 686)
Contact: Ilona Vester
Principal Investigator: Jürgen Novotny, MD

Hamburg, 20246
University Cancer Center Hamburg (Site 524)
Hubertus Wald Tumorzentrum
Contact: Juliane Granzow
Principal Investigator: Philippe Schafhausen, MD

Jena, 07747
Universitätsklinikum Jena (Site 946)
Contact: Denise Mathes
Principal Investigator: Andreas Hochhaus, PhD, MD

Mannheim, 68169
University of Heidelberg (Site 947)
Contact: Regina Pleil-Losch
Principal Investigator: Susanne Saussele, MD

Rostock, 18057
Universitatsmedizin Rostock

Ulm, 89081
University Hospital of Ulm (Site 694)
Contact: Beate Böltau
Principal Investigator: Frank Stegelmann, MD

Hong Kong

Hong Kong, 852
Queen Mary Hospital

Italy

Catania, 95124
University Hospital Policlinico (Site 530)
Contact: Giovanna Pappalardo
Principal Investigator: Francesco Di Raimondo, MD

Genova, 16132
Azienda Ospedaliera Universitaria San Martino
V.O. Clinica Ematologica (Site 528)
Contact: Maria Attilia Grassi
Principal Investigator: Marco Gobbi

Monza, 20090
ASST San Gerardo Hospital (Site 355)
Contact: Dario Cerri
Principal Investigator: Carlo Gambacorti-Passerini, MD

Pesaro, Pesaro e Urbino, 61100
A.O. Ospedali Riuniti Marche Nord (Site 689)
Contact: Maurizio Nardelli
Principal Investigator: Giuseppe Visani, MD

Pescara, 65124
Pescara Civil Hospital (Site 688)
Contact: Giuseppina Di Florio
Principal Investigator: Paolo Di Bartolomeo, MD

Roma, 00161
University La Spienza (Site 511)
Contact: Enrica Arduini
Principal Investigator: Giuliana Alimena

Verona, 37134
Ospedale Borgo Roma – Verona (Site 687)
Contact: Giorgia Barbiero
Principal Investigator: Massimiliano Bonifacio, MD

Korea, Republic of

Seoul, Korea, Republic of, 137-701
The Catholic University of Korea Seoul
St. Mary’s Hospital (Site 938)
Principal Investigator: Dong-Wook Kim, M.D., PhD

Poland

Gdansk, Pomorskie, Poland, 80-952
Uniwersyteckie Centrum Kliniczne

Krakow, 30-510
Malopolskie Medical Center (Site 546)
Contact: Marta Kowalowka
Principal Investigator: Tomasz Sacha, MD

Łódź, Poland, 93-510
Klinika Hematologii Uniwersytetu Medycznego w Łodzi (Site 550)
Contact: Magdalena Przybysz
Principal Investigator: Tadeusz Robak, MD

Warszawa, Poland, 02-776
Klinika Hematologii (Site 691)
Contact: Urszula Szustkiewicz
Principal Investigator: Krzysztof Warzocha, MD

Wrocław, Poland, 50-369
Independent Public Clinical Hospital No. 1 in Wroclaw (Site 547)
Contact: Mariusz Grajcar
Principal Investigator: Ewa Medras, MD

Portugal

Lisboa, 1090-023
Instituto Portugues de Oncologia de Lisboa (Site 545)
Contact: Ana Inacio
Principal Investigator: Antonio M Almeida, MD/PhD

Porto, 4200-319
Centro Hospitalar de S. João (Site 559)
Contact: Raquel Ribeiro
Principal Investigator: Manuel S Simões

Russian Federation

Chelyabinsk, 454076
Chelyabinsk Regional Clinical Hospital

Kemerovo, 650066
Kemerovo Regional Clinical Hospital (Site 455)
Contact: Ludmila Chervova
Principal Investigator: Marina Kosinova, MD

Moscow, 111123
GBUZ Moscow Clinical Scientific Center (Site 453)
Contact: Galina Dudina
Principal Investigator: Mikhail Y Byakhov, MD

Moscow, 125167
Russian Academy of Medical Science
Haematological Scientific Center (Site 452)
Contact: Nemchenko Irina, MD
Principal Investigator: Anna Turkina, MD

Rostov-na-Donu, Rostov, 344022
Rostov State Medical University

Saint Petersburg, 191024
FGU Russian Scientific Research Institute of Hematology and Transfusiology

Saint-Petersburg, 197341
Federal State Budgetary Institution V. A. Almazov
Federal North-West Medical (Site 454)
Contact: Irina Shakhomirova
Principal Investigator: Elza Lomaia, MD

Samara, 443099
Samara State Medical University

Saratov, Russian Federation, 355018
Saratov State Medical University

Singapore

Outram Road, Singapore, 169608
Singapore General Hospital (Site 939)
Principal Investigator: Dr. Charles Chuah Thuan Heng

Spain

Barcelona, Cataluna, 08036
Hospital Clinic, Service de Hematologia (Site 963)
Principal Investigator: Francisco Cervantes

Las Palmas de Gran Canaria, Islas Canarias, 35010
Hospital Universitario de Gran Canaria Dr Negrin (Site 692)
Contact: Mireya A Lopez
Principal Investigator: Maria Teresa Gomez Casares, MD

Madrid, 28006
Hospital Universitario de la Princesa
Hematology Service, 2a Planta (Site 555)
Principal Investigator: Juan Luis Steegmann Olmedillas

Madrid, 28034
Hospital Universitario Ramon y Cajal (Site 538)
Principal Investigator: Valentin Garcia Gutierrez
Hospital Clinico Universitario de Valencia (Site 964)

Malaga, Andalucia, 29010
Hospital Regional Universitario Carlos Haya (Site 698)
Principal Investigator: Antonio Jimenez Velasco

Valencia, Spain, 46010
Hospital Clinico Universitario de Valencia (Site 964)
Principal Investigator: Juan Carlos Hernandez Boluda

Sweden

Uppsala, SE-751 85
University Hospital Uppsala (Site 945)
Contact: Aime Mukenyuzi
Principal Investigator: Ulla Olsson-Stromberg, M.D., Ph.D.

Switzerland

Zurich, 8091
University Hospital Zurich (Site 562)
Contact: Isabell Pieper-Scholz
Principal Investigator: Stefan Balabanov, MD

Taiwan

Taipei, 100
National Taiwan University Hospital (Site 979)
Principal Investigator: Jih-Luh Tang, M.D., PhD.

United Kingdom

Glasgow, G12 0YN
NHS Greater Glasgow & Clyde
The Beatson West of Scotland Cancer Centre (Site 797)
Principal Investigator: Professor Tessa Holyoake

Liverpool, L7 8XP
The Royal Liverpool University Hospital (Site 969)
Principal Investigator: Professor Richard Clark

London, SE5 9RS
King’s College Hospital NHS Foundation Trust (Site 693)
Principal Investigator: Dr. Hugues de Lavallade

London, W12 0NN
Imperial College Healthcare NHS Trust (Site 967)
Contact: Regina Storch
Principal Investigator: Jane F Apperley, MD

Nottingham, NG5 1PB
The Centre for Clinical Haematology
Notthingham University Hospitals NHS Trust (Site 968)
ontact: Maria Scott
Principal Investigator: Jennifer Byrne

Oxford, OX3 7LE
Churchill Hospital

United States

Georgia
Atlanta, Georgia, 30322
Emory University Hospital Winship Cancer Institute (Site 058)
Principal Investigator: Vamsi Kota, MD

Indiana
Indianapolis, Indiana, 46237
Indiana Blood and Marrow Transplantation Clinic (Site 138)
Principal Investigator: Luke Akard, MD

Maryland
Baltimore, Maryland, 21201
University of Maryland Medical Center (Site 040)
Principal Investigator: Maria Baer, MD

Michigan
Ann Arbor, Michigan, 48109
University of Michigan Health System (Site 011)
Principal Investigator: Moshe Talpaz, MD

Detroit, Michigan, 48201
Karmanos Cancer Institute (Site 034)
Principal Investigator: Charles Schiffer, MD

Minnesota
Minneapolis, Minnesota, 55455
University of Minnesota Medical School

Nebraska
Omaha, Nebraska, 68198-7680
University of Nebraska Medical Center (Site 235)
Principal Investigator: Lori Maness-Harris, MD

New Jersey
Hackensack, New Jersey, 07601
Hackensack University Medical Center (Site 128)
Principal Investigator: James McCloskey II

New York
New York, New York, 10065
Memorial Sloan Kettering Cancer Center (Site 078)
Contact: Gerald O’Neill
Principal Investigator: Michael Mauro, MD

New York, New York, 10065
Weill Medical College of Cornell University and New York Presbyterian Hospital (Site 006)
Contact: Rachael Alettie
Principal Investigator: Ellen Ritchie, MD

North Carolina
Durham, North Carolina, 27710
Duke University Medical Center (Site 003)
Contact: Cheryl M Maxey
Principal Investigator: Joseph Moore, MD

Ohio
Cleveland, Ohio, 44195
Cleveland Clinic Foundation (Site 004)
Principal Investigator: Dr. Sudipto Mukherjee

Oregon
Portland, Oregon, 97239
Oregon Health & Science University (Site 048)
Contact: Jeanne Liming
Principal Investigator: Michael Heinrich

Pennsylvania
Philadelphia, Pennsylvania, 19104
Abramson Cancer Center (Site 013)
Principal Investigator: Selena Luger, MD

Texas
Houston, Texas, 77030
MD Anderson Cancer Center (Site 005)
Principal Investigator: Jorge E. Cortes, MD

Utah
Salt Lake City, Utah, 84112
Huntsman Cancer Institute (Site 043)
Principal Investigator: Michael Deiningeri, MD