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A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia
Sponsor: Takeda
Summary
In this study, adults with newly-diagnosed Philadelphia Chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) will receive first-line therapy of ponatinib or imatinib. The main aim of this study is to compare the number of participants on each treatment that show no signs of disease. Participants will take tablets of either ponatinib or imatinib at the same time each day combined with reduced-intensity chemotherapy for up to 20 months. Then, they will continue with single-agent therapy (ponatinib or imatinib) until they meet the discontinuation criteria from the study.
Official title: A Phase 3, Randomized, Open-label, Multicenter Study Comparing Ponatinib Versus Imatinib, Administered in Combination With Reduced-Intensity Chemotherapy, in Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
245
Start Date
2018-10-04
Completion Date
2027-07-31
Last Updated
2025-11-26
Healthy Volunteers
No
Interventions
Ponatinib
Ponatinib Tablets.
Imatinib
Imatinib Tablets.
Vincristine
Vincristine IV injection.
Dexamethasone
Dexamethasone Tablets.
Cytarabine
Cytarabine IV infusion.
Methotrexate
Methotrexate IV infusion.
Prednisone
Prednisone Tablets.
Locations (92)
University of Alabama at Birmingham
Birmingham, Alabama, United States
City of Hope - Duarte
Duarte, California, United States
University of California Los Angeles
Los Angeles, California, United States
Augusta University Georgia Cancer Center
Augusta, Georgia, United States
Indiana University
Indianapolis, Indiana, United States
Indiana Blood & Marrow Transplantation
Indianapolis, Indiana, United States
University of Kansas Medical Center Research Institute
Kansas City, Kansas, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Monter Cancer Center
New Hyde Park, New York, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Oregon Health and Science University
Portland, Oregon, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Methodist Hospital
San Antonio, Texas, United States
Sanatorio Allende
Córdoba, Argentina
Hospital Privado Centro Medico de Cordoba
Córdoba, Argentina
Royal North Shore Hospital
Saint Leonards, New South Wales, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Ordensklinikum Linz Elisabethinen
Linz, Upper Austria, Austria
Hanusch Krankenhaus Wiener Gebietskrankenkasse
Vienna, Vienna, Austria
Universitaetsklinik Fuer Innere Medizin I
Vienna, Austria
Hospital Sao Rafael-Monte Tabor
Salvador, Estado de Bahia, Brazil
Hospital Erasto Gaertner
Curitiba, Paraná, Brazil
Hospital da Cidade
Passo Fundo, Rio Grande do Sul, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hemocentro Campinas Unicamp
Campinas, São Paulo, Brazil
Fundacao Doutor Amaral Carvalho
Jaú, São Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina da Riberao Preto da Universidade de Sao Paulo
Ribeirão Preto, São Paulo, Brazil
HEMORIO Instituto Estadual de Hematologia Arthur Siqueira de Cavalcanti
Rio de Janeiro, Brazil
Instituto do Cancer do Estado de Sao Paulo
São Paulo, Brazil
Fundacao Antonio Prudente - A.C.Camargo Cancer Center
São Paulo, Brazil
University Multiprofile Hospital for Active Treatment Saint Ivan Rilski
Sofia, Sofia, Bulgaria
855 West 12th Avenue
Vancouver, British Columbia, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Hopital Charles-LeMoyne
Greenfield Park, Quebec, Canada
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Soochow University/Suzhou First People's Hospital
Suzhou, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, China
Institute of Hematology & Blood Diseases Hospital of CAMS & PUMC
Tianjin, China
Helsingin ja Uudenmaan sairaanhoitopiiri
Helsinki, Finland
Centre Hospitalier Lyon Sud
Pierre-Bénite, Auvergne-Rhône-Alpes, France
Institut Universitaire du Cancer de Toulouse Oncopole
Toulouse, Midi-pyrenees, France
Center Hospitalier Universitaire d'Angers
Angers, Pays de la Loire Region, France
Centre Hospitalier de Versailles Hopital Andre Mignot
Le Chesnay, Île-de-France Region, France
University General Hospital of Athens Attikon
Chaïdári, Attica, Greece
Evaggelismos General Hospital
Athens, Ipsiladou 45-47, Greece
General University Hospital of Patras Panagia I Voithia
Pátrai, Rio, Greece
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola, Forli-cesena, Italy
Azienda Policlinico San Martino
Genoa, Liguria, Italy
Azienda Ospedaliera San Gerardo di Monza
Monza, Monza E Brianza, Italy
Arcispedale Santa Maria Nuova
Reggio Emilia, Reggio Nella Emilia, Italy
Ospedale dell'Angelo
Mestre, Venezia, Italy
Azienda Ospedaliero Universitaria di Bologna Policlinico Sant'Orsola-Malpighi
Bologna, Italy
Azienda Ospedaliera Vito Fazzi
Lecce, Italy
Istituto Scientifico Universitario San Raffaele
Milan, Italy
Azienda Ospedaliero-Universitaria di Modena Policlinico
Modena, Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello
Palermo, Italy
Azienda USL della Romagna
Ravenna, Italy
Centro di Ematologia Policlinico Umberto I Universita Sapienza di Roma
Roma, Italy
Fondazione Policlinico Universitario Agostino Gemelli
Roma, Italy
Chiba Aoba Municipal Hospital
Chiba, Chiba, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Fukushima Medical University Hospital
Fukushima, Fukushima, Japan
Aiiku Hospital
Sapporo, Hokkaido, Japan
Tokai University Hospital
Isehara, Kanagawa, Japan
Okayama University Hospital
Okayama, Okayama-ken, Japan
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo León, Mexico
Szpital Uniwersytecki w Krakowie
Krakow, Lesser Poland Voivodeship, Poland
Uniwersytecki Szpital Kliniczny we Wroclawiu
Wroclaw, Lower Silesian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurs
Olsztyn, Warmian-Masurian Voivodeship, Poland
City Clinical Hospital named after Vikentiy Vikentyevich Veresaev
Moscow, Moscow CITY, Russia
Sverdlovsk Regional Clinical Hospital #1
Yekaterinburg, Sverdlovsk Oblast, Russia
National Research Center for Hematology, Dept. of Hematology/Oncology and BMT
Moscow, Russia
Almazov Federal North-West Medical Research Centre of Department of Health of Russian Federation
Saint Petersburg, Russia
The Catholic University of Korea St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea
Kyungpook National University Hospital
Daegu, Gyeongsangbuk-do, South Korea
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, South Korea
Inje University Haeundae Paik Hospital
Busan, South Korea
Yeungnam University Hospital
Daegu, South Korea
Institut Catala d'Oncologia Badalona - Hospital Germans Trias i Pujol
Badalona, Catalonia, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Hospital Universitario de Salamanca
Salamanca, Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, Spain
Hualien Tzu Chi Hospital
Hualien City, Hualien, Taiwan
China Medical University Hospital
Taichung, Taichung CITY, Taiwan
National Cheng Kung University Hospital
Tainan, Tainan CITY, Taiwan
Ankara Universitesi Tp Fakultesi
Ankara, Turkey (Türkiye)