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ACTIVE NOT RECRUITING
NCT03589326
PHASE3

A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia

Sponsor: Takeda

View on ClinicalTrials.gov

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

DRUG

Ponatinib

Ponatinib Tablets.

DRUG

Imatinib

Imatinib Tablets.

DRUG

Vincristine

Vincristine IV injection.

DRUG

Dexamethasone

Dexamethasone Tablets.

DRUG

Cytarabine

Cytarabine IV infusion.

DRUG

Methotrexate

Methotrexate IV infusion.

DRUG

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)