Spots Global Cancer Trial Database for A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia
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Trial Identification
Brief Title: A Study of Ponatinib Versus Imatinib in Adults With Acute Lymphoblastic Leukemia
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)
Study ID: NCT03589326
Study Description
Brief 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.
Detailed Description: The drug being tested in this study is called ponatinib. Ponatinib is being tested to treat people who have newly diagnosed Ph+ ALL. This study will look at the efficacy of ponatinib in participants in addition to standard care. The study will enroll approximately 230 participants. Participants will be randomized in a 2:1 ratio to receive oral ponatinib or imatinib (Cohort A and Cohort B, respectively) daily throughout the study. All participants will be asked to take ponatinib or imatinib at the same time each day with reduced-intensity chemotherapy in induction phase (Cycles 1 to 3), consolidation phase (Cycles 4 to 9) and maintenance phase (Cycles 10 to 20). At the end of the 20 cycles, participants will remain on ponatinib or imatinib (administered as a single agent). The dose of ponatinib in consolidation and maintenance phase will start with the last dose given in the previous phase. The dose can be modified based on MRD-negative CR results. This multi-center trial will be conducted in Argentina, Australia, Austria, Belarus, Brazil, Bulgaria, Canada, Chile, France, Mexico, Greece, Italy, Japan, Korea, Republic Of, Poland, Romania, Russia, Spain, Taiwan, Province Of China, Turkey, Finland and the United States. Participants including those who achieve a clinical response, may receive study drug until they are deceased, have failed to achieve the primary endpoint, have experienced relapse from CR or have progressive disease, have an unacceptable toxicity, have withdrawn consent, have proceeded to HSCT, or until the sponsor terminates the study, whichever occurs first. After disease progression, all participants will be contacted every 3 months for survival follow-up. Participants will be followed until completion of the study or until the participant's death has been reported.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Cordoba, , Argentina
Hospital Privado Centro Medico de Cordoba, Cordoba, , 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, Wien, Vienna, Austria
Universitaetsklinik Fuer Innere Medizin I, Vienna, , Austria
Hospital Sao Rafael-Monte Tabor, Salvador, Bahia, Brazil
Hospital Erasto Gaertner, Curitiba, Parana, 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, SAO Paulo, Brazil
Fundacao Doutor Amaral Carvalho, Jau, SAO Paulo, Brazil
Hospital das Clinicas da Faculdade de Medicina da Riberao Preto da Universidade de Sao Paulo, Ribeirao Preto, SAO Paulo, Brazil
HEMORIO Instituto Estadual de Hematologia, Rio de Janeiro, , Brazil
Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, , Brazil
Fundacao Antonio Prudente - A.C.Camargo Cancer Center, Sao Paulo, , Brazil
University Multiprofile Hospital for Active Treatment Saint Ivan Rilski, Sofia, Sofiya, 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 de Versailles Hopital Andre Mignot, Le Chesnay, Ile-de-france, France
Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse Cedex 09, Midi-pyrenees, France
Center Hospitalier Universitaire d'Angers, Angers Cedex 9, PAYS DE LA Loire, France
Centre Hospitalier Lyon Sud, Pierre Benite Cedex, Rhone-alpes, France
Evaggelismos General Hospital, Athens, Attica, Greece
University General Hospital of Athens Attikon, Chaidari, Attica, Greece
University General Hospital of Patras Panagia I Voithia, Patra, Peloponnese, Greece
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Forli-cesena, Italy
Azienda Policlinico San Martino, Genova, 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, Milano, , 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
National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan
Aiiku Hospital, Sapporo, Hokkaido, Japan
Tokai University Hospital, Isehara City, Kanagawa, Japan
Okayama University Hospital, Okayama-shi, Okayama, Japan
Chiba Aoba Municipal Hospital, Chiba, , Japan
Fukushima Medical University Hospital, Fukushima, , Japan
The Catholic University of Korea St. Vincent's Hospital, Suwon, Gyeonggi-do, Korea, Republic of
Kyungpook National University Hospital, Daegu, Gyeongsangbuk-do, Korea, Republic of
Chonbuk National University Hospital, Jeonju, Jeollabuk-do, Korea, Republic of
Inje University Haeundae Paik Hospital, Busan, , Korea, Republic of
Yeungnam University Hospital, Daegu, , Korea, Republic of
Hospital Universitario Dr. Jose Eleuterio Gonzalez, Monterrey, Nuevo LEON, Mexico
Uniwersytecki Szpital Kliniczny we Wroclawiu, Wroclaw, Dolnoslaskie, Poland
Szpital Uniwersytecki w Krakowie, Krakow, Malopolskie, Poland
Uniwersyteckie Centrum Kliniczne, Gdansk, Pomorskie, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych z Warminsko-Mazurs, Olsztyn, Warminsko-mazurskie, Poland
City Clinical Hospital named after Vikentiy Vikentyevich Veresaev, Moscow, Moscow CITY, Russian Federation
Sverdlovsk Regional Clinical Hospital #1, Ekaterinburg, Sverdlovsk, Russian Federation
National Research Center for Hematology, Dept. of Hematology/Oncology and BMT, Moscow, , Russian Federation
Almazov Federal North-West Medical Research Centre of Department of Health of Russian Federation, Saint Petersburg, , Russian Federation
Institut Catala d'Oncologia Badalona - Hospital Germans Trias i Pujol, Badalona, Cataluna, 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
Contact Details
Name: Study Director
Affiliation: Takeda
Role: STUDY_DIRECTOR
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