11
Participants
Start Date
February 24, 2021
Primary Completion Date
December 19, 2023
Study Completion Date
July 19, 2024
Ponatinib
Ponatinib tablets.
Chemotherapy Agents
Chemotherapy agents for reinduction include vincristine, dexamethasone, polyethylene glycol (PEG)-asparaginase (Erwinia asparaginase when PEG-asparaginase is not available), daunorubicin. Agents for intrathecal (IT) chemotherapy, central nervous system (CNS)-1/2: IT methotrexate chemotherapy, or CNS-3: triple intrathecal (ITT) methotrexate, hydrocortisone, cytarabine. Chemotherapy agents for consolidation include dexamethasone, vincristine, methotrexate, PEG-asparaginase (Erwinia asparaginase when PEG-asparaginase is not available), cyclophosphamide, etoposide, CNS-1/2: IT methotrexate chemotherapy, CNS-3: ITT chemotherapy methotrexate, hydrocortisone, cytarabine. The doses for chemotherapy agents for reinduction will be given as per standard of care.
IRCCS Ospedale Pediatrico Bambino Gesu - INCIPIT - PIN, Rome
Royal Children's Hospital Melbourne - PIN, Parkville
Seoul National University Hospital, Seoul
Severance Hospital Yonsei University Health System, Seoul
Queensland Childrens Hospital, South Brisbane
Instituto Nacional de Pediatria, Mexico City
Asan Medical Center - PPDS, Seoul
Perth Childrens Hospital, Nedlands
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul
Hospital Universitario Vall d'Hebron - PPDS, Barcelona
Ospedale Infantile Regina Margherita - INCIPIT - PIN, Turin
Assistance Publique Hopitaux de Marseille, Marseille
Fakultni nemocnice v Motole, Prague
Istituto G Gaslini Ospedale Pediatrico IRCCS - INCIPIT - PIN, Genoa
Children's Hospital of Philadelphia, Philadelphia
Alfred I Dupont Hospital For Children, Wilmington
Fndazione MBBM (MONZA E BRIANZA PER IL BAMBINO E LA SUA MAMMA) - c/o Centro Maria Letizia Verga, Monza
Hospital Infantil Universitario Nino Jesus - PIN, Madrid
Hopital Des Enfants, Toulouse
Hopital Sud, Rennes
St Jude Children's Research Hospital, Memphis
Hospital Universitario Virgen del Rocio - PPDS, Seville
Nationwide Children's Hospital, Columbus
Nuevo Hospital Civil de Guadalajara Dr. Juan I. Menchaca, Guadalajara
Cincinnati Children's Hospital Medical Center - PIN, Cincinnati
Ann and Robert H Lurie Childrens Hospital of Chicago, Chicago
Fakultni nemocnice Brno, Brno
Children's Mercy Hospital and Clinica, Kansas City
Hospital Universitario Dr. Jose Eleuterio Gonzalez, Monterrey
Arkansas Children's Hospital, Little Rock
Hopital Robert Debre, Paris
Children's Hospital Los Angeles, Los Angeles
Rady Childrens Hospital San Diego - PIN, San Diego
Children's Hospital of Shanghai, Shanghai
Shanghai Childrens Medical Center, Shanghai
Children's Hospital of Soochow University, Suzhou
The Second Hospital of Anhui Medical University, Hefei
Qilu Hospital of Shandong University, Jinan
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences, Tianjin
Children's Hospital of Chongqing Medical University, Chongqing
Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan
The Affiliated Hospital of Guizhou Medical University, Guiyang
West China Second University Hospital, Sichuan Univesity, Chengdu
UCSF Medical Comprehensive Cancer, San Francisco
Riley Hospital For Children, Indianapolis
Childrens Medical Center Research Institute at UT Southwestern, Dallas
Hospital Universitario Austral, Pilar
Hospital Italiano de Buenos Aires, Buenos Aires
Rua Ramiro Barcelos, 2350, Curitiba
Irmandade Da Santa Casa de Misericordia de Porto Alegre, Porto Alegre
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS, Porto Alegre
Fundacao Pio XII Hospital de Cancer de Barretos, Barretos
Hospital Das Clinicas da Faculdade de Medicina de Ribeirao Preto - USP, Ribeirão Preto
Graacc Grupo de Apoio Ao Adolescente E A Crianca Com Cancer, São Paulo
Hospital Santa Marcelina, São Paulo
Princess Maxima Center for Pediatric Oncology - PIN, Utrecht
Uniwersytecki Szpital Dzieciecy, Krakow
SPSK Nr 1 im. Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego, Zabrze
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E., Lisbon
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS, Porto
Royal Marsden Hospital - Surrey, Surrey Quays
Cambridge University Hospitals NHS Foundation Trust, Cambridge
Royal Hospital for Children (Glasgow) - PPDS - PIN, Glasgow
Lead Sponsor
Takeda
INDUSTRY