Spots Global Cancer Trial Database for Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia
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Trial Identification
Brief Title: Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia
Official Title: Phase 3 Randomized, Controlled Study of Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia With Safety Run-in (Golden Gate Study)
Study ID: NCT04994717
Study Description
Brief Summary: The safety run-in part of the study aims to evaluate the safety and tolerability of blinatumomab alternating with low-intensity chemotherapy. The phase 3 part of the study aims to compare event-free survival (EFS) and overall survival (OS) of participants receiving blinatumomab alternating with low-intensity chemotherapy to EFS and (OS) of participants receiving standard of care (SOC) chemotherapy.
Detailed Description:
Eligibility
Minimum Age: 40 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope National Medical Center, Duarte, California, United States
University of California Irvine, Orange, California, United States
University of California San Francisco Medical Center, San Francisco, California, United States
Adventist Health System/Sunbelt, Inc d/b/a AdventHealth Orlando, Orlando, Florida, United States
Saint Francis Hospital, Inc, Greenville, South Carolina, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Canberra Hospital, Garran, Australian Capital Territory, Australia
Royal North Shore Hospital, St Leonards, New South Wales, Australia
Westmead Hospital, Westmead, New South Wales, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Monash Medical Centre, Clayton, Victoria, Australia
Austin Health, Austin Hospital, Heidelberg, Victoria, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
Fiona Stanley Hospital, Murdoch, Western Australia, Australia
Medizinische Universitaet Graz, Graz, , Austria
Medizinische Universitaet Innsbruck, Innsbruck, , Austria
Hanusch Krankenhaus, Wien, , Austria
Institut Jules Bordet, Anderlecht, , Belgium
AZ Sint-Jan Brugge-Oostende AV, Brugge, , Belgium
Universite Catholique de Louvain Cliniques Universitaires Saint Luc, Bruxelles, , Belgium
Universitair Ziekenhuis Antwerpen, Edegem, , Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
Jessa Ziekenhuis - Campus Virga Jesse, Hasselt, , Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman, Liege, , Belgium
AZ Delta Campus Rumbeke, Roeselare, , Belgium
Centre Hospitalier Universitaire Dinant Godinne - Universite Catholique de Louvain Namur, Yvoir, , Belgium
University Multiprofile Hospital for Active Treatment Sveti Georgi EAD, Plovdiv, , Bulgaria
Specialized Hospital for Active Treatment of Hematology Diseases EAD, Sofia, , Bulgaria
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Cancer Care Manitoba, Winnipeg, Manitoba, Canada
CEMTL Hopital Maisonneuve Rosemont, Montreal, Quebec, Canada
Aalborg Universitetshospital, Aalborg, , Denmark
Aarhus Universitetshospital, Aarhus N, , Denmark
Rigshospitalet, København Ø, , Denmark
Odense Universitetshospital, Odense, , Denmark
Helsinki University Hospital, Helsinki, , Finland
Turku University Hospital, Turku, , Finland
Hôpital Henri Mondor, Creteil, , France
Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez, Lille, , France
Institut Paoli Calmettes, Marseille, , France
Centre Hospitalier Universitaire de Nantes - Hopital Hotel Dieu, Nantes Cedex 1, , France
Centre Hospitalier Universitaire Archet 2, Nice cedex 3, , France
Hôpital Saint Louis, Paris, , France
Hopital Saint Antoine, Paris, , France
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut Leveque, Pessac Cedex, , France
Hopital Lyon Sud, Pierre Benite, , France
Centre Hospitalier Universitaire de Rennes, Rennes Cedex 9, , France
Institut Universitaire du Cancer Toulouse Oncopole, Toulouse cedex 9, , France
Centre Hospitalier Universitaire de Nancy - Hopital de Brabois, Vandoeuvre les Nancy Cedex, , France
Universitaetsklinikum Augsburg, Augsburg, , Germany
Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin, Berlin, , Germany
Universitaetsklinikum Dresden, Dresden, , Germany
Universitaetsklinikum Duesseldorf, Duesseldorf, , Germany
Universitaetsklinikum Heidelberg, Heidelberg, , Germany
Universitaetsklinikum Jena, Jena, , Germany
Universitaetsklinikum Schleswig-Holstein, Kiel, , Germany
Klinikum der LMU Muenchen, Muenchen, , Germany
Evangelismos Hospital, Athens, , Greece
Laiko General Hospital of Athens, Athens, , Greece
Attiko General University Hospital, Athens, , Greece
University Hospital of Ioannina, Ioannina, , Greece
University Hospital of Larissa, Larissa, , Greece
University Hospital of Patras, Patras, , Greece
General Hospital of Thessaloniki Georgios Papanikolaou, Thessaloniki, , Greece
Semmelweis Egyetem, Budapest, , Hungary
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont, Debrecen, , Hungary
Heves Varmegyei Markhot Ferenc Oktatokorhaz es Rendelointezet, Eger, , Hungary
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz Nyiregyhazi Josa Andras Tagkorhaz, Nyiregyhaza, , Hungary
Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari, Bari, , Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii, Bergamo, , Italy
IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola, Bologna, , Italy
Ospedale Policlinico San Martino IRCCS, Genova, , Italy
Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II, Lecce, , Italy
Azienda Unità Locale Socio Sanitaria 3 Ospedale Dell Angelo, Mestre (VE), , Italy
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli, Napoli, , Italy
Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia, Perugia, , Italy
Azienda Unita Sanitaria Locale Pescara Ospedale Civile Santo Spirito, Pescara, , Italy
Azienda Ospedaliera Policlinico Umberto I, Roma, , Italy
Nagoya University Hospital, Nagoya-shi, Aichi, Japan
Akita University Hospital, Akita-shi, Akita, Japan
University of Fukui Hospital, Yoshida-gun, Fukui, Japan
Kyushu University Hospital, Fukuoka-shi, Fukuoka, Japan
Kurume University Hospital, Kurume-shi, Fukuoka, Japan
Fukushima Medical University Hospital, Fukushima-shi, Fukushima, Japan
Sapporo Hokuyu Hospital, Sapporo-shi, Hokkaido, Japan
Kobe City Medical Center General Hospital, Kobe-shi, Hyogo, Japan
Kanazawa University Hospital, Kanazawa-shi, Ishikawa, Japan
Tokai University Hospital, Isehara-shi, Kanagawa, Japan
Yokohama City University Medical Center, Yokohama-shi, Kanagawa, Japan
Nagasaki University Hospital, Nagasaki-shi, Nagasaki, Japan
National Hospital Organization Okayama Medical Center, Okayama-shi, Okayama, Japan
Osaka Metropolitan University Hospital, Osaka-shi, Osaka, Japan
Kindai University Hospital, Osakasayama-shi, Osaka, Japan
Jichi Medical University Hospital, Shimotsuke-shi, Tochigi, Japan
Yamagata University Hospital, Yamagata-shi, Yamagata, Japan
The Catholic University of Korea Seoul St Marys Hospital, Seoul, , Korea, Republic of
Boca Clinical Trials Mexico SC, Ciudad de Mexico, Distrito Federal, Mexico
Centro Oncologico Internacional, Mexico City, Distrito Federal, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez, Monterrey, Nuevo León, Mexico
Hematologica Alta Especialidad, Huixquilucan, , Mexico
Universitair Medisch Centrum Groningen, Groningen, , Netherlands
Unidade Local de Saude de Coimbra, EPE, Coimbra, , Portugal
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE, Lisboa, , Portugal
Unidade Local de Saude de Sao Jose, EPE - Hospital de Santo Antonio dos Capuchos, Lisboa, , Portugal
Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria, Lisboa, , Portugal
Institutul Clinic Fundeni, Bucharest, , Romania
Institutul Oncologic Prof Dr Ion Chiricuta, Cluj-Napoca, , Romania
Institutul Regional de Oncologie Iasi, Iasi, , Romania
Spitalul Clinic Judetean de Urgenta Sibiu, Sibiu, , Romania
Hospital Universitario Reina Sofia, Cordoba, Andalucía, Spain
Hospital Universitario Virgen del Rocio, Sevilla, Andalucía, Spain
Hospital Universitario Marques de Valdecilla, Santander, Cantabria, Spain
Complejo Asistencial Universitario de Salamanca Hospital Universitario de Salamanca, Salamanca, Castilla León, Spain
Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol, Badalona, Cataluña, Spain
Hospital Universitari Vall d Hebron, Barcelona, Cataluña, Spain
Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals, Hospitalet de Llobregat, Cataluña, Spain
Hospital Universitari i Politecnic La Fe, Valencia, Comunidad Valenciana, Spain
Sahlgrenska Universitetssjukhuset, Goteborg, , Sweden
Inselspital Bern, Bern, , Switzerland
China Medical University Hospital, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Cheng Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Hacettepe Universitesi Tip Fakultesi Hastanesi, Ankara, , Turkey
Bagcilar Medipol Mega Universite Hastanesi, Istanbul, , Turkey
Dokuz Eylul Universitesi Tip Fakultesi Hastanesi, Izmir, , Turkey
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi, Samsun, , Turkey
University College London, London, , United Kingdom
Contact Details
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR
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