Spots Global Cancer Trial Database for Volasertib in Combination With Low-dose Cytarabine in Patients Aged 65 Years and Above With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy (POLO-AML-2)
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Trial Identification
Brief Title: Volasertib in Combination With Low-dose Cytarabine in Patients Aged 65 Years and Above With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy (POLO-AML-2)
Official Title: A Phase III Randomised, Double-blind, Controlled, Parallel Group Study of Intravenous Volasertib in Combination With Subcutaneous Low-dose Cytarabine vs. Placebo + Low-dose Cytarabine in Patients >=65 Years With Previously Untreated Acute Myeloid Leukaemia, Who Are Ineligible for Intensive Remission Induction Therapy
Study ID: NCT01721876
Conditions
Study Description
Brief Summary: To investigate the efficacy, safety, and pharmacokinetics of intravenous volasertib + subcutaneous low dose cytarabine in patients \>= 65 years of age with previously untreated acute myeloid leukaemia, ineligible for intensive remission induction therapy
Detailed Description:
Keywords
Eligibility
Minimum Age: 65 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California, Los Angeles, California, United States
St. Luke's Hospital Association of Duluth, Inc., Duluth, Minnesota, United States
Henry-Joyce Cancer Clinic, Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Fundacion COIR, Mendoza, , Argentina
Hospital Central de Salud Zenón Santillan, San Miguel de Tucumán, , Argentina
LKH-Univ. Hospital Graz, Graz, , Austria
LKH Leoben, Leoben, , Austria
Hospital Hietzing, Wien, , Austria
AZ Sint-Jan Brugge, Brugge, , Belgium
Brussels - UNIV Saint-Luc, Bruxelles, , Belgium
Haine-St-Paul - HOSP Jolimont, Haine-Saint-Paul, , Belgium
Jessa Ziekenhuis - Campus Virga Jesse, Hasselt, , Belgium
UZ Leuven, Leuven, , Belgium
Centre Hospitalier Universitaire de Liège, Liège, , Belgium
Roeselare - HOSP AZ Delta, Roeselare, , Belgium
Yvoir - UNIV UCL de Mont-Godinne, Yvoir, , Belgium
Hospital Doutor Amaral Carvalho, Jau, , Brazil
Hospital Mãe de Deus, Porto Alegre, , Brazil
H.C.da Fac. de Medicina de Ribeirao Preto, Ribeirao Preto, , Brazil
University of Alberta Hospital (University of Alberta), Edmonton, Alberta, Canada
Vancouver General Hospital, Vancouver, British Columbia, Canada
Maisonneuve-Rosemont Hospital, Montreal, Migration Data, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Montreal General Hospital - McGill University Health Centre, Montreal, Quebec, Canada
Hospital Hradec Kralove, Hradec Kralove, , Czechia
University Hospital Plzen, Plzen-Lochotin, Plzen - Lochotin, , Czechia
Univ. Hospital Kralovske Vinohrady, Praha 10, , Czechia
Meilahden sairaala, Helsinki, , Finland
TYKS, Sisätautien klinikka, Turku, , Finland
HOP Amiens-Picardie Sud, Amiens, , France
HOP Côte de Nacre, Caen, , France
HOP Michallon, La Tronche, , France
HOP André Mignot, Le Chesnay, , France
HOP Dupuytren 1, Limoges Cedex 1, , France
INS Paoli-Calmettes, Marseille, , France
HOP Nantes, Hémato, Nantes, Nantes, , France
HOP Saint-Antoine, Paris Cedex 12, , France
HOP Haut-Lévêque, Pessac, , France
HOP Lyon Sud, Pierre Bénite, , France
HOP Pontchaillou, Rennes Cedex 9, , France
INS Universitaire du Cancer, Toulouse, , France
Universitätsklinikum Augsburg, Augsburg, , Germany
Med. Klinik m.S. Hämatologie und Onkologie, Berlin, , Germany
Städtisches Klinikum Braunschweig gGmbH, Braunschweig, , Germany
Universitätsklinikum Erlangen, Erlangen, , Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH, Essen, , Germany
Universitätsklinikum Frankfurt, Frankfurt/Main, , Germany
Universitätsmedizin Göttingen, Georg-August-Universität, Göttingen, , Germany
Martin-Luther-Universität Halle-Wittenberg, Halle (Saale), , Germany
Universitätsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Universitätsklinikum Heidelberg, Heidelberg, , Germany
Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz, , Germany
Universitätsklinikum Gießen und Marburg GmbH, Marburg, , Germany
Klinikum rechts der Isar der Technischen Universität München, München, , Germany
Universitätsklinikum Münster, Münster, , Germany
Universitätsklinikum Regensburg, Regensburg, , Germany
Robert-Bosch-Krankenhaus GmbH, Stuttgart, , Germany
Universitätsklinikum Ulm, Ulm, , Germany
Schwarzwald-Baar Klinikum, Villingen-Schwenningen, , Germany
General Hospital of Athens "G. Gennimatas", Athens, , Greece
General Hospital of Athens "Laiko", Athens, , Greece
Univ. Gen. Hosp. of Ioannina, Ioannina, , Greece
University of Patras Medical School, Patras, , Greece
General Hospital of Thessaloniki "G. Papanikolaou", Thessaloniki, , Greece
Semmelweis University, Budapest, , Hungary
Petz Aldar Hospital, 2nd Dept. of Internal Med., Haematology, Gyor, , Hungary
Univ. of Szeged, 2nd Dept. of Internal Med., Haematology, Szeged, , Hungary
St. John Medical College and hospital, Bangalore, , India
Tata Memorial Hospital, Mumbai, , India
A.O. Spedali Civili di Brescia, Brescia, , Italy
ASST Grande Ospedale Metropolitano Niguarda, Milano, , Italy
AO Città della Salute e della, Torino, , Italy
National Hospital Organization Nagoya Medical Center, Aichi, Nagoya, , Japan
Japanese Red Cross Nagoya Daini Hospital, Aichi, Nagoya, , Japan
Akita University Hospital, Akita, Akita, , Japan
University of Fukui Hospital, Fukui, Yoshida-gun, , Japan
Kyushu University Hospital, Fukuoka, Fukuoka, , Japan
Kobe University Hospital, Hyogo, Kobe, , Japan
Tokai University Hospital, Kanagawa, Isehara, , Japan
Yokohama City University Medical Center, Kanagawa, Yokohama, , Japan
Tohoku University Hospital, Miyagi, Sendai, , Japan
Nagasaki University Hospital, Nagasaki, Nagasaki, , Japan
Kurashiki Central Hospital, Okayama, Kurashiki, , Japan
Okayama University Hospital, Okayama, Okayama, , Japan
Osaka City University Hospital, Osaka, Osaka, , Japan
National Cancer Center Hospital, Tokyo, Chuo-ku, , Japan
NTT Medical Center Tokyo, Tokyo, Sinagawa-ku, , Japan
Chonnam National University Hwasun Hospital, Hwasun, , Korea, Republic of
The Catholic University of Korea, Seoul St.Mary's Hospital, Seoul, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Hospital Universitario Dr Jose Eleuterio Gonzalez, Monterrey, , Mexico
Amsterdam UMC Locatie VUMC, Amsterdam, , Netherlands
Haukeland Universitetssykehus, Bergen, , Norway
Sykehuset Østfold Kalnes, Grålum, , Norway
Reg. Specialist Hospital of M. Kopernik, Dept. Haematology, Lodz, , Poland
City Hospital Torun, Department of Hematology, Torun, , Poland
CHULN, EPE - Hospital de Santa Maria, Lisboa, , Portugal
Centro Hospitalar Universitário do Porto, EPE - Hospital de Santo António, Porto, , Portugal
IPO Porto Francisco Gentil, EPE, Porto, , Portugal
Centro Hospitalar Universitário São João,EPE, Porto, , Portugal
Regional Clinical Hospital 'The Badge of Honor Order', Irkutsk, , Russian Federation
FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF, Moscow, , Russian Federation
Nizhniy Novgorod Reg. Clinical Hospital, Dept. Haematology, Nizhniy Novgorod, , Russian Federation
Leningrad Reg. Clin. Hosp., Oncohematology Department No. 2, St. Petersburg, , Russian Federation
Netcare Pretoria East Hospital, Moreleta Park, Pretoria, , South Africa
Hospital Germans Trias i Pujol, Badalona, , Spain
Hospital Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Vall d'Hebron, Barcelona, , Spain
Hospital Clínic de Barcelona, Barcelona, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital La Paz, Madrid, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
Hospital Politècnic La Fe, Valencia, , Spain
Chang-Hua Christian Hospital, ChangHua, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Mackay Memorial Hospital, Taipei, , Taiwan
Contact Details
Name: Boehringer Ingelheim
Affiliation: Boehringer Ingelheim
Role: STUDY_CHAIR
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