551
Participants
Start Date
January 6, 2016
Primary Completion Date
September 15, 2023
Study Completion Date
November 10, 2023
Copanlisib (BAY80-6946)
"Copanlisib is supplied as lyophilized preparation in a 6 mL injection vial. The total amount of copanlisib per vial is 60 mg. The solution for IV infusions is obtained after reconstitution with normal saline solution. For patients on R-B dosing of copanlisib will be administered on Days 1, 8 and 15 of each 28-day cycle. Copanlisib will be administered and then rituximab followed by bendamustine. For patients on R-CHOP dosing of copanlisib will be administered on Days 1 and 8 of each 21-day cycle. Treatment with copanlisib/placebo will be continued up to 12 months.~Copanlisib will be administered before rituximab followed by cyclophosphamide, doxorubicin and vincristine infusions. Prednisone/prednisolone tablets to be taken for 5 days."
Placebo
Placebo is supplied as lyophilized preparation in a 6 mL injection vial. The developed placebo lyophilisate is equivalent to the 60 mg copanlisib formulation, with regard to the composition of excipients and the instructions for reconstitution and dose preparation. Placebo dosing will be administered as per copanlisib described above. Applies to the phase III part of the study only.
Rituximab
Rituximab is administered as an infusion at a dose of 375 mg/m2 body surface on Day 1 of each 28-day cycle for patients assigned to R-B and on Day 2 of each 21-day cycle for patients assigned to R-CHOP.
Cyclophosphamide
Cyclophosphamide is administered as an infusion at a dose of 750 mg/m2 body surface on Day 2 of each 21-day cycle for patients assigned to R-CHOP
Doxorubicin
Doxorubicin is administered as an infusion at a dose of 50 mg/m2 body surface on Day 2 of each 21-day cycle for patients assigned to R-CHOP
Vincristine
Vincristine is administered as an infusion at a dose of 1.4 mg/m2 body surface (maximum dose 2.0 mg) on Day 2 of each 21-day cycle for patients assigned to R-CHOP
Bendamustine
Bendamustine is administered as an infusion at a dose of 90 mg/m2 body surface on Day 1 and Day 2 for patients assigned to R-B
Prednisone
Prednisone is given as 100 mg tablets daily from Day 2 to Day 6 for patients assigned to R-CHOP
Albert Alberts Stem Cell Transplant Research Centre, Pretoria
National Taiwan University Hospital, Taipei
National Cheng Kung University Hospital, Tainan City
Chang Gung Memorial Hospital Kaohsiung, Kaohsiung City
Institut Jules Bordet/Jules Bordet Instituut, Brussels
Semmelweis University, Budapest
Orszagos Onkologiai Intezet, Budapest
University Multiprofile Hosp. for Active Treat. Sveti Ivan, Sofia
SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD, Sofia
Rigshospitalet - Hjertesygdomme, København Ø
St George's Hospital, Kogarah
Calvary Mater Hospital Newcastle, Waratah
Komarom-Esztergom Varmegyei Szent Borbala Korhaz, Tatabánya
UZ Leuven Gasthuisberg, Leuven
Multiprofile Hospital for Active Treatment Hristo Botev AD, Vratsa
The Alfred Hospital, Melbourne
Seoul National University Hospital, Seoul
Eastern Health Integrated Renal Service, Box Hill
CHU de Liège, Liège
UMHAT Sveti Georgi, Plovdiv
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz, Nyíregyháza
Odense Universitetshospital - Hæmatologisk afdeling, Odense C
Ashford Cancer Centre Research Pty Ltd, Kurralta Park
Flinders Medical Centre, Bedford Park
Cancercare Langenhoven, Port Elizabeth
Ankara Universitesi Tip Fakultesi Hastanesi, Ankara
Med. Fakultät der Martin-Luther-Universität Halle-Wittenberg, Halle
Samsung Medical Center, Seoul
Outeniqua Cancercare Oncology Unit, George
Hospital General de México SS, México, D. F.
Fiona Stanley Hospital, Murdoch
Somogy Varmegyei Kaposi Mor Oktato Korhaz, Kaposvár
Pecsi Tudomanyegyetem Klinikai Kozpont, Pécs
Constantiaberg Medi Clinic, Cape Town
Institut Català d'Oncologia Badalona, Badalona
UZ Gent, Ghent
Memorial Sloan Kettering Cancer Center- Bergen, New York
Fakultni nemocnice Kralovske Vinohrady, Prague
Memorial Sloan-Kettering Cancer Center, New York
Phramongkutklao Hospital, Bangkok
Siriraj Hospital, Mahidol, Bangkok
Taipei Veterans General Hospital, Taipei
General Hospital of Athens LAIKO, Athens
New York Cancer and Blood Specialists, Port Jefferson Station
"University General Hospital of Athens ATTIKON", Chaïdári
IRCCS Ospedale Policlinico San Martino, Genoa
"CNE Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of the Cherkasy Regional Council", Cherkasy
Humanitas Mirasole S.p.A., Milan
Spitalul Clinic Colentina, Bucharest
Turun yliopistollinen keskussairaala, Turku
Trakya Univ. Tip Fak., Edirne
Fundeni Clinical Institute, Bucharest
University General Hospital of Patras, Pátrai
IRCCS Fondazione Policlinico San Matteo, Pavia
Hospital Universitario Clinica Puerta de Hierro, Majadahonda
Spitalul Clinic Coltea, Bucharest
Medizinische Hochschule Hannover (MHH), Hanover
Lewis Hall Singletary Oncology Center, Thomasville
Tampereen yliopistollinen sairaala, Tampere
Centre François Magendie - Pessac, Pessac
Hôpital Saint-Eloi, Montpellier
Istanbul Universitesi Istanbul Tip Fakultesi, Istanbul
Marmara Uni. Tip Fak. Pendik EAH Hematoloji BD, Istanbul
Dokuz Eylul Universitesi Tip Fakultesi, Izmir
Ege Universitesi Tip Fakultesi, Izmir
Erciyes Universitesi Tip Fakultesi, Kayseri
Centre Hospitalier Universite de Grenoble, Grenoble
Univ. General Hospital of Larissa, Larissa
Hopital Hotel Dieu - Nantes, Nantes
Marienhospital Herne Universitätsklinik, Herne
Gabrail Cancer Center, Canton
Oncologianova GmbH, Recklinghausen
Universitaetsklinikum Muenster, Münster
"Municipal Non-Profit Enterprise City Clinical Hospital ?4 of the Dnipro City Council", Dnipro
Centre Hospitalier Universitaire - Angers, Angers
Changhua Christian Hospital, Changhua
Hospital Clínico Universitario Lozano Blesa, Zaragoza
Ondokuz Mayis Uni Tip Fakultesi, Samsun
Centro de Investigación Clínica Chapultepec S.A. de C.V., Morelia
"A.O.U. Ospedali Riuniti Umberto I - G.M.Lancisi - G.Salesi", Ancona
Karadeniz Teknik Universitesi Tip Fakultesi, Trabzon
Centre Hospitalier Intercommunal de la Côte Basque-Bayonne, Bayonne
Clinique Saint Anne, Strasbourg
"CNE Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia regional council", Zaporizhzhya
Clinique Victor Hugo - Le Mans, Le Mans
Stauferklinikum Schwäbisch-Gmünd, Mutlangen
Hôpital Saint Louis, Paris
Texas Oncology- McAllen, McAllen
State Institution - Institute of Blood Pathology and Transfusion Medicine NAMS of Ukraine, Lviv
SCL Health Research at St Joseph's Hospital Denver CO, Denver
Klinikum der Universität München Grosshadern, München
Centre Hospitalier de la Durance - Avignon, Avignon
Ironwood Physicians P.C. DBA Ironwood Cancer & Res. Ctr., Chandler
Hôpital de la Milétrie, Poitiers
Haematologie-Onkologie im Zentrum MVZ GmbH, Augsburg
Hôpital Dupuytren, Limoges
Oulun yliopistollinen sairaala, Oulu
Brian J. LeBerthon, MD, West Covina
Centro Especializado en Investigación Clínica S.C., Boca del Río
Centro de Atencion e Investigacion Clinica en Oncologia SCP, Mérida
Fifth Medical Center, General Hospital of the Chinese People, Beijing
Beijing Friendship Hospital, Capital Medical University, Beijing
National University Hospital, Singapore
Jilin Cancer Hospital, Changchun
National Cancer Center Singapore, Singapore
Singapore General Hospital, Singapore
RSRI of Hematology and Transfusiology, Saint Petersburg
Fudan University Shanghai Cancer Center, Shanghai
Xinhua Hos Affiliated to SH Jiaotong Uni School of Medicine, Shanghai
Spitalul Clinic Municipal Filantropia Craiova, Craiova
Jiangsu Cancer Hospital, Nanjing
1st Affiliated hospital of Soochow University, Suzhou
The Affiliated Hospital of Qingdao University, Shandong
Tianjin Medical University Cancer Institute & Hospital, Tianjin
Tianjin Union Medicine Centre (People's Hospital of Tianjin), Tianjin
The 1st Affiliated Hospital of Zhejiang University, Hangzhou
Zhejiang Cancer Hospital, Hangzhou
Research Institute of Oncology, Rostov-on-Don
FuJian Medical University Union Hospital, Fuzhou
Oncology Dispensary #2, Sochi
Sp. Judetean de Urgenta Dr. Constantin Opris Baia Mare, Baia Mare
Henan Cancer Hospital, Zhengzhou
Republican Clinical Oncology Dispensary, Ufa
Sc Onco Card Srl, Brasov
Guangdong Provincial People's Hospital, Guangzhou
Sun Yat-sen University Cancer Center, Guangzhou
Spitalul Clinic Judetean de Urgenta Sibiu, Sibiu
West China Hospital Sichuan University, Chengdu
Siberian State Medical University, Tomsk
Clinical Oncological Dispensary of Omsk Region, Omsk
Kemerovo Regional Clinical Hospital, Kemerovo
Institutul Regional de Oncologie Iasi, Iași
Centro de Investigaciones Clínicas Vina del Mar Ltda., Viña del Mar
Rambam Health Corporation, Haifa
Sociedad de Investigaciones Medicas Ltda, Temuco
Chaim Sheba Medical Center, Ramat Gan
Shamir Medical Center (Assaf Harofeh), Ẕerifin
Hadassah Hebrew University Hospital Ein Kerem, Jerusalem
Oncology Consultants, Houston
Centro Integrado de Oncologia de Curitiba, Curitiba
"Irmandade da Santa Casa de Misericordia de Porto Alegre , Hospital Sao Francisco - Centro Medico Pesquisa Clinica Cardiologia"
"Hospital de Clinicas de Porto Alegre , Clinical Research Center - Surgery Research Center"
Centro de Pesquisas Oncológicas, Florianópolis
Faculdade de Ciencias Medicas-Universidade Estadual Campinas, Campinas
Centro Multidisciplinar de Estudos Clínicos EPP - Ltda., São Bernardo do Campo
IEP São Lucas, São Paulo
Instituto Nacional do Cancer Jose Alencar Gomes da Silva, Rio de Janeiro
Hospital das Clínicas da Faculdade de Medicina da USP, São Paulo
"Hospital Israelita Albert Einstein , Morumbi - Clinical Research Department"
"Centro Clinico Academico Braga , Braga, Portugal"
"Centro Hospitalar Vila Nova de Gaia e Espinho , Unit 1 - Clinical Research Center"
Hopital Maisonneuve-Rosemont, Montreal
Hopital du Sacre-Coeur de Montreal, Montreal
Hopital de L'Enfant Jesus, Québec
Centre Universitaire de Sante de l'Estrie, Sherbrooke
Instituto Nacional del Cáncer, Santiago
Tumor Hospital of Hebei Province, Hebei
Fakultni Nemocnice Hradec Kralove, Hradec Králové
HUS, Meilahden sairaala, Helsinki
EVANGELISMOS General Hospital of Athens, Athens
Prince of Wales Hospital, Hong Kong
Cork University Hospital, Cork
Mater Misericordiae University Hospital, Dublin
Aichi Cancer Center Hospital, Nagoya
Nagoya City University Hospital, Nagoya
JCHO Kyushu Hospital, Kitakyushu
Gunma University Hospital, Maebashi
Hyogo Cancer Center, Akashi
Kobe University Hospital, Kobe
Kanagawa Cancer Center, Yokohama
Tohoku University Hospital, Sendai
Tenri Hospital, Tenri
Kindai University Hospital, Osakasayama-shi
Saitama Medical University International Medical Center, Hidaka
National Cancer Center Hospital, Chuo-ku
Aomori Prefectural Central Hospital, Aomori
National Hospital Organization Kyushu Cancer Center, Fukuoka
Hiroshima Red Cross & Atomic-bomb Survivors Hospital, Hiroshima
National Hospital Organization Kumamoto Medical Center, Kumamoto
Kumamoto University Hospital, Kumamoto
Osaka Red Cross Hospital, Osaka
Osaka Metropolitan University Hospital, Osaka
Yamagata University Hospital, Yamagata
"Hospital Universitario José Eleuterio González", Monterrey
Szpital Morski im. PCK, Gdynia
Pratia McM Kraków, Krakow
Wojew. Szpital Specjalistyczny im. M. Kopernika, Lodz
Centro Hospitalar Universitario do Porto, Porto
IPO Porto, Porto
Narodny onkologicky ustav, Bratislava
Severance Hospital, Yonsei University Health System, Seoul
Asan Medical Center, Seoul
Institut Català d'Oncologia Hospitalet, L'Hospitalet de Llobregat
"Hospital Regional de Malaga , Oncologia"
Ciutat Sanitaria i Universitaria de la Vall d'Hebron, Barcelona
Clinic of National cancer institute - scientific and research department of pediatric oncology, Kyiv
Royal Devon & Exeter Hospital, Exeter
Northwick Park Hospital, Harrow
Dorset County Hospital, Dorchester
Royal Marsden Hospital (London), London
Singleton Hospital, Swansea
Lead Sponsor
Bayer
INDUSTRY