stop_circleTerminated/Withdrawn
Lymphoma, Non-Hodgkin
Bayer Identifier:
17833
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Study of copanlisib in combination with standard immunochemotherapy in relapsed indolent non-Hodgkin’s lymphoma (iNHL)
Trial purpose
The purpose of this study is to assess whether copanlisib in combination with standard immunochemotherapy (rituximab in combination with bendamustine [R-B] and rituximab in combination with a 4 drug combination of cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone [R-CHOP]) is effective and safe, compared with placebo in combination with standard immunochemotherapy (R-B or R-CHOP) in patients with relapsed iNHL who have received at least one, but at most three, lines of treatment, including rituximab-based immunochemotherapy and alkylating agents.
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
547Trial Dates
January 2016 - November 2023Phase
Phase 3Could I Receive a placebo
YesProducts
Copanlisib/RB or RCHOP (BAY80-6946)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | The Alfred Hospital | Melbourne, 3004, Australia |
Completed | Klinikum der Universität München Grosshadern | München, 81377, Germany |
Completed | Universitätsklinikum Münster (UKM) | Münster, 48149, Germany |
Completed | HUS, Meilahden sairaala | Helsinki, FIN-00260, Finland |
Completed | Tampereen yliopistollinen sairaala | Tampere, 33520, Finland |
Withdrawn | Keski-Suomen sairaala Nova | Jyväskylä, 40620, Finland |
Completed | National Cancer Center Singapore | Singapore, 168583, Singapore |
Completed | National Taiwan University Hospital | Taipei, 100, Taiwan |
Completed | Taipei Veterans General Hospital | Taipei, 11217, Taiwan |
Completed | Rigshospitalet - Hjertesygdomme | København Ø, 2100, Denmark |
Withdrawn | Hôpital Henri Mondor | CRETEIL, 94010, France |
Withdrawn | Centre Henri Becquerel | Rouen, 76038, France |
Completed | Hôpital Dupuytren | LIMOGES CEDEX, 87042, France |
Completed | Hôpital de la Milétrie | POITIERS, 86021, France |
Completed | Wojew. Szpital Specjalistyczny im. M. Kopernika | Lodz, 93-513, Poland |
Withdrawn | Hospital Clínic i Provincial de Barcelona | Barcelona, 8036, Spain |
Completed | UZ Leuven Gasthuisberg | LEUVEN, 3000, Belgium |
Withdrawn | Edith Wolfson Medical Center | Internal Medicine Department | Holon, 5822012, Israel |
Completed | Seoul National University Hospital | Seoul, 3080, Korea,_republic_of |
Completed | Samsung Medical Center | Seoul, 6351, Korea,_republic_of |
Completed | Hospital Universitario Clinica Puerta de Hierro | Majadahonda, 28222, Spain |
Completed | UZ Gent | GENT, 9000, Belgium |
Withdrawn | A.O.U. di Bologna Policlinico S.Orsola Malpighi | Bologna, 40138, Italy |
Completed | Humanitas Mirasole S.p.A. | Milano, 20089, Italy |
Withdrawn | Freeman Hospital | Newcastle, NE7 7DN, United Kingdom |
Completed | Fiona Stanley Hospital | Murdoch, 6961, Australia |
Withdrawn | Royal Brisbane & Women's Hospital | Brisbane, 4029, Australia |
Completed | Dokuz Eylul Universitesi Tip Fakultesi | Izmir, 35100, Turkey |
Completed | Marmara Uni. Tip Fak. Pendik EAH Hematoloji BD | Istanbul, 34899, Turkey |
Completed | Ashford Cancer Centre Research Pty Ltd | Kurralta Park, 5037, Australia |
Completed | Fakultni nemocnice Kralovske Vinohrady | Praha 10, 10034, Czech Republic |
Withdrawn | Hackensack University Medical Center | Hackensack, 07601, United States |
Completed | Memorial Sloan-Kettering Cancer Center | New York, 10065, United States |
Completed | Gabrail Cancer Center | Canton, 44718, United States |
Withdrawn | Medical Oncology Associates, PS | Spokane, 99208-1129, United States |
Withdrawn | Detroit Clinical Research Center | Farmington Hills, 48334, United States |
Withdrawn | Compassionate Cancer Care Medical Group, Inc. | Fountain Valley, 92708, United States |
Withdrawn | Royal Marsden NHS Trust (Surrey) | Sutton, SM2 5PT, United Kingdom |
Withdrawn | GZA Ziekenhuizen | Wilrijk, 2610, Belgium |
Withdrawn | AZ Groeninge Campus Kennedylaan | KORTRIJK, 8500, Belgium |
Completed | Tianjin Union Medicine Centre (People's Hospital of Tianjin) | Tianjin, 300121, China |
Completed | The 1st Affiliated Hospital of Zhejiang University | Hangzhou, 310000, China |
Completed | Zhejiang Cancer Hospital | Hangzhou, 310022, China |
Completed | Fudan University Shanghai Cancer Center | Shanghai, 200000, China |
Completed | 1st Affiliated hospital of Soochow University | Suzhou, 215000, China |
Withdrawn | Cancer Hospital, Chinese Academy of Medical Sciences | Beijing, 100000, China |
Completed | Fifth Medical Center, General Hospital of the Chinese People | Beijing, 100000, China |
Withdrawn | Frankston Hospital | Frankston, 3199, Australia |
Withdrawn | The Kinghorn Cancer Centre - Medical Oncology Department | Darlinghurst, 2010, Australia |
Completed | FuJian Medical University Union Hospital | Fuzhou, 350000, China |
Completed | Beijing Friendship Hospital, Capital Medical University | Beijing, 100050, China |
Completed | Jiangsu Cancer Hospital | Nanjing, 210000, China |
Completed | Singleton Hospital | Swansea, SA2 8QA, United Kingdom |
Recruiting | Royal Marsden Hospital (London) | London, SW3 6JJ, United Kingdom |
Completed | Dorset County Hospital | Dorchester, DT1 2JY, United Kingdom |
Completed | West China Hospital Sichuan University | Chengdu, 610041, China |
Completed | Oulun yliopistollinen sairaala | Oulu, 90220, Finland |
Completed | Turun yliopistollinen keskussairaala | Turku, 20520, Finland |
Completed | Hadassah Hebrew University Hospital Ein Kerem | Jerusalem, 9112001, Israel |
Completed | Rambam Health Corporation | Haifa, 3109601, Israel |
Completed | Shamir Medical Center (Assaf Harofeh) | Zerifin, 7030000, Israel |
Completed | Mater Misericordiae University Hospital | Dublin, D07R2WY, Ireland |
Completed | Cork University Hospital | Cork, T12DC4A, Ireland |
Completed | Centre Universitaire de Sante de l'Estrie | Sherbrooke, J1H 5N4, Canada |
Completed | Hopital Maisonneuve-Rosemont | Montreal, H1T 2M4, Canada |
Completed | Hopital de L'Enfant Jesus | Quebec City, G1J 1Z4, Canada |
Completed | Calvary Mater Hospital Newcastle | Waratah, 2298, Australia |
Withdrawn | Clínica Santa María | Santiago, 7520378, Chile |
Completed | Instituto Nacional del Cáncer | Santiago, 838-0455, Chile |
Completed | Centro de Investigaciones Clínicas Vina del Mar Ltda. | Vina del Mar, 2540364, Chile |
Withdrawn | Fundación Arturo López Perez | Santiago, 7500921, Chile |
Completed | Hôpital Saint Louis | PARIS, 75010, France |
Completed | Hôpital Saint-Eloi | MONTPELLIER CEDEX, 34059, France |
Active, not recruiting | St George's Hospital | Kogarah, 2217, United Kingdom |
Completed | Guangdong Provincial People's Hospital | Guangzhou, 510000, China |
Completed | Tianjin Medical University Cancer Institute & Hospital | Tianjin, 300000, China |
Completed | Asan Medical Center | Seoul, 138-736, Korea,_republic_of |
Completed | Severance Hospital, Yonsei University Health System | Seoul, 03722, Korea,_republic_of |
Withdrawn | Pusan National University Hospital | Busan, 49241, Korea,_republic_of |
Completed | Northwick Park Hospital | Harrow, HA1 3UJ, United Kingdom |
Completed | Royal Devon & Exeter Hospital | Exeter, EX2 5DW, United Kingdom |
Completed | Changhua Christian Hospital | Changhua, 50006, Taiwan |
Completed | National Cheng Kung University Hospital | Tainan, 704, Taiwan |
Completed | Chang Gung Memorial Hospital Kaohsiung | Kaohsiung, 833, Taiwan |
Completed | IRCCS Fondazione Policlinico San Matteo | Pavia, 27100, Italy |
Completed | A.O.U. Ospedali Riuniti "Umberto I - G.M.Lancisi - G.Salesi" | Ancona, 60126, Italy |
Completed | Narodny onkologicky ustav | Bratislava, 833 10, Slovakia |
Withdrawn | Vychodoslovensky onkologicky ustav a.s. | Kosice, 041 91, Slovakia |
Withdrawn | Centre Hospitalier Lyon Sud | PIERRE BENITE, 69495, France |
Completed | Centre Hospitalier Universite de Grenoble | Grenoble, 38043, France |
Completed | Centre François Magendie - Pessac | PESSAC, 33600, France |
Withdrawn | Centre Léon Bérard | lyon, 69008, France |
Withdrawn | Kantonsspital Baselland - Standort Liestal | Liestal, 4410, Switzerland |
Withdrawn | Ospedale Regionale Bellinzona | Bellinzona, 6500, Switzerland |
Completed | Ankara Universitesi Tip Fakultesi Hastanesi | Ankara, 6100, Turkey |
Completed | Karadeniz Teknik Universitesi Tip Fakultesi | Trabzon, 61080, Turkey |
Completed | Erciyes Universitesi Tip Fakultesi | Kayseri, 38039, Turkey |
Completed | Xinhua Hos Affiliated to SH Jiaotong Uni School of Medicine | Shanghai, 200092, China |
Completed | Istanbul Universitesi Istanbul Tip Fakultesi | Istanbul, 34093, Turkey |
Withdrawn | CHU de Caen - Hôpital Côte de Nacre | CAEN cedex 9, 14033, France |
Completed | Jilin Cancer Hospital | Changchun, 130000, China |
Completed | Henan Cancer Hospital | Zhengzhou, 450000, China |
Completed | Tumor Hospital of Hebei Province | Hebei, 050000, China |
Completed | Prince of Wales Hospital | Shatin, MISSING, Hong Kong |
Withdrawn | Queen Mary Hospital | Hong Kong, Hong Kong |
Withdrawn | Tuen Mun Hospital | Hongkong, Hong Kong |
Withdrawn | Queen Elizabeth Hospital Hong Kong | Kowloon, Hong Kong |
Completed | Med. Fakultät der Martin-Luther-Universität Halle-Wittenberg | Halle, 6120, Germany |
Completed | Fakultni Nemocnice Hradec Kralove | Hradec Kralove, 500 05, Czech Republic |
Completed | Ege Universitesi Tip Fakultesi | Izmir, 35100, Turkey |
Completed | Trakya Univ. Tip Fak. | Edirne, 22030, Turkey |
Completed | Ondokuz Mayis Uni Tip Fakultesi | Samsun, 55139, Turkey |
Completed | Institut Jules Bordet/Jules Bordet Instituut | Bruxelles, 1070, Belgium |
Completed | CHU de Liège | LIEGE, 4000, Belgium |
Completed | Albert Alberts Stem Cell Transplant Research Centre | Pretoria, 44, South Africa |
Completed | Outeniqua Cancercare Oncology Unit | George, 6530, South Africa |
Completed | Cancercare Langenhoven | Port Elizabeth, 6045, South Africa |
Completed | State Institution - Institute of Blood Pathology and Transfusion Medicine NAMS of Ukraine | Lviv, 79044, Ukraine |
Completed | Governmental Noncommercial Institution "National Cancer Institute | Kyiv, 03022, Ukraine |
Completed | CNE "Zaporizhzhia Regional Clinical Hospital" of Zaporizhzhia regional council | Zaporizhzhya, 69600, Ukraine |
Completed | CNE "Clinical Center of Oncology, Hematology, Transplantology and Palliative Care of the Cherkasy Regional Council" | Cherkasy, 18009, Ukraine |
Completed | IPO Porto | Porto, 4200-072, Portugal |
Withdrawn | Centro Hospitalar Universitario de Sao Joao | Polo Porto - Centro de Investigacao e Ensaios Clinicos | Porto, 4200-319, Portugal |
Completed | Centro Hospitalar Universitario do Porto | Porto, 4099-001, Portugal |
Completed | Centro Hospitalar Vila Nova de Gaia e Espinho | Unit 1 - Clinical Research Center | Porto, 4434-502, Portugal |
Completed | Centro Clinico Academico Braga | Braga, Portugal | Braga, 4710-243, Portugal |
Completed | Centro Multidisciplinar de Estudos Clínicos EPP - Ltda. | São Bernardo do Campo, 09715-090, Brazil |
Completed | IRCCS Ospedale Policlinico San Martino | Genova, 16132, Italy |
Completed | Odense Universitetshospital - Hæmatologisk afdeling | Odense C, 5000, Denmark |
Withdrawn | Klinikum Wels-Grieskirchen GmbH | Wels, 4600, Austria |
Withdrawn | Kantonsspital Aarau | Aarau, 5001, Switzerland |
Withdrawn | Royal Cornwall Hospital | Truro, TR1 3LJ, United Kingdom |
Completed | Institut Català d'Oncologia Hospitalet | Hospitalet de Llobregat, 08907, Spain |
Completed | Hospital Regional de Malaga | Oncologia | Malaga, 29010, Spain |
Withdrawn | Complejo Hospitalario Universitario A Coruña | Oncologia | A Coruña, 15006, Spain |
Completed | Hospital Clínico Universitario Lozano Blesa | Zaragoza, 50009, Spain |
Completed | The Affiliated Hospital of Qingdao University | shandong, 266000, China |
Completed | Haematologie-Onkologie im Zentrum MVZ GmbH | Augsburg, 86150, Germany |
Completed | Institut Català d'Oncologia Badalona | Badalona, 8916, Spain |
Completed | Flinders Medical Centre | Bedford Park, 5042, Australia |
Completed | General Hospital of Athens LAIKO | Athens, 11527, Greece |
Completed | University General Hospital of Athens "ATTIKON" | Chaidari, 12462, Greece |
Completed | EVANGELISMOS General Hospital of Athens | Athens, 106 76, Greece |
Completed | University General Hospital of Patras | Patras, 26500, Greece |
Completed | Univ. General Hospital of Larissa | Larissa, 41110, Greece |
Withdrawn | PAPANIKOLAOU General Hospital of Thessaloniki | Thessaloniki, 57010, Greece |
Withdrawn | Meir Medical Center | Kfar Saba, 4428164, Israel |
Completed | Hospital de Clinicas de Porto Alegre | Clinical Research Center - Surgery Research Center | Porto Alegre, 90035-903, Brazil |
Completed | Hospital Israelita Albert Einstein | Morumbi - Clinical Research Department | Sao Paulo, 05651-901, Brazil |
Completed | Instituto Nacional do Cancer Jose Alencar Gomes da Silva | Rio de Janeiro, 20231-050, Brazil |
Withdrawn | Hosp Bruno Born Sociedade Beneficência e Caridade de Lajeado | Lajeado, TBC, Brazil |
Completed | Centro de Pesquisas Oncológicas | Florianópolis, 88034-000, Brazil |
Withdrawn | Casa de Saúde Santa Marcelina | São Paulo, 08.270-070, Brazil |
Completed | Centro Integrado de Oncologia de Curitiba | Curitiba, 80810-050, Brazil |
Completed | UMHAT Sveti Georgi | Plovdiv, 4000, Bulgaria |
Completed | University Multiprofile Hosp. for Active Treat. Sveti Ivan | Sofia, 1431, Bulgaria |
Completed | SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD | Sofia, 1756, Bulgaria |
Completed | Multiprofile Hospital for Active Treatment Hristo Botev AD | Vratsa, 3000, Bulgaria |
Completed | Semmelweis University | Budapest, 1083, Hungary |
Completed | Pecsi Tudomanyegyetem Klinikai Kozpont | Pecs, 7623, Hungary |
Completed | Somogy Varmegyei Kaposi Mor Oktato Korhaz | Kaposvar, 7400, Hungary |
Completed | Komarom-Esztergom Varmegyei Szent Borbala Korhaz | Tatabanya, 2800, Hungary |
Completed | Semmelweis University | Budapest, 1083, Hungary |
Withdrawn | St. Petersburg Clinical Hospital of RAS | St. Petersburg, 194017, Russia |
Completed | Oncology Dispensary #2 | Sochi, 354057, Russia |
Completed | Republican Clinical Oncology Dispensary | Ufa, 450054, Russia |
Completed | RSRI of Hematology and Transfusiology | Saint-Petersburg, 191024, Russia |
Withdrawn | Regional Clinical Hospital Yaroslavl | Yaroslavl, 150062, Russia |
Completed | Siberian State Medical University | Tomsk, 634050, Russia |
Withdrawn | Institut de Cancérologie de l'Ouest - Saint Herblain | Saint-Herblain, 44800, France |
Completed | Oncologianova GmbH | Recklinghausen, 45659, Germany |
Withdrawn | Bacs-Kiskun Varmegyei Oktatokorhaz | Kecskemét, 6000, Hungary |
Completed | Eastern Health Integrated Renal Service | Box Hill, 3128, Australia |
Completed | Stauferklinikum Schwäbisch-Gmünd | Mutlangen, 73557, Germany |
Withdrawn | Mayo Clinic - Rochester | Rochester, 55905, United States |
Withdrawn | Hartford Hospital | Hartford, 06102-5037, United States |
Completed | Singapore General Hospital | Singapore, 169608, Singapore |
Completed | National University Hospital | Singapore, 119074, Singapore |
Withdrawn | Raffles Hospital | Singapore, 188770, Singapore |
Withdrawn | Onkolog. Gemeinschaftspraxis Dres. D.Reichert & J.Janssen | Westerstede, 26655, Germany |
Withdrawn | University of Mississippi Medical Center | Shafi Group | Jackson, 39216, United States |
Withdrawn | Universität Rostock - Medizinische Fakultät | Rostock, 18057, Germany |
Withdrawn | Alaska Cancer Treatment Center | Anchorage, 99503, United States |
Withdrawn | Prairie Lakes Cancer Center | Watertown, 57201, United States |
Withdrawn | Mountain Blue Cancer Care Center | Englewood, 80113, United States |
Completed | National Cancer Center Hospital | Chuo-ku, 104-0045, Japan |
Completed | Tohoku University Hospital | Sendai, 980-8574, Japan |
Withdrawn | National Hospital Organization Nagoya Medical Center | Nagoya, 460-0001, Japan |
Completed | Nagoya City University Hospital | Nagoya, 467-8602, Japan |
Withdrawn | Kyoto Prefectural University of Medicine | Kyoto, 602-8566, Japan |
Completed | Kobe University Hospital | Kobe, 650-0017, Japan |
Completed | Orszagos Onkologiai Intezet | Budapest, 1122, Hungary |
Withdrawn | Kaluga Regional Clinical Hospital | Kaluga, 248007, Russia |
Completed | Research Institute of Oncology | Rostov-on-Don, 344037, Russia |
Completed | Clinical Oncological Dispensary of Omsk Region | Omsk, 644013, Russia |
Completed | Kemerovo Regional Clinical Hospital | Kemerovo, 650066, Russia |
Withdrawn | St James' Hospital | Dublin, D08NHY1, Ireland |
Completed | Phramongkutklao Hospital | Bangkok, 10400, Thailand |
Completed | Siriraj Hospital, Mahidol | Bangkok, 10700, Thailand |
Completed | Hospital General de México SS | México, D. F., 6726, Mexico |
Withdrawn | Instituto Nacional de Cancerología | México, 14080, Mexico |
Completed | PRATIA MCM KRAKÓW | Krakow, 30-727, Poland |
Completed | Szpital Morski im. PCK | Gdynia, 81-519, Poland |
Withdrawn | Centrum Onkologii Ziemi Lubelskiej im. Sw. Jana z Dukli | Lublin, 20-090, Poland |
Completed | SC ONCO CARD SRL | Brasov, 500152, Romania |
Withdrawn | Sp. Univ. de Urgenta Militar Central Dr. Carol Davila | Bucuresti, 10825, Romania |
Completed | Sp. Judetean de Urgenta Dr. Constantin Opris Baia Mare | Baia Mare, 430031, Romania |
Withdrawn | Institutul Oncologic Prof. Dr. Ion Chiricuta | Cluj-Napoca, 400124, Romania |
Completed | Fundeni Clinical Institute | Bucuresti, 22328, Romania |
Completed | Spitalul Clinic Colentina | Bucuresti, 20125, Romania |
Completed | Spitalul Clinic Coltea | Bucuresti, 30171, Romania |
Withdrawn | Spitalul Clinic Judetean de Urgenta Targu-Mures | Targu Mures, 540136, Romania |
Completed | Institutul Regional de Oncologie Iasi | Iasi, 700483, Romania |
Completed | Spitalul Clinic Municipal Filantropia Craiova | Craiova, 200143, Romania |
Withdrawn | Henry Ford Health System | Detroit, 48202, United States |
Completed | Centre Hospitalier Intercommunal de la Côte Basque-Bayonne | BAYONNE, 64100, France |
Completed | Centro de Investigación Clínica Chapultepec S.A. de C.V. | Morelia, 58260, Mexico |
Completed | Lewis Hall Singletary Oncology Center | Thomasville, 31792, United States |
Withdrawn | Tangdu Hospital, the 4th Military Medical University of PLA | Xian, 710000, China |
Completed | Chaim Sheba Medical Center | Ramat Gan, 5262000, Israel |
Withdrawn | Shanghai East Hospital Affiated to Tongji University | shanghai, 200100, China |
Completed | IEP São Lucas | São Paulo, 01234-030, Brazil |
Completed | Hospital das Clínicas da Faculdade de Medicina da USP | Sao Paulo, 05403-000, Brazil |
Completed | Faculdade de Ciencias Medicas-Universidade Estadual Campinas | Campinas, 130839 970, Brazil |
Withdrawn | Hanoi, Viet Nam | |
Withdrawn | Ho Chi Minh City, Viet Nam | |
Completed | Centre Hospitalier Universitaire - Angers | Angers, 49933, France |
Completed | Sun Yat-sen University Cancer Center | Guangzhou, 510000, China |
Withdrawn | Ho Chi Minh City, Viet Nam | |
Withdrawn | Pacific Shores Medical Group | Long Beach, 90813, United States |
Withdrawn | Japanese RedCross Aichi Medical Center Nagoya Daini Hospital | Nagoya, 466-8650, Japan |
Completed | National Hospital Organization Kyushu Cancer Center | Fukuoka, 811-1395, Japan |
Completed | Aichi Cancer Center Hospital | Nagoya, 464-8681, Japan |
Completed | Gunma University Hospital | Maebashi, 371-8511, Japan |
Withdrawn | Niigata Cancer Center Hospital | Niigata, 951-8566, Japan |
Withdrawn | Jichi Medical University Hospital | Shimotsuke, 329-0498, Japan |
Withdrawn | Toranomon Hospital | Minato-ku, 105-8470, Japan |
Completed | Osaka Metropolitan University Hospital | Osaka, 545-8586, Japan |
Withdrawn | Shimane University Hospital | Izumo, 693-8501, Japan |
Completed | Yamagata University Hospital | Yamagata, 990-9585, Japan |
Completed | Hyogo Cancer Center | Akashi, 673-8558, Japan |
Completed | Aomori Prefectural Central Hospital | Aomori, 030-8553, Japan |
Withdrawn | Shinshu University Hospital | Matsumoto, 390-8621, Japan |
Completed | National Hospital Organization Kumamoto Medical Center | Kumamoto, 860-0008, Japan |
Completed | Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz | Nyiregyhaza, 4400, Hungary |
Withdrawn | Univ.of California-San Diego Moores Cancer Center | La Jolla, 92093-0698, United States |
Completed | Clinique Saint Anne | STRASBOURG, 67000, France |
Completed | Marienhospital Herne Universitätsklinik | Herne, 44625, Germany |
Withdrawn | Valley Hospital Bolger Medical Arts Building | Westwood, 7675, United States |
Withdrawn | St. Luke's Mountain States Tumor Institute - Boise | Boise, 83712, United States |
Withdrawn | DBA-Envision Cancer Care, LLC | San Antonio, 78235, United States |
Completed | Brian J. LeBerthon, MD | West Covina, 91790, United States |
Completed | Constantiaberg Medi Clinic | Cape Town, 7800, South Africa |
Withdrawn | Loyola University Medical Center | Maywood, 60153, United States |
Completed | Sociedad de Investigaciones Medicas Ltda | Temuco, 4810469, Chile |
Withdrawn | Vista Oncology Inc PS | Olympia, 98506, United States |
Completed | New York Cancer and Blood Specialists | Port Jefferson Station, 11776, United States |
Completed | Ironwood Physicians P.C. DBA Ironwood Cancer & Res. Ctr. | Chandler, 85224, United States |
Withdrawn | Grand Hôpital de Charleroi | GILLY, 6060, Belgium |
Withdrawn | Southwest Oklahoma Cancer Research | Lawton, 73505, United States |
Withdrawn | Department of Oncology | Pietermaritzburg, 3201, South Africa |
Completed | SCL Health Research at St Joseph's Hospital Denver CO | Denver, 80218, United States |
Completed | Centro Especializado en Investigación Clínica S.C. | Boca del Río, 94290, Mexico |
Completed | Centro de Atencion e Investigacion Clinica en Oncologia SCP | Merida, 97134, Mexico |
Completed | Medizinische Hochschule Hannover (MHH) | Hannover, 30625, Germany |
Completed | Ciutat Sanitaria i Universitaria de la Vall d'Hebron | Barcelona, 08035, Spain |
Withdrawn | MVZ Praxis Pihusch GbR | Rosenheim, 83022, Germany |
Completed | Oncology Consultants | Houston, 77024-2645, United States |
Withdrawn | Detroit Clinical Research Center | Farmington Hills, 48334, United States |
Withdrawn | Manchester Royal Infirmary | Manchester, M13 9WL, United Kingdom |
Completed | Irmandade da Santa Casa de Misericordia de Porto Alegre | Hospital Sao Francisco - Centro Medico Pesquisa Clinica Cardiologia | Porto Alegre, 90020-090, Brazil |
Withdrawn | Morristown Memorial Hospital | Morristown, 07962-1956, United States |
Withdrawn | NYU Langone Medical Center | Brooklyn, 11220, United States |
Withdrawn | University Health System | Lubbock, 79415, United States |
Completed | Hospital Universitario "José Eleuterio González" | Monterrey, TBC, Mexico |
Completed | Hopital du Sacre-Coeur de Montreal | Montreal, QC H4J 1C5, Canada |
Withdrawn | Joe Arrington Cancer Research & Treatment Center | Lubbock, 79410, United States |
Completed | Texas Oncology- McAllen | McAllen, 78503, United States |
Withdrawn | Mid Ohio Oncology/Hematology Inc. | Columbus, 43219, United States |
Withdrawn | Hematology Oncology Center at Nyack Hospital | Nyack, 19060, United States |
Withdrawn | Mission Hospital | Asheville, 28801, United States |
Withdrawn | Mid Florida Cancer Centers | Orange City, 32763-8316, United States |
Withdrawn | AUSL della Romagna | Forlì Cesena, 47521, Italy |
Withdrawn | Istituto Europeo di Oncologia s.r.l | Milano, 20141, Italy |
Withdrawn | East Carolina University | Greenville, 27834, United States |
Completed | Municipal Non-Profit Enterprise "City Clinical Hospital ?4" of the Dnipro City Council | Dnipro, 49102, Ukraine |
Withdrawn | Winthrop-University Hospital | Mineola, United States |
Completed | Kindai University Hospital | Osakasayama-shi, 589-8511, Japan |
Completed | Kumamoto University Hospital | Kumamoto, 860-8556, Japan |
Withdrawn | Kurume University Hospital | Kurume, 830-0011, Japan |
Completed | Saitama Medical University International Medical Center | Hidaka, 350-1298, Japan |
Completed | JCHO Kyushu Hospital | Kitakyushu, 806-8501, Japan |
Withdrawn | Pindara Private Hospital | Benowa, 4217, Australia |
Withdrawn | The Queen's Medical Center | Honolulu, 96813, United States |
Withdrawn | Memorial Sloan Kettering Cancer Center- Monmouth | Middletown, 7748, United States |
Withdrawn | Memorial Sloan Kettering Cancer Center- Basking Ridge | Basking Ridge, 07920, United States |
Completed | Memorial Sloan Kettering Cancer Center- Bergen | New York, 10021, United States |
Withdrawn | Memorial Sloan Kettering Cancer Center- Commack | Commack, 11725, United States |
Withdrawn | Memorial Sloan Kettering- Nassau | Uniondale, 11553, United States |
Withdrawn | Memorial Sloan Kettering Cancer Center- Westchester | Harrison, 10604, United States |
Withdrawn | University of Texas MD Anderson Cancer Center | Houston, 77030, United States |
Completed | Hopital Hotel Dieu - Nantes | NANTES, 44000, France |
Withdrawn | Alexian Brothers Medical Center | Elk Grove Village, 60007, United States |
Completed | Clinique Victor Hugo - Le Mans | LE MANS CEDEX 2, 72015, France |
Completed | Centre Hospitalier de la Durance - Avignon | AVIGNON, 84000, France |
Withdrawn | Saitama Medical Center | Kawagoe, 350-8550, Japan |
Withdrawn | Hopital Saint Antoine - Paris | PARIS, 75571, France |
Withdrawn | Greenebaum Comprehensive Cancer Center | Baltimore, 21201, United States |
Withdrawn | Ruppiner Kliniken GmbH | Neuruppin, 16816, Germany |
Completed | Hiroshima Red Cross & Atomic-bomb Survivors Hospital | Hiroshima, 730-8619, Japan |
Withdrawn | Shizuoka Cancer Center | Sunto, 411-8777, Japan |
Completed | Osaka Red Cross Hospital | Osaka, 543-8555, Japan |
Completed | Kanagawa Cancer Center | Yokohama, 241-8515, Japan |
Completed | Tenri Hospital | Tenri, 632-8552, Japan |
Completed | Spitalul Clinic Judetean de Urgenta Sibiu | Sibiu, 550245, Romania |
Withdrawn | Hospital Samaritano de São Paulo LTDA | Sao Paulo, 01236-000, Brazil |
Withdrawn | John B. Amos Cancer Center | Columbus, 31904, United States |
Primary Outcome
- SRI: Occurrence of dose-limiting toxicities (DLT)Dose-limiting toxicity is defined as any of the following occurring during Cycle 1 at a given dose level and regarded by the investigator and/or the sponsor to be possibly, probably, or definitely related to copanlisib given in combination with R-B or R-CHOP. General: any grade 5 hematologic or non-hematologic toxicity or any delay of >2 weeks of Cycle 2 due to study treatment-related toxicity; Non-hematologic DLT: any non-hematologic toxicity grade ≥ 3; Hematologic DLT: grade 4 absolute neutrophil count decrease lasting >7 days, or grade 4 febrile neutropenia, or grade 4 platelet count decreased or grade 3 platelet count decreased with serious bleeding, or signs of serious bleeding and/or international normalized ratio (INR) increased or partial thromboplastin time (PTT) prolonged of grade 3.date_rangeTime Frame:At Cycle 1: 28 days for Copa+R-B or 21 days for Copa+R-CHOP
- Phase 3: Progression-free survival (PFS) by independent central reviewPFS is defined as the time from randomization to progressive disease (PD) or death from any cause (if no progression is documented).date_rangeTime Frame:Approximately 6 years 4 months
Secondary Outcome
- SRI: Best overall responseBest overall response is defined as the best response achieved during the treatment and active follow-up periods; prior to end of study or start of new anti-tumor treatment, whichever occurs first.date_rangeTime Frame:Approximately 7 years 8 months
- SRI: Number of subjects with treatment-emergent adverse event (TEAE)A treatment-emergent AE is defined as any event arising or worsening after start of study drug administration until 30 days after the last study drug intake.date_rangeTime Frame:Approximately 4 years 10 months
- Phase 3: Objective tumor response rate (ORR)-Independent central reviewORR, as assessed by independent central review, is defined as the percentage of participants who had a best response rating of CR or PR according to the Lugano classification and for subjects with LPL/WM, a response rating of CR, VGPR, PR, or MR according to the Owen criteria, over the whole duration of the study (i.e., until time of analysis of PFS).date_rangeTime Frame:Up to 6 years 4 months
- Phase 3: ORR-Investigator assessmentORR, as assessed by investigator, is defined as the percentage of participants who had a best response rating of CR or PR according to the Lugano classification and for subjects with LPL/WM, a response rating of CR, VGPR, PR, or MR according to the Owen criteria, over the whole duration of the study (i.e., until time of analysis of PFS).date_rangeTime Frame:Up to 6 years 4 months
- Phase 3: Duration of tumor response (DOR)-Independent central reviewDOR, as assessed by independent central review, is defined as the time (in days) from first observed tumor response (CR, VGPR, PR, or MR) until progression or death from any cause, whichever occurred earlier. The DOR was only defined for patients with at least 1 CR, VGPR, PR, or MR.date_rangeTime Frame:Approximately 6 years 4 months
- Phase 3: DOR-Investigator assessmentDOR, as assessed by investigator, is defined as the time (in days) from first observed tumor response (CR, VGPR, PR, or MR) until progression or death from any cause, whichever occurred earlier. The DOR was only defined for patients with at least 1 CR, VGPR, PR, or MR.date_rangeTime Frame:Approximately 6 years 4 months
- Phase 3: Complete tumor response rate (CRR)-Independent central reviewCRR, as assessed by independent central review, is defined as the proportion of patients who had a best response rating of CR according to the Lugano classification, and for patients with LPL/WM, a response rating of CR according to the Owen criteria, over the whole duration of the study (i.e., until the time of analysis of PFS).date_rangeTime Frame:Approximately 6 years 4 months
- Phase 3: CRR-Investigator assessmentCRR, as assessed by investigator, is defined as the proportion of patients who had a best response rating of CR according to the Lugano classification, and for patients with LPL/WM, a response rating of CR according to the Owen criteria, over the whole duration of the study (i.e., until the time of analysis of PFS).date_rangeTime Frame:Approximately 6 years 4 months
- Phase 3: Disease control rate (DCR)-Independent central reviewDCR, as assessed by independent central review, is defined as the proportion of patients who had a best response rating of CR, VGPR, PR, MR, or stable disease (excluding unconfirmed early stable disease).date_rangeTime Frame:Approximately 6 years 4 months
- Phase 3: DCR-Investigator assessmentDCR, as assessed by investigator, is defined as the proportion of patients who had a best response rating of CR, VGPR, PR, MR, or stable disease (excluding unconfirmed early stable disease).date_rangeTime Frame:Approximately 6 years 4 months
- Phase 3: Time to tumor progression (TTP)-Independent central reviewTTP, as assessed by independent central review, is defined as the time from randomization to progression or death related to progression, whichever occurred earlier. Death related to progression was any death except for: death due to an AE unrelated to progression; or death with a specification of “other” as reason (which excludes PD).date_rangeTime Frame:Approximately 6 years 4 months
- Phase 3: TTP-Investigator assessmentTTP, as assessed by investigator, is defined as the time from randomization to progression or death related to progression, whichever occurred earlier. Death related to progression was any death except for: death due to an AE unrelated to progression; or death with a specification of “other” as reason (which excludes PD).date_rangeTime Frame:Approximately 6 years 4 months
- Phase 3: Time to next anti-lymphoma treatment (TTNT)A new anti-lymphoma therapy is any new systemic anticancer treatment or radiotherapy for lymphoma, with a consolidation intent. TTNT was defined as the time from the date of randomization to the start of new anti-lymphoma therapy, where the date of randomization was considered Day 1. '99999' denotes value could not be estimated due to censored datadate_rangeTime Frame:Approximately 6 years 4 months
- Phase 3: Overall survival (OS)Overall survival is defined as the time from randomization until death from any cause. The OS for patients alive at the time of the database cut-off date was censored to the last date they were known to be alive. Deaths that occurred after the database cut-off date, reported during data cleaning, were considered for establishing the last known alive date at data cut-off. '99999' denotes value could not be estimated due to censored data.date_rangeTime Frame:Approximately 6 years 4 months
- Phase 3: time to deterioration in disease-related symptoms-physical (DRS-P) of at least 3 points of lymphomaTime to deterioration in DRS-P of at least 3 points, as measured by the FLymSI-18 questionnaire, was evaluated in all patients. It is defined as the time from randomization to DRS-P decline, progression, or death from any reason, whichever occurred earlier.date_rangeTime Frame:Approximately 6 years 4 months
- Phase 3: time to improvement in disease-related symptoms-physical (DRS-P) of at least 3 points of lymphomaTime to improvement in DRS-P of at least 3 points, as measured by the FLymSI-18 questionnaire, was evaluated for all patients. It is defined as the time from randomization to DRS-P improvement of at least 3 points.date_rangeTime Frame:Approximately 6 years 4 months
- Phase 3: Number of subjects with treatment-emergent adverse event (TEAE)A treatment-emergent AE is defined as any event arising or worsening after start of study drug administration until 30 days after the last study drug intake.date_rangeTime Frame:Approximately 4 years
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
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