Spots Global Cancer Trial Database for A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.
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Trial Identification
Brief Title: A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma.
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to Rituximab Versus Lenalidomide in Addition to Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma Grade 1 to 3a or R/R Marginal Zone Lymphoma
Study ID: NCT04680052
Study Description
Brief Summary: This is a Phase 3 double-blind, placebo-controlled, randomized study designed to investigate whether tafasitamab and lenalidomide as an add-on to rituximab provides improved clinical benefit compared with lenalidomide as an add-on to rituximab in patients with R/R FL Grade 1 to 3a or R/R MZL.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
John Muir Health Clinical Research Center, Concord, California, United States
Marin Cancer Care, Greenbrae, California, United States
The Oncology Institute of Hope and Innovation, Pasadena, California, United States
Sharp Memorial Hospital, San Diego, California, United States
Middlesex Hospital Cancer Center, Middletown, Connecticut, United States
Smilow Cancer Hospital, New Haven, Connecticut, United States
Cancer Specialists of North Florida, Jacksonville, Florida, United States
Brcr Medical Center, Inc, Plantation, Florida, United States
Asclepes Research Centers, Weeki Wachee, Florida, United States
Northwest Georgia Oncology Centers,P.C, Marietta, Georgia, United States
Straub Medical Center, Honolulu, Hawaii, United States
Des Moines Oncology Research Association, Des Moines, Iowa, United States
Baptist Health Lexington, Lexington, Kentucky, United States
Norton Cancer Institute, Louisville, Kentucky, United States
Tulane University, New Orleans, Louisiana, United States
University of Maryland-Greenebaum Cancer Center, Baltimore, Maryland, United States
Cancer Center For Blood Disorders, Bethesda, Maryland, United States
Barbara Ann Karmanos Cancer Hospital, Detroit, Michigan, United States
Metro-Minnesota Community Oncology Reserch Consortium (Mmcorc), Saint Louis Park, Minnesota, United States
Hattiesburg Clinic Hematology, Hattiesburg, Mississippi, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Nyu Clinical Cancer Center, New York, New York, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Integris Cancer Institute, Oklahoma City, Oklahoma, United States
Charleston Hematology Oncology Associates, Charleston, South Carolina, United States
Prisma Health Upstate, Greenville, South Carolina, United States
Prairie Lakes Health Care System, Inc., Watertown, South Dakota, United States
Texas Oncology-Baylor Charles A. Sammons, Dallas, Texas, United States
The Center For Cancer and Blood Disorders, Fort Worth, Texas, United States
Lyndon B Johnson General Hospital, Houston, Texas, United States
Md Anderson Cancer Center, Houston, Texas, United States
Renovatio Clinical, Spring, Texas, United States
Utah Cancer Specialists, Salt Lake City, Utah, United States
University of Virginia Medical Center, Charlottesville, Virginia, United States
Vista Oncology Inc Ps, Olympia, Washington, United States
Virginia Mason Medical Center, Seattle, Washington, United States
University of Washington-Seattle Cancer Care Alliance, Seattle, Washington, United States
Northwest Medical Specialties Pllc, Tacoma, Washington, United States
St George Hospital, Kogarah, New South Wales, Australia
Liverpool Hospital, Sydney, New South Wales, Australia
Wollongong Hospital - Illawarra Regional Hospital, Wollongong, New South Wales, Australia
Gold Coast Hospital, Southport, Queensland, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
Flinders Medical Centre, Bedford Park, South Australia, Australia
The Alfred Hospital, Melbourne, Victoria, Australia
Northern Hospital, Melbourne, Victoria, Australia
Western Health, St. Albans, Victoria, Australia
Perth Blood Institute, West Perth, Western Australia, Australia
Eastern Health, Box Hill, , Australia
Royal Hobart Hospital, Hobart, , Australia
Landeskrankenhaus Universitatsklinikum Graz, Graz, , Austria
Innsbruck University Hospital, Innsbruck, , Austria
Kepler Universitat Klinikum, Linz, , Austria
*Krankenhaus*, Wien, , Austria
Zna Stuivenberg, Antwerpen, , Belgium
A.Z. St.-Jan-Dienst Hematologie, Brugge, , Belgium
Institut Jules Bordet, Brussels, , Belgium
Cliniques Universitaires Ucl Saint-Luc, Brussels, , Belgium
Universitair Ziekenhuis Antwerpen, Dienst Hematologie, Edegem, , Belgium
Ghent University Hospital, Gent, , Belgium
Universitair Ziekenhuis (Uz) Leuven, Leuven, , Belgium
Centre Hospitalier Universitaire de Liege - Sart Tilman, Liège, , Belgium
AZ Delta, Roeselare, , Belgium
Chu Ucl Namur University Hospital Mont-Godinne, Yvoir, , Belgium
Cross Cancer Institute, Edmonton, Alberta, Canada
British Columbia Cancer Agency, Vancouver, British Columbia, Canada
Queen Elizabeth Ii Health Sciences Centre, Halifax, Nova Scotia, Canada
London Health Sciences Centre, London, Ontario, Canada
Hospital Maisonneuve Rosemont, Montréal, Quebec, Canada
McGill University Jewish General Hospital, Montréal, Quebec, Canada
Chu de Quebec - Universite Laval (Chul), Québec, Quebec, Canada
University, Brno, , Czechia
University Hospital Hradec Kralove, Hradec Kralove, , Czechia
University Hospital Ostrava, Ostrava, , Czechia
Vseobecna Fakultni Nemocnice, Prague, , Czechia
University Hospital Kralovkse Vinohrady, Praha, , Czechia
University Hospital Motol, Praha, , Czechia
Aalborg University Hospital, Aalborg, , Denmark
Aarhus University Hospital, Aarhus, , Denmark
Odense University Hospital, Odense, , Denmark
Sjaellands Universitetshospital Naestved, Roskilde, , Denmark
Kuopio University Hospital, Kuopio, , Finland
Oulu University Hospital, Oulu, , Finland
Tampere University Hospital, Tampere, , Finland
Turku University Hospital, Turku, , Finland
Chu Amiens Picardie - Hopital Sud, Amiens, , France
Chu Angers Hotel Dieu Nord, Angers, , France
Groupe Bordeaux Nord Aquitaine Gbna Polycliniques - Polyclinique Bordeaux Nord Aquitaine Pbna, Bordeaux, , France
Centre Hospitalier Universitaire Chu Dijon Bourgogne - Hopital Francois Mitterrand, Dijon, , France
Centre Hospitalier de Versailles - Hopital Andre Mignot, Le Chesnay, , France
CHU Nantes, Nantes, , France
Hospital Saint-Louis Service Oncologie Medicale, Paris, , France
A.P.H. Paris Hopital Cochin, Paris, , France
Hôpital Pitié Salpêtrière, Paris, , France
Centre Hospitalier de Pontoise, Pontoise, , France
Centre Hospitalier Annecy-Genevois, Pringy, , France
Chru Hopitaux de Tours Hospital Bretonneau, Tours, , France
Klinikum St. Marien Amberg, Amberg, , Germany
Klinik Fur Innere Medizin Hamatologie and Onkologie, Berlin, , Germany
Universitatsklinikum Essen, Essen, , Germany
University Clinic Giessen Und Marburg Ukgm, GIEßEN, , Germany
Universitaetsmedizin Greifswald, Greifswald, , Germany
Statistics and Data Corporation (Sdc), Landshut, , Germany
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii, Mainz, , Germany
Medizinische Fakultaet Mannheim Der Universitaet Heidelberg, Mannheim, , Germany
Universitatsklinikum Munster, Muenster, , Germany
Onkologische Schwerpunktpraxis, Oldenburg, , Germany
Universitarsfrauenklinik Ulm, ULM, , Germany
Universitaetsklinikum Wuerzburg, Würzburg, , Germany
251 Air Force General Hospital, Athens, , Greece
General Hospital of Athens Laiko, Athens, , Greece
University Hospital of West Attica - Attikon, Athens, , Greece
University General Hospital of Patras, Patras, , Greece
Semmelweis Egyetem, Budapest, , Hungary
National Institute of Oncology, Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpon Belgyogy Klinika, Debrecen, , Hungary
Markhot Ferenc Korhaz, Eger, , Hungary
Petz Aladar County Teaching Hospital, Győr, , Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Nyíregyháza, , Hungary
University of Szeged, Szeged, , Hungary
Beaumont Hospital, Dublin, , Ireland
University Hospital Galway, Galway, , Ireland
Ha Emek Medical Center, Afula, , Israel
Soroka, Bear Sheva, , Israel
Shamir Medical Center Formerly Assaf Harofeh Medical Center, Beer Yaaqov, , Israel
Wolfson, Holon, , Israel
Shaare Zedek Mc, Jerusalem, , Israel
"Laiko" General Hospital of Athens, Hematology of the First Propaedeutic Internal Medicine Clinic, Jerusalem, , Israel
Hadassah, Jerusalem, , Israel
Meir Medical Center, Kfar Saba, , Israel
Rabin Medical Center - Beilinson Hospital, Petah Tikva, , Israel
Sheba Medical Center, Tel Hashomer, , Israel
Istituto Tumori Giovanni Paolo Ii Irccs Ospedale Oncologico Bari, Bari, , Italy
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia, Brescia, , Italy
Divisione Clinicizzata Di Ematologia, Brescia, , Italy
Fondazione Del Piemonte Per L Oncologia Ircc Candiolo, Candiolo, , Italy
Divisione Clinicizzata Di Ematologia, Catania, , Italy
Presidio Ospedaliero Vito Fazzi, Lecce, , Italy
Comitato Etico Fondazione Irccs Istituto Nazionale Dei Tumori Milano, Milano, , Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milano, , Italy
Istituto Nazionale Tumori Irccs Fondazione Pascale, Naples, , Italy
Universita Di Napoli Federico Ii, Napoli, , Italy
Azienda Ospedaliero Universitaria Maggiore Della Carita Di Novara, Novara, , Italy
Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano, Orbassano, , Italy
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello, Palermo, , Italy
Fondazione Irccs Policlinico San Matteo, Pavia, , Italy
Ausl Di Placenza Ospedale Guglielmo Da Saliceto, Piacenza, , Italy
Uo Ematologia Univ - Aoup Santa Chiara Pisa, Pisa, , Italy
Ospedale Santa Maria Delle Croci, Ravenna, , Italy
Arcispedale Santa Maria Nuova, Reggio Emilia, , Italy
Ausl Della Romagna, Rimini, , Italy
Universita Degli Studi Di Roma La Sapienza - Umberto I Policlinico Di Roma - Centro Di Ematologia, Roma, , Italy
Ospedale Sant. Eugenio, Rome, , Italy
Irccs Azienda Ospedaliera Universitaria San Martino, San Martino, , Italy
Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza, Torino, , Italy
Asugi Ospedale Maggiore, Trieste, , Italy
National Hospital Organization Kyushu Cancer Center, Fukuoka-shi, , Japan
Chugoku Center Hospital, Fukuyama-shi, , Japan
Gifu Municipal Hospital, Gifu-shi, , Japan
Kagoshima University Hospital, Kagoshima-shi, , Japan
National Cancer Center Hospital East, Kashiwa-shi, , Japan
Hospital of the University of Occupation and Environmental Health, Kitakyushu-shi, , Japan
Kobe City Medical Center General Hospital, Kobe-shi, , Japan
Japanese Red Cross Nagoya Daini Hospital, Nagoya-shi, , Japan
Iuhw Narita Hospital, Narita City, , Japan
Kindai University Hospital, Osakasayama-shi, , Japan
Saitama Medical University Hospital, Saitama, , Japan
Osaka University Hospital, Suita-shi, , Japan
Juntendo University Hospital, Tokyo, , Japan
Mie University Hospital, Tsu-shi, , Japan
Yamagata University Hospital, Yamagata-shi, , Japan
Pusan National University Yangsan Hospital, Busan-si, , Korea, Republic of
Pusan National University Yangsan Hospital, Busan-si, , Korea, Republic of
Inje University Busan Paik Hospital, Busan, , Korea, Republic of
Dong-A University Hospital, Busan, , Korea, Republic of
Kyungpook National University Hospital, Daegu, , Korea, Republic of
Daegu Catholic University Medical Center, Daegu, , Korea, Republic of
Keimyung University Dongsan Medical Center, Daegu, , Korea, Republic of
Chungnam National University, Daejeon, , Korea, Republic of
Gacheon University Gil Medical Center, Incheon, , Korea, Republic of
Jeonbuk National University Hospital, Jeonju, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea Yeoido St.Mary'S Hospital, Seoul, , Korea, Republic of
Amsterdam University Medical Centre, Amsterdam, , Netherlands
Hospital Rijnstate, Arnhem, , Netherlands
Medisch Spectrum Twente, Enschede, , Netherlands
Medisch Centrum Leeuwarden, Leeuwarden, , Netherlands
HMC, Leidschendam, , Netherlands
Innlandet Hospital Trust, Brumunddal, , Norway
Universitetssykehuset I Trondheim - St. Olavs Hospital, Trondheim, , Norway
Szpital Spec Brzozowiepoland, Brzozow, , Poland
Pratia Poznan, Katowice, , Poland
Pratia McM Krakow, Krakow, , Poland
Sp Zoz Szpital Uniwersytecki, Krakow, , Poland
Uniwersytet Medyczny W Lodzi - Klinika Hematologii, Lodz, , Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1, Lublin, , Poland
Specjalistyczny Szpital Onkologiczny, Tomaszow Mazowiecki, , Poland
Maria Sklodowska-Curie National Research Institute of Oncology, Warszawa, , Poland
Institute of Hematology and Transfusion Medicine, Warszawa, , Poland
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego, Wroclaw, , Poland
Rostov State Medical University, Rostov-on-don, , Russian Federation
Pavlov First Saint Petersburg State Medical University, St.petersburg, , Russian Federation
Complejo Hospitalario Universitario A Coruna, A Coruña, , Spain
Hospital General Unviersitario de Alicante, Alicante, , Spain
Ico Hospital Germans Trias I Pujol, Badalona, , Spain
Hospital Del Mar, Barcelona, , Spain
Hospital General Universitario Vall D Hebron, Barcelona, , Spain
Hospital de La Santa Creu I Sant Pau, Barcelona, , Spain
Hospital Universitario de Burgos, Burgos, , Spain
Hospital Universitario de Cabuenes, Gijon, , Spain
Institut Catala Doncologia Ico - Hospital Duran I Reynals Location, Hospitalet de Llobregat, , Spain
Hospital General Universitario Gregorio Maranon, Madrid, , Spain
Hospital Universitario Ramon Y Cajal, Madrid, , Spain
Fundacion Jimenez Diaz University Hospital, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario Quironsalud Madrid, Madrid, , Spain
Hospital Puerta de Hierro, Majadahonda, , Spain
Hospital Universitario Virgen de La Victoria, Malaga, , Spain
Hospital Universitario Virgen de La Arrixaca, Murcia, , Spain
Hospital Son Llatzer, Palma de Mallorca, , Spain
Consorci Hospitalari Parc Tauli de Sabadell, Sabadell, , Spain
Hospital Clinico Universitario de Salamanca, Salamanca, , Spain
Hospital Universitario Marques de Valdecilla, Santander, , Spain
Hospital Universitario Virgen del Rocio Sevilla, Sevilla, , Spain
Hospital Universitari Mutua Terrassa, Terrassa, , Spain
Hospital Universitario Doctor Peset, Valencia, , Spain
Hospital Universitari I Politecnic La Fe, Valencia, , Spain
Hospital Universitario de Alava, Vitoria-gasteiz, , Spain
Karolinska University Hospital Solna, Solna, , Sweden
Goetalandsregionen - Uddevalla Sjukhus Us, Uddevalla, , Sweden
Uppsala Universitet - Akademiska Sjukhuset, Uppsala, , Sweden
University Hospital of Basel Department of Oncology, Basel, , Switzerland
Oncological Institute of Southern Switzerland, Bellinzona, , Switzerland
Inselspital - Universitaetsspital Bern, Bern, , Switzerland
Kantonsspital St. Gallen, St. Gallen, , Switzerland
Kantonsspital Winterthur, Winterthur, , Switzerland
Universitatsspital Zurich, Zurich, , Switzerland
E-Da Hospital, Kaohsiung City, , Taiwan
Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, , Taiwan
Far Eastern Memorial Hospital, New Taipei City, , Taiwan
China Medical University Hospital, Taichung, , Taiwan
National Cheng Kung University (Ncku) Hospital, Tainan, , Taiwan
Hematology and Medical Oncology Too Foundation Sun Yat Sen Cancer Center, Taipei City, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Tri Service General Hospital, Taipei, , Taiwan
Institutional Review Board Taipei Veterans General Hospital, Taipei, , Taiwan
Hacettepe Universitesi Tip Fakultesi Hastanesi, Ankara, , Turkey
Ankara University Medical Faculty, Ankara, , Turkey
Acibadem Maslak Hospital, Istanbul, , Turkey
Communal Non-Profit Enterprise Regional Center of Oncology, Kharkiv, , Ukraine
National Cancer Institute of Ministry of Health, Kyiv, , Ukraine
University Hospitals Birmingham Nhs Foundation Trust, Birmingham, , United Kingdom
Bristol Haematology and Oncology Centre, Bristol, , United Kingdom
Leicester Royal Infirmary, Leicester, , United Kingdom
The Royal Marsden Nhs Foundation Trust - Chelsea, London, , United Kingdom
The Christie Nhs Foundation Trust Uk, Manchester, , United Kingdom
James Cook University Hospital, Middlesbrough, , United Kingdom
The Royal Marsden Nhs Foundation Trust - Sutton, Sutton, , United Kingdom
The Royal Wolverhampton Nhs Trust, Wolverhampton, , United Kingdom
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