Spots Global Cancer Trial Database for A Study to Evaluate the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Gemcitabine and Oxaliplatin Compared to Rituximab, Gemcitabine and Oxaliplatin Alone in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
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Trial Identification
Brief Title: A Study to Evaluate the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab, Gemcitabine and Oxaliplatin Compared to Rituximab, Gemcitabine and Oxaliplatin Alone in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Official Title: A Phase III, Open-Label, Multicenter, Randomized, Study Evaluating the Safety and Efficacy of Polatuzumab Vedotin in Combination With Rituximab Plus Gemcitabine Plus Oxaliplatin (R-GEMOX) Versus R-GEMOX Alone in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Study ID: NCT04182204
Conditions
Study Description
Brief Summary: This study is a multicenter, open-label study of polatuzumab vedotin administered by intravenous (IV) infusion in combination with rituximab, gemcitabine and oxaliplatin (R-GemOx) in participants with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study comprises of two stages: a safety run-in stage and a randomized controlled trial (RCT).
Detailed Description: The safety run-in stage (Stage 1) will assess the safety of polatuzumab vedotin plus rituximab, gemcitabine and oxaliplatin (Pola-R-GemOx) in 10 participants. The randomized controlled trial (RCT) (Stage 2) will compare Pola-R-GemOx versus R-GemOx alone using overall survival (OS). This is an event-driven trial.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Memorial Regional Hospital, Hollywood, Florida, United States
Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy), Jacksonville, Florida, United States
Memorial Cancer Institute at Memorial West, Pembroke Pines, Florida, United States
IHA Hematology Oncology Consultants - Ann Arbor; Michigan Orthopedic Center, Ypsilanti, Michigan, United States
Nebraska Cancer Specialists; Oncology Hematology West, PC, Omaha, Nebraska, United States
MSKCC at Basking Ridge, Basking Ridge, New Jersey, United States
Memorial Sloan Kettering - Monmouth, Middletown, New Jersey, United States
Memorial Sloan Kettering Cancer Center at Bergen, Montvale, New Jersey, United States
MSKCC @ Commack, Commack, New York, United States
Memorial Sloan Kettering Cancer Center at Westchester, Harrison, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Memorial Sloan Kettering Nassau, Uniondale, New York, United States
Hospital Sao Rafael - HSR, Salvador, BA, Brazil
Liga Norte Riograndense Contra O Câncer, Natal, RN, Brazil
Hospital das Clinicas - UFRGS, Porto Alegre, RS, Brazil
Hospital das Clinicas - FMUSP, Sao Paulo, SP, Brazil
London Health Sciences Centre, London, Ontario, Canada
Niagara Health Systems - St. Catherines General Site; Niagara Health System-St. Catharines Site, St. Catharines, Ontario, Canada
McGill University Health Centre - Glen Site, Montreal, Quebec, Canada
Centre hospitalier regional de Trois-Rivieres, Trois-Rivieres, Quebec, Canada
Hu Nan Provincial Cancer Hospital, Changsha, , China
West China Hospital - Sichuan University, Chengdu City, , China
Cancer Center, Sun Yat-sen University of Medical Sciences; Department of Medical Oncology, Guangzhou City, , China
The 1st Affiliated Hospital of Nanchang Unversity, Nanchang, , China
Guangxi Cancer Hospital of Guangxi Medical University, Nanning City, , China
Institute of Hematology and Hospital of Blood Disease, Tianjin City, , China
Union Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan City, , China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University, Xi'an, , China
Oulu University Hospital; Oncology, Oulu, , Finland
Tampere University Hospital; Dept of Oncology, Tampere, , Finland
Hopital Henri Mondor; 51 Av Mal Lattre De Tassigny, Creteil, , France
CHU de Nîmes - Hôpital Carémeau, Nimes, , France
Hopital De Haut Leveque; Hematologie Clinique, Pessac, , France
Centre Henri Becquerel; Service Hématologie, Rouen, , France
ICANS, Strasbourg, , France
Hopital Bretonneau; Hematologie Therapie Cellulaire, TOURS Cedex, , France
Gemeinschaftsklinikum Mittelrhein gGmbH; Ev. Stift St. Martin, Koblenz, , Germany
Universitaetsklinikum Schleswig Holstein - Campus Luebeck; Haematologie, Onkologie, Luebeck, , Germany
Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo., Ulm, , Germany
Laiko General Hospital; Hematology Clinic, Athens, , Greece
Attiko Hospital; Haematology Clinic, Athens, , Greece
All India Institute of Medical Sciences ,Institute Rotary Cancer Hospital; Department of Oncology, New Delhi, Delhi, India
Tata Memorial Hospital, Mumbai, Maharashtra, India
Tata Medical Center, Kolkata, WEST Bengal, India
St James' Hospital; Cancer Clinical Trials Office, Dublin, , Ireland
Azienda Ospedaliero-Universitaria Policlinico di Modena Ematologia, Modena, Emilia-Romagna, Italy
Az. Osp. Uni Ria Policlinico Tor Vergata; Unita Di Ematologia, Roma, Lazio, Italy
Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica, Bari, Puglia, Italy
USL 4 di Prato - Nuovo Ospeale di Prato, Prato, Toscana, Italy
Ematologia/immunologia Clinica Azienda Ospedaliera Policlinico di Padova, Padova, Veneto, Italy
Pusan National University Hospital, Busan, , Korea, Republic of
Chungnam National University Hospital, Daejeon, , Korea, Republic of
Gyeongsang National University Hospital, Gyeongsangnam-do, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Health Pharma Professional Research, Cdmx, Mexico CITY (federal District), Mexico
Hospital de Especialidades Centro Medico Nacional La Raza; Haematology, Mexico City, Mexico CITY (federal District), Mexico
Instituto Nacional de Cancerologia; Oncology, Mexico City, , Mexico
Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia, Badalona, Barcelona, Spain
Hospital Universitario de Canarias;servicio de Hematologia, La Laguna, Tenerife, Spain
Hospital Univ. 12 de Octubre; Servicio de Hematologia, Madrid, , Spain
Hospital Clinico Universitario de Salamanca;Servicio de Hematologia, Salamanca, , Spain
Hospital Universitario Dr. Peset; Servicio de Hematologia, Valencia, , Spain
Sakarya Universitesi Egitim ve Arastirma Hastanesi, Adapazari/Sakarya, , Turkey
Abdurrahman Yurtarslan Onkoloji Training and Research Hospital, Ankara, , Turkey
Akdeniz Uni School of Medicine; Hematology, Antalya, , Turkey
Istanbul Uni Istanbul Medical Faculty, Istanbul, , Turkey
Istanbul University Cerrahpasa Medical Faculty; Hematology Department, Istanbul, , Turkey
Kocaeli Universitesi Tip Fakultesi, Kocaeli, , Turkey
Amerikan HAstanesi Onkoloji Birimi Te?vikiye, Ni?anta??, , Turkey
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Kings College Hospital, London, , United Kingdom
Nottingham City Hospital; Dept of Haematology, Nottingham, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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