Spots Global Cancer Trial Database for A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-Treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
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Trial Identification
Brief Title: A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-Treatment Dose of Obinutuzumab in Participants With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
Official Title: A Multicenter, Open-Label, Phase I/II Study to Evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of Escalating Doses of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab Administered After a Fixed, Single Dose Pre-Treatment of Obinutuzumab (Gazyva®/Gazyvaro™) in Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
Study ID: NCT03075696
Conditions
Study Description
Brief Summary: This is a Phase I/II, multicenter, open-label, dose-escalation study designed to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of a novel T-Cell bispecific (TCB), glofitamab, administered by intravenous (IV) infusion as a single agent and in combination with obinutuzumab, following pre-treatment with a one-time, fixed dose of obinutuzumab. This entry-to-human study is divided in 3 parts: dose escalation (Parts I and II) and dose expansion (Part III). Single-participant dose-escalation cohorts will be used in Part I, followed by conversion to multiple participant dose-escalation cohorts (Part II), in order to define a tentative maximum tolerated dose (MTD) or optimal biological dose (OBD). The expansion cohorts (Part III) will be initiated when the tentative MTD/OBD is defined, to further evaluate the safety, PK and therapeutic activity of glofitamab.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Cedars Sinai Medical Center, Los Angeles, California, United States
Ingalls Memorial Hospital, Harvey, Illinois, United States
University of Kansas Medical Centre, Kansas City, Kansas, United States
University of Michigan, Ann Arbor, Michigan, United States
Washington University; Wash Uni. Sch. Of Med, Saint Louis, Missouri, United States
Mount Sinai Medical Center, New York, New York, United States
MSKCC, New York, New York, United States
Allegheny Health Network (Pittsburg PA), Pittsburgh, Pennsylvania, United States
Hunstman Cancer Institute, Salt Lake City, Utah, United States
Virginia Commonwealth University Medical Center, Richmond, Virginia, United States
Swedish Cancer Inst., Seattle, Washington, United States
Prince of Wales Hospital; Haematology, Randwick, New South Wales, Australia
Peter Maccallum Cancer Centre, Melbourne, Victoria, Australia
Cliniques Universitaires St-Luc, Bruxelles, , Belgium
UZ Gent, Gent, , Belgium
Princess Margaret Cancer Center, Toronto, Ontario, Canada
Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK, Praha 2, , Czechia
Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT, København Ø, , Denmark
Helsinki University Central Hospital; Dept of Oncology, Helsinki, , Finland
Hopital Henri Mondor; Hematologie Clinique, Creteil, , France
Hopital Claude Huriez; Hematologie, Lille, , France
CHU Saint Eloi; Service d'Hématologie Clinique, Montpellier, , France
Ch Lyon Sud; Hemato Secteur Jules Courmont, Pierre Benite, , France
CHU DE RENNES - CHU Pontchaillou; Service d'Hématologie Clinique Adulte, Rennes, , France
AUSL della Romagna; Dipartimento Oncoematologico - U.O.C. Oncologia, Ravenna, Emilia-Romagna, Italy
Fond. IRCCS Istituto Nazionale Tumori; S. C. Ematologia, Milano, Lombardia, Italy
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia, Rozzano, Lombardia, Italy
A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia, Torino, Piemonte, Italy
Auckland Cancer Trial Centre; Ward 64, Auckland City Hospital,, Auckland, , New Zealand
Uniwersyteckie Centrum Kliniczne; Osrodek Badan Wczesnych Faz, Gda?sk, , Poland
Uniwersytecki Szpital Kliniczny w Poznaniu; Oddzial Hematologii i Transplantacji Szpiku, Pozna?, , Poland
Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie; Oddzial Badan Wczesnych Faz, Warszawa, , Poland
Uniwersytecki Szpital Kliniczny; Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku, Wroc?aw, , Poland
Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia, Badalona, Barcelona, Spain
Hospital Duran i Reynals L'Hospitalet; Hematology Department, L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Marques de Valdecilla; Servicio de Hematologia, Santander, Cantabria, Spain
Hospital del Mar; Servicio de Hematologia, Barcelona, , Spain
Hospital Universitari Vall d'Hebron; Servicio de Hematologia, Barcelona, , Spain
Hospital Univ. 12 de Octubre; Servicio de Hematologia, Madrid, , Spain
China Medical University Hospital; Oncology and Hematology, Taichung, , Taiwan
National Taiwan Universtiy Hospital; Division of Hematology, Taipei, , Taiwan
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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