Spots Global Cancer Trial Database for A Study of Glofitamab in Combination With Rituximab or Obinutuzumab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP), or Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (CHP) in Participants With Non-Hodgkin Lymphomas or With DLBCL
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Trial Identification
Brief Title: A Study of Glofitamab in Combination With Rituximab or Obinutuzumab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP), or Polatuzumab Vedotin Plus Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (CHP) in Participants With Non-Hodgkin Lymphomas or With DLBCL
Official Title: A Phase Ib Study Evaluating Glofitamab (RO7082859) in Combination With Rituximab (R) or Obinutuzumab (G) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP), or Polatuzumab Vedotin (POLA) Plus Rituximab (R), Cyclophosphamide, Doxorubicin, and Prednisone (CHP) in Participants With Relapsed or Refractory Non-Hodgkin Lymphoma (R/R NHL) or in Participants With Untreated Diffuse Large B-Cell Lymphoma (DLBCL)
Study ID: NCT03467373
Study Description
Brief Summary: This is a phase 1B, multi-center, dose-finding study of glofitamab administered in combination with obinutuzumab (Gazyva; \[G\]), rituximab (R) and standard doses of CHOP (G/R-CHOP or R-CHOP) in participants with r/r NHL and G/R CHOP or Pola-R-CHP in participants with untreated diffuse large B-cell lymphoma (DLBCL). Evaluating the safety, preliminary activity, pharmacokinetic (PK), and pharmacodynamic effects of this combination will be the main objectives of this study. The study is divided in two parts: * Part I: Dose finding in participants with r/r NHL; test use of G vs R in Cycle 1 * Part II: Dose Expansion. The maximum tolerated dose or optimal biological dose (MTD or OBD) will be further assessed in participants with untreated DLBCL (\>18 years of age with an age-adjusted International Prognostic Index (IPI) of 2-5). Glofitamab will be studied in combination with R-CHOP and Pola-R-CHP.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama Medical Center, Birmingham, Alabama, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Fox Chase-Temple Cancer Center, Philadelphia, Pennsylvania, United States
West Virginia University; Health Sciences Center, Morgantown, West Virginia, United States
Peter Maccallum Cancer Centre, Melbourne, Victoria, Australia
Princess Margaret Cancer Center, Toronto, Ontario, Canada
Rigshospitalet; HĂŚmatologisk Klinik, Klinisk Afprøvnings Team KAT, København Ă, , Denmark
Hopital Claude Huriez; Hematologie, Lille, , France
Hopital Hotel Dieu Et Hme; Clinique Hematologie, Nantes, , France
Centre Henri Becquerel; Hematologie, Rouen, , France
Universitätsklinikum Erlangen, Translational Research Center (TRC), Medizin 5, Erlangen, , Germany
Universitätsklinikum Freiburg; Klinik fßr Innere Medizin I; Hämatologie/Onkologie, Freiburg, , Germany
Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo., Ulm, , Germany
Universitätsklinikum Wßrzburg; Studienzentrale Hämatologie/Onkologie, Wßrzburg, , Germany
Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica, Napoli, Campania, Italy
UO Ematologia, Ospedale S.Maria delle Croci, Ravenna, Emilia-Romagna, Italy
ASST PAPA GIOVANNI XXIII; Ematologia, Bergamo, Lombardia, Italy
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia, Rozzano, Lombardia, Italy
Hospital Universitari Vall d'Hebron; Servicio de Hematologia, Barcelona, , Spain
Hospital ClĂnic i Provincial; Servicio de HematologĂa y OncologĂa, Barcelona, , Spain
START Madrid-FJD, Hospital Fundacion Jimenez Diaz, Madrid, , Spain
University College London Hospitals NHS Foundation Trust; NIHR UCLH Clinical Research Facility, London, , United Kingdom
Nottingham University Hospitals NHS Trust - City Hospital, Nottingham, , United Kingdom
Derriford Hospital; Haematology, Plymouth, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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