Spots Global Cancer Trial Database for An Open-Label Phase lB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
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Trial Identification
Brief Title: An Open-Label Phase lB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
Official Title: An Open-Label, Multi-Center, Phase IB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin (Plus a Single Pre-Treatment Dose of Obinutuzumab) in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma
Study ID: NCT03533283
Conditions
Study Description
Brief Summary: This is an open-label, single arm, multicenter, dose finding, Phase Ib study in order to assess the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) for this combination treatment and to evaluate the general safety, tolerability, pharmacokinetic (PK), pharmacodynamic, and preliminary anti-tumor activity of this combination treatment in adult patients. This study includes an additional open-label imaging feasibility sub-study using a tracer in adult participants with relpased/refractory B-cell non-Hodgkin's lymphoma to image CD8+T-cells at baseline and after treatment with glofitamab, including pre-treatment with obinutuzumab.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Novant Health Cancer Institute, Charlotte, North Carolina, United States
UZ Gent, Gent, , Belgium
Aarhus Universitetshospital Skejby; Blodsygdomme, Aarhus N, , Denmark
Rigshospitalet; Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT, København Ø, , Denmark
Odense Universitetshospital; Hæmatologisk Afdeling, Odense C, , Denmark
Hadassah Ein Karem Hospital; Haematology, Jerusalem, , Israel
Rabin Medical Center-Beilinson Campus;Hematology-Oncology, Petach Tikva, , Israel
Chaim Sheba Medical Center; Department of Hematology, Ramat-Gan, , Israel
Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica, Napoli, Campania, Italy
Policlinico S.Orsola-Malpighi;Istituto di Ematologia "Seragnoli", Bologna, Emilia-Romagna, Italy
ASST PAPA GIOVANNI XXIII; Ematologia, Bergamo, Lombardia, Italy
Fond. IRCCS Istituto Nazionale Tumori; S. C. Ematologia, Milano, Lombardia, Italy
Hospital Universitari Vall d'Hebron; Servicio de Hematologia, Barcelona, , Spain
Hospital Duran i Reynals; Servicio de Hematologia, Barcelona, , Spain
START Madrid-FJD, Hospital Fundacion Jimenez Diaz, Madrid, , Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia, Malaga, , Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia, Valencia, , Spain
The HOPE Clinical Trials Unit, Leicester, , United Kingdom
University College London Hospitals NHS Foundation Trust; NIHR UCLH Clinical Research Facility, London, , United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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