Clinical trial • Phase III • Oncology
Glofitamab for Relapsed or refractory B-cell non-Hodgkin lymphoma
Phase III trial of Glofitamab for Relapsed or refractory B-cell non-Hodgkin lymphoma. None/Not specified-controlled. 73 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Relapsed or refractory B-cell non-Hodgkin lymphoma
- Trial Stage
- Phase III
- Drug Modality
- Bispecific antibody|Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 23-05-2024
- First CTIS Authorization Date
- 25-06-2024
Trial design
None/Not specified-controlled Phase III trial across 11 sites in Belgium, Denmark, Italy and others.
- Comparator
- None/Not specified
- Target Sample Size
- 73
Eligibility
Recruits 73 Vulnerable population selected (isVulnerablePopulationSelected=true); no details on consent or assent provided..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected=true); no details on consent or assent provided.
Recruitment
- Planned Sample Size
- 73
- Recruitment Window Months
- 64
Geography
- Total Number Of Sites
- 11
- Total Number Of Participants
- 73
Belgium
- Latest Decision Or Authorization Date
- 25-06-2024
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Hematology
- Contact Person Name
- Fritz Offner
- Contact Person Email
- fritz.offner@uzgent.be
Denmark
- Latest Decision Or Authorization Date
- 26-06-2024
- Number Of Sites
- 1
- Number Of Participants
- 8
Sites
- Site Name
- Rigshospitalet
- Department Name
- Hæmatologisk Klinik, Klinisk Afprøvnings Team KAT
- Contact Person Name
- Martin Hutchings
- Contact Person Email
- Martin.hutchings@regionh.dk
Italy
- Latest Decision Or Authorization Date
- 03-07-2024
- Number Of Sites
- 2
- Number Of Participants
- 24
Sites
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- UOC Ematologia
- Contact Person Name
- Carmelo Carlo-Stella
- Contact Person Email
- carmelo.carlostella@hunimed.eu
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
- Department Name
- S.C. Ematologia
- Contact Person Name
- Giuseppe Gritti
- Contact Person Email
- g.gritti@asst-pg23.it
Spain
- Latest Decision Or Authorization Date
- 27-06-2024
- Number Of Sites
- 4
- Number Of Participants
- 23
Sites
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Servicio de Hematologia
- Contact Person Name
- Maria José Terol Castera
- Contact Person Email
- terol_mjo@gva.es
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Servicio de Hematologia
- Contact Person Name
- Daniel Morillo
- Contact Person Email
- dmorillo@startmadrid.com
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Servicio de Hematologia
- Contact Person Name
- Armando López-Guillermo
- Contact Person Email
- alopezg@clinic.cat
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Servicio de Hematologia
- Contact Person Name
- Juan Manuel Sancho Cía
- Contact Person Email
- jsancho@iconcologia.net
Poland
- Latest Decision Or Authorization Date
- 01-07-2024
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
- Department Name
- Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych
- Contact Person Name
- Tomasz Wróbel
- Contact Person Email
- tomasz.wrobel@umw.edu.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Ośrodek Badań Klinicznych Faz Wczesnych
- Contact Person Name
- Jan Zaucha
- Contact Person Email
- jzaucha@gumed.edu.pl
- Site Name
- Uniwersytecki Szpital Kliniczny W Poznaniu
- Department Name
- Oddzial Hematologii i Transplantacji Szpiku
- Contact Person Name
- Lidia Gil
- Contact Person Email
- lidia.gil@skpp.edu.pl
Sponsor
Primary sponsor
- Full Name
- F. Hoffmann-La Roche AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- Glofitamab
- Active Substance
- Glofitamab
- Modality
- Bispecific antibody
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Investigational Product Name
- Obinutuzumab (pretreatment)
- Active Substance
- Obinutuzumab
- Modality
- Monoclonal antibody
- Combination Treatment
- Yes
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