Clinical trial • Phase III • Oncology
Mosunetuzumab for Chronic lymphocytic leukemia | Relapsed or refractory chronic lymphocytic leukemia
Phase III trial of Mosunetuzumab for Chronic lymphocytic leukemia | Relapsed or refractory chronic lymphocytic leukemia. None/Not specified-controlled.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Chronic lymphocytic leukemia | Relapsed or refractory chronic lymphocytic leukemia
- Trial Stage
- Phase III
- Drug Modality
- Bispecific antibody | Small molecule
Key dates
- Initial CTIS Submission Date
- 10-06-2025
- First CTIS Authorization Date
- 25-09-2025
Trial design
None/Not specified-controlled Phase III trial across 8 sites in Poland, Spain, France.
- Comparator
- None/Not specified
- Target Sample Size
- 22
Recruitment
- Planned Sample Size
- 22
- Recruitment Window Months
- 46
Geography
- Total Number Of Sites
- 8
- Total Number Of Participants
- 22
Poland
- Earliest CTIS Part Ii Submission Date
- 15-09-2025
- Latest Decision Or Authorization Date
- 27-09-2025
- Processing Time Days
- 12
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- Pratia S.A.
- Department Name
- Pratia MCM Kraków
- Contact Person Name
- Wojciech Jurczak
- Contact Person Email
- biuro.mcm@pratia.com
- Site Name
- Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
- Department Name
- Oddział Wieloprofilowy Zachowawczy
- Contact Person Name
- Krzysztof Giannopoulos
- Contact Person Email
- cwbk@umlub.pl
- 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
- knh@usk.wroc.pl
Spain
- Earliest CTIS Part Ii Submission Date
- 28-07-2025
- Latest Decision Or Authorization Date
- 02-10-2025
- Processing Time Days
- 66
- Number Of Sites
- 3
- Number Of Participants
- 5
Sites
- Site Name
- Clinica Universidad De Navarra (Pamplona)
- Department Name
- Hematology
- Contact Person Name
- Miguel Ángel Canales Albendea
- Contact Person Email
- macanales@unav.es
- Site Name
- Clinica Universidad De Navarra (Madrid)
- Department Name
- Hematology
- Contact Person Name
- Miguel Ángel Canales Albendea
- Contact Person Email
- macanales@unav.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Hematology
- Contact Person Name
- Ángel Serna Pareja
- Contact Person Email
- aserna@vhio.net
France
- Earliest CTIS Part Ii Submission Date
- 04-07-2025
- Latest Decision Or Authorization Date
- 21-11-2025
- Processing Time Days
- 140
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- University Hospital Of Clermont-Ferrand
- Department Name
- Thérapie cellulaire et hématologie clinique
- Contact Person Name
- Olivier Tournilhac
- Contact Person Email
- otournilhac@chu-clermontferrand.fr
- Site Name
- Oncopole Claudius Regaud
- Department Name
- Hématologie
- Contact Person Name
- Loïc Ysebaert
- Contact Person Email
- ysebaert.loic@iuct-oncopole.fr
Sponsor
Primary sponsor
- Full Name
- F. Hoffmann-La Roche AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Investigational products
- Investigational Product Name
- Mosunetuzumab
- Active Substance
- Mosunetuzumab
- Modality
- Bispecific antibody
- Investigational Product Name
- Pirtobrutinib
- Active Substance
- Pirtobrutinib
- Modality
- Small molecule
- Combination Treatment
- Yes
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