Clinical trial • Phase III • Oncology
IKS03 for Advanced B-cell Non-Hodgkin lymphoma
Phase III trial of IKS03 for Advanced B-cell Non-Hodgkin lymphoma. 60 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced B-cell Non-Hodgkin lymphoma
- Trial Stage
- Phase III
Key dates
- Initial CTIS Submission Date
- 23-05-2024
- First CTIS Authorization Date
- 13-09-2024
Trial design
Phase III trial across 8 sites in Italy, Spain.
- Target Sample Size
- 60
- Trial Duration For Participant
- 1141
Eligibility
Recruits 60 Vulnerable population selected (isVulnerablePopulationSelected: true); no further details on consent/assent handling provided in the record..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected: true); no further details on consent/assent handling provided in the record.
Recruitment
- Planned Sample Size
- 60
- Recruitment Window Months
- 37
Geography
- Total Number Of Sites
- 8
- Total Number Of Participants
- 80
Italy
- Earliest CTIS Part Ii Submission Date
- 27-08-2024
- Latest Decision Or Authorization Date
- 02-12-2024
- Processing Time Days
- 97
- Number Of Sites
- 4
- Number Of Participants
- 40
Sites
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Sezione Linfomi e Mieloma
- Contact Person Name
- Carmelo Carlo-Stella
- Contact Person Email
- carmelo.carlostella@hunimed.eu
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Unità di Ricerca Clinica sui Linfomi - L’Unità di Ematologia
- Contact Person Name
- Andrés José Maria Ferreri
- Contact Person Email
- ferreri.andres@hsr.it
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Oncoematologia
- Contact Person Name
- Enrico Derenzini
- Contact Person Email
- enrico.derenzini@ieo.it
- Site Name
- Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
- Department Name
- Ematologia
- Contact Person Name
- Umberto Vitolo
- Contact Person Email
- umberto.vitolo@ircc.it
Spain
- Earliest CTIS Part Ii Submission Date
- 19-08-2024
- Latest Decision Or Authorization Date
- 28-11-2024
- Processing Time Days
- 101
- Number Of Sites
- 4
- Number Of Participants
- 40
Sites
- Site Name
- Institut Catala D'oncologia
- Department Name
- Hematology
- Contact Person Name
- Mireia Franch Sarto
- Contact Person Email
- uicico_badalona@iconcologia.net
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Hematology
- Contact Person Name
- Rafael Andreu Lapiedra
- Contact Person Email
- andreu_raflap@gva.es
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Hematology
- Contact Person Name
- Alejandro Martin Garcia-Sancho
- Contact Person Email
- amartingarcia@saludcastillayleon.es
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Hematology
- Contact Person Name
- Carmen Martinez Chamorro
- Contact Person Email
- mcarmen.chamorro@quironsalud.es
Sponsor
Primary sponsor
- Full Name
- Iksuda Therapeutics Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United Kingdom
Investigational products
- Investigational Product Name
- IKS03
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