Clinical trial • Phase I • Oncology
ARV-393 for Advanced Non-Hodgkin lymphoma
Phase I trial of ARV-393 for Advanced Non-Hodgkin lymphoma. 196 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Advanced Non-Hodgkin lymphoma
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 31-05-2024
- First CTIS Authorization Date
- 10-09-2024
Trial design
Phase I trial across 7 sites in Spain, Denmark.
- Target Sample Size
- 196
Eligibility
Recruits 196 Vulnerable population selected; no information on consent or assent handling provided in the record..
- Vulnerable Population
- Vulnerable population selected; no information on consent or assent handling provided in the record.
Recruitment
- Planned Sample Size
- 196
- Recruitment Window Months
- 75
- Consent Approach
- No information on consent or assent process provided in the record.
Geography
- Total Number Of Sites
- 7
- Total Number Of Participants
- 59
Spain
- Earliest CTIS Part Ii Submission Date
- 28-08-2024
- Latest Decision Or Authorization Date
- 12-01-2026
- Processing Time Days
- 502
- Number Of Sites
- 5
- Number Of Participants
- 36
Sites
- Site Name
- Institut Catala D'oncologia
- Department Name
- Hematologist
- Contact Person Name
- Ana María Sureda Balari
- Contact Person Email
- asureda@iconcologia.net
- Site Name
- Hospital Universitario Hm Sanchinarro
- Department Name
- Hematologist
- Contact Person Name
- Damian Cubillas Garcia de la Torre
- Contact Person Email
- damian.cubillas@startresearch.com
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- Hematologist
- Contact Person Name
- Almudena Cascales Hernandez
- Contact Person Email
- Almudena.cascales@gmail.com
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Hematologist
- Contact Person Name
- Alejandro Martin García- Sancho
- Contact Person Email
- amartingarcia@saludcastillayleon.es
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Hematology
- Contact Person Name
- Miguel Angel Canales
- Contact Person Email
- macanales@unav.es
Denmark
- Earliest CTIS Part Ii Submission Date
- 28-08-2024
- Latest Decision Or Authorization Date
- 12-01-2026
- Processing Time Days
- 502
- Number Of Sites
- 2
- Number Of Participants
- 23
Sites
- Site Name
- Rigshospitalet
- Department Name
- Department of Hematology
- Contact Person Name
- Martin Hutchings
- Contact Person Email
- Martin.Hutchings@regionh.dk
- Site Name
- Odense University Hospital
- Department Name
- Hematological Research Unit
- Contact Person Name
- Jacob Haaber Christensen
- Contact Person Email
- jacob.h.christensen@rsyd.dk
Sponsor
Primary sponsor
- Full Name
- Arvinas Operations Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- ARV-393
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