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
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
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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