Clinical trial • Phase I • Oncology

JNJ-89853413 for Acute myeloid leukemia | Myelodysplastic syndromes

Phase I trial of JNJ-89853413 for Acute myeloid leukemia | Myelodysplastic syndromes. 80 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Acute myeloid leukemia | Myelodysplastic syndromes
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
07-10-2024
First CTIS Authorization Date
20-01-2025

Trial design

Phase I trial across 3 sites in Spain.

Target Sample Size
80
Trial Duration For Participant
911

Eligibility

Recruits 80 No vulnerable population selected; consent or assent handling not specified..

Vulnerable Population
No vulnerable population selected; consent or assent handling not specified.

Recruitment

Planned Sample Size
80
Recruitment Window Months
30

Geography

Total Number Of Sites
3
Total Number Of Participants
80

Spain

Earliest CTIS Part Ii Submission Date
26-11-2024
Latest Decision Or Authorization Date
20-01-2025
Processing Time Days
55
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
Clinica Universidad De Navarra
Department Name
Hematology
Contact Person Name
Ana Alfonso Pierola
Contact Person Email
aalfonso@unav.es
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Hematology
Contact Person Name
Daniel Morillo Giles
Contact Person Email
d.morillo@startmadrid.com
Site Name
Hospital Clinic De Barcelona
Department Name
Hematology
Contact Person Name
Jordi Esteve Reyner
Contact Person Email
jesteve@clinic.cat

Sponsor

Primary sponsor

Full Name
Janssen Cilag International
Organisation Type
Pharmaceutical company
Country Of Registered Address
Belgium

Investigational products

Investigational Product Name
JNJ-89853413

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