Clinical trial • Phase I • Oncology

JNJ-90189892 for Acute myeloid leukemia (relapsed or refractory) | Myelodysplastic syndrome (higher-risk, relapsed or refractory)

Phase I trial of JNJ-90189892 for Acute myeloid leukemia (relapsed or refractory) | Myelodysplastic syndrome (higher-risk, relapsed or refractory).

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Acute myeloid leukemia (relapsed or refractory) | Myelodysplastic syndrome (higher-risk, relapsed or refractory)
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
10-02-2025
First CTIS Authorization Date
05-05-2025

Trial design

adaptive Phase I trial across 9 sites in Spain, France.

Adaptive
True, described as a dose-escalation (first-in-human) design; specific escalation rules, interim analyses or stopping rules are not provided in the available source.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
107

Eligibility

Recruits 107 Vulnerable population selected (isVulnerablePopulationSelected = true) in the CTIS record; no further details on consent, assent, or special handling of vulnerable participants are provided in the available source..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true) in the CTIS record; no further details on consent, assent, or special handling of vulnerable participants are provided in the available source.

Recruitment

Planned Sample Size
107
Recruitment Window Months
41

Geography

Total Number Of Sites
9
Total Number Of Participants
107

Spain

Earliest CTIS Part Ii Submission Date
11-04-2025
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
384
Number Of Sites
3
Number Of Participants
76

Sites

Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Hematology
Contact Person Name
Gala Vega
Contact Person Email
Gala.Vega@startmadrid.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Hematology
Contact Person Name
Eduardo Rodriguez
Contact Person Email
edurodarb@gmail.com
Site Name
Clinica Universidad De Navarra
Department Name
Hematology
Contact Person Name
Ana Alfonso
Contact Person Email
aalfonso@unav.es

France

Earliest CTIS Part Ii Submission Date
11-04-2025
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
382
Number Of Sites
6
Number Of Participants
31

Sites

Site Name
Oncopole Claudius Regaud
Department Name
Hématologie
Contact Person Name
Christian RECHER
Site Name
Institut Paoli Calmettes
Department Name
Hématologie
Contact Person Name
Sylvain GARCIAZ
Contact Person Email
GARCIAZS@ipc.unicancer.fr
Site Name
Hopital Saint Louis
Department Name
Centre d'investigations cliniques
Contact Person Name
Lina BENAJIBA
Contact Person Email
souhil.allaoua@aphp.fr
Site Name
Institut De Cancerologie Strasbourg Europe
Department Name
Hématologie
Contact Person Name
Anne ZILLIOX
Contact Person Email
a.zilliox@icans.eu
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Hématologie
Contact Person Name
Anne ZILLIOX
Contact Person Email
a.zilliox@icans.eu
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Hématologie
Contact Person Name
Célestine SIMAND

Sponsor

Primary sponsor

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

Investigational products

Investigational Product Name
JNJ-90189892
First In Human
Yes

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