Clinical trial • Phase I • Oncology
JNJ-88549968 for CALR-mutated myeloproliferative neoplasms
Phase I trial of JNJ-88549968 for CALR-mutated myeloproliferative neoplasms. 170 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- CALR-mutated myeloproliferative neoplasms
- Trial Stage
- Phase I
- Drug Modality
- Bispecific antibody
Key dates
- Initial CTIS Submission Date
- 17-10-2023
- First CTIS Authorization Date
- 16-02-2024
Trial design
Phase I trial across 12 sites in Spain, France, Italy and others.
- Biomarker Stratified
- True, biomarker: CALR mutation
- Target Sample Size
- 170
Eligibility
Recruits 170 No vulnerable population selected (isVulnerablePopulationSelected=false); no information provided on consent or assent handling in the available records..
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected=false); no information provided on consent or assent handling in the available records.
Recruitment
- Planned Sample Size
- 170
- Recruitment Window Months
- 35
Geography
- Total Number Of Sites
- 12
- Total Number Of Participants
- 50
Spain
- Earliest CTIS Part Ii Submission Date
- 22-01-2024
- Latest Decision Or Authorization Date
- 16-02-2024
- Processing Time Days
- 25
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- Institut Catala D'oncologia
- Department Name
- Hematology
- Contact Person Name
- Blanca Xicoy
- Contact Person Email
- bxicoy@iconcologia.net
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Hematology
- Contact Person Name
- Juan Carlos Hernandez
- Contact Person Email
- hernandez_jca@gva.es
France
- Earliest CTIS Part Ii Submission Date
- 23-01-2024
- Latest Decision Or Authorization Date
- 11-03-2024
- Processing Time Days
- 48
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Centre d'investigation Clinique
- Contact Person Name
- Jean-Jacques KILADJIAN
- Contact Person Email
- jean-jacques.kiladjian@aphp.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Service Hématologie
- Contact Person Name
- Fiorenza BARRACO
- Contact Person Email
- fiorenza.barraco@chu-lyon.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 10-06-2025
- Latest Decision Or Authorization Date
- 07-07-2025
- Processing Time Days
- 27
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- UO Ematologia
- Contact Person Name
- Francesca Palandri
- Contact Person Email
- francesca.palandri@unibo.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- SC Ematologia
- Contact Person Name
- Francesco Passamonti
- Contact Person Email
- francesco.passamonti@policlinico.mi.it
Germany
- Earliest CTIS Part Ii Submission Date
- 05-06-2024
- Latest Decision Or Authorization Date
- 13-06-2024
- Processing Time Days
- 8
- Number Of Sites
- 6
- Number Of Participants
- 27
Sites
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Zentrum für Innere Medizin, Klinik für Hämatologie, Onkologie und Rheumatologie, Innere Medizin V
- Contact Person Name
- Tim Sauer
- Contact Person Email
- tim.sauer@med.uni-heidelberg.de
- Site Name
- Universitaetsklinikum Aachen AöR
- Department Name
- Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation (Med. Klinik IV)
- Contact Person Name
- Steffen Koschmieder
- Contact Person Email
- skoschmieder@ukaachen.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation
- Contact Person Name
- Florian Heidel
- Contact Person Email
- Heidel.Florian@mh-hannover.de
- Site Name
- Universitaetsklinikum Regensburg AöR
- Department Name
- Klinik und Poliklinik für Innere Medizin III, Hämatologie und Internistische Onkologie
- Contact Person Name
- Daniel Heudobler
- Contact Person Email
- daniel.heudobler@ukr.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Am Campus Benjamin Franklin, Medizinische Klinik mit Schwerpunkt Hämatologie und Onkologie
- Contact Person Name
- Philipp le Coutre
- Contact Person Email
- philipp.lecoutre@charite.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Klinik für Hämatologie und Stammzelltransplantation
- Contact Person Name
- Joachim Goethert
- Contact Person Email
- joachim.goethert@uk-essen.de
Sponsor
Primary sponsor
- Full Name
- Janssen - Cilag International
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Belgium
Investigational products
- Investigational Product Name
- JNJ-88549968
- Modality
- Bispecific antibody
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