Clinical trial • Phase I • Haematology

BGB-11417 for Mature B-cell malignancies

Phase I trial of BGB-11417 for Mature B-cell malignancies. None/Not specified-controlled. 368 participants.

Overview

Trial Therapeutic Area
Haematology
Trial Disease
Mature B-cell malignancies
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
30-09-2024
First CTIS Authorization Date
10-10-2024

Trial design

None/Not specified-controlled Phase I trial across 14 sites in Italy, Spain.

Comparator
None/Not specified
Target Sample Size
368

Eligibility

Recruits 368 Vulnerable population selected (isVulnerablePopulationSelected: true). No details on consent or assent handling provided in the record..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected: true). No details on consent or assent handling provided in the record.

Recruitment

Planned Sample Size
368
Recruitment Window Months
92

Geography

Total Number Of Sites
14
Total Number Of Participants
69

Italy

Earliest CTIS Part Ii Submission Date
27-08-2024
Latest Decision Or Authorization Date
12-02-2026
Processing Time Days
534
Number Of Sites
6
Number Of Participants
34

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
U.O.C. Ematologia e Trapianto di cellule staminali emopoietiche
Principal Investigator Name
Luca Laurenti
Principal Investigator Email
luca.laurenti@unicatt.it
Contact Person Name
Luca Laurenti
Contact Person Email
luca.laurenti@unicatt.it
Site Name
Hospital Santa Maria Della Misericordia
Department Name
S.C. Ematologia e Trapianto
Principal Investigator Name
Paolo Sportoletti
Contact Person Name
Paolo Sportoletti
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
U.O. di Ematologia
Principal Investigator Name
Monica Tani
Principal Investigator Email
monica.tani@auslromagna.it
Contact Person Name
Monica Tani
Contact Person Email
monica.tani@auslromagna.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
Dipartimento Ematologia, Oncologia e Medicina Molecolare
Principal Investigator Name
Anna Maria Frustaci
Principal Investigator Email
annamaria.frustaci@ospedaleniguarda.it
Contact Person Name
Anna Maria Frustaci
Site Name
Ospedale San Raffaele S.r.l.
Department Name
U.O. Ematologia e Trapianto di Midollo Osseo
Principal Investigator Name
Paolo Ghia
Principal Investigator Email
ghia.paolo@hsr.it
Contact Person Name
Paolo Ghia
Contact Person Email
ghia.paolo@hsr.it
Site Name
Centro Ricerche Cliniche Di Verona S.r.l.
Department Name
U.O.C Ematologia
Principal Investigator Name
Andrea Bernardelli
Principal Investigator Email
andrea.bernardelli@aovr.veneto.it
Contact Person Name
Andrea Bernardelli

Spain

Earliest CTIS Part Ii Submission Date
27-08-2024
Latest Decision Or Authorization Date
12-02-2026
Processing Time Days
534
Number Of Sites
8
Number Of Participants
35

Sites

Site Name
Hospital Clinic De Barcelona
Department Name
Hematology Department
Principal Investigator Name
LAURA MAGNANO
Principal Investigator Email
protecciodades@clinic.cat
Contact Person Name
LAURA MAGNANO
Contact Person Email
protecciodades@clinic.cat
Site Name
Institut Catala D'oncologia
Department Name
Hematology Department
Principal Investigator Name
EVA GONZALEZ BARCA
Principal Investigator Email
opd@iconcologia.net
Contact Person Name
EVA GONZALEZ BARCA
Contact Person Email
opd@iconcologia.net
Site Name
Vall D Hebron Institute Of Oncology
Department Name
Department of Hematology
Principal Investigator Name
FRANCESC BOSCH
Principal Investigator Email
dpd@ticsalutsocial.cat
Contact Person Name
FRANCESC BOSCH
Contact Person Email
dpd@ticsalutsocial.cat
Site Name
Clinica Universidad De Navarra
Department Name
Hematology department
Principal Investigator Name
MIGUEL CANALES
Principal Investigator Email
dpocun@unav.es
Contact Person Name
MIGUEL CANALES
Contact Person Email
dpocun@unav.es
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Hematology Department
Principal Investigator Name
MIGUEL ARGÜELLO
Principal Investigator Email
dpd@santpau.cat
Contact Person Name
MIGUEL ARGÜELLO
Contact Person Email
dpd@santpau.cat
Site Name
Hospital Universitario Marques De Valdecilla
Department Name
Hematology unit
Principal Investigator Name
LUCRECIA YAÑEZ
Principal Investigator Email
alfonso.romano@scsalud.es
Contact Person Name
LUCRECIA YAÑEZ
Contact Person Email
alfonso.romano@scsalud.es
Site Name
Hospital Universitario De Salamanca
Department Name
Hematology
Principal Investigator Name
ALMUDENA NAVARRO
Principal Investigator Email
dpd@saludcastillayleon.es
Contact Person Name
ALMUDENA NAVARRO
Contact Person Email
dpd@saludcastillayleon.es
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Hematology
Principal Investigator Name
DANIEL MORILLO
Principal Investigator Email
dmorillo@startmadrid.com
Contact Person Name
DANIEL MORILLO
Contact Person Email
dmorillo@startmadrid.com

Sponsor

Primary sponsor

Full Name
BeOne Medicines AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Investigational products

Investigational Product Name
BGB-11417

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