Clinical trial • Phase III • Oncology
NAVTEMADLIN for Myelofibrosis | Primary myelofibrosis | Secondary myelofibrosis
Phase III trial of NAVTEMADLIN for Myelofibrosis | Primary myelofibrosis | Secondary myelofibrosis.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Myelofibrosis | Primary myelofibrosis | Secondary myelofibrosis
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 24-05-2024
- First CTIS Authorization Date
- 17-09-2024
Trial design
Randomised, navtemadlin (oral tablet formulations including navtemadlin 25-30, navtemadlin 25-60, navtemadlin 25-120, navtemadlin 25-180) as add-on therapy to continuous ruxolitinib versus matching placebo as add-on therapy to continuous ruxolitinib.-controlled Phase III trial in Belgium, Croatia, Germany and others.
- Randomised
- Yes
- Comparator
- Navtemadlin (oral tablet formulations including Navtemadlin 25-30, Navtemadlin 25-60, Navtemadlin 25-120, Navtemadlin 25-180) as add-on therapy to continuous ruxolitinib versus matching placebo as add-on therapy to continuous ruxolitinib.
- Biomarker Stratified
- True, TP53 (TP53 wild-type (TP53WT) required by central testing)
- Target Sample Size
- 57
- Trial Duration For Participant
- 168
Eligibility
Recruits 57 Vulnerable population flag is selected in the application. The trial population is limited to adults (Adults ≥ 18 years of age able to provide informed consent). Informed consent must be provided by the participant (adult). No assent procedures for minors are provided because the trial excludes participants <18..
- Vulnerable Population
- Vulnerable population flag is selected in the application. The trial population is limited to adults (Adults ≥ 18 years of age able to provide informed consent). Informed consent must be provided by the participant (adult). No assent procedures for minors are provided because the trial excludes participants <18.
Inclusion criteria
- {"criterion_text":"- Ruxolitinib Run-In Period: 1.\tAdults ≥ 18 years of age able to provide informed consent."}
- {"criterion_text":"- Ruxolitinib Run-In Period: 2. Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by the treating physician according to the World Health Organization (WHO) criteria"}
- {"criterion_text":"- Ruxolitinib Run-In Period: 3.\tHigh, Intermediate-1, Intermediate-2 risk category International Prognosis System Score (IPSS)"}
- {"criterion_text":"- Ruxolitinib Run-In Period: 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2."}
- {"criterion_text":"- Ruxolitinib Run-In Period: 5. JAK-inhibitor treatment naive"}
- {"criterion_text":"- Randomized Add-on Period: 1.\tPMF, post-PV MF, or post-ET MF that is TP53WT as assessed by central testing."}
- {"criterion_text":"- Randomized Add-on Period: 2. ECOG performance status of 0 to 2."}
- {"criterion_text":"- Randomized Add-on Period: 3.\tTreatment with a stable dose of ruxolitinib"}
- {"criterion_text":"- Randomized Add-on Period: 4.\t Suboptimal response to run-in ruxolitinib therapy"}
Exclusion criteria
- {"criterion_text":"- Ruxolitinib Run-In Period: 1.\tPrior Splenectomy"}
- {"criterion_text":"- Ruxolitinib Run-In Period: 2. Splenic irradiation within 3 months prior to the first dose"}
- {"criterion_text":"- Ruxolitinib Run-In Period: 3. Prior BCL-XL, BET, MDM2, PI3K, PIM, or XPO1 inhibitors therapy or p53- directed therapy"}
- {"criterion_text":"- Ruxolitinib Run-In Period: 4. Eligible for Bone Marrow Transplant"}
- {"criterion_text":"- Ruxolitinib Run-In Period: 5. Peripheral blood or bone marrow blast count ≥ 10%"}
- {"criterion_text":"- Randomized Period: 1. Peripheral blood or bone marrow blast count ≥ 10%"}
Endpoints
Primary endpoints
- {"endpoint_text":"- SVR will be evaluated 24 weeks after randomized treatment begins by MRI/CT scan (central review).","definition_or_measurement_approach":"Spleen volume reduction (SVR) evaluated 24 weeks after randomization by MRI or CT scan with central review."}
- {"endpoint_text":"- TSS reduction will be evaluated 24 weeks after randomized treatment begins using the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0.","definition_or_measurement_approach":"Total Symptom Score (TSS) reduction measured at 24 weeks using the Myelofibrosis Symptom Assessment Form (MFSAF) version 4.0."}
Secondary endpoints
- {"endpoint_text":"- The proportion of patients who have spleen volume reduction between Arm 1 and Arm 2","definition_or_measurement_approach":"Proportion of patients achieving spleen volume reduction comparing Arm 1 vs Arm 2 (measurement method as per SVR; imaging-based assessment)."}
- {"endpoint_text":"- The proportion of patients who have TSS reduction between Arm 1 and Arm 2","definition_or_measurement_approach":"Proportion of patients with reduction in Total Symptom Score (TSS) between Arm 1 and Arm 2 measured using MFSAF v4.0."}
- {"endpoint_text":"- Time to death from any cause in patients randomized to each arm","definition_or_measurement_approach":"Overall survival (time from randomization to death from any cause)."}
- {"endpoint_text":"- Time to progression or death from any cause in patients randomized to each arm","definition_or_measurement_approach":"Time to disease progression or death (composite endpoint) measured from randomization."}
- {"endpoint_text":"- Analyses of the safety endpoints will include the following measurements or assessments: physical examinations, laboratory tests, adverse events (AEs), serious AEs (SAEs), electrocardiograms (ECGs), and vital signs","definition_or_measurement_approach":"Safety and tolerability assessed via physical exams, laboratory tests, AE/SAE reporting, ECGs and vital signs according to study schedule."}
- {"endpoint_text":"- Change in SVR 24 weeks after the randomized treatment begins","definition_or_measurement_approach":"Change in spleen volume reduction from baseline to 24 weeks (imaging assessment)."}
- {"endpoint_text":"- Change in TSS 24 weeks after the randomized treatment begins","definition_or_measurement_approach":"Change in Total Symptom Score from baseline to 24 weeks measured by MFSAF v4.0."}
Recruitment
- Digital Remote Recruitment
- True, recruitment materials include website content (POIESIS), online study materials for HCP and non-HCP, and electronic patient-reported outcome (ePRO) systems (ePRO vendor listed among third parties).
- Planned Sample Size
- 57
- Recruitment Window Months
- 56
- Consent Approach
- Informed consent is obtained from the participant (adults ≥18 years). Subject information sheets and informed consent forms are provided; documents are available in multiple languages (English and country-specific languages as per uploaded documents, e.g., BE-FR, BE-NL, AT-DE, FR, ES, IT, PL, PT, HU, HR, CZ, RO and others). Specific pregnancy-related information/ICFs are provided (separate pregnancy ICF documents are included).
Methods
- Referral letters to physicians (Dr-to-Dr / referral letter) — documented in recruitment materials (e.g., 'Referral Letter' PDFs).
- POIESIS website content for healthcare professionals (HCP) and non-HCP (patient/caregiver) — documented in recruitment materials (POIESIS Website HCP / Non HCP PDFs).
- Study flyers and postcards for patient/caregiver outreach (Advertisement Study Flyer Print; Schema Postcard).
- Study webpage postings and online materials (country-specific recruitment materials and website content PDFs).
- HCP-targeted communications (materials labelled Website HCP, HCP referral materials).
Geography
- Total Number Of Sites
- 123
- Total Number Of Participants
- 126
Belgium
- Earliest CTIS Part Ii Submission Date
- 20-08-2024
- Latest Decision Or Authorization Date
- 17-09-2024
- Processing Time Days
- 28
- Number Of Sites
- 5
- Number Of Participants
- 5
Sites
- Site Name
- Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
- Department Name
- Hematology
- Principal Investigator Name
- Julien Devreux
- Principal Investigator Email
- julien.devreux@chuuclnamur.uclouvain.be
- Contact Person Name
- Julien Devreux
- Contact Person Email
- julien.devreux@chuuclnamur.uclouvain.be
- Site Name
- UZ Leuven
- Department Name
- Hematology
- Principal Investigator Name
- Timothy Devos
- Principal Investigator Email
- timothy.devos@uzleuven.be
- Contact Person Name
- Timothy Devos
- Contact Person Email
- timothy.devos@uzleuven.be
- Site Name
- Algemeen Ziekenhuis Delta
- Department Name
- Hematology
- Principal Investigator Name
- Lien Deleu
- Principal Investigator Email
- lien.deleu@azdelta.be
- Contact Person Name
- Lien Deleu
- Contact Person Email
- lien.deleu@azdelta.be
- Site Name
- Het Ziekenhuisnetwerk Antwerpen
- Department Name
- Hematology
- Principal Investigator Name
- Nikki Granacher
- Principal Investigator Email
- nikki.granacher@zna.be
- Contact Person Name
- Nikki Granacher
- Contact Person Email
- nikki.granacher@zna.be
- Site Name
- Centre hospitalier universitaire de Liege
- Department Name
- Hematology
- Principal Investigator Name
- Gaelle Vertenoeil
- Principal Investigator Email
- gaelle.vertenoeil@chuliege.be
- Contact Person Name
- Gaelle Vertenoeil
- Contact Person Email
- gaelle.vertenoeil@chuliege.be
Croatia
- Earliest CTIS Part Ii Submission Date
- 27-08-2024
- Latest Decision Or Authorization Date
- 22-09-2024
- Processing Time Days
- 26
- Number Of Sites
- 8
- Number Of Participants
- 7
Sites
- Site Name
- Clinical Hospital Dubrava
- Department Name
- Hematology
- Principal Investigator Name
- Marko Lucijanic
- Principal Investigator Email
- markolucijanic@yahoo.com
- Contact Person Name
- Marko Lucijanic
- Contact Person Email
- markolucijanic@yahoo.com
- Site Name
- Klinicka bolnica Merkur
- Department Name
- Hematology
- Principal Investigator Name
- Marko Martinovic
- Principal Investigator Email
- Marko.Martinovic@kb-merkur.hr
- Contact Person Name
- Marko Martinovic
- Contact Person Email
- Marko.Martinovic@kb-merkur.hr
- Site Name
- General Hospital Sibenik
- Department Name
- Hematology
- Principal Investigator Name
- Ivan Krecak
- Principal Investigator Email
- krecak.ivan@gmail.com
- Contact Person Name
- Ivan Krecak
- Contact Person Email
- krecak.ivan@gmail.com
- Site Name
- University Hospital Centre Zagreb
- Department Name
- Hematology
- Principal Investigator Name
- Pavle Roncevic
- Principal Investigator Email
- kronac@gmail.com
- Contact Person Name
- Pavle Roncevic
- Contact Person Email
- kronac@gmail.com
- Site Name
- KBC Split
- Department Name
- Hematology
- Principal Investigator Name
- Davor Galusic
- Principal Investigator Email
- davorgalusic@net.hr
- Contact Person Name
- Davor Galusic
- Contact Person Email
- davorgalusic@net.hr
- Site Name
- Poliklinika Solmed d.o.o.
- Department Name
- Hematology
- Principal Investigator Name
- Goran Rincic
- Principal Investigator Email
- grincic@yahoo.com
- Contact Person Name
- Goran Rincic
- Contact Person Email
- grincic@yahoo.com
- Site Name
- Clinical Hospital Centre Rijeka
- Department Name
- Hematology
- Principal Investigator Name
- Dragana Grohovac
- Principal Investigator Email
- dzdrijeka@gmail.com
- Contact Person Name
- Dragana Grohovac
- Contact Person Email
- dzdrijeka@gmail.com
- Site Name
- Clinical Hospital Dubrava (additional site listing) or duplicate entries
Germany
- Earliest CTIS Part Ii Submission Date
- 23-08-2024
- Latest Decision Or Authorization Date
- 18-09-2024
- Processing Time Days
- 26
- Number Of Sites
- 13
- Number Of Participants
- 15
Sites
- Site Name
- Universitaetsklinikum Jena KöR
- Department Name
- Clinic for Internal Medicine II. Department of Haematology and Oncology
- Principal Investigator Name
- Carl Crodel
- Principal Investigator Email
- Carl.Crodel@med.uni-jena.de
- Contact Person Name
- Carl Crodel
- Contact Person Email
- Carl.Crodel@med.uni-jena.de
- Site Name
- Marien Hospital Duesseldorf GmbH
- Department Name
- Clinic for Oncology, Haematology and Palliative Medicine
- Principal Investigator Name
- Stefanie Groepper
- Principal Investigator Email
- stefanie.groepper@vkkd-kliniken.de
- Contact Person Name
- Stefanie Groepper
- Contact Person Email
- stefanie.groepper@vkkd-kliniken.de
- Site Name
- Martin-Luther-Universitaet Halle-Wittenberg
- Department Name
- Internal Medicine IV (Haematology and Oncology)
- Principal Investigator Name
- Haifa Kathrin Al-Ali
- Principal Investigator Email
- haifa.al-ali@uk-halle.de
- Contact Person Name
- Haifa Kathrin Al-Ali
- Contact Person Email
- haifa.al-ali@uk-halle.de
- Site Name
- Kliniken Ostalb
- Department Name
- Oncology Center
- Principal Investigator Name
- Holger Hebart
- Principal Investigator Email
- holger.hebart@kliniken-ostalb.de
- Contact Person Name
- Holger Hebart
- Contact Person Email
- holger.hebart@kliniken-ostalb.de
- Site Name
- Robert Bosch Krankenhaus GmbH
- Department Name
- Haemotology, Oncology and Palliative Medicine
- Principal Investigator Name
- Martin Kaufmann
- Principal Investigator Email
- martin.kaufmann@rbk.de
- Contact Person Name
- Martin Kaufmann
- Contact Person Email
- martin.kaufmann@rbk.de
- Site Name
- Klinikum rechts der Isar der TU Muenchen AöR
- Department Name
- III. Medical Department
- Principal Investigator Name
- Peter Herhaus
- Principal Investigator Email
- peter.herhaus@mri.tum.de
- Contact Person Name
- Peter Herhaus
- Contact Person Email
- peter.herhaus@mri.tum.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- II. Medical Clinic and Polyclinic
- Principal Investigator Name
- Philippe Schafhausen
- Principal Investigator Email
- schafhausen@uke.de
- Contact Person Name
- Philippe Schafhausen
- Contact Person Email
- schafhausen@uke.de
- Site Name
- Medizinische Hochschule Hannover
- Department Name
- Clinic for Haematology, Haemostaseology, Oncology and Stem Cell Transplantation
- Principal Investigator Name
- Susanne Isfort
- Principal Investigator Email
- isfort.susanne@mh-hannover.de
- Contact Person Name
- Susanne Isfort
- Contact Person Email
- isfort.susanne@mh-hannover.de
- Site Name
- Medical Center - University Of Freiburg
- Department Name
- Clinic for Internal Medicine I Haematology, Oncology and Stell Cell Transplantation
- Principal Investigator Name
- Heiko Becker
- Principal Investigator Email
- heiko.becker@uniklinik-freiburg.de
- Contact Person Name
- Heiko Becker
- Contact Person Email
- heiko.becker@uniklinik-freiburg.de
- Site Name
- MVZ Leipzig Mitte
- Department Name
- Onkology, Haematology, Palliative Medicine
- Principal Investigator Name
- Baerbel Schaedlich
- Principal Investigator Email
- b.schaedlich@mvz-mitte-leipzig.de
- Contact Person Name
- Baerbel Schaedlich
- Contact Person Email
- b.schaedlich@mvz-mitte-leipzig.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Centre for Internal Medicine (Krehl Clinic), Department of Haematology, Oncology, Rheumatology
- Principal Investigator Name
- Tim Sauer
- Principal Investigator Email
- tim.sauer@med.uni-heidelberg.de
- Contact Person Name
- Tim Sauer
- Contact Person Email
- tim.sauer@med.uni-heidelberg.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Clinic for Internal Medicine III Medical Clinic (oberer Eselsberg)
- Principal Investigator Name
- Konstanze Doehner
- Principal Investigator Email
- konstanze.doehner@uniklinik-ulm.de
- Contact Person Name
- Konstanze Doehner
- Contact Person Email
- konstanze.doehner@uniklinik-ulm.de
- Site Name
- Klinikum Nuernberg
- Department Name
- Clinic for Internal Medicine V
- Principal Investigator Name
- Stefan Knop
- Principal Investigator Email
- stefan.knop@klinikum-nuernberg.de
- Contact Person Name
- Stefan Knop
- Contact Person Email
- stefan.knop@klinikum-nuernberg.de
Greece
- Earliest CTIS Part Ii Submission Date
- 06-09-2024
- Latest Decision Or Authorization Date
- 18-09-2024
- Processing Time Days
- 12
- Number Of Sites
- 5
- Number Of Participants
- 5
Sites
- Site Name
- Geniko Nosokomeio Thessalonikis George Papanikolaou
- Department Name
- Haematology Clinic
- Principal Investigator Name
- Damianos Sotiropoulos
- Principal Investigator Email
- dsotiro@otenet.gr
- Contact Person Name
- Damianos Sotiropoulos
- Contact Person Email
- dsotiro@otenet.gr
- Site Name
- General University Hospital Of Patras
- Department Name
- Haematology Department
- Principal Investigator Name
- Alexandros Spyridonidis
- Principal Investigator Email
- spyridonidis@upatras.gr
- Contact Person Name
- Alexandros Spyridonidis
- Contact Person Email
- spyridonidis@upatras.gr
- Site Name
- University General Hospital Of Ioannina
- Department Name
- Department of Haematology
- Principal Investigator Name
- Eleftheria Hatzimichael
- Principal Investigator Email
- ehatzim@uoi.gr
- Contact Person Name
- Eleftheria Hatzimichael
- Contact Person Email
- ehatzim@uoi.gr
- Site Name
- University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
- Department Name
- 2nd Department of Propaedeutic Internal Medicine
- Principal Investigator Name
- Panagiotis Tsirigotis
- Principal Investigator Email
- panagtsirigotis@gmail.com
- Contact Person Name
- Panagiotis Tsirigotis
- Contact Person Email
- panagtsirigotis@gmail.com
- Site Name
- Laiko General Hospital Of Athens
- Department Name
- Haematology Clinic
- Principal Investigator Name
- Panayiotis Panayiotidis
- Principal Investigator Email
- ppanayi@med.uoa.gr
- Contact Person Name
- Panayiotis Panayiotidis
- Contact Person Email
- ppanayi@med.uoa.gr
Poland
- Earliest CTIS Part Ii Submission Date
- 19-08-2024
- Latest Decision Or Authorization Date
- 22-09-2024
- Processing Time Days
- 34
- Number Of Sites
- 18
- Number Of Participants
- 18
Sites
- Site Name
- Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
- Department Name
- Department of Hematology
- Principal Investigator Name
- Marta Sobas
- Principal Investigator Email
- marta.sobas@gmail.com
- Contact Person Name
- Marta Sobas
- Contact Person Email
- marta.sobas@gmail.com
- Site Name
- Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie
- Department Name
- Oddział Kliniczny Hematologii i Chorób Wewnętrznych z Ośrodkiem Transplantacji Szpiku
- Principal Investigator Name
- Janusz Hałka
- Principal Investigator Email
- janusz.halka@poliklinika.net
- Contact Person Name
- Janusz Hałka
- Contact Person Email
- janusz.halka@poliklinika.net
- Site Name
- Pratia Hematologia Sp. z o.o.
- Department Name
- Pratia Onkologia Katowice
- Principal Investigator Name
- Sebastian Grosicki
- Principal Investigator Email
- kontakt.onkologia@pratia.com
- Contact Person Name
- Sebastian Grosicki
- Contact Person Email
- kontakt.onkologia@pratia.com
- Site Name
- "InterHem" Katarzyna Mazgajska-Barczyk, Marek Milewski, Jarosław Piszcz, Piotr Radziwon Sp. j
- Department Name
- Oddział Hematologiczny Nowotworów Krwi
- Principal Investigator Name
- Jarosław Piszcz
- Principal Investigator Email
- jaroslaw.piszcz@gmail.com
- Contact Person Name
- Jarosław Piszcz
- Contact Person Email
- jaroslaw.piszcz@gmail.com
- Site Name
- Szpital Specjalistyczny Im. Jedrzeja Sniadeckiego W Nowym Saczu SPZOZ
- Department Name
- Oddział Hematologiczny
- Principal Investigator Name
- Szymon Fornagiel
- Principal Investigator Email
- szf@wp.pl
- Contact Person Name
- Szymon Fornagiel
- Contact Person Email
- szf@wp.pl
- Site Name
- Clinical Best Solutions Sp. z o.o. S.K.
- Principal Investigator Name
- Joanna Barankiewicz
- Principal Investigator Email
- Joanna.barankiewicz@gmail.com
- Contact Person Name
- Joanna Barankiewicz
- Contact Person Email
- Joanna.barankiewicz@gmail.com
- Site Name
- Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego
- Department Name
- Oddział Hematologiczny
- Principal Investigator Name
- Aleksandra Butrym
- Principal Investigator Email
- aleksandra.butrym@zdrowie.walbrzych.pl
- Contact Person Name
- Aleksandra Butrym
- Contact Person Email
- aleksandra.butrym@zdrowie.walbrzych.pl
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
- Department Name
- Poradnia Hematologiczna
- Principal Investigator Name
- Tomasz Sacha
- Principal Investigator Email
- sachatom@gmail.com
- Contact Person Name
- Tomasz Sacha
- Contact Person Email
- sachatom@gmail.com
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Hematologii, Transplantologii i Terapii Komórkowych
- Principal Investigator Name
- Witold Prejzner
- Principal Investigator Email
- wpre@gumed.edu.pl
- Contact Person Name
- Witold Prejzner
- Contact Person Email
- wpre@gumed.edu.pl
- Site Name
- Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu
- Department Name
- Oddział Hematologii
- Principal Investigator Name
- Magdalena Szczepańska
- Principal Investigator Email
- magzal@vp.pl
- Contact Person Name
- Magdalena Szczepańska
- Contact Person Email
- magzal@vp.pl
- Site Name
- Centrum Medyczne Damiana Holding Sp. z o.o.
- Department Name
- DOM LEKARSKI - AMBULATORIUM STRUGA
- Principal Investigator Name
- Marcin Flont
- Principal Investigator Email
- marcin.flont@domlekarski.pl
- Contact Person Name
- Marcin Flont
- Contact Person Email
- marcin.flont@domlekarski.pl
- Site Name
- Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
- Department Name
- Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych
- Principal Investigator Name
- Tomasz Wróbel
- Principal Investigator Email
- tomasz_wrobel@wp.pl
- Contact Person Name
- Tomasz Wróbel
- Contact Person Email
- tomasz_wrobel@wp.pl
- Site Name
- Aidport Sp. z o.o.
- Department Name
- AIDPORT
- Principal Investigator Name
- Łukasz Pruchniewski
- Principal Investigator Email
- lukasz.pruchniewski@aidport.pl
- Contact Person Name
- Łukasz Pruchniewski
- Contact Person Email
- lukasz.pruchniewski@aidport.pl
- Site Name
- Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
- Department Name
- Oddział hematologiczny
- Principal Investigator Name
- Wojciech Homenda
- Principal Investigator Email
- wojhom@sl.home.pl
- Contact Person Name
- Wojciech Homenda
- Contact Person Email
- wojhom@sl.home.pl
- Site Name
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
- Department Name
- Oddział Hematoonkologii i Chorób Wewnętrznych z Pododdziałem Chemioterapii Dziennej
- Principal Investigator Name
- Joanna Góra-Tybor
- Principal Investigator Email
- joannagora@op.pl
- Contact Person Name
- Joanna Góra-Tybor
- Contact Person Email
- joannagora@op.pl
- Site Name
- Other Poland listed sites (multiple)
Romania
- Earliest CTIS Part Ii Submission Date
- 07-06-2024
- Latest Decision Or Authorization Date
- 23-09-2024
- Processing Time Days
- 108
- Number Of Sites
- 5
- Number Of Participants
- 7
Sites
- Site Name
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
- Department Name
- Hematology
- Principal Investigator Name
- Ionut-Ciprian Tomuleasa
- Principal Investigator Email
- ciprian.tomuleasa@gmail.com
- Contact Person Name
- Ionut-Ciprian Tomuleasa
- Contact Person Email
- ciprian.tomuleasa@gmail.com
- Site Name
- Onco Card S.R.L.
- Department Name
- Hematology
- Principal Investigator Name
- Mihaela Cornelia Lazaroiu
- Principal Investigator Email
- mihaela.c.lazaroiu@gmail.com
- Contact Person Name
- Mihaela Cornelia Lazaroiu
- Contact Person Email
- mihaela.c.lazaroiu@gmail.com
- Site Name
- Spitalul Clinic Colentina Bucuresti
- Department Name
- Hematology
- Principal Investigator Name
- Viola Maria Popov
- Principal Investigator Email
- violamariap@gmail.com
- Contact Person Name
- Viola Maria Popov
- Contact Person Email
- violamariap@gmail.com
- Site Name
- Spitalul Clinic Judetean De Urgenta Bihor
- Department Name
- Hematology
- Principal Investigator Name
- Cristian Marcian Burca
- Principal Investigator Email
- cristian.burca@gmail.com
- Contact Person Name
- Cristian Marcian Burca
- Contact Person Email
- cristian.burca@gmail.com
- Site Name
- Spitalul Clinic Judetean De Urgenta Targu Mures
- Department Name
- Hematology
- Principal Investigator Name
- Ioan Macarie
- Principal Investigator Email
- macarie.ioan07@gmail.com
- Contact Person Name
- Ioan Macarie
- Contact Person Email
- macarie.ioan07@gmail.com
Italy
- Earliest CTIS Part Ii Submission Date
- 07-06-2024
- Latest Decision Or Authorization Date
- 18-09-2024
- Processing Time Days
- 103
- Number Of Sites
- 19
- Number Of Participants
- 19
Sites
- Site Name
- Azienda Ospedaliera Ospedali Riuniti Marche Nord
- Department Name
- Hematology and Stem Cell Transplant Centre
- Principal Investigator Name
- Alessandro Isidori
- Principal Investigator Email
- alessandro.isidori@ospedalimarchenord.it
- Contact Person Name
- Alessandro Isidori
- Contact Person Email
- alessandro.isidori@ospedalimarchenord.it
- Site Name
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
- Department Name
- Department of clinical and biological sciences
- Principal Investigator Name
- Alessandro Morotti
- Principal Investigator Email
- alessandro.morotti@unito.it
- Contact Person Name
- Alessandro Morotti
- Contact Person Email
- alessandro.morotti@unito.it
- Site Name
- Careggi University Hospital
- Department Name
- Department of Medical oncology
- Principal Investigator Name
- Alessandro Vannucchi
- Principal Investigator Email
- amvannucchi@unifi.it
- Contact Person Name
- Alessandro Vannucchi
- Contact Person Email
- amvannucchi@unifi.it
- Site Name
- Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
- Department Name
- Hematology with bone marrow transplantation
- Principal Investigator Name
- Giuseppe Palumbo
- Principal Investigator Email
- na.na@na.com
- Contact Person Name
- Giuseppe Palumbo
- Contact Person Email
- na.na@na.com
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Onco-Hematology
- Principal Investigator Name
- Federica Gigli
- Principal Investigator Email
- federica.gigli@ieo.it
- Contact Person Name
- Federica Gigli
- Contact Person Email
- federica.gigli@ieo.it
- Site Name
- Azienda Sanitaria Locale Roma 2
- Department Name
- UOC Hematology
- Principal Investigator Name
- Elisabetta Abruzzese
- Principal Investigator Email
- ufficio.sperimentazioni@aslroma2.it
- Contact Person Name
- Elisabetta Abruzzese
- Contact Person Email
- ufficio.sperimentazioni@aslroma2.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- Oncology and Hematology Department
- Principal Investigator Name
- Arbana Dizdari
- Principal Investigator Email
- Dizdari.Arbana@auslromagna.it
- Contact Person Name
- Arbana Dizdari
- Contact Person Email
- Dizdari.Arbana@auslromagna.it
- Site Name
- Azienda Socio Sanitaria Territoriale Dei Sette Laghi
- Department Name
- Haematology Department
- Principal Investigator Name
- Marco Brociner
- Principal Investigator Email
- marco.brociner@asst-settelaghi.it
- Contact Person Name
- Marco Brociner
- Contact Person Email
- marco.brociner@asst-settelaghi.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- SSD Medical Oncology Addarii
- Principal Investigator Name
- Francesca Palandri
- Principal Investigator Email
- francesca.palandri@unibo.it
- Contact Person Name
- Francesca Palandri
- Contact Person Email
- francesca.palandri@unibo.it
- Site Name
- Azienda Ospedaliera Ordine Mauriziano Di Torino
- Department Name
- SCDU Ematologia e Terapie cellulari
- Principal Investigator Name
- Elisabetta Rumi
- Principal Investigator Email
- s.rumi@smatteo.pv.it
- Contact Person Name
- Elisabetta Rumi
- Contact Person Email
- s.rumi@smatteo.pv.it
- Site Name
- Fondazione IRCCS Policlinico San Matteo
- Department Name
- Oncohematology, Operative Unit of Hematology
- Principal Investigator Name
- Elisabetta Rumi
- Principal Investigator Email
- s.rumi@smatteo.pv.it
- Contact Person Name
- Elisabetta Rumi
- Contact Person Email
- s.rumi@smatteo.pv.it
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- Hematology
- Principal Investigator Name
- Alessandra Tucci
- Principal Investigator Email
- alessandra.tucci@asst-spedalicivili.it
- Contact Person Name
- Alessandra Tucci
- Contact Person Email
- alessandra.tucci@asst-spedalicivili.it
- Site Name
- Azienda Ospedaliero-Universitaria Maggiore Della Carita
- Department Name
- SCDU Ematology
- Principal Investigator Name
- Andrea Patriarca
- Principal Investigator Email
- andrea.patriarca@unipo.it
- Contact Person Name
- Andrea Patriarca
- Contact Person Email
- andrea.patriarca@unipo.it
- Site Name
- Azienda Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare Arrigo
- Department Name
- Hematology Department
- Principal Investigator Name
- Monia Marchetti
- Principal Investigator Email
- monia.marchetti@ospedale.al.it
- Contact Person Name
- Monia Marchetti
- Contact Person Email
- monia.marchetti@ospedale.al.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- Hematology
- Principal Investigator Name
- Francesco Passamonti
- Principal Investigator Email
- francesco.passamonti@policlinico.mi.it
- Contact Person Name
- Francesco Passamonti
- Contact Person Email
- francesco.passamonti@policlinico.mi.it
- Site Name
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
- Department Name
- Hematology
- Principal Investigator Name
- Marco Santoro
- Principal Investigator Email
- marco.santoro1@policlinico.pa.it
- Contact Person Name
- Marco Santoro
- Contact Person Email
- marco.santoro1@policlinico.pa.it
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- Complex Structure of Clinical and Experimental Oncology in Innovative and High-Dose Thera
- Principal Investigator Name
- Alessandro Lucchesi
- Principal Investigator Email
- alessandro.lucchesi@irst.emr.it
- Contact Person Name
- Alessandro Lucchesi
- Contact Person Email
- alessandro.lucchesi@irst.emr.it
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- Hematology
- Principal Investigator Name
- Giulia Benevolo
- Principal Investigator Email
- gbenevolo@cittadellasalute.to.it
- Contact Person Name
- Giulia Benevolo
- Contact Person Email
- gbenevolo@cittadellasalute.to.it
Hungary
- Earliest CTIS Part Ii Submission Date
- 22-08-2024
- Latest Decision Or Authorization Date
- 17-09-2024
- Processing Time Days
- 26
- Number Of Sites
- 5
- Number Of Participants
- 5
Sites
- Site Name
- Tolna Varmegyei Balassa Janos Korhaz
- Department Name
- Department of Hematology
- Principal Investigator Name
- Renata Csalodi
- Principal Investigator Email
- csalodi.renata@tmkorhaz.hu
- Contact Person Name
- Renata Csalodi
- Contact Person Email
- csalodi.renata@tmkorhaz.hu
- Site Name
- Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
- Department Name
- Department of Internal Medicine III, Hematology
- Principal Investigator Name
- Arpad Szomor
- Principal Investigator Email
- info@mail.fmkorhaz.hu
- Contact Person Name
- Arpad Szomor
- Contact Person Email
- info@mail.fmkorhaz.hu
- Site Name
- Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
- Department Name
- Department of Hematology
- Principal Investigator Name
- Laszlo Rejto
- Principal Investigator Email
- lrejto@med.unideb.hu
- Contact Person Name
- Laszlo Rejto
- Contact Person Email
- lrejto@med.unideb.hu
- Site Name
- Semmelweis University
- Department Name
- Department of Internal Medicine and Haematology, Division of Hematology
- Principal Investigator Name
- Zsolt Nagy
- Principal Investigator Email
- nagy.zsolt@med.semmelweis-univ.hu
- Contact Person Name
- Zsolt Nagy
- Contact Person Email
- nagy.zsolt@med.semmelweis-univ.hu
- Site Name
- Other Hungary listed sites
Austria
- Earliest CTIS Part Ii Submission Date
- 07-06-2024
- Latest Decision Or Authorization Date
- 22-09-2024
- Processing Time Days
- 107
- Number Of Sites
- 7
- Number Of Participants
- 7
Sites
- Site Name
- Johannes Kepler University Linz
- Department Name
- Kepler University Hospital, Clinical Department of Internal Medicine III, Hematology and Oncology
- Principal Investigator Name
- Clemens Schmitt
- Principal Investigator Email
- c.schmitt@kepleruniklinikum.at
- Contact Person Name
- Clemens Schmitt
- Contact Person Email
- c.schmitt@kepleruniklinikum.at
- Site Name
- Medical University Of Graz
- Department Name
- Department of Internal Medicine Clinical Department of Hematology
- Principal Investigator Name
- Albert Woelfler
- Principal Investigator Email
- albert.woelfler@medunigraz.at
- Contact Person Name
- Albert Woelfler
- Contact Person Email
- albert.woelfler@medunigraz.at
- Site Name
- Medizinische Universitaet Innsbruck
- Department Name
- Medical University Innsbruck, Department of Internal Medicine V (Hematology and Oncology)
- Principal Investigator Name
- Dominik Wolf
- Principal Investigator Email
- dominik.wolf@i-med.ac.at
- Contact Person Name
- Dominik Wolf
- Contact Person Email
- dominik.wolf@i-med.ac.at
- Site Name
- Stadt Wien Wiener Gesundheitsverbund
- Department Name
- Hospital Ottakring, Department of Internal Medicine I
- Principal Investigator Name
- Frédéric Hermann Witte
- Principal Investigator Email
- Frederic.Witte@gesundheitsverbund.at
- Contact Person Name
- Frédéric Hermann Witte
- Contact Person Email
- Frederic.Witte@gesundheitsverbund.at
- Site Name
- Steiermaerkische Krankenanstalten Ges.m.b.H.
- Department Name
- LKH Hochsteiermark, Department of Internal Medicine, Hematology and Internal Oncology
- Principal Investigator Name
- Thamer Sliwa
- Principal Investigator Email
- Thamer.Sliwa@kages.at
- Contact Person Name
- Thamer Sliwa
- Contact Person Email
- Thamer.Sliwa@kages.at
- Site Name
- Medical University Of Vienna
- Department Name
- Department of Internal Medicine I, Clinical Department of Hematology and Hemostaseology
- Principal Investigator Name
- Maria-Theresa Krauth
- Principal Investigator Email
- maria.krauth@meduniwien.ac.at
- Contact Person Name
- Maria-Theresa Krauth
- Contact Person Email
- maria.krauth@meduniwien.ac.at
- Site Name
- Ordensklinikum Linz GmbH
- Department Name
- Department of Internal Medicine I, Hemostaseology and Medical Oncology
- Principal Investigator Name
- Veronika Buxhofer-Ausch
- Principal Investigator Email
- veronika.buxhofer-ausch@ordensklinikum.at
- Contact Person Name
- Veronika Buxhofer-Ausch
- Contact Person Email
- veronika.buxhofer-ausch@ordensklinikum.at
France
- Earliest CTIS Part Ii Submission Date
- 21-08-2024
- Latest Decision Or Authorization Date
- 17-09-2024
- Processing Time Days
- 27
- Number Of Sites
- 12
- Number Of Participants
- 12
Sites
- Site Name
- Centre Hospitalier Universitaire Amiens Picardie
- Department Name
- Hématologie Clinique et Thérapie Cellulaire
- Principal Investigator Name
- Etienne Paubelle
- Principal Investigator Email
- paubelle.etienne@chu-amiens.fr
- Contact Person Name
- Etienne Paubelle
- Contact Person Email
- paubelle.etienne@chu-amiens.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Hématologie
- Principal Investigator Name
- Shanti Amé
- Principal Investigator Email
- s.ame@icans.eu
- Contact Person Name
- Shanti Amé
- Contact Person Email
- s.ame@icans.eu
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Hématologie
- Principal Investigator Name
- Viviane Dubruille
- Principal Investigator Email
- viviane.dubruille@chu-nantes.fr
- Contact Person Name
- Viviane Dubruille
- Contact Person Email
- viviane.dubruille@chu-nantes.fr
- Site Name
- Institut Universitaire Du Cancer Toulouse-Oncopole
- Department Name
- Hématologie
- Principal Investigator Name
- Suzanne Tavitian
- Principal Investigator Email
- tavitian.suzanne@iuct-oncopole.fr
- Contact Person Name
- Suzanne Tavitian
- Contact Person Email
- tavitian.suzanne@iuct-oncopole.fr
- Site Name
- Centre Leon Berard
- Department Name
- Oncologie Médicale
- Principal Investigator Name
- Franck-Emmanuel Nicolini
- Principal Investigator Email
- franck-emmanuel.nicolini@lyon.unicancer.fr
- Contact Person Name
- Franck-Emmanuel Nicolini
- Contact Person Email
- franck-emmanuel.nicolini@lyon.unicancer.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Hématologie et Thérapie Cellulaire, Hôpital Bretonneau
- Principal Investigator Name
- Antoine Machet
- Principal Investigator Email
- a.machet@chu-tours.fr
- Contact Person Name
- Antoine Machet
- Contact Person Email
- a.machet@chu-tours.fr
- Site Name
- Centre Hospitalier Universitaire D'Angers
- Department Name
- Maladies du sang
- Principal Investigator Name
- Françoise Boyer
- Principal Investigator Email
- frboyer-perrard@chu-angers.fr
- Contact Person Name
- Françoise Boyer
- Contact Person Email
- frboyer-perrard@chu-angers.fr
- Site Name
- Centre Hospitalier Universitaire De Nimes
- Department Name
- Institut de Cancérologie du Gard
- Principal Investigator Name
- Stefan Wickenhauser
- Principal Investigator Email
- stefan.wickenhauser@chu-nimes.fr
- Contact Person Name
- Stefan Wickenhauser
- Contact Person Email
- stefan.wickenhauser@chu-nimes.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Oncologie Hématologique et Thérapie Cellulaire
- Principal Investigator Name
- Jose Miguel Torregrosa-Diaz
- Principal Investigator Email
- jose-miguel.torregrosa-diaz@chu-poitiers.fr
- Contact Person Name
- Jose Miguel Torregrosa-Diaz
- Contact Person Email
- jose-miguel.torregrosa-diaz@chu-poitiers.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Maladie du Sang, Hôpital Claude Huriez
- Principal Investigator Name
- Mathieu Wemeau
- Principal Investigator Email
- mathieu.wemeau@chu-lille.fr
- Contact Person Name
- Mathieu Wemeau
- Contact Person Email
- mathieu.wemeau@chu-lille.fr
- Site Name
- Centre Hospitalier Universitaire De Nice
- Department Name
- Hématologie, Hôpital Archet 1
- Principal Investigator Name
- Michael Loschi
- Principal Investigator Email
- loschi.m@chu-nice.fr
- Contact Person Name
- Michael Loschi
- Contact Person Email
- loschi.m@chu-nice.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Hématologie, Hôpital Haut Lévêque
- Principal Investigator Name
- Clémence Mediavilla
- Principal Investigator Email
- cIemence.mediavilla@chu-bordeaux.fr
- Contact Person Name
- Clémence Mediavilla
- Contact Person Email
- cIemence.mediavilla@chu-bordeaux.fr
Czechia
- Earliest CTIS Part Ii Submission Date
- 21-08-2024
- Latest Decision Or Authorization Date
- 19-09-2024
- Processing Time Days
- 29
- Number Of Sites
- 5
- Number Of Participants
- 5
Sites
- Site Name
- Fakultni Nemocnice Ostrava
- Department Name
- Klinika hematologie
- Principal Investigator Name
- Lukáš Stejskal
- Principal Investigator Email
- lukas.stejskal@fno.cz
- Contact Person Name
- Lukáš Stejskal
- Contact Person Email
- lukas.stejskal@fno.cz
- Site Name
- Fakultni Nemocnice Brno
- Department Name
- Interní hematologická a onkologická klinika
- Principal Investigator Name
- Jiří Mayer
- Principal Investigator Email
- mayer.jiri@fnbrno.cz
- Contact Person Name
- Jiří Mayer
- Contact Person Email
- mayer.jiri@fnbrno.cz
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- IV. Interní klinica hematologie
- Principal Investigator Name
- Petra Bělohlávková
- Principal Investigator Email
- petra.belohlavkova@fnhk.cz
- Contact Person Name
- Petra Bělohlávková
- Contact Person Email
- petra.belohlavkova@fnhk.cz
- Site Name
- Institute Of Hematology And Blood Transfusion
- Department Name
- Ústav hematologie a krevní transfuze
- Principal Investigator Name
- Jacqueline Soukupová Maaloufová
- Principal Investigator Email
- jacqueline.maaloufova@uhkt.cz
- Contact Person Name
- Jacqueline Soukupová Maaloufová
- Contact Person Email
- jacqueline.maaloufova@uhkt.cz
- Site Name
- Fakultni Nemocnice Kralovske Vinohrady
- Department Name
- Interní hematologická klinika
- Principal Investigator Name
- Olga Černá
- Principal Investigator Email
- olga.cerna@fnkv.cz
- Contact Person Name
- Olga Černá
- Contact Person Email
- olga.cerna@fnkv.cz
Spain
- Earliest CTIS Part Ii Submission Date
- 30-08-2024
- Latest Decision Or Authorization Date
- 23-09-2024
- Processing Time Days
- 24
- Number Of Sites
- 15
- Number Of Participants
- 15
Sites
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Hematology
- Principal Investigator Name
- Elvira Mora Castera
- Principal Investigator Email
- mora_elv@gva.es
- Contact Person Name
- Elvira Mora Castera
- Contact Person Email
- mora_elv@gva.es
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Hematology
- Principal Investigator Name
- Jesús María Hernández Rivas
- Principal Investigator Email
- jmhr@usal.es
- Contact Person Name
- Jesús María Hernández Rivas
- Contact Person Email
- jmhr@usal.es
- Site Name
- Hospital Del Mar
- Department Name
- Hematology
- Principal Investigator Name
- Alicia Senin Magan
- Principal Investigator Email
- msenin@psmar.cat
- Contact Person Name
- Alicia Senin Magan
- Contact Person Email
- msenin@psmar.cat
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Hematology
- Principal Investigator Name
- Maria Laura Fox
- Principal Investigator Email
- mlfox@vhio.net
- Contact Person Name
- Maria Laura Fox
- Contact Person Email
- mlfox@vhio.net
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Hematology
- Principal Investigator Name
- Juan Carlos Hernández Boluda
- Principal Investigator Email
- hernandez_jca@gva.es
- Contact Person Name
- Juan Carlos Hernández Boluda
- Contact Person Email
- hernandez_jca@gva.es
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Hematology
- Principal Investigator Name
- Regina García Delgado
- Principal Investigator Email
- reginagarciadel@yahoo.es
- Contact Person Name
- Regina García Delgado
- Contact Person Email
- reginagarciadel@yahoo.es
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Hematology
- Principal Investigator Name
- José Valentín García Gutiérrez
- Principal Investigator Email
- jvalentingg@gmail.com
- Contact Person Name
- José Valentín García Gutiérrez
- Contact Person Email
- jvalentingg@gmail.com
- Site Name
- University Hospital Son Espases
- Department Name
- Hematology and Hemotherapy
- Principal Investigator Name
- Sara Montolío Chiva
- Principal Investigator Email
- sara.montolio@ssib.es
- Contact Person Name
- Sara Montolío Chiva
- Contact Person Email
- sara.montolio@ssib.es
- Site Name
- Institut Catala D'oncologia (Badalona)
- Department Name
- Hematology
- Principal Investigator Name
- Blanca Xicoy Cirici
- Principal Investigator Email
- bxicoy@iconcologia.net
- Contact Person Name
- Blanca Xicoy Cirici
- Contact Person Email
- bxicoy@iconcologia.net
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Hematology
- Principal Investigator Name
- Rosa Ayala Díaz
- Principal Investigator Email
- rayaladiaz12@gmail.com
- Contact Person Name
- Rosa Ayala Díaz
- Contact Person Email
- rayaladiaz12@gmail.com
- Site Name
- El Hospital Universitario De Gran Canaria Dr. Negrin
- Department Name
- Hematology
- Principal Investigator Name
- Adrián Segura Díaz
- Principal Investigator Email
- adsegura@hotmail.es
- Contact Person Name
- Adrián Segura Díaz
- Contact Person Email
- adsegura@hotmail.es
- Site Name
- Institut Catala D'oncologia (L'Hospitalet)
- Department Name
- Hematology
- Principal Investigator Name
- Carolina Martínez Gómez
- Principal Investigator Email
- carolinamariamartinez@iconcologia.net
- Contact Person Name
- Carolina Martínez Gómez
- Contact Person Email
- carolinamariamartinez@iconcologia.net
- Site Name
- Hospital Quironsalud Zaragoza
- Department Name
- Hematology
- Principal Investigator Name
- Pilar Giraldo Castellano
- Principal Investigator Email
- giraldocastellano@gmail.com
- Contact Person Name
- Pilar Giraldo Castellano
- Contact Person Email
- giraldocastellano@gmail.com
- Site Name
- Hospital Universitario De Salamanca (additional listings)
Portugal
- Earliest CTIS Part Ii Submission Date
- 23-08-2024
- Latest Decision Or Authorization Date
- 23-09-2024
- Processing Time Days
- 31
- Number Of Sites
- 6
- Number Of Participants
- 6
Sites
- Site Name
- CCAB Centro Clinico Academico Braga Associacao
- Department Name
- Oncology
- Principal Investigator Name
- Marco Dias
- Principal Investigator Email
- marco.dias@hb.min-saude.pt
- Contact Person Name
- Marco Dias
- Contact Person Email
- marco.dias@hb.min-saude.pt
- Site Name
- Unidade Local De Saude Da Regiao De Aveiro E.P.E.
- Department Name
- Hematology
- Principal Investigator Name
- Fernando Silva
- Principal Investigator Email
- fernando.silva.70836@chbv.min-saude.pt
- Contact Person Name
- Fernando Silva
- Contact Person Email
- fernando.silva.70836@chbv.min-saude.pt
- Site Name
- Unidade Local De Saude De Gaia/Espinho E.P.E.
- Department Name
- Hematolgy
- Principal Investigator Name
- Marcio Tavares
- Principal Investigator Email
- marcio.tavares@chvng.min-saude.pt
- Contact Person Name
- Marcio Tavares
- Contact Person Email
- marcio.tavares@chvng.min-saude.pt
- Site Name
- Unidade Local De Saude De Lisboa Ocidental E.P.E.
- Department Name
- Hematology
- Principal Investigator Name
- Celina Afonso
- Principal Investigator Email
- ccafonso@chlo.min-saude.pt
- Contact Person Name
- Celina Afonso
- Contact Person Email
- ccafonso@chlo.min-saude.pt
- Site Name
- Unidade Local De Saude Do Alto Minho E.P.E.
- Department Name
- Hematology
- Principal Investigator Name
- Mafalda Pimenta de Castro
- Principal Investigator Email
- mafalda.pimenta.castro@ulsam.min-saude.pt
- Contact Person Name
- Mafalda Pimenta de Castro
- Contact Person Email
- mafalda.pimenta.castro@ulsam.min-saude.pt
- Site Name
- Unidade Local De Saude De Santa Maria E.P.E.
- Department Name
- Hematolgy
- Principal Investigator Name
- Maria Blanca Polo Guerrero
- Principal Investigator Email
- maria.guerrero@chln.min-saude.pt
- Contact Person Name
- Maria Blanca Polo Guerrero
- Contact Person Email
- maria.guerrero@chln.min-saude.pt
Sponsor
Primary sponsor
- Full Name
- Kartos Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Psi CRO Greece
- Responsibilities
- Operational CRO responsibilities (listed sponsor duties include administrative and operational support)
- Name
- Psi Cro AG
- Responsibilities
- Operational CRO responsibilities (multiple sponsor duties listed)
- Name
- Ppd Inc.
- Responsibilities
- Vendor services (assay services)
- Name
- IQVIA Laboratories
- Responsibilities
- Laboratory/genetic testing support
Third parties
- {"country":"United States","full_name":"EPL Pathology Archives LLC","duties_or_roles":"Storage of the samples for future testing","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Ppd Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Flagship Biosciences Inc.","duties_or_roles":"Genetic testing","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Aperio Clinical Outcomes LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"IQVIA Laboratories","duties_or_roles":"Genetic Testing","organisation_type":"Industry"}
- {"country":"Ireland","full_name":"Signant Health Global Solutions Limited","duties_or_roles":"ePRO","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Myriad RBM Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Greece","full_name":"Psi CRO Greece","duties_or_roles":"Multiple sponsor duties (administrative/operational roles as listed)","organisation_type":"Pharmaceutical company / CRO"}
- {"country":"Switzerland","full_name":"Psi Cro AG","duties_or_roles":"Multiple sponsor duties (administrative/operational roles as listed)","organisation_type":"Pharmaceutical company / CRO"}
- {"country":"United States","full_name":"Celerion Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"PrimeVigilance GmbH","duties_or_roles":"Pharmacovigilance","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company (Vendor)"}
- {"country":"United States","full_name":"Eurofins Central Laboratory LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Central imaging","organisation_type":"Pharmaceutical company / vendor"}
Investigational products
- Investigational Product Name
- Navtemadlin (KRT-232) / Navtemadlin 25-120 / Navtemadlin 25-60 / Navtemadlin 25-30 / Navtemadlin 25-180
- Active Substance
- NAVTEMADLIN
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral tablet
- Authorisation Status
- Investigational (product entries indicate PRD numbers; not standard marketing authorisation)
- Dose Levels
- Available tablet strengths referenced: 25-30 mg, 25-60 mg, 25-120 mg, 25-180 mg (product names indicate strength ranges)
- Maximum Dose
- 240 mg (max daily dose amount listed)
- Investigational Product Name
- RUXOLITINIB
- Active Substance
- RUXOLITINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral tablet
- Authorisation Status
- Authorised (product entry shows market authorisation status code indicating authorised product record)
- Maximum Dose
- 50 mg (max daily dose amount listed)
- Investigational Product Name
- ONDANSETRON (auxiliary antiemetic)
- Active Substance
- ONDANSETRON
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral tablet/capsule
- Authorisation Status
- Authorised (marketing product record present)
- Maximum Dose
- 16 mg (max daily dose amount listed)
- Investigational Product Name
- LOPERAMIDE (auxiliary)
- Active Substance
- LOPERAMIDE HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral tablet/capsule
- Authorisation Status
- Authorised (marketing product record present)
- Dose Levels
- 2 mg tablet formulation referenced
- Maximum Dose
- 16 mg (max daily dose amount listed)
- Combination Treatment
- Yes
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