Clinical trial • Phase III • Oncology|Haematology

ASCIMINIB HYDROCHLORIDE for Chronic Myeloid Leukemia

Phase III trial of ASCIMINIB HYDROCHLORIDE for Chronic Myeloid Leukemia.

Overview

Trial Therapeutic Area
Oncology|Haematology
Trial Disease
Chronic Myeloid Leukemia
Trial Stage
Phase III
Drug Modality
Small molecule
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
21-05-2024
First CTIS Authorization Date
19-06-2024

Trial design

Randomised, open-label, nilotinib (nilotinib) oral comparator; max daily dose amount listed as 600 mg (no administration schedule specified in the provided data).-controlled Phase III trial in Germany, Romania, Netherlands and others.

Randomised
Yes
Open Label
Yes
Comparator
Nilotinib (NILOTINIB) oral comparator; max daily dose amount listed as 600 mg (no administration schedule specified in the provided data).
Target Sample Size
187
Trial Duration For Participant
1800

Eligibility

Recruits 187 Vulnerable population flag is selected. The trial enrols adults (≥18 years) only; signed informed consent must be obtained prior to participation. Subject information and ICF documents (country-specific and language versions) are provided, including follow-up information for pregnant participants and for pregnant partners. Assent is not applicable as minors (<18) are excluded; consent is provided by the adult participant..

Pregnancy Exclusion
Pregnant or nursing (lactating) women
Vulnerable Population
Vulnerable population flag is selected. The trial enrols adults (≥18 years) only; signed informed consent must be obtained prior to participation. Subject information and ICF documents (country-specific and language versions) are provided, including follow-up information for pregnant participants and for pregnant partners. Assent is not applicable as minors (<18) are excluded; consent is provided by the adult participant.

Inclusion criteria

  • {"criterion_text":"- Signed informed consent must be obtained prior to participation in the study.\n- Male or female patients ≥ 18 years of age\n- Patients with CML-CP within 3 months of diagnosis\n- Diagnosis of CML-CP (European Leukemia Network [ELN] 2020 criteria) with cytogenetic confirmation of the Philadelphia (Ph) chromosome. A cryptic Ph chromosome should be confirmed by metaphase Fluorescence in situ Hybridization (FISH) •Documented chronic phase CML will meet all the below criteria (Baccarani et al 2013): •< 15% blasts in peripheral blood and bone marrow, •< 30% blasts plus promyelocytes in peripheral blood and bone marrow, •< 20% basophils in the peripheral blood, •Platelet (PLT) count ≥ 100 x 109/L (≥ 100,000/mm3) •No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly.\n- Evidence of typical BCR::ABL1 transcript [e14a2 and/or e13a2] which is amenable to standardized RQ-PCR quantification by the central laboratory assessment. However, if a local qualitative assay, validated according to local regulation, from an accredited local laboratory has confirmed evidence of typical BCR::ABL1 transcript [e14a2 and/or e13a2], these results can be used for eligibility if the central Real Time Quantitative Polymerase Chain Reaction (RQ-PCR) results arrived are not available at the time of randomization.\n- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n- Adequate end organ function as defined by: •Total bilirubin (TBL) < 3 x Upper Limit of Normal (ULN); patients with Gilbert’s syndrome may only be included if TBL ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN, •Creatinine Clearance (CrCl) ≥ 30 milliliters per minute (mL/min) as calculated using Cockcroft-Gault formula, Serum lipase ≤ 1.5 x ULN. For serum lipase > ULN - ≤ 1.5 x ULN, value must be considered not clinically significant and not associated with risk factors for acute pancreatitis.\n- Patients must have the following laboratory values within normal limits or corrected to within normal limits with supplements prior to randomization: •Potassium (potassium increase of up to 6.0 mmol/L is acceptable if associated with CrCl* ≥ 90 mL/min)**, •Total calcium (corrected for serum albumin); (calcium increase of up to 12.5 mg/dl or 3.1 mmol/L is acceptable if associated with CrCl* ≥ 90 mL/min), •Magnesium (magnesium increase of up to 3.0 mg/dL or 1.23 mmol/L if associated with CrCl* ≥ 90 mL/min), •For patients with mild to moderate renal impairment (CrCl* ≥ 30 mL/min and <90 mL/min) - potassium, total calcium (corrected for serum albumin) and magnesium should be within normal limits or corrected to within normal limits with supplements prior to randomization. *CrCl as calculated using Cockcroft-Gault formula. ** pseudohyperkaliemia in case of thrombocytosis is not an exclusion criterion"}

Exclusion criteria

  • {"criterion_text":"- Previous treatment of CML with any other anticancer agents including chemotherapy and/or biologic agents or prior stem cell transplant, with the exception of hydroxyurea and/or anagrelide.\n- Known history of chronic Hepatitis B (HBV), or chronic Hepatitis C (HCV) infection. Testing for Hepatitis B surface antigen (HBs Ag) and Hepatitis B core antibody (HBc Ab/anti HBc) will be performed at screening. If anti-HBc is positive, HBV-DNA evaluation will be carried out at screening. A patient having positive HBV-DNA will not be enrolled in the study. Also, a patient with positive HBsAg will not be enrolled in the study. HCV Ab testing will also be performed at screening. For details on the criteria see Appendix 4.\n- History of Human Immunodeficiency Virus (HIV) unless well-controlled on a stable dose of anti-retroviral therapy at the time of screening.\n- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study treatment (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or gastric bypass surgery).\n- Participation in a prior investigational study within 30 days prior to randomization or within 5 half-lives of the investigational product, whichever is longer.\n- Pregnant or nursing (lactating) women\n- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for a period of time after stopping study medication.\n- Known hypersensitivity to the study treatment.\n- Known cytopathologically confirmed CNS infiltration (in absence of suspicion of CNS involvement, lumbar puncture not required).\n- Impaired cardiac function or cardiac repolarization abnormality including but not limited to any one of the following: •\tHistory of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG) within 6 months prior to starting study treatment. •\tClinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block). •\tQTcF ≥ 450 ms on the average of three serial baseline ECG (using the QTcF formula). If QTcF ≥ 450 ms and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTcF. •\tLong QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following: •\tRisk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia. •\tConcomitant medication(s) with a “Known risk of Torsades de Pointes” per crediblemeds.org that cannot be discontinued or replaced 7 days prior to starting study treatment by safe alternative medication. •\tInability to determine the QTcF interval.\n- Severe and/or uncontrolled concurrent medical disease that in the opinion of the Investigator could cause unacceptable safety risks or compromise compliance with the protocol (e.g. uncontrolled diabetes, active or uncontrolled infection; uncontrolled arterial or pulmonary hypertension, uncontrolled clinically significant hyperlipidemia).\n- History of significant congenital or acquired bleeding disorder unrelated to cancer.\n- Major surgery within 4 weeks prior to study entry or patients who have not recovered from prior surgery.\n- History of other active malignancy within 3 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively.\n- History of acute pancreatitis within 1 year prior to randomization or medical history of chronic pancreatitis.\n- History of chronic liver disease leading to severe hepatic impairment, or ongoing acute liver disease."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Time to discontinuation of study treatment due to adverse event (TTDAE). TTDAE is defined as the time from the date of first dose of study treatment to the date of discontinuation of study treatment due to adverse event (AE).","definition_or_measurement_approach":"TTDAE is defined as the time from the date of first dose of study treatment to the date of discontinuation of study treatment due to adverse event (AE)."}

Secondary endpoints

  • {"endpoint_text":"- Secondary endpoint on efficacy: •MMR at and by all scheduled time points •MR4.0 and MR4.5 at and by all scheduled time points •Complete Hematological Response at and by all scheduled time points •BCR::ABL1 ≤1% at and by all scheduled time points •Duration of MMR, MR4.0, MR4.5 •Time to first MMR, first MR4.0, first MR4.5 •Time to treatment failure •Event Free Survival •Progression free survival •Overall survival •TTD due to selected reasons","definition_or_measurement_approach":"Efficacy endpoints measured at and by scheduled data collection time points; includes molecular response metrics (MMR, MR4.0, MR4.5), hematological response, BCR::ABL1 quantification, durations and time-to-event outcomes (time to treatment failure, EFS, PFS, OS). Specific definitions and schedules are in protocol."}
  • {"endpoint_text":"- Secondary endpoint on PRO: Change from baseline in overall scores and individual scales of the EORTC QLQ-C30, EORTC QLQ-CML24.","definition_or_measurement_approach":"Patient-reported outcomes assessed by EORTC QLQ-C30 and EORTC QLQ-CML24; change from baseline in overall and scale scores."}
  • {"endpoint_text":"- Secondary endpoint on safety: Type, frequency and severity of adverse events, dose modification due to adverse event, changes in laboratory values that fall outside the pre-determined ranges and clinically notable ECG changes, and other safety data (vital signs, physical examination).","definition_or_measurement_approach":"Safety assessed by collection and grading of adverse events, dose modifications, laboratory value shifts outside predefined ranges, clinically notable ECG changes, vital signs and physical examinations."}

Recruitment

Planned Sample Size
187
Recruitment Window Months
104
Consent Approach
Signed informed consent must be obtained prior to participation. Participants are adults (≥18 years) and provide their own consent. Subject information and ICF documents are available in multiple country-specific language versions (multiple ICFs and follow-up ICFs listed). No assent procedures are required because minors are excluded.

Geography

Total Number Of Sites
78
Total Number Of Participants
383

Germany

Latest Decision Or Authorization Date
16-07-2025
Number Of Sites
31
Number Of Participants
145

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
#2040:Hämatologie, Onkologie und Tumorimmunologie
Principal Investigator Name
Philipp Le Coutre
Principal Investigator Email
philipp.lecoutre@charite.de
Contact Person Name
Philipp Le Coutre
Contact Person Email
philipp.lecoutre@charite.de
Site Name
Gesundheit Nord gGmbH Klinikverbund Bremen
Department Name
#2050:Medizinische Klinik I
Principal Investigator Name
Matthias Bormann
Principal Investigator Email
matthias.bormann@klinikum-bremen-mitte.de
Contact Person Name
Matthias Bormann
Site Name
Martin-Luther-Universitaet Halle-Wittenberg
Department Name
#2059:Universitätsklinik und Poliklinik für Innere Medizin IV
Principal Investigator Name
Nadja Jäkel
Principal Investigator Email
Nadja.jaekel@uk-halle.de
Contact Person Name
Nadja Jäkel
Contact Person Email
Nadja.jaekel@uk-halle.de
Site Name
Gemeinschaftspraxis Haematologie Onkologie
Department Name
#2042:Hämatologie und Onkologie
Principal Investigator Name
Thomas Illmer
Principal Investigator Email
illmer@onkologie-dresden.net
Contact Person Name
Thomas Illmer
Contact Person Email
illmer@onkologie-dresden.net
Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
#2057:Klinik und Poliklinik für Innere Medizin III
Principal Investigator Name
Peter Herhaus
Principal Investigator Email
peter.herhaus@tum.de
Contact Person Name
Peter Herhaus
Contact Person Email
peter.herhaus@tum.de
Site Name
Klinikum Bayreuth GmbH
Department Name
#2048:Hämatologie und internistische Onkologie
Principal Investigator Name
Alexander Kiani
Principal Investigator Email
alexander.kiani@klinikum-bayreuth.de
Contact Person Name
Alexander Kiani
Site Name
Medical Center - University Of Freiburg
Department Name
#2064:Klinik für Innere Medizin I
Principal Investigator Name
Cornelius Waller
Principal Investigator Email
cornelius.waller@uniklinik-freiburg.de
Contact Person Name
Cornelius Waller
Site Name
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH
Department Name
#2053:Onkologie und Hämatologie
Principal Investigator Name
Michael Schenk
Principal Investigator Email
michael.schenk@barmherzige-regensburg.de
Contact Person Name
Michael Schenk
Site Name
Haematologie und Onkologie Muenchen-Pasing MVZ GmbH
Department Name
#2067:Gemeinschaftspraxis Hämato-Onkologie
Principal Investigator Name
Burkhard Schmidt
Principal Investigator Email
schmidt@onkologie-pasing.de
Contact Person Name
Burkhard Schmidt
Contact Person Email
schmidt@onkologie-pasing.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
#2047:Hämatologie und Stammzelltransplantaation
Principal Investigator Name
Joachim Goethert
Principal Investigator Email
joachim.goethert@uk-essen.de
Contact Person Name
Joachim Goethert
Contact Person Email
joachim.goethert@uk-essen.de
Site Name
Universitaetsklinikum Mannheim GmbH
Department Name
#2039:Hämatologie und Onkologie
Principal Investigator Name
Susanne Saussele
Principal Investigator Email
Susanne.saussele@medma.uni-heidelberg.de
Contact Person Name
Susanne Saussele
Site Name
Universitaetsklinikum Augsburg
Department Name
#2052:II. Medizinische Klinik
Principal Investigator Name
Klaus Hirschbühl
Principal Investigator Email
Klaus.hirschbuehl@uk-augsburg.de
Contact Person Name
Klaus Hirschbühl
Site Name
Universitaetsklinikum Aachen AöR
Department Name
#2038:Hämatologie,Onkologie,Hämostaseologie und Stammzelltransplantation
Principal Investigator Name
Martina Crysandt
Principal Investigator Email
mcrysandt@ukaachen.de
Contact Person Name
Martina Crysandt
Contact Person Email
mcrysandt@ukaachen.de
Site Name
Universitaetsklinikum Giessen und Marburg GmbH
Department Name
#2044:Hämatologie, Onkologie und Immunologie
Principal Investigator Name
Andreas Burchert
Principal Investigator Email
Studien-onkologie@uni-marburg.de
Contact Person Name
Andreas Burchert
Site Name
Universitaetsklinikum Schleswig-Holstein AöR
Department Name
#2055:Klinik für Hämatologie und Onkologie
Principal Investigator Name
Nikolas Von Bubnoff
Principal Investigator Email
Nikolas.vonBubnoff@uksh.de
Contact Person Name
Nikolas Von Bubnoff
Contact Person Email
Nikolas.vonBubnoff@uksh.de
Site Name
Onkologisches Zentrum am Raschplatz GbR
Department Name
#2051:Onkologische Praxis
Principal Investigator Name
Eyck Von der Heyde
Principal Investigator Email
vdheyde@onokologie-am-raschplatz.de
Contact Person Name
Eyck Von der Heyde
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
#2062:II Medizinische Klinik und Poliklinik
Principal Investigator Name
Philippe Schafhausen
Principal Investigator Email
schafhausen@uke.de
Contact Person Name
Philippe Schafhausen
Contact Person Email
schafhausen@uke.de
Site Name
Universitaetsklinikum Ulm AöR
Department Name
#2049:Klinik für Innere Medizin
Principal Investigator Name
Frank Stegelmann
Principal Investigator Email
Frank.Stegelmann@uniklinik-ulm.de
Contact Person Name
Frank Stegelmann
Site Name
Goethe University Frankfurt
Department Name
#2041:Hämatologie und Onkologie
Principal Investigator Name
Fabian Lang
Principal Investigator Email
Fabian.Lang@kgu.de
Contact Person Name
Fabian Lang
Contact Person Email
Fabian.Lang@kgu.de
Site Name
Eberhard Karls Universitaet Tuebingen
Department Name
#2061:Onkologie,Hämatologie, Immunologie, Rheumatologie und Pulmonologie
Principal Investigator Name
Robert Möhle
Principal Investigator Email
robert.moehle@med.uni-tuebingen.de
Contact Person Name
Robert Möhle
Site Name
Brüderkrankenhaus St. Josef Paderborn
Department Name
#2054:Hämatologie und Onkologie
Principal Investigator Name
Tobias Gaska
Principal Investigator Email
t.gaska@bk-paderborn.de
Contact Person Name
Tobias Gaska
Contact Person Email
t.gaska@bk-paderborn.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
#2068:Medizinische Klinik 5 – Hämatologie und Internistische Onkologie
Principal Investigator Name
Valeska Brückl
Principal Investigator Email
Valeska.brueckl@uk-erlangen.de
Contact Person Name
Valeska Brückl
Contact Person Email
Valeska.brueckl@uk-erlangen.de
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
#2056:Klinik für Hämatologie, Onkologie und Rheumatologie
Principal Investigator Name
Tim Sauer
Principal Investigator Email
Tim.Sauer@med.uni-heidelberg.de
Contact Person Name
Tim Sauer
Site Name
MVZ Onkologie Velbert GbR
Department Name
#2058:MVZ für Hämatologie und Onkologie
Principal Investigator Name
Arnd Nusch
Principal Investigator Email
nusch@aol.com
Contact Person Name
Arnd Nusch
Contact Person Email
nusch@aol.com
Site Name
Schwerpunktpraxis für Hämatologie und Onkologie
Department Name
#2066:Hämatologie und Onkologie
Principal Investigator Name
Kathleen Jentsch-Ullrich
Principal Investigator Email
ju@onkologie-magdeburg.de
Contact Person Name
Kathleen Jentsch-Ullrich
Contact Person Email
ju@onkologie-magdeburg.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
#2045:Medizinische Klinik und Poliklinik III
Principal Investigator Name
Lino Teichmann
Principal Investigator Email
Lino.teichmann@ukbonn.de
Contact Person Name
Lino Teichmann
Contact Person Email
Lino.teichmann@ukbonn.de
Site Name
Universitaet Leipzig
Department Name
#2043:Hämatologie, Zelltherapie und Hämostaseologie
Principal Investigator Name
Georg-Nikolaus Franke
Contact Person Name
Georg-Nikolaus Franke
Site Name
Universitaetsklinikum Jena KöR
Department Name
#2037:Hämatologie und Internistische Onkologie
Principal Investigator Name
Andreas Hochhaus
Principal Investigator Email
andreas.hochhaus@med.uni-jena.de
Contact Person Name
Andreas Hochhaus
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
#2065:Interdisziplinäres Studienzentrum
Principal Investigator Name
Thomas Bumm
Principal Investigator Email
bumm_t@ukw.de
Contact Person Name
Thomas Bumm
Contact Person Email
bumm_t@ukw.de
Site Name
Klinikum Chemnitz gGmbH
Department Name
#2046:Hämatologie und Onkologie
Principal Investigator Name
Mathias Hänel
Principal Investigator Email
m.haenel@skc.de
Contact Person Name
Mathias Hänel
Contact Person Email
m.haenel@skc.de
Site Name
HELIOS Klinikum Bad Saarow GmbH
Department Name
#2060:Klinik für Hämatologie
Principal Investigator Name
Daniel Schöndube
Principal Investigator Email
daniel.schoendube@helios-gesundheit.de
Contact Person Name
Daniel Schöndube

Romania

Latest Decision Or Authorization Date
02-07-2024
Number Of Sites
8
Number Of Participants
20

Sites

Site Name
Spitalul Clinic Judetean De Urgenta Targu Mures
Department Name
#2119: 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
Site Name
Spitalul Clinic Municipal Filantropia Craiova
Department Name
#2111: Hematology
Principal Investigator Name
Luminita Ocroteala
Principal Investigator Email
diaconu_luminita@yahoo.com
Contact Person Name
Luminita Ocroteala
Contact Person Email
diaconu_luminita@yahoo.com
Site Name
Institutul Clinic Fundeni
Department Name
#2116: Hematology
Principal Investigator Name
Daniel Coriu
Principal Investigator Email
daniel_coriu@yahoo.com
Contact Person Name
Daniel Coriu
Contact Person Email
daniel_coriu@yahoo.com
Site Name
Centrul De Diagnostic Si Tratament Provita S.A.
Department Name
#2113: Hematology
Principal Investigator Name
Nicoleta Berbec
Principal Investigator Email
nicole_olt@yahoo.com
Contact Person Name
Nicoleta Berbec
Contact Person Email
nicole_olt@yahoo.com
Site Name
Spitalul Clinic Judetean de Urgenta Sibiu
Department Name
#2112: Hematology
Principal Investigator Name
Alina Camelia Catana
Principal Investigator Email
alinabrabete@yahoo.com
Contact Person Name
Alina Camelia Catana
Contact Person Email
alinabrabete@yahoo.com
Site Name
Spitalul Clinic Coltea
Department Name
#2114: Hematology
Principal Investigator Name
Oana Stanca
Principal Investigator Email
oacioc@yahoo.com
Contact Person Name
Oana Stanca
Contact Person Email
oacioc@yahoo.com
Site Name
Spitalul Clinic Municipal De Urgenta Timisoara
Department Name
#2115: Hematology
Principal Investigator Name
Ioana Ionita
Principal Investigator Email
mdioanaionita@yahoo.com
Contact Person Name
Ioana Ionita
Contact Person Email
mdioanaionita@yahoo.com
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
#2117: Hematology
Principal Investigator Name
Delia Monica Dima
Principal Investigator Email
deli_dima@yahoo.com
Contact Person Name
Delia Monica Dima
Contact Person Email
deli_dima@yahoo.com

Netherlands

Latest Decision Or Authorization Date
19-06-2024
Number Of Sites
1
Number Of Participants
2

Sites

Site Name
Albert Schweitzer Ziekenhuis
Department Name
#2153: Hematology
Principal Investigator Name
Peter Westerweel
Principal Investigator Email
p.e.westerweel@asz.nl
Contact Person Name
Peter Westerweel
Contact Person Email
p.e.westerweel@asz.nl

Italy

Latest Decision Or Authorization Date
01-07-2024
Number Of Sites
5
Number Of Participants
25

Sites

Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
#2101: SSDB Ematologia e Trapianti CSE
Principal Investigator Name
Alessandro Lucchesi
Principal Investigator Email
alessandro.lucchesi@irst.emr.it
Contact Person Name
Alessandro Lucchesi
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
#2100: U.O. Ematologia
Principal Investigator Name
Sara Galimberti
Principal Investigator Email
sara.galimberti@unipi.it
Contact Person Name
Sara Galimberti
Contact Person Email
sara.galimberti@unipi.it
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
#2096: S.C. Ematologia
Principal Investigator Name
Marianna Caramella
Principal Investigator Email
marianna.caramella@ospedaleniguarda.it
Contact Person Name
Marianna Caramella
Site Name
Universita' Degli Studi Di Roma Tor Vergata
Department Name
#2098: U.O.C. Ematologia Presidio Ospedaliero S. Eugenio
Principal Investigator Name
Elisabetta Abbruzzese
Principal Investigator Email
elisabetta.abruzzese@uniroma2.it
Contact Person Name
Elisabetta Abbruzzese
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
#2097: S.C. Ematologia Presidio Ospedaliero Molinette
Principal Investigator Name
Marco Cerrano
Principal Investigator Email
mcerrano@cittadellasalute.to.it
Contact Person Name
Marco Cerrano

Slovakia

Latest Decision Or Authorization Date
24-06-2024
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
University Hospital Bratislava
Department Name
#2125: Nemocnica sv.Cyrila a Metoda, Klinika hematológie a tranfúziológie
Principal Investigator Name
Zuzana Sninská
Principal Investigator Email
zuzana.sninska@gmail.com
Contact Person Name
Zuzana Sninská
Contact Person Email
zuzana.sninska@gmail.com
Site Name
Univerzitna nemocnica L. Pasteura Kosice
Department Name
#2126: Klinika hematológie a onkohematológie
Principal Investigator Name
Tomáš Guman
Principal Investigator Email
tomas.guman@unlp.sk
Contact Person Name
Tomáš Guman
Contact Person Email
tomas.guman@unlp.sk

Czechia

Latest Decision Or Authorization Date
20-06-2024
Number Of Sites
4
Number Of Participants
25

Sites

Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
#2011: Hematologicka klinika
Principal Investigator Name
Olga Cerna
Principal Investigator Email
Olga.cerna@fnkv.cz
Contact Person Name
Olga Cerna
Contact Person Email
Olga.cerna@fnkv.cz
Site Name
Institute Of Hematology And Blood Transfusion
Department Name
#2012:Hematologie
Principal Investigator Name
Dana Srbova
Principal Investigator Email
dana.srbova@uhkt.cz
Contact Person Name
Dana Srbova
Contact Person Email
dana.srbova@uhkt.cz
Site Name
Fakultni Nemocnice Plzen
Department Name
#2010: Hematoonkologicke-onkologicke oddeleni
Principal Investigator Name
Pavel Jindra
Principal Investigator Email
jindra@fnplzen.cz
Contact Person Name
Pavel Jindra
Contact Person Email
jindra@fnplzen.cz
Site Name
Fakultni Nemocnice Brno
Department Name
#2013: Interni hematologicka a onkologicka klinika
Principal Investigator Name
Jiri Mayer
Principal Investigator Email
Mayer.jiri@fnbrno.cz
Contact Person Name
Jiri Mayer
Contact Person Email
Mayer.jiri@fnbrno.cz

Greece

Latest Decision Or Authorization Date
22-07-2024
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
General University Hospital Of Patras
Department Name
#2078: Hematology 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
Laiko General Hospital Of Athens
Department Name
#2077: Hematology 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
Site Name
University General Hospital Of Ioannina
Department Name
#2080: Hematology Department
Principal Investigator Name
Eleni Kapsali
Principal Investigator Email
elkapsali@gmail.com
Contact Person Name
Eleni Kapsali
Contact Person Email
elkapsali@gmail.com
Site Name
Evangelismos S.A.
Department Name
#2082: Hematology Clinic
Principal Investigator Name
Maria Pagoni
Principal Investigator Email
marianpagoni@yahoo.com
Contact Person Name
Maria Pagoni
Contact Person Email
marianpagoni@yahoo.com
Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
#2079: Heamatology Clinic
Principal Investigator Name
Michail Iskas
Principal Investigator Email
mic_iskas@yahoo.fr
Contact Person Name
Michail Iskas
Contact Person Email
mic_iskas@yahoo.fr

France

Latest Decision Or Authorization Date
27-06-2024
Number Of Sites
13
Number Of Participants
100

Sites

Site Name
Centre Leon Berard
Department Name
#2035: Medical oncology department
Principal Investigator Name
Franck-Emmanuel Nicolini
Principal Investigator Email
franck-emmanuel.nicolini@lyon.unicancer.fr
Contact Person Name
Franck-Emmanuel Nicolini
Site Name
Institut Bergonie
Department Name
#2020: Oncologie Medicale
Principal Investigator Name
Gabriel ETIENNE
Principal Investigator Email
g.etienne@bordeaux.unicancer.fr
Contact Person Name
Gabriel ETIENNE
Site Name
University Hospital Of Clermont-Ferrand
Department Name
#2027: Department of Hematology
Principal Investigator Name
Marc Berger
Principal Investigator Email
mberger@chu-clermontferrand.fr
Contact Person Name
Marc Berger
Contact Person Email
mberger@chu-clermontferrand.fr
Site Name
CHRU De Nancy
Department Name
#2022: Department of Hematology
Principal Investigator Name
Gabrielle Roth-Guepin
Principal Investigator Email
g.roth-guepin@chru-nancy.fr
Contact Person Name
Gabrielle Roth-Guepin
Contact Person Email
g.roth-guepin@chru-nancy.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
#2024: Department of Haematology
Principal Investigator Name
Valerie Coiteux
Principal Investigator Email
valerie.coiteux@chru-lille.fr
Contact Person Name
Valerie Coiteux
Contact Person Email
valerie.coiteux@chru-lille.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
#2029: Department of Hematology
Principal Investigator Name
Shanti Ame
Principal Investigator Email
s.ame@icans.eu
Contact Person Name
Shanti Ame
Contact Person Email
s.ame@icans.eu
Site Name
Institut Paoli Calmettes
Department Name
#2023: Department of Hematology
Principal Investigator Name
Aude Charbonnier
Principal Investigator Email
charbonniera@ipc.unicancer.fr
Contact Person Name
Aude Charbonnier
Contact Person Email
charbonniera@ipc.unicancer.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
#2033: Hematology and Immunology department
Principal Investigator Name
Delphine Rea
Principal Investigator Email
delphine.rea@aphp.fr
Contact Person Name
Delphine Rea
Contact Person Email
delphine.rea@aphp.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
#2026: Department of Hematology
Principal Investigator Name
Thomas Cluzeau
Principal Investigator Email
cluzeau.t@chu-nice.fr
Contact Person Name
Thomas Cluzeau
Contact Person Email
cluzeau.t@chu-nice.fr
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
#2028: Department of Hematology
Principal Investigator Name
Atchroué Johnson-Ansah
Principal Investigator Email
johnsonansah-a@chu-caen.fr
Contact Person Name
Atchroué Johnson-Ansah
Contact Person Email
johnsonansah-a@chu-caen.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
#2034: Department of Hematology clinic
Principal Investigator Name
Viviane Dubruille
Principal Investigator Email
viviane.dubruille@chu-nantes.fr
Contact Person Name
Viviane Dubruille
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
#2025: Hematological oncology and cellular therapy
Principal Investigator Name
Emilie CAYSSIALS
Principal Investigator Email
emilie.cayssials@chu-poitiers.fr
Contact Person Name
Emilie CAYSSIALS
Site Name
Institut Universitaire Du Cancer Toulouse-Oncopole
Department Name
#2021: Department of Hematology
Principal Investigator Name
Francoise Huguet
Principal Investigator Email
huguet.francoise@iuct-oncopole.fr
Contact Person Name
Francoise Huguet

Hungary

Latest Decision Or Authorization Date
20-06-2024
Number Of Sites
3
Number Of Participants
15

Sites

Site Name
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Department Name
#2088: Heamatology
Principal Investigator Name
Arpad Batai
Principal Investigator Email
batai.arpad@dpckorhaz.hu
Contact Person Name
Arpad Batai
Contact Person Email
batai.arpad@dpckorhaz.hu
Site Name
Heves Varmegyei Markhot Ferenc Oktatokorhaz Es Rendelointezet
Department Name
#2087: Belgyogyaszati Centrum
Principal Investigator Name
Balazs Tajti
Principal Investigator Email
tajti.balazs@mfkh.hu
Contact Person Name
Balazs Tajti
Contact Person Email
tajti.balazs@mfkh.hu
Site Name
Semmelweis University
Department Name
#2086: Belgyogyaszati es Hematologiai Klin
Principal Investigator Name
Zsolt Nagy
Principal Investigator Email
nagy.zsolt@med.semmelweis-univ.hu
Contact Person Name
Zsolt Nagy

Bulgaria

Latest Decision Or Authorization Date
02-08-2024
Number Of Sites
6
Number Of Participants
30

Sites

Site Name
University Hospital St Marina Varna
Department Name
#2000: Clinic of Clinical Hematology
Principal Investigator Name
Ilina Micheva
Principal Investigator Email
ilinamicheva@gmail.com
Contact Person Name
Ilina Micheva
Contact Person Email
ilinamicheva@gmail.com
Site Name
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Department Name
#2004: Clinic of Clinical Hematology
Principal Investigator Name
Victoria Babacheva-Bahchevanova
Principal Investigator Email
drbabacheva@gmail.com
Contact Person Name
Victoria Babacheva-Bahchevanova
Contact Person Email
drbabacheva@gmail.com
Site Name
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Department Name
#2002: Clinic of Clinical Hematology
Principal Investigator Name
Lachezar Bogdanov
Principal Investigator Email
bogdanov71@gmail.com
Contact Person Name
Lachezar Bogdanov
Contact Person Email
bogdanov71@gmail.com
Site Name
Alexandrovska University Hospital
Department Name
#2001: Clinic of Clinical Hematology
Principal Investigator Name
Gergana Tsvetkova
Principal Investigator Email
g.tsvetkova@yahoo.com
Contact Person Name
Gergana Tsvetkova
Contact Person Email
g.tsvetkova@yahoo.com
Site Name
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Department Name
#2005: Department of Clinical Hematology
Principal Investigator Name
Atanas Radinoff
Principal Investigator Email
aradinoff@hotmail.com
Contact Person Name
Atanas Radinoff
Contact Person Email
aradinoff@hotmail.com
Site Name
Specialized Hospital For Active Treatment Of Hematological Diseases EAD
Department Name
#2003: Clinic of Clinical Hematology
Principal Investigator Name
Penka Ganeva
Principal Investigator Email
ganevapenka@yahoo.com
Contact Person Name
Penka Ganeva
Contact Person Email
ganevapenka@yahoo.com

Sponsor

Primary sponsor

Full Name
Novartis Pharma AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
Syneos Health Inc.
Responsibilities
code:1
Name
Icon Clinical Research Limited
Responsibilities
code:1; code:4
Name
PRA Hellas CRO A.E.
Responsibilities
code:1
Name
Parexel International (IRL) Limited
Responsibilities
code:12
Name
IQVIA Limited
Responsibilities
code:1; code:3

Third parties

  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Opis S.r.l.","duties_or_roles":"code 15: TMF archive","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"code:4","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Greece","full_name":"Famar Anonymous Industrial Single Member Company Of Pharmaceuticals And Cosmetics","duties_or_roles":"code 15: Local Drug Relabeling","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Phardis S.r.l.","duties_or_roles":"code 15: Local equipment storage","organisation_type":"Pharmaceutical company"}
  • {"country":"Romania","full_name":"Alliance Healthcare Romania S.R.L.","duties_or_roles":"code:14; code 15: Ax MP management (storage; site distribution; return and destruction) IMP collection from site, return and destruction","organisation_type":"Pharmaceutical company"}
  • {"country":"Czechia","full_name":"Movianto Ceska republika s.r.o.","duties_or_roles":"code:14; code 15: Medicinal product re-labelling, storage, destruction of unused medicinal product","organisation_type":"Pharmaceutical company"}
  • {"country":"Slovakia","full_name":"Movianto Slovensko s.r.o.","duties_or_roles":"code:14; code 15: Storage, distribution, labelling of IMP, storage,after return from site and prior to destruction","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"code 15: Certified translations","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"PRA Hellas CRO A.E.","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"code:1; code:4","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Creapharm Clinical Supplies","duties_or_roles":"code:14; code 15: Drug distribution, storage, relabeling, return and destruction","organisation_type":"Pharmaceutical company"}
  • {"country":"Bulgaria","full_name":"World Courier Bulgaria EOOD","duties_or_roles":"code 15: IMPD transportation from sites","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Hungary","full_name":"ADR Logistics Kft.","duties_or_roles":"code 15: Drug storage, distribution, and destruction","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"code:12","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"code:7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Various","full_name":"Movianto (other entries in different MSCs)","duties_or_roles":"various logistics and labelling roles (see parties list)","organisation_type":"Pharmaceutical company"}
  • {"country":"Various","full_name":"Remainder third-party organisations","duties_or_roles":"See sponsor thirdParties list for individual duties/roles (storage, labelling, translations, transport, IMP management, TMF archive, certified translations, local relabelling)","organisation_type":"Various"}

Investigational products

Investigational Product Name
ASCIMINIB HYDROCHLORIDE
Active Substance
ASCIMINIB HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Orphan Designation
Yes
Maximum Dose
80 mg
Investigational Product Name
NILOTINIB
Active Substance
NILOTINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL
Maximum Dose
600 mg

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