Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
405
Countries
15
Sites
41
Chronic Myeloid Leukemia
To compare the efficacy of asciminib versus Investigator selected TKI with respect to the proportion of participants that are in Major Molecular Response (MMR) at Week 48. To compare the efficacy of asciminib versus Investigator selected TKI, within the stratum of participants with imatinib as the pre-randomization sel…
Key facts
- Sponsor
- Novartis Pharma AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 6 Oct 2021 → ongoing
- Decision date (initial)
- 2024-05-21
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
- Funding sources
- Novartis Pharma AG
External identifiers
- EU CT number
- 2023-508838-33-00
- EudraCT number
- 2021-000678-27
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Pharmacodynamic, Pharmacogenetic, Therapy, Efficacy, Safety
To compare the efficacy of asciminib versus Investigator selected TKI with respect to the proportion of participants that are in Major Molecular Response (MMR) at Week 48.
To compare the efficacy of asciminib versus Investigator selected TKI, within the stratum of participants with imatinib as the pre-randomization selected TKI, with respect to the proportion of participants that are in MMR at Week 48.
Secondary objectives 2
- To compare the efficacy of asciminib versus Investigator selected TKI, with respect to the proportion of participants that are in MMR at Week 96.
- To compare the efficacy of asciminib versus Investigator selected TKI, within the stratum of participants with imatinib as the pre-randomization selected TKI, with respect to the proportion of participants that are in MMR at Week 96.
Conditions and MedDRA coding
Chronic Myeloid Leukemia
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Male or female participants ≥ 18 years of age.
- Participants with CML-CP within 3 months of diagnosis.
- Diagnosis of CML-CP (ELN 2020 criteria) with cytogenetic confirmation of the Philadelphia chromosome • Documented chronic phase CML will meet all the below criteria (Hochhaus et al 2020): • < 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.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate end organ function as defined by: • Total bilirubin (TBL) < 3 x upper limit of normal (ULN); participants 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 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
- Participants 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 participants 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 ≥ LLN or corrected to within normal limits with supplements prior to randomization. • CrCl* as calculated using Cockcroft-Gault formula
- Signed informed consent must be obtained prior to any study related screening procedures being performed.
- Evidence of typical BCR-ABL1 transcript [e14a2 and/or e13a2] at the time of screening which is amenable to standardized Real time quantitative polymerase chain reaction (RQ-PCR) quantification.
Exclusion criteria 9
- 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. Treatment with either imatinib, or nilotinib, or dasatinib or bosutinib for ≤ 2 weeks is allowed. No treatment with other tyrosine kinase inhibitors prior to randomization is permitted.
- Known cytopathologically confirmed CNS infiltration (in absence of suspicion of CNS involvement, lumbar puncture not required).
- Impaired cardiac function or cardiac repolarization abnormality including but not limited to any one of the following: • History within 6 months prior to starting study treatment of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG). • Clinically 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). • QTc ≥ 450 ms (male participants), ≥ 460 ms (female participants) on the average of three serial baseline ECG (using the QTcF formula) as determined by central reading. If QTcF ≥ 450 ms and electrolytes are not within normal ranges, electrolytes should be corrected and then the participant re-screened for QTc. • Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following: • Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia. • Concomitant 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 drug by safe alternative medication. • Inability to determine the QTcF interval.
- 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).
- History of significant congenital or acquired bleeding disorder unrelated to cancer.
- Major surgery within 4 weeks prior to study entry or who have not recovered from prior surgery.
- 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.
- History of acute pancreatitis within 1 year prior to randomization or medical history of chronic pancreatitis.
- History of chronic liver disease leading to severe hepatic impairment, or ongoing acute liver disease.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Major Molecular Response (MMR) at Week 48 (Yes/No)
Secondary endpoints 2
- Major Molecular Response (MMR) at Week 96 (Yes/No)
- Major Molecular response (MMR) at Week 96 (Yes/No)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB204228 · Substance
- Active substance
- Asciminib Hydrochloride
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 267667.20 mg milligram(s)
- Max treatment duration
- 110 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/20/2261
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Packaged in bottles for clinical trials as compared to the commercial presentation in blisters. SL is 48 months for HDPE bottle (clinical packaging) and SL is 36 months for blister packs (commercial packaging).
Comparator 13
SUB29176 · Substance
- Active substance
- Bosutinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 1338336 mg milligram(s)
- Max treatment duration
- 110 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Sourced locally from the commercial market, may be over-labelled.
SUB29176 · Substance
- Active substance
- Bosutinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 1338336 mg milligram(s)
- Max treatment duration
- 110 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Sourced locally from the commercial market, may be over-labelled.
SUB25387 · Substance
- Active substance
- Imatinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 1338336 mg milligram(s)
- Max treatment duration
- 110 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Sourced locally from the commercial market, may be over-labelled.
SUB25387 · Substance
- Active substance
- Imatinib
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 1338336 mg milligram(s)
- Max treatment duration
- 110 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Sourced locally from the commercial market, may be over-labelled.
SUB25225 · Substance
- Active substance
- Nilotinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 2007504 mg milligram(s)
- Max treatment duration
- 110 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Sourced locally from the commercial market, may be over-labelled.
SUB25225 · Substance
- Active substance
- Nilotinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 2007504 mg milligram(s)
- Max treatment duration
- 110 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Sourced locally from the commercial market, may be over-labelled.
SUB25387 · Substance
- Active substance
- Imatinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 1338336 mg milligram(s)
- Max treatment duration
- 110 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Sourced locally from the commercial market, may be over-labelled.
SUB23322 · Substance
- Active substance
- Dasatinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 334584 mg milligram(s)
- Max treatment duration
- 110 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Sourced locally from the commercial market, may be over-labelled.
SUB23322 · Substance
- Active substance
- Dasatinib
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 334584 mg milligram(s)
- Max treatment duration
- 110 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Sourced locally from the commercial market, may be over-labelled.
SUB23322 · Substance
- Active substance
- Dasatinib
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 334584 mg milligram(s)
- Max treatment duration
- 110 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Sourced locally from the commercial market, may be over-labelled.
SUB23322 · Substance
- Active substance
- Dasatinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 334584 mg milligram(s)
- Max treatment duration
- 110 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Sourced locally from the commercial market, may be over-labelled.
SUB23322 · Substance
- Active substance
- Dasatinib
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 334584 mg milligram(s)
- Max treatment duration
- 110 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Sourced locally from the commercial market, may be over-labelled.
SUB23322 · Substance
- Active substance
- Dasatinib
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 334584 mg milligram(s)
- Max treatment duration
- 110 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Sourced locally from the commercial market, may be over-labelled.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novartis Pharma AG
- Sponsor organisation
- Novartis Pharma AG
- Address
- Lichtstrasse 35
- City
- Basel
- Postcode
- 4056
- Country
- Switzerland
Scientific contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Public contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Third parties 19
| Organisation | City, country | Duties |
|---|---|---|
| Clinical Outcomes Solutions LLC ORG-100045476
|
Tucson, United States | Code 10 |
| Mipharm S.p.A. ORG-100000724
|
Milan, Italy | Other |
| Specific Pharma A/S ORG-100015041
|
Copenhagen Sv, Denmark | Code 14, Other |
| Opis S.r.l. ORG-100011127
|
Desio, Italy | Other |
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | Code 12 |
| Q Squared Solutions LLC ORG-100043195
|
Durham, United States | Other, Laboratory analysis |
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | On site monitoring |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Data management, E-data capture |
| Creapharm Clinical Supplies ORG-100020131
|
Le Haillan, France | Code 14, Other |
| Illingworth Research Group Limited ORG-100042356
|
Macclesfield, United Kingdom | Code 13 |
| Mag. Andreas Raffeiner GmbH ORG-100043223
|
Walding, Austria | Code 8 |
| Sa Pathology ORG-100044405
|
Adelaide, Australia | Other, Laboratory analysis |
| Eurofins Genomics Europe AgriGenomics Products & Services A/S ORG-100044656
|
Aarhus N, Denmark | Other, Laboratory analysis |
| Veeda Clinical Research Limited ORG-100012827
|
Ahmedabad, India | Other, Laboratory analysis |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring, Other, Interactive response technologies (IRT) |
| Navigate Biopharma Services Inc. ORG-100032721
|
Carlsbad, United States | Other, Laboratory analysis |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | On site monitoring, Laboratory analysis |
| Wuxi Apptec Co. Ltd. ORG-100012470
|
Shanghai, China | Other, Laboratory analysis |
| Yprime LLC ORG-100042888
|
Malvern, United States | Other, E-data capture |
Locations
15 EU/EEA countries · 41 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 1 | 1 |
| Belgium | Ongoing, recruitment ended | 2 | 2 |
| Bulgaria | Ongoing, recruitment ended | 5 | 1 |
| Czechia | Ongoing, recruitment ended | 25 | 3 |
| Denmark | Ongoing, recruitment ended | 3 | 2 |
| Finland | Ongoing, recruitment ended | 3 | 1 |
| France | Ongoing, recruitment ended | 25 | 4 |
| Germany | Ongoing, recruitment ended | 35 | 6 |
| Hungary | Ongoing, recruitment ended | 6 | 3 |
| Italy | Ongoing, recruitment ended | 19 | 5 |
| Norway | Ongoing, recruitment ended | 7 | 2 |
| Portugal | Ongoing, recruitment ended | 5 | 2 |
| Slovakia | Ongoing, recruitment ended | 5 | 1 |
| Spain | Ongoing, recruitment ended | 12 | 5 |
| Sweden | Ongoing, recruitment ended | 6 | 3 |
| Rest of world
Korea, Republic of, Japan, Canada, United States, Australia, India, Israel, Switzerland, Taiwan, Singapore, Malaysia, United Kingdom, China
|
— | 246 | — |
Investigational sites
Institut Jules Bordet
#2033: Hematology, Mijlenmeersstraat 90, 1070, Anderlecht
UZ Leuven
#2030: Hematology, Herestraat 49, 3000, Leuven
University Hospital St Marina Varna
#2091: Clinic of Clinical Hematology, Hristo Smirnenski St 1, 9010, Varna
Fakultni Nemocnice Brno
#2080: Interni hematologicka a onkologicka klinika, Jihlavska 340/20, Bohunice, Brno
Fakultni Nemocnice Ostrava
#2082: Klinika hematoonkologie, 17. Listopadu 1790/5, 708 00, Poruba
Fakultni Nemocnice Hradec Kralove
#2081: IV. interni hematologicka klinika, Sokolska 581, 500 03, Novy Hradec Kralove
Aarhus Universitetshospital
#2070: Blodsygdomme, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Rigshospitalet
#2071: Afdeling for Blodsygdomme, Klinsk forskningsenhed, Blegdamsvej 9, 2100, Copenhagen Oe
Hopital Saint Louis
#2010: Hematologie et Immunologie, 1 Avenue Claude Vellefaux, 75010, Paris
Institut Bergonie
#2011: Oncologie medicale, 229 Cours De L Argonne, 33000, Bordeaux
Centre Leon Berard
#2012: Hematologie, 28 Rue Laennec, 69008, Lyon
Centre Hospitalier Universitaire De Nantes
#2014: Hematologie clinique, 1 Place Alexis Ricordeau, 44000, Nantes
Goethe University Frankfurt
#2153: Hämatologie und Onkologie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Universitaetsklinikum Aachen AöR
#2152: Hämatologie und Onkologie, Pauwelsstrasse 30, 52074, Aachen
Universitaetsklinikum Mannheim GmbH
#2151: III. Medizinische Klinik – Hämatologie und Internistische Onkologie, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Universitaetsklinikum Schleswig-Holstein AöR
#2155: Hämatologie und Onkologie, Ratzeburger Allee 160, 23538, Luebeck
Charite Universitaetsmedizin Berlin KöR
#2154: Hämatologie und Onkologie und Tumorimmunologie, Augustenburger Platz 1, Wedding, Berlin
Universitaetsklinikum Jena KöR
#2150: Hämatologie und Internistische Onkologie, Am Klinikum 1, Lobeda, Jena
Bacs-Kiskun Varmegyei Oktatokorhaz
#2001: II. Belgyogyaszati Osztaly, Nyiri Ut 38, 6000, Kecskemet
Somogy Varmegyei Kaposi Mor Oktato Korhaz
#2002: Hematológiai Osztály, Tallian Gyula Utca 20-32, 7400, Kaposvar
University Of Debrecen
#2000: Hematologia Osztaly, Nagyerdei Korut 98, 4032, Debrecen
Azienda Ospedaliera Universitaria Integrata Verona
#2160: UOC Ematologia, Ospedale Borgo Roma Policlinico G. B. Rossi, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
Azienda USL IRCCS Di Reggio Emilia
#2164: UOC Ematologia, Presidio Ospedaliero Arcispedale S. Maria Nuova, Viale Risorgimento 80, 42123, Reggio Emilia
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
#2163: SC Ematologia, Via Francesco Sforza 35, 20122, Milan
Azienda Ospedaliero-Universitaria Policlinico Umberto I
#2162: UOC Ematologia, Università La Sapienza, Viale Del Policlinico 155, 00161, Rome
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
#2161: Istituto di Ematologia L.e A.Seragnoli, Via Pietro Albertoni 15, 40138, Bologna
Oslo University Hospital HF
#2050: Avdeling for blodsykdommer, Sognsvannsveien 20, 0372, Oslo
Helse Bergen HF
#2051: Seksjon for blodsjukdommar, Haukelandsveien 22, 5021, Bergen
Centro Hospitalar De Vila Nova De Gaia/Espinho E.P.E.
#2140: Serviço de Hematologia, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
#2142: Serviço de Hematologia, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Univerzitna nemocnica L. Pasteura Kosice
#2112: Klinika Hematológie a Onkohematológie, Trieda Snp 1, Zapad, Kosice - Zapad
Hospital Universitario Virgen De Las Nieves
#2043: Consulta Hematología, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Hospital Universitario La Paz
#2044: Servicio Hematología, Paseo Castellana 261, 28046, Madrid
University Clinical Hospital Virgen De La Arrixaca
#2042: Unidad de trasplante hematopoyético y terapia celular, Carretera De Cartagena Sn, El Palmar, Murcia
Hospital Clinic De Barcelona
#2041: Inther unit, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario De Navarra
#2040: ensayos clínicos, Irunlarrea Kalea 3, 31008, Pamplona
Region Skane Skanes Universitetssjukhus
#2101: Hematologimottagningen, Entregatan 7, 222 42, Lund
Karolinska University Hospital
#2103: Cancerstudieenheten, M62, Halsovagen, Flemingsberg, Huddinge
Sahlgrenska University Hospital-Vastra Gotalandsregionen
#2102: Sektionen för hematologi och koagulation, Bruna Straket 16, 413 46, Gothenburg
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2022-05-11 | 2022-05-11 | 2022-12-20 | ||
| Belgium | 2022-05-31 | 2022-05-31 | 2022-12-20 | ||
| Bulgaria | 2022-07-06 | 2022-07-06 | 2022-12-20 | ||
| Czechia | 2021-10-20 | 2021-10-20 | 2022-12-20 | ||
| Denmark | 2022-05-11 | 2022-05-11 | 2022-12-20 | ||
| Finland | 2022-10-12 | 2022-10-12 | 2022-12-20 | ||
| France | 2022-01-11 | 2022-01-11 | 2022-12-20 | ||
| Germany | 2021-12-16 | 2021-12-16 | 2022-12-20 | ||
| Hungary | 2021-11-18 | 2021-11-18 | 2022-12-20 | ||
| Italy | 2022-01-27 | 2022-01-27 | 2022-12-20 | ||
| Norway | 2022-03-02 | 2022-03-02 | 2022-12-20 | ||
| Portugal | 2022-05-20 | 2022-05-20 | 2022-12-20 | ||
| Slovakia | 2022-03-23 | 2022-03-23 | 2022-12-20 | ||
| Spain | 2021-10-06 | 2021-10-06 | 2022-12-20 | ||
| Sweden | 2022-05-09 | 2022-05-09 | 2022-12-20 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 145 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Clinical study report (for publication) | CSR_CRF_2023-508838-33-00_1_Red | 1 |
| Clinical study report (for publication) | CSR_CRF_2023-508838-33-00_2_Red | 1 |
| Clinical study report (for publication) | CSR_Protocol_2023-508838-33-00_1_Red | 1 |
| Clinical study report (for publication) | CSR_Protocol_2023-508838-33-00_2_Red | 1 |
| Clinical study report (for publication) | CSR_Report Body_2023-508838-33-00_1_Red | 3 |
| Clinical study report (for publication) | CSR_Report Body_2023-508838-33-00_2_Red | 1 |
| Clinical study report (for publication) | CSR_stat_methods_2023-508838-33-00_1_Red | 1 |
| Clinical study report (for publication) | CSR_stat_methods_2023-508838-33-00_2_Red | 1 |
| Clinical study report (for publication) | CSR_Synopsis_2023-508838-33-00_1_Red | 1 |
| Clinical study report (for publication) | CSR_Synopsis_2023-508838-33-00_2_Red | 1 |
| Protocol (for publication) | D1_Benefit Risk Assessment_1_English_NonRed | 1.6.2021 |
| Protocol (for publication) | D1_Protocol - Signature Page_2023-508838-33-00_1_English_Red | 4.0 |
| Protocol (for publication) | D1_Protocol_2023-508838-33-00_1_English_Red | 4.0 |
| Protocol (for publication) | D4_Patient-facing document - Other_1_SE_Slovak_NonRed | V1 |
| Protocol (for publication) | D4_Patient-facing document - Other_2_SE_Slovak_NonRed | V1 |
| Protocol (for publication) | D4_Patient-facing document - Patient Card_1_SE_Slovak_NonRed | V1 |
| Protocol (for publication) | D4_Patient-facing document - PRO_1_Note to Assesor_NonRed | 14Nov2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_AT_English_NonRed | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_BE_English_Red | 11Oct2021 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_BG_Bulgarian_NonRed | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_CZ_English_NonRed | 07Aug2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_DE_English_NonRed | 27Sep2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_DK_English_NonRed_T | v1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_ES_English_Note to Assesor_NonRed | 07Aug2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_FI_Finnish_NonRed | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_FR_English_Note to Assesor_NonRed | 09Jul2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_HU_English_NonRed | v1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_IT_Italian_NonRed | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_PT_English_NonRed | 07Aug2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_SE_English_Note to Assesor_NonRed | 20Aug2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_SK_English_Note to Assesor_NonRed | 01 |
| Recruitment arrangements (for publication) | K1_Recruitments Arrangements_1_English_Red | 2 |
| Subject information and informed consent form (for publication) | L1_CF - Follow up for pregnant participant_1_DK_Danish_NonRed | V00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Additional Biomarkers_1_CZ_Czech_NonRed | V00.01.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Additional Biomarkers_1_DE_German_NonRed | V00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Efficacy Evaluation_1_SK_Slovak_Red | 04.00.01.M |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_AT_German_NonRed | 00.00.05 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_BG_Bulgarian_NonRed | 1 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_BG_English_NonRed | 00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_CZ_Czech_NonRed | V00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_DE_German_NonRed | V00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_ES_Spanish_NonRed | v00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_FI_Finnish_NonRed | 00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_FR_French_NonRed | V00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_HU_Hungarian_NonRed | V00.00.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_IT_Italian_NonRed | 00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_NO_Norwegian_NonRed | 00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_PT_Portuguese_NonRed | 1 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_SE_Swedish_NonRed | V00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_SK_Slovak_NonRed | V1 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_2_HU_Hungarian_NonRed | 00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant partner of participant_1_AT_German_NonRed | 00.00.05 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant partner of participant_1_DE_German_NonRed | V00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant partner of participant_1_PT_Portuguese_NonRed | 1 |
| Subject information and informed consent form (for publication) | L1_ICF - Home Nursing Service_1_HU_Hungarian_NonRed | V00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Home Nursing Service_2_HU_Hungarian_NonRed | 00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - ICF - Optional treatment beyond disease progression_1_BG_Bulgarian_Red | 04.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - ICF - Optional treatment beyond disease progression_1_BG_English_Red | 04.00 |
| Subject information and informed consent form (for publication) | L1_ICF - ICF - Optional treatment beyond disease progression_1_IT_Italian_NonRed | 00.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Info Sheet Female Partner_1_DE_German_NonRed | V00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Addendum - Adult_1_FR_French_NonRed | v03.07.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_AT_German_Red | v04.08.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_BE_Dutch_Red | v04.08.12 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_BE_English_Red | v04.08.12 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_BE_French_Red | v04.08.12 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_BG_Bulgarian_Red | v04.08.11 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_BG_English_Red | 04.08 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_CZ_Czech_Red | V01.05.05 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_DE_German_Red | V04.08.06 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_DK_Danish_Red | V04.08.05 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_ES_Spanish_Red | V04.08.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_FI_Finnish_Red | 04.08.08 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_FR_French_Red | 01.05.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_HU_Hungarian_Red | v04.08.07 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_IT_Italian_Red | 04.08.08 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_NO_Norwegian_Red | v04.08.09 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_PT_Portuguese_Red | 07.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_SE_Swedish_Red | 04.08.05 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_SK_Slovak_Red | 04.08.06.M |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_2_CZ_Czech_NonRed | V02.06.06 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_2_DE_German_Red | V04.08.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_2_ES_Spanish_Red | v04.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_2_FR_French_Red | 02.06.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_2_HU_Hungarian_NonRed | 02.06.05 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_2_Italian_Red | 04.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_2_PT_Portuguese_Red | 01.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_2_SE_Swedish_NonRed | V00.02.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_3_CZ_Czech_Red | V03.07.07 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_3_FR_French_Red | V04.00.05 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_3_SE_Swedish_NonRed | V00.02.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_4_CZ_Czech_Red | V04.08.08 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_4_SE _Swedish_Red | 04.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF addendum - Adult_2_FR_French_Red | V04.08.05 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF addendum - Adult_3_FR_French_Red | V04.08.06 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF TFR - Adult_1_HU_Hungarian_Red | v04.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_1_BE_Dutch_Red | v04.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_1_BE_English_Red | v04.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_1_BE_French_Red | v04.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_1_CZ_Czech_Red | V04.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_1_DE_German_Red | V04.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_1_DK_Danish_Red | V04.08.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_1_FI_English_Red | 15Jul2025 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_1_NO_Norwegian_Red | v04.00.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_2_CZ_Czech_Red | V04.08.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_2_DK_Danish_Red | V04.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_2_NO_Norwegian_Red | v04.08.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Parent Legal Guardian_1_FR_French_NonRed | V00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Pharmacokinetics_1_CZ_Czech_NonRed | V02.02.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Research_1_SE_Swedish_Red | 04.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent_1_CZ_Czech_NonRed | V03.07.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent_1_IT_Italian_NonRed | 02.06.06 |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent_1_SK_Slovak_NonRed | 2 |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent_2_SK_Slovak_NonRed | 2 |
| Subject information and informed consent form (for publication) | L1_List of submitted documents Part II | 07Oct2024 |
| Subject information and informed consent form (for publication) | L1_List of submitted documents Part II_2_HU_NonRed | 16Jul2025 |
| Subject information and informed consent form (for publication) | L1_Patient Card_1_Hungarian_NonRed | v02.06.02 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_1_AT_German_Red | 2 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_1_SK_Slovak_NonRed | V1 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_2_AT_German_Red | v3.1 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_2_DK_Danish_NonRed | 01Jan1900 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_2_SK_Slovak_NonRed | V1 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_3_AT_English_Note to Assesor_NonRed | 04Feb2025 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_3_DK_Danish_NonRed | 01Jan1900 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_PT_English_NonRed | 1 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_SE_Swedish_NonRed | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Reference SmPC_1_bosutinib_English_NonRed | 3-May-22 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Reference SmPC_1_dasatinib_English_NonRed | 17-Jun-22 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Reference SmPC_1_imatinib_English_NonRed | 13-Mar-22 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Reference SmPC_1_imatinib_English_NonRed | 13-Mar-22 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Reference SmPC_1_nilotinib_English_NonRed | 15-Jun-22 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-508838-33-00_1_Bulgarian_Red | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-508838-33-00_1_Czech_Red | V2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-508838-33-00_1_Dutch_Red | 01 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-508838-33-00_1_English_Red | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-508838-33-00_1_French_Red | 01 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-508838-33-00_1_German_Red | 01 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-508838-33-00_1_Hungarian_Red | V01 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-508838-33-00_1_Italian_Red | 01 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-508838-33-00_1_Norwegian_Red | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-508838-33-00_1_Portuguese_Red | 02.00 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-508838-33-00_1_Slovak_Red | V2 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-508838-33-00_1_Spanish_Red | v01 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-508838-33-00_1_Swedish_Red | 01 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Technical Language_2023-508838-33-00_1_Czech_Red | V3 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Technical Language_2023-508838-33-00_1_German_Red | 04 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-01 | Germany | Acceptable 2024-05-13
|
2024-05-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-01 | Germany | Acceptable 2025-02-12
|
2025-02-12 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-27 | Germany | Acceptable 2025-02-12
|
2025-02-27 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-24 | Germany | Acceptable 2025-06-20
|
2025-06-20 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-08-22 | Germany | Acceptable 2025-11-06
|
2025-11-07 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-11-21 | Acceptable | 2025-12-18 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-12-12 | Acceptable | 2026-01-08 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-01-22 | Acceptable | 2026-01-22 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-02-18 | Acceptable | 2026-03-18 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-03-13 | Acceptable | 2026-04-20 |