Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
461
Countries
14
Sites
85
chronic myelogenous leukemia (CML) or Philadelphia Chromosome positive acute lymphoblastic leukemia (Ph+ ALL)
The primary objective of this study is to assess long term safety data (i.e. Serious Adverse Events (SAEs) and Adverse Events (AEs)) of asciminib treatment in participants with Ph+CML-CP/-AP/-BP or Ph+ ALL that rollover from parent studies and provide continued access to study treatment received in the parent protocol.
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
- 31 Aug 2022 → ongoing
- Decision date (initial)
- 2024-05-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Novartis Pharma AG
External identifiers
- EU CT number
- 2023-507557-16-00
- EudraCT number
- 2021-000602-17
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy, Safety
The primary objective of this study is to assess long term safety data (i.e. Serious Adverse Events (SAEs) and Adverse Events (AEs)) of asciminib treatment in participants with Ph+CML-CP/-AP/-BP or Ph+ ALL that rollover from parent studies and provide continued access to study treatment received in the parent protocol.
Secondary objectives 1
- The secondary objective of this study is to evaluate clinical benefit as assessed by the Investigator.
Conditions and MedDRA coding
chronic myelogenous leukemia (CML) or Philadelphia Chromosome positive acute lymphoblastic leukemia (Ph+ ALL)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10009013 | Chronic myeloid leukaemia | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Participant with Ph+ CML or Ph+ ALL, currently receiving treatment with asciminib (single agent or in combination with imatinib, nilotinib or dasatinib) or study treatment received in the comparator arm while enrolled within a Novartis-sponsored study, who has fulfilled the requirements for the primary objective and has completed treatment phase and, in the opinion of the Investigator, would benefit from continued treatment.
Exclusion criteria 5
- Participant has been discontinued from parent study treatment due to any reason.
- Participant currently has unresolved toxicities of grade 3 or 4 reported as possibly related to study treatment in the parent study, which have: • not resolved to Grade 2 or lower within 42 days and /or require dose interruption for longer than 42 days for hematological toxicities, • not resolved to Grade 2 or lower within 28 days and /or require dose interruption for longer than 28 days in case of non-hematological toxicities.
- Participant’s ongoing treatment is currently approved and reimbursed at country level. In exceptional cases where the treatment is reimbursed at country but not individual level, please contact the Novartis Study Team.
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential unless they are using highly effective methods of contraception.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The frequency and severity of AEs/SAEs
Secondary endpoints 1
- Proportion of participants with clinical benefit as assessed by the investigator at scheduled visits
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 24
SUB25387 · Substance
- Active substance
- Imatinib
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 36000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Supplies of commercial imatinib obtained locally may be over labeled with clinical label.
SUB25387 · Substance
- Active substance
- Imatinib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 36000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Supplies of commercial imatinib obtained locally may be over labeled with clinical label.
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
- 36000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Supplies of commercial imatinib obtained locally may be over labeled with clinical label.
SUB204228 · Substance
- Active substance
- Asciminib Hydrochloride
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 560 mg milligram(s)
- Max total dose
- 36000 mg milligram(s)
- Max treatment duration
- 60 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
- Asciminib sourced locally from the commercial market, if available, may be over labeled.
SUB204228 · Substance
- Active substance
- Asciminib Hydrochloride
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 560 mg milligram(s)
- Max total dose
- 36000 mg milligram(s)
- Max treatment duration
- 60 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
- Asciminib sourced locally from the commercial market, if available, may be over labeled.
SUB29176 · Substance
- Active substance
- Bosutinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 45000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Supplies of commercial bosutinib obtained locally may be over labeled with clinical label.
SUB29176 · Substance
- Active substance
- Bosutinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 45000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Supplies of commercial bosutinib obtained locally may be over labeled with clinical label.
SUB23322 · Substance
- Active substance
- Dasatinib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 9000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- Eu/3/05/339
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Supplies of commercial dasatinib obtained locally may be over labeled with clinical label.
SUB23322 · Substance
- Active substance
- Dasatinib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 9000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- Eu/3/05/339
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Supplies of commercial dasatinib obtained locally may be over labeled with clinical label.
SUB23322 · Substance
- Active substance
- Dasatinib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 9000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- Eu/3/05/339
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Supplies of commercial dasatinib obtained locally may be over labeled with clinical label.
SUB23322 · Substance
- Active substance
- Dasatinib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 9000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- Eu/3/05/339
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Supplies of commercial dasatinib obtained locally may be over labeled with clinical label.
PRD3367272 · Product
- Active substance
- Nilotinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 54000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EA03 — -
- Marketing authorisation
- EU/1/07/422/013
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Supplies may be relabeled with a clinical label
PRD406804 · Product
- Active substance
- Nilotinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 54000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EA03 — -
- Marketing authorisation
- EU/1/07/422/010
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Supplies may be relabeled with a clinical label
PRD406805 · Product
- Active substance
- Nilotinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 54000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EA03 — -
- Marketing authorisation
- EU/1/07/422/001
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Supplies may be relabeled with a clinical label
PRD406803 · Product
- Active substance
- Nilotinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 54000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EA03 — -
- Marketing authorisation
- EU/1/07/422/009
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Supplies may be relabeled with a clinical label
PRD406811 · Product
- Active substance
- Nilotinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 54000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EA03 — -
- Marketing authorisation
- EU/1/07/422/011
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Supplies may be relabeled with a clinical label
PRD406810 · Product
- Active substance
- Nilotinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 54000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EA03 — -
- Marketing authorisation
- EU/1/07/422/008
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Supplies may be relabeled with a clinical label
PRD3367271 · Product
- Active substance
- Nilotinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 54000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EA03 — -
- Marketing authorisation
- EU/1/07/422/014
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Supplies may be relabeled with a clinical label
PRD406802 · Product
- Active substance
- Nilotinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 54000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EA03 — -
- Marketing authorisation
- EU/1/07/422/006
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Supplies may be relabeled with a clinical label
PRD406809 · Product
- Active substance
- Nilotinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 54000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EA03 — -
- Marketing authorisation
- EU/1/07/422/007
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Supplies may be relabeled with a clinical label
PRD406801 · Product
- Active substance
- Nilotinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 54000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EA03 — -
- Marketing authorisation
- EU/1/07/422/005
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Supplies may be relabeled with a clinical label
PRD406812 · Product
- Active substance
- Nilotinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 54000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EA03 — -
- Marketing authorisation
- EU/1/07/422/012
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Supplies may be relabeled with a clinical label
SUB25225 · Substance
- Active substance
- Nilotinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 54000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Supplies of commercial nilotinib obtained locally may be over labeled with clinical label.
SUB25225 · Substance
- Active substance
- Nilotinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 54000 mg milligram(s)
- Max treatment duration
- 60 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Supplies of commercial nilotinib obtained locally may be over labeled with clinical label.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novartis Pharma AG
- Sponsor organisation
- Novartis Pharma AG
- Address
- Lichtstrasse 35
- City
- Basel Town
- 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 16
| Organisation | City, country | Duties |
|---|---|---|
| Movianto Ceska republika s.r.o. ORG-100012787
|
Podoli, Czechia | Code 14 |
| Opis S.r.l. ORG-100011127
|
Desio, Italy | Other |
| Alliance Healthcare Romania S.R.L. ORG-100034371
|
Rudeni, Romania | Code 14, Other |
| Specific Pharma A/S ORG-100015041
|
Copenhagen Sv, Denmark | Code 14, Other |
| PRA Hellas CRO A.E. ORG-100048208
|
Nea Ionia, Greece | On site monitoring |
| Abf Pharmaceutical Services GmbH ORG-100014752
|
Vienna, Austria | Other |
| World Courier Bulgaria Ltd ORL-000001024
|
Sofia, Bulgaria | Other |
| S & D Pharma Logistics BG EOOD ORG-100017521
|
Sofia, Bulgaria | Other |
| Mag. Andreas Raffeiner GmbH ORG-100043223
|
Walding, Austria | Code 8 |
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | On site monitoring |
| Phardis S.r.l. ORG-100019559
|
Calvenzano, Italy | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | On site monitoring |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring |
| Creapharm Clinical Supplies ORG-100020131
|
Le Haillan, France | Code 14, Other |
| Iqvia Biotech LLC ORG-100008704
|
Durham, United States | Interactive response technologies (IRT) |
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | Code 12 |
Locations
14 EU/EEA countries · 85 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 11 | 3 |
| Bulgaria | Ongoing, recruiting | 20 | 5 |
| Czechia | Ongoing, recruiting | 8 | 5 |
| Denmark | Ended | 1 | 1 |
| France | Ongoing, recruiting | 60 | 13 |
| Germany | Ongoing, recruiting | 55 | 22 |
| Greece | Authorised, recruitment pending | 16 | 4 |
| Hungary | Authorised, recruitment pending | 11 | 2 |
| Italy | Ongoing, recruiting | 29 | 7 |
| Poland | Ongoing, recruiting | 10 | 4 |
| Portugal | Ongoing, recruiting | 3 | 2 |
| Romania | Ongoing, recruiting | 7 | 4 |
| Slovakia | Authorised, recruitment pending | 2 | 1 |
| Spain | Ongoing, recruiting | 27 | 12 |
| Rest of world
Saudi Arabia, United States, Malaysia, Singapore, Russian Federation, China, Taiwan, United Kingdom, South Africa, Lebanon, Oman, India, Canada, Korea, Republic of, United Arab Emirates, Turkey, Brazil, Japan, Vietnam, Argentina, Jordan, Mexico
|
— | 201 | — |
Investigational sites
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse
2000: 3.Med.Abteilung, Hämatologie u. Onkologie, Heinrich-Collin-Strasse 30/1100, Penzing, Vienna
Ordensklinikum Linz GmbH
2002: Interne I: Medizinische Onkologie und Haematologie, Seilerstaette 4, 4010, Linz
Medical University Of Graz
2001: Klinische Abteilung fuer Haematologie, Neue Stiftingtalstrasse 6, 8010, Graz
Medicinski Centar Hipokrat-N EOOD
2104, Bulgaria Blvd 61, Fl 2 Fl 1 Fl 3, Plovdiv
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
2103: Clinic of clinical hematology, Ulitsa Georgi Kochev 8a, 5803, Pleven
University Hospital St Marina Varna
2100: Clinic of clinical hematology, Hristo Smirnenski St 1, 9010, Varna
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
2101:Department of Clinical Hematology, Boulevard Akademik Ivan Evstratiev Geshov 15, 1431, Sofia
Specialized Hospital For Active Treatment Of Hematological Diseases EAD
2102: Clinic of Clinical Hematology, Bulevard Kliment Ohridski 1a, 1797, Sofiya
Fakultni Nemocnice Brno
2201: Interni hematologicka a onkologicka klinika, Jihlavska 340/20, Bohunice, Brno
Fakultni Nemocnice Ostrava
2200: Klinika hematoonkologie, 17. Listopadu 1790/5, 708 00, Poruba
Fakultni Nemocnice Plzen
2202: Hematologicko-onkologicke oddeleni, Alej Svobody 923/80, 323 00, Plzen 23
Fakultni Nemocnice Kralovske Vinohrady
2203: Hematologicka klinika, Srobarova 1150/50, Vinohrady, Prague
Institute Of Hematology And Blood Transfusion
2204: NA, U Nemocnice 2094/1, Nove Mesto, Prague
Rigshospitalet
2300: Hæmatologisk afdeling, Klinisk Forskningsenhed 2081, Blegdamsvej 9, 2100, Copenhagen Oe
Institut Paoli-Calmettes
2403: Hématologie, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Oncopole Claudius Regaud
2406:Hématologie, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Centre Hospitalier Universitaire De Caen Normandie
2411: Hématologie, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Centre Hospitalier Universitaire De Nice
2409: Hématologie, 151 Route De Saint Antoine, 06200, Nice
Hopital Saint Louis
2400: Unité de thérapie cellulaire et service des maladies du sang, 1 Avenue Claude Vellefaux, 75010, Paris
University Hospital Of Clermont-Ferrand
2410: Hématologie, 1 Place Lucie Et Raymond Aubrac, 63100, Clermont-Ferrand
CHRU De Nancy
2402: Hématologie, Rue Du Morvan, 54500, Vandoeuvre Les Nancy
Centre Hospitalier Universitaire De Poitiers
2408: Onco-hématologie et thérapie cellulaire, 2 Rue De La Miletrie, 86000, Poitiers
Institut Bergonie
2401: Hématologie, 229 Cours De L Argonne, 33000, Bordeaux
Centre Hospitalier Universitaire De Lille
2407: Hématologie, Rue Michel Polonowski, 59000, Lille
Centre Leon Berard
2405:Hématologie, 28 Rue Laennec, 69008, Lyon
Centre Hospitalier Universitaire De Nantes
2404:Hématologie, 5 Allee De L Ile Gloriette, Cs 69301, Nantes Cedex 1
Les Hopitaux Universitaires De Strasbourg
2412: Hématologie, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Universitaetsklinikum Wuerzburg AöR
2522: CCC Mainfranken Interdisiplinäres Studienzentrum (ISZ) mit ECTU, Straubmuehlweg 2a, Grombuehl, Wuerzburg
Philipps-Universitaet Marburg
2509: Klinik Haematology, oncology and Immunology, Baldingerstrasse, 35043, Marburg
Universitaetsklinikum Augsburg
2515: II Medizinische Klinik, Stenglinstrasse 2, Kriegshaber, Augsburg
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
2517: Klinik und Poliklinik fuer Innere Medizin III, Ismaninger Strasse 22, Au-Haidhausen, Munich
University Medical Center Hamburg-Eppendorf
2520: II. Medizinische Klinik und Poliklinik, Martinistrasse 52, Eppendorf, Hamburg
Klinikum Chemnitz gGmbH
2511: Innere Medizin III Hämatologie / Onkologie, Flemmingstrasse 2, Altendorf, Chemnitz
Universitaetsklinikum Erlangen AöR
2524: Medizinische Klinik 5 - Hämatologie und Internistische Onkologie, Ulmenweg 18, Innenstadt, Erlangen
Universitaetsklinikum Jena KöR
2500: Klinik für Innere Medizin II Abteilung Hämatologie und Internistische Onkologie, Am Klinikum 1, Lobeda, Jena
Martin-Luther-Universitaet Halle-Wittenberg
2518: Universitätsklinik und Poliklinik für Innere Medizin IV, Ernst-Grube-Strasse 40, Kroellwitz, Halle (Saale)
Staedtisches Krankenhaus Kiel GmbH
2504:2. Medizinische Klinik, Chemnitzstrasse 33, Schreventeich, Kiel
Charite Universitaetsmedizin Berlin KöR
2502: Medizinische Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunologie, Augustenburger Platz 1, Wedding, Berlin
Universitaet Leipzig
2508:Medizinische Klinik und Poliklinik I, Liebigstrasse 22, Zentrum-Suedost, Leipzig
Universitaetsklinikum Bonn AöR
2510: Medizinische Klinik und Poliklinik III, Venusberg-Campus 1, Venusberg, Bonn
Haemato-Überoertliche Gemeinschaftspraxis Pasing und Fuerstenfeldbruck GbR
2523, Baeckerstr. 4 Pasing-Obermenzing, 81241, Muenchen
HELIOS Klinikum Bad Saarow GmbH
2519: Haema Onkologie, Pieskower Strasse 33, 15526, Bad Saarow
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH
2516: Klinik für Onkologie und Hämatologie Studienzentrum Onkologie, Pruefeninger Strasse 86, Westenviertel, Regensburg
Gemeinschaftspraxis Haematologie Onkologie
2507, Arnoldstrasse 18, Johannstadt-Nord, Dresden
Medical Center - University Of Freiburg
2521: Klinik für Innere Medizin I, ITZ, Hugstetter Strasse 49, Stuehlinger, Freiburg Im Breisgau
Heidelberg University
2506: III. Medizinische Klinik, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Goethe University Frankfurt
2501: Medizinische Klinik II, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Universitaetsklinikum Ulm AöR
2513: Klinik für Innere Medizin III, Albert-Einstein-Allee 23, Eselsberg, Ulm
Universitaetsklinikum Aachen AöR
2505: Medizinische Klinik IV Centrum für Integrierte Onkologie - CIO Aachen, Pauwelsstrasse 30, 52074, Aachen
Geniko Nosokomeio Thessalonikis George Papanikolaou
1403: Hematology Clinic, Exochi, 570 10, Thessaloniki
Geniko Nosokomeio Thessalonikis George Papanikolaou
1401: Hematology Clinic, Exochi, 570 10, Thessaloniki
Laiko General Hospital Of Athens
1400: Hematology Clinic and Bone Marrow Transplantation Unit, Sevastoupoleos 16, 115 26, Athens
Evaggelismos Hospital
1404: Hematology Clinic, Ipsiladou 45-47, 106 76, Athens
Semmelweis University
2700: Department of Internal Medicine and Haematology, Szentkiralyi Utca 46, VIII Kerulet, Budapest VIII
Heves Varmegyei Markhot Ferenc Oktatokorhaz Es Rendelointezet
2701: Belgyógyászati-Infektológiai Centrum - BIC Belgyógyászati Osztály, Knezich Karoly Utca 1, 3300, Eger
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
2601: U.O.C. Ematologia, Via Antonio Cardarelli 9, 80131, Naples
Azienda Ospedaliero-Universitaria Policlinico Umberto I
2602: U.O.C. Ematologia, Viale Del Policlinico 155, 00161, Rome
ASST Grande Ospedale Metropolitano Niguarda
2600: S.C. Ematologia Day Hospital (Blocco Sud), Piazza Dell'ospedale Maggiore 3, 20162, Milan
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
2606: SSDB Ematologia e Trapianti CSE, Via Piero Maroncelli 40, 47014, Meldola
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
2604:S.C. Ematologia, Corso Bramante 88, 10126, Turin
Azienda Sanitaria Locale Roma 2
2605: U.O.C. Ematologia, Piazzale Dell' Umanesimo 10, 00144, Rome
Azienda Ospedaliero Universitaria Pisana
2603: U.O. Ematologia, Via Roma 67, 56126, Pisa
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
2800: Oddział Kliniczny Hematologii, Ul. Macieja Jakubowskiego 2, 30-688, Krakow
Instytut Hematologii I Transfuzjologii
2801: Klinika Hematologii, Ul Indiry Gandhi 14, 02-776, Warsaw
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
2802: Klinika Hematologii, Nowotworów krwi i Transplantacji Szpiku, Ul. Wybrzeze Ludwika Pasteura 4, 50-367, Wroclaw
Pratia Onkologia Katowice
#2803, Kościuszki 59, 40-519, Katowice
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
2901: Serviço de Hematologia, Rua Professor Lima Basto, 1099-023, Lisbon
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
2900: Serviço de Hematologia, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Institutul Clinic Fundeni
3003: Hematology, Soseaua Fundeni 258, 022328, Bucharest
Spitalul Clinic Municipal De Urgenta Timisoara
3001: Hematology, Strada Dima Gheorghe Nr.5, 300079, Timisoara
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
3004: Hematology, Strada Republicii 34-36, 400015, Cluj-Napoca
Spitalul Clinic Coltea
3002: Hematology, Bulevardul Bratianu C. Ion 1-3, 030171, Bucharest
University Hospital Bratislava
3500: Klinika hematológie a tranfúziológie, Antolska 11, Petrzalka, Bratislava
Hospital Universitario De La Princesa
3206: Hematologia, Calle De Diego De Leon 62, 28006, Madrid
Hospital Clinic De Barcelona
3201: Hematologia, Calle Villarroel 170, 08036, Barcelona
Institut Catala D'oncologia
3203: Hematologia, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Basurto
3202: Hematologia, Montevideo Etorbidea 16-18, 48013, Bilbao
Hospital Universitario Y Politecnico La Fe
3205: Hematologia, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Virgen De La Macarena
3204: Hematologia, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitario Ramon Y Cajal
3200: Hematologia, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario 12 De Octubre
3210: Hematologia, Bloque D, Avenida De Cordoba Sn, Madrid
Complexo Hospitalario Universitario De Santiago
3207: Hematologia, Calle Choupana Da S/n, 15706, Santiago De Compostela
Institut Catala D'oncologia
3211: Hematologia, Carretera Canyet S/n, 08916, Badalona
Hospital Universitari Vall D Hebron
3208: Hematologia, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Nuestra Senora De Candelaria
3209: Hematologia, Carretera De Rosario 145, Resto, Santa Cruz De Tenerife
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 | 2023-02-02 | 2023-02-02 | |||
| Bulgaria | 2022-10-11 | 2022-10-11 | |||
| Czechia | 2022-10-31 | 2022-10-31 | |||
| Denmark | 2022-11-16 | 2024-06-19 | 2022-11-16 | ||
| France | 2022-08-31 | 2022-08-31 | |||
| Germany | 2022-11-16 | 2022-11-16 | |||
| Italy | 2022-11-02 | 2022-11-02 | |||
| Poland | 2022-10-17 | 2022-10-17 | |||
| Portugal | 2022-11-22 | 2022-11-22 | |||
| Romania | 2022-11-01 | 2022-11-01 | |||
| Spain | 2022-10-07 | 2022-10-07 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 94 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol - Extract (for publication) | D1_Protocol_2023-507557-16-00_1_German_Soc_NonRed | V03 |
| Protocol (for publication) | D1_Benefit Risk Assessment_1_2023-507557-16-00_English_NonRed | V01 |
| Protocol (for publication) | D1_Protocol - Signature Page_2023-507557-16-00_1_English_Red | V03 |
| Protocol (for publication) | D1_Protocol_2023-507557-16-00_1_English_NonRed | V03 |
| Protocol (for publication) | D1_Protocol_2023-507557-16-00_1_Greek_NonRed | v03 |
| Protocol (for publication) | D4_Patient-facing document - Other_1_ES_English_NonRed | V02.03 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_AT_English_Note to Assesor_NonRed | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_BG_English_NonRed | V00 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_CZ_Czech_NonRed | 06Jun2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_DE_English_NonRed | V1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_DK_English_NonRed_T | 06/10/2023 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_ES_Spanish_NonRed | 14May2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_FR_NonRed | 00 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_GR_English_Red | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_HU_English_NonRed | v1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_IT_English_NonRed | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_PT_Portuguese_NonRed | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_RO_English_Note to Assesor_NonRed | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_SK_English_NonRed | V1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Poland_1_PL_Polish_NonRed | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Site_1_BG_Bulgarian_NonRed | v1.0 |
| Subject information and informed consent form (for publication) | L1_ICF - Child Assent_1_FR_French_NonRed | 00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_BG_Bulgarian_NonRed | 2 |
| 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 | V00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_DE_German_NonRed | V03.04.00 |
| 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_FR_French_NonRed | 00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_GR_Greek_NonRed | 00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_HU_Hungarian_NonRed | v00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_IT_Italian_NonRed | v00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_PL_Polish_NonRed | v00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_PT_Portuguese_NonRed | 01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_RO_Romanian_Red | 00.00.00 |
| 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 partner of participant_1_DE_German_NonRed | V03.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant partner of participant_1_SK_Slovak_NonRed | V1 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_AT_German_Red | v03.04.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_BG_Bulgarian_Red | v03.04.07 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_BG_English_NonRed | 03.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_CZ_Czech_Red | V03.04.05 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_DE_German_NonRed | V03.04.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_DK_Danish_Red | 03.04.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_ES_Spanish_NonRed | v03.04.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_FR_French_Red | 03.04.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_GR_Greek_NonRed | 03.04.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_HU_Hungarian_Red | v03.04.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_IT_Italian_Red | 03.04.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_PL_Polish_NonRed | 03.04.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_PT_Portuguese_NonRed | 04.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_RO_Romanian_Red | 03.04.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_SK_Slovak_Red | 03.04.02.M |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_2_CZ_Czech_Red | V03.04.05 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_2_DE_German_NonRed | V03.04.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_2_FR_French_NonRed | 03.04.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_3_DE_German_NonRed | V03.04.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional Assessment_1_DK_Danish_NonRed | 03.04.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Optional treatment beyond disease progression_1_CZ_Czech_NonRed | V00.00.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent_1_CZ_Czech_NonRed | V03.04.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent_1_ES_Spanish_NonRed | v03 |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent_1_PL_Polish_NonRed | v01 |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent_1_SK_Slovak_NonRed | V1 |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent_2_CZ_Czech_NonRed | V03.04.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent_2_ES_Spanish_NonRed | v03 |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent_2_SK_Slovak_NonRed | V1 |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent_3_SK_Slovak_NonRed | V1 |
| Subject information and informed consent form (for publication) | L1_List of submitted documents_1_HU_NonRed | 14Jan2025 |
| Subject information and informed consent form (for publication) | L1_Patient Card_1_Hungarian_NonRed | v03.04.00 |
| Subject information and informed consent form (for publication) | L1_Patient Card_1_Slovak_NonRed | V1 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_1_AT_German_Red | 3 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_1_DK_Danish_NonRed | v1 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_1_IT_Italian_NonRed | v00.00 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_DE_English_NonRed | V1.0 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_DK_English_NonRed_T | 06/10/2023 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_ES_Spanish_NonRed | 18May2024 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_GR_English_Red | 1.0 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_HU_English_NonRed | v1.0 |
| Subject information and informed consent form (for publication) | L2_ICF Procedure_1_PL_English_NonRed_T | 06.10.2023 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Reference SmPC_1_Bosutinib_English_NonRed | 01May2024 |
| Synopsis of the protocol (for publication) | D1_Protocol - Protocol Summary in Technical Language_2023-507557-16-00_1_German_NonRed | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol - Protocol Summary in Technical Language_2023-507557-16-00_1_Czech_NonRed | V3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol - Protocol Summary in Technical Language_2023-507557-16-00_1_French_NonRed | V3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-507557-16-00_1_Bulgarian_NonRed | v1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-507557-16-00_1_Czech_NonRed | V01 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-507557-16-00_1_English_NonRed | V01 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-507557-16-00_1_French_NonRed | V01 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-507557-16-00_1_Greek_NonRed | 01 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-507557-16-00_1_Hungarian_NonRed | v01.00 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-507557-16-00_1_Italian_NonRed | v01 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-507557-16-00_1_Polish_NonRed | V01 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-507557-16-00_1_Portuguese_NonRed | 01.00 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-507557-16-00_1_Romanian_Red | v01 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-507557-16-00_1_Slovak_NonRed | v1 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Lay Language_2023-507557-16-00_1_Spanish_NonRed | v01 |
Application history
14 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-31 | Germany | Acceptable 2024-03-06
|
2024-03-06 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-18 | Germany | Acceptable 2024-10-18
|
2024-10-18 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-11-11 | Acceptable | 2024-12-19 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-11-13 | Acceptable | 2025-03-03 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-15 | Acceptable | 2025-02-06 | |
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2024-11-28 | Acceptable 2024-10-18
|
2025-03-07 | |
| 7 | SUBSEQUENT ADDITION OF MSC | APP-7 | 2024-12-02 | Acceptable 2024-10-18
|
2025-03-13 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-12-05 | Acceptable | 2025-03-10 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-12-06 | Acceptable | 2025-01-31 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-12-16 | Germany | Acceptable | 2025-03-05 |
| 11 | SUBSEQUENT ADDITION OF MSC | APP-11 | 2024-12-20 | 2025-03-20 | ||
| 12 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-06-16 | Germany | Acceptable 2025-09-10
|
2025-09-10 |
| 13 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-10-07 | Acceptable | 2025-11-03 | |
| 14 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-01-15 | Acceptable | 2026-01-15 |