Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
183
Countries
13
Sites
122
Primary Myelofibrosis
Co-primary objectives: To compare spleen volume reduction (SVR) between Arm 1 and Arm 2 To compare total symptom score (TSS) reduction between Arm 1 and Arm 2
Key facts
- Sponsor
- Kartos Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 16 Oct 2024 → ongoing
- Decision date (initial)
- 2024-09-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Kartos Therapeutics, Inc.
External identifiers
- EU CT number
- 2023-504724-25-00
- WHO UTN
- U1111-1300-7285
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacogenomic, Pharmacokinetic, Efficacy, Therapy
Co-primary objectives:
To compare spleen volume reduction (SVR) between Arm 1 and Arm 2
To compare total symptom score (TSS) reduction between Arm 1 and Arm 2
Secondary objectives 5
- To compare spleen volume reduction between Arm 1 and Arm 2
- To compare total symptom score reduction between Arm 1 and Arm 2
- To compare overall survival (OS) between Arm 1 and Arm 2
- To compare time to progression between Arm 1 and Arm 2
- To compare the safety and tolerability of navtemadlin vs placebo as add-on therapy to ruxolitinib
Conditions and MedDRA coding
Primary Myelofibrosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10028537 | Myelofibrosis | 100000004864 |
Study design 6 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Screening 28 days prior to initiation of the run-in period
|
Not Applicable | None | ||
| 2 | Run-in The run-in period will extend from the initiation of treatment with ruxolitinib monotherapy until randomization to navtemadlin/placebo as add-on therapy to ruxolitinib treatment (or study discontinuation for subjects who are ineligible for participation in the randomized period of the study).
|
Not Applicable | None | ||
| 3 | Pre-randomization Within 14 days prior to randomization
|
Not Applicable | None | ||
| 4 | Randomized period 28-day treatment cycles and will extend from the first dose of add-on navtemadlin/placebo until the end of treatment (EOT) visit, which should occur within 28 days from the last dose of study drug.
|
Randomised Controlled | Double | [{"id":188978,"code":4,"name":"Analyst"},{"id":188981,"code":1,"name":"Subject"},{"id":188979,"code":3,"name":"Monitor"},{"id":188980,"code":2,"name":"Investigator"}] | Navtemadlin+Ruxolitinib: Navtemadlin as add-on therapy to the continuous ruxolitinib treatment. Navtemadlin Placebo+Ruxolitininb: Navtemadlin Placebo as add-on therapy to the continuous ruxolitinib treatment. |
| 5 | Response follow-up For randomized subjects who discontinue treatment for reasons other than disease progression.
|
Randomised Controlled | Double | [{"id":188983,"code":3,"name":"Monitor"},{"id":188986,"code":1,"name":"Subject"},{"id":188984,"code":4,"name":"Analyst"},{"id":188985,"code":2,"name":"Investigator"}] | Navtemadlin+Ruxolitinib: Navtemadlin as add-on therapy to continuous ruxolitinib treatment. Navtemadlin Placebo+Ruxolitinib: Navtemadlin placebo as add-on therapy to the continuous ruxolitinib treatment. |
| 6 | Long-term follow-up For randomized subjects with disease progression who will be followed for survival and subsequent anti-cancer therapy
|
Randomised Controlled | Double | [{"id":188991,"code":4,"name":"Analyst"},{"id":188990,"code":2,"name":"Investigator"},{"id":188989,"code":3,"name":"Monitor"},{"id":188988,"code":1,"name":"Subject"}] | Navtemadlin+Ruxolitinib: Navtemadlin as add-on therapy to continuous ruxolitinib treatment. Navtemadlin Placebo+Ruxolitinib: Navtemadlin Placebo as add-on therapy to continuous ruxolitinib treatment. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- Ruxolitinib Run-In Period: 1. Adults ≥ 18 years of age able to provide informed consent.
- Ruxolitinib Run-In Period: 2. Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by the treating physician according to the World Health Organization (WHO) criteria
- Ruxolitinib Run-In Period: 3. High, Intermediate-1, Intermediate-2 risk category International Prognosis System Score (IPSS)
- Ruxolitinib Run-In Period: 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Ruxolitinib Run-In Period: 5. JAK-inhibitor treatment naive
- Randomized Add-on Period: 1. PMF, post-PV MF, or post-ET MF that is TP53WT as assessed by central testing.
- Randomized Add-on Period: 2. ECOG performance status of 0 to 2.
- Randomized Add-on Period: 3. Treatment with a stable dose of ruxolitinib
- Randomized Add-on Period: 4. Suboptimal response to run-in ruxolitinib therapy
Exclusion criteria 6
- Ruxolitinib Run-In Period: 1. Prior Splenectomy
- Ruxolitinib Run-In Period: 2. Splenic irradiation within 3 months prior to the first dose
- Ruxolitinib Run-In Period: 3. Prior BCL-XL, BET, MDM2, PI3K, PIM, or XPO1 inhibitors therapy or p53- directed therapy
- Ruxolitinib Run-In Period: 4. Eligible for Bone Marrow Transplant
- Ruxolitinib Run-In Period: 5. Peripheral blood or bone marrow blast count ≥ 10%
- Randomized Period: 1. Peripheral blood or bone marrow blast count ≥ 10%
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- SVR will be evaluated 24 weeks after randomized treatment begins by MRI/CT scan (central review).
- TSS reduction will be evaluated 24 weeks after randomized treatment begins using the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0.
Secondary endpoints 7
- The proportion of patients who have spleen volume reduction between Arm 1 and Arm 2
- The proportion of patients who have TSS reduction between Arm 1 and Arm 2
- Time to death from any cause in patients randomized to each arm
- Time to progression or death from any cause in patients randomized to each arm
- Analyses of the safety endpoints will include the following measurements or assessments: physical examinations, laboratory tests, adverse events (AEs), serious AEs (SAEs), electrocardiograms (ECGs), and vital signs
- Change in SVR 24 weeks after the randomized treatment begins
- Change in TSS 24 weeks after the randomized treatment begins
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 8
PRD10314828 · Product
- Active substance
- Navtemadlin
- Other product name
- AMG 232
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 240 mg milligram(s)
- Max total dose
- 75600 mg milligram(s)
- Max treatment duration
- 45 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- KARTOS THERAPEUTICS INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD10314829 · Product
- Active substance
- Navtemadlin
- Other product name
- AMG 232
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 240 mg milligram(s)
- Max total dose
- 75600 mg milligram(s)
- Max treatment duration
- 45 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- KARTOS THERAPEUTICS INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11293322 · Product
- Active substance
- Navtemadlin
- Substance synonyms
- AMG 232, KRT-232, {(3R,5R,6S)-5-(3-CHLOROPHENYL)-6-(4-CHLOROPHENYL)-3-METHYL-1-[(2S)-3-METHYL-1-(PROPAN-2-YLSULFONYL)BUTAN-2-YL]-2-OXOPIPERIDIN-3-YL}ACETIC ACID, (3R,5R,6S)-5-(3-CHLOROPHENYL)-6-(4-CHLOROPHENYL)-3-METHYL-1-((1S)-2-METHYL-1-(((1-METHYLETHYL)SULFONYL)METHYL)PROPYL)-2-OXO-3-PIPERIDINEACETIC ACID, AMG-232
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 240 mg milligram(s)
- Max total dose
- 75600 mg milligram(s)
- Max treatment duration
- 45 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- KARTOS THERAPEUTICS INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD10314830 · Product
- Active substance
- Navtemadlin
- Other product name
- AMG 232
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 240 mg milligram(s)
- Max total dose
- 75600 mg milligram(s)
- Max treatment duration
- 45 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- KARTOS THERAPEUTICS INC.
- Paediatric formulation
- No
- Orphan designation
- No
SUB32273 · Substance
- Active substance
- Ruxolitinib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 70000 mg milligram(s)
- Max treatment duration
- 50 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB32273 · Substance
- Active substance
- Ruxolitinib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 70000 mg milligram(s)
- Max treatment duration
- 50 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB32273 · Substance
- Active substance
- Ruxolitinib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 70000 mg milligram(s)
- Max treatment duration
- 50 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB32273 · Substance
- Active substance
- Ruxolitinib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 70000 mg milligram(s)
- Max treatment duration
- 50 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 7
Placebo to match navtemadlin 30mg, film-coated tablet
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Placebo to match navtemadlin 120mg, film-coated tablet
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Placebo to match navtemadlin 60mg, film-coated tablet
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Placebo to match navtemadlin 180mg, film-coated tablet
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Placebo to match EU-sourced loperamide, capsule
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Placebo to match US-sourced loperamide, capsule
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- over-encapsulation
Placebo to match ondansetron, capsule
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Auxiliary 3
SUB09445MIG · Substance
- Active substance
- Ondansetron
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 16 mg milligram(s)
- Max total dose
- 2688 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Over-encapsulated
PRD325341 · Product
- Active substance
- Loperamide Hydrochloride
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 16 mg milligram(s)
- Max total dose
- 56 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- A07DA03 — LOPERAMIDE
- Marketing authorisation
- R/0382
- MA holder
- ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- over-encapsulation
SUB02969MIG · Substance
- Active substance
- Loperamide Hydrochloride
- Pharmaceutical form
- FILM COATED TABLETS
- Route of administration
- ORAL
- Max daily dose
- 16 mg milligram(s)
- Max total dose
- 56 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- over-encapsulation
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Kartos Therapeutics Inc.
- Sponsor organisation
- Kartos Therapeutics Inc.
- Address
- 275 Shoreline Drive Suite 300
- City
- Redwood City
- Postcode
- 94065-1490
- Country
- United States
Scientific contact point
- Organisation
- Kartos Therapeutics Inc.
- Contact name
- Clinical Operations Lead
Public contact point
- Organisation
- Kartos Therapeutics Inc.
- Contact name
- John Mei
Third parties 15
| Organisation | City, country | Duties |
|---|---|---|
| Eurofins Central Laboratory LLC ORG-100043608
|
Lancaster, United States | Laboratory analysis |
| Signant Health Global Solutions Limited ORG-100047290
|
Dublin 2, Ireland | Other |
| Psi Cro AG ORG-100034251
|
Zug, Switzerland | On site monitoring, Code 12, Other, Code 2, Code 5 |
| Myriad RBM Inc. ORG-100045698
|
Austin, United States | Laboratory analysis |
| Ppd Inc. ORG-100018960
|
Middleton, United States | Laboratory analysis |
| Flagship Biosciences Inc. ORG-100043268
|
Morrisville, United States | Other, Laboratory analysis |
| EPL Pathology Archives LLC ORG-100042096
|
Leesburg, United States | Other |
| Perceptive Informatics Inc. ORG-100013171
|
Billerica, United States | Other |
| Celerion Inc. ORG-100029202
|
Lincoln, United States | Laboratory analysis |
| Psi CRO Greece ORG-100047165
|
Athens, Greece | On site monitoring, Code 12, Code 2 |
| PrimeVigilance GmbH ORG-100043197
|
Frankfurt Am Main, Germany | Code 8 |
| Fisher Clinical Services GmbH ORG-100017323
|
Rheinfelden (Baden), Germany | Code 14 |
| IQVIA Laboratories ORL-000014394
|
Durham, United States | Other, Laboratory analysis |
| Suvoda LLC ORG-100043523
|
Conshohocken, United States | Interactive response technologies (IRT) |
| Aperio Clinical Outcomes LLC ORG-100046387
|
Durham, United States | Data management |
Locations
13 EU/EEA countries · 122 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 7 | 7 |
| Belgium | Ongoing, recruiting | 5 | 5 |
| Croatia | Ongoing, recruiting | 7 | 7 |
| Czechia | Ongoing, recruiting | 5 | 5 |
| France | Ongoing, recruiting | 12 | 15 |
| Germany | Ongoing, recruiting | 15 | 15 |
| Greece | Ongoing, recruiting | 5 | 5 |
| Hungary | Ongoing, recruiting | 5 | 4 |
| Italy | Ongoing, recruiting | 19 | 20 |
| Poland | Ongoing, recruiting | 18 | 15 |
| Portugal | Ongoing, recruiting | 6 | 6 |
| Romania | Ongoing, recruiting | 7 | 5 |
| Spain | Ongoing, recruiting | 15 | 13 |
| Rest of world
Serbia, New Zealand, United States, Georgia, Switzerland, Australia, Canada, Taiwan, Korea, Republic of, United Kingdom
|
— | 57 | — |
Investigational sites
Medical University Of Graz
Department of Internal Medicine Clinical Department of Hematology, Neue Stiftingtalstrasse 6, 8010, Graz
Ordensklinikum Linz GmbH
Department of Internal Medicine I, Hemostaseology and Medical Oncology, Fadingerstrasse 1, 4020, Linz
Stadt Wien Wiener Gesundheitsverbund
Hospital Ottakring, Department of Internal Medicine I, Montleartstrasse 37, Ottakring, Vienna
Medizinische Universitaet Innsbruck
Medical University Innsbruck, Department of Internal Medicine V (Hematology and Oncology), Anichstrasse 35, 6020, Innsbruck
Medical University Of Vienna
Department of Internal Medicine I, Clinical Department of Hematology and Hemostaseology, Waehringer Guertel 18-20, Alsergrund, Vienna
Steiermaerkische Krankenanstalten Ges.m.b.H.
LKH Hochsteiermark, Department of Internal Medicine, Hematology and Internal Oncology, Vordernberger Strasse 42, 8700, Leoben
Johannes Kepler University Linz
Kepler University Hospital, Clinical Department of Internal Medicine III, Hematology and Oncology, Med Campus III, Krankenhausstrasse 9, Linz
Centre hospitalier universitaire de Liege
Hematology, Avenue De L'hopital 1, 4000, Liege
UZ Leuven
Hematology, Herestraat 49, 3000, Leuven
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Hematology, Avenue Docteur Gaston Therasse 1, 5530, Yvoir
Het Ziekenhuisnetwerk Antwerpen
Hematology, Kempenstraat 100, 2030, Antwerp
Algemeen Ziekenhuis Delta
Hematology, Deltalaan 1, 8800, Roeselare
General Hospital Sibenik
Hematology, Stjepana Radica 83, 22000, Sibenik
KBC Split
Hematology, Soltanska 1, 21000, Split
University Hospital Centre Zagreb
Hematology, Ulica Mije Kispatica 12, 10000, Zagreb
Clinical Hospital Centre Rijeka
Hematology, Kresimirova 42, 51000, Rijeka
Poliklinika Solmed d.o.o.
Hematology, Preradoviceva Ulica 20, Zagreb, Grad Zagreb
Clinical Hospital Dubrava
Hematology, Avenija Gojka Suska 6, Zagreb, Grad Zagreb
Klinicka bolnica Merkur
Hematology, Ulica Ivana Zajca 19, 10000, Zagreb
Fakultni Nemocnice Kralovske Vinohrady
Interní hematologická klinika, Srobarova 1150/50, Vinohrady, Prague
Institute Of Hematology And Blood Transfusion
Ústav hematologie a krevní transfuze, U Nemocnice 2094/1, Nove Mesto, Prague
Fakultni Nemocnice Hradec Kralove
IV. Interní klinica hematologie, Sokolska 581, 500 03, Novy Hradec Kralove
Fakultni Nemocnice Brno
Interní hematologická a onkologická klinika, Obilni Trh 526/11, Veveri, Brno-Stred
Fakultni Nemocnice Ostrava
Klinika hematologie, 17. Listopadu 1790/5, Poruba, Ostrava
Centre Hospitalier Universitaire D'Angers
Maladies du sang, 4 Rue Larrey, 49100, Angers
Centre Hospitalier Universitaire De Bordeaux
Hématologie, Hôpital Haut Lévêque, Avenue De Magellan, 33600, Pessac
Les Hopitaux Universitaires De Strasbourg
Hématologie, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Centre Hospitalier Regional Et Universitaire De Brest
Hématologie, Hôpital de la Cavale Blanche, Boulevard Tanguy Prigent, 29200, Brest
Institut Universitaire Du Cancer Toulouse-Oncopole
Hématologie, 1 Avenue Irene Joliot Curie, 31100, Toulouse
Centre Hospitalier Universitaire De Nantes
Hématologie, 1 Place Alexis Ricordeau, 44000, Nantes
Assistance Publique Hopitaux De Paris
Centre d'Investigations Clinique (CIC), Hôpital Saint-Louis, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Universitaire De Nice
Hématologie, Hôpital Archet 1, 151 Route De Saint Antoine, 06200, Nice
Centre Leon Berard
Oncologie Médicale, 28 Rue Laennec, 69008, Lyon
Centre Hospitalier Universitaire Amiens Picardie
Hématologie Clinique et Thérapie Cellulaire, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Centre Hospitalier Universitaire De Lille
Maladie du Sang, Hôpital Claude Huriez, Rue Michel Polonovski, 59037, Lille Cedex
Centre Hospitalier Universitaire De Nimes
Institut de Cancérologie du Gard, Rue de Pr Henri Pujol, 30029, Nimes, Cedex 9, Place Du Professeur Robert Debre, 30900, Nimes
Centre Hospitalier Regional Universitaire De Tours
Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, 2 Boulevard Tonnelle, 37000, Tours
Centre Hospitalier Universitaire De Poitiers
Oncologie Hématologique et Thérapie Cellulaire, 2 Rue De La Miletrie, 86000, Poitiers
Hospices Civils De Lyon
Hématologie, Hôpital Lyon Sud, 165 Chemin Du Grand Revoyet, 69310, Pierre Benite
Robert Bosch Krankenhaus GmbH
Haemotology, Oncology and Palliative Medicine, Auerbachstrasse 110, Bad Cannstatt, Stuttgart
Marien Hospital Duesseldorf GmbH
Clinic for Oncology, Haematology and Palliative Medicine, Rochusstrasse 2, Pempelfort, Duesseldorf
Martin-Luther-Universitaet Halle-Wittenberg
Internal Medicine IV (Haematology and Oncology), Ernst-Grube-Strasse 40, Kroellwitz, Halle (Saale)
Gemeinschaftspraxis Haematologie Onkologie
Hematology and Oncology, Arnoldstrasse 18, Johannstadt-Nord, Dresden
Universitaetsklinikum Ulm AöR
Clinic for Internal Medicine III Medical Clinic (oberer Eselsberg), Albert-Einstein-Allee 23, Eselsberg, Ulm
Medical Center - University Of Freiburg
Clinic for Internal Medicine I Haematology, Oncology and Stell Cell Transplantation, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Universitaetsklinikum Heidelberg AöR
Centre for Internal Medicine (Krehl Clinic), Department of Haematology, Oncology, Rheumatology, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
MVZ Leipzig Mitte
Onkology, Haematology, Palliative Medicine, Johannisplatz 1, Zentrum-Südost, Leipzig
Klinikum rechts der Isar der TU Muenchen AöR
III. Medical Department, Ismaninger Strasse 22, Au-Haidhausen, Munich
Kliniken Ostalb gemeinnuetzige kommunale Anstalt des oeffentlichen Rechts
Oncology Center, Wetzgauer Strasse 85, 73557, Mutlangen
Universitaetsklinikum Schleswig-Holstein AöR
Medical Clinic II, Arnold-Heller-Strasse 3, Brunswik, Kiel
University Medical Center Hamburg-Eppendorf
II. Medical Clinic and Polyclinic, Martinistrasse 52, Eppendorf, Hamburg
Medizinische Hochschule Hannover
Clinic for Haematology, Haemostaseology, Oncology and Stem Cell Transplantation, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Universitaetsklinikum Jena KöR
Clinic for Internal Medicine II. Department of Haematology and Oncology, Am Klinikum 1, Lobeda, Jena
Klinikum Nuernberg
Clinic for Internal Medicine V, Prof.-Ernst-Nathan-Strasse 1, St. Johannis, Nuremberg
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
2nd Department of Propaedeutic Internal Medicine, Rimini 1, 124 61, Chaidari
University General Hospital Of Ioannina
Department of Haematology, Niarchou Stavrou Avenue, 455 00, Ioannina
General University Hospital Of Patras
Haematology Department, Rio, 265 04, Patras
Geniko Nosokomeio Thessalonikis George Papanikolaou
Haematology Clinic, Exochi, 570 10, Thessaloniki
Laiko General Hospital Of Athens
Haematology Clinic, Sevastoupoleos 16, 115 26, Athens
Tolna Varmegyei Balassa Janos Korhaz
Department of Hematology, Beri Balogh Adam Utca 5-7, 7100, Szekszard
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
Department of Internal Medicine III, Hematology, Seregelyesi Ut 3, 8000, Szekesfehervar
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Department of Hematology, Szent Istvan Utca 68, 4400, Nyiregyhaza
Semmelweis University
Department of Internal Medicine and Haematology, Division of Hematology, Szentkiralyi Utca 46, VIII Kerulet, Budapest VIII
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
Hematology with bone marrow transplantation, Via Santa Sofia 78, 95123, Catania
Azienda Sanitaria Locale Roma 2
UOC Hematology, Piazzale Dell' Umanesimo 10, 00144, Rome
Azienda Unita Sanitaria Locale Della Romagna
Oncology and Hematology Department, Viale Vincenzo Randi 5, 48121, Ravenna
Istituto Europeo Di Oncologia S.r.l.
Onco-Hematology, Via Giuseppe Ripamonti 435, 20141, Milan
Azienda Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare Arrigo
Hematology Department, Via Venezia 16, 15121, Alexandria
Azienda Ospedaliero-Universitaria Maggiore Della Carita
SCDU Ematology, Corso Giuseppe Mazzini 18, 28100, Novara
Azienda USL IRCCS Di Reggio Emilia
Hematology, Viale Risorgimento 80, 42123, Reggio Emilia
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Hematology, Corso Bramante 88, 10126, Turin
Careggi University Hospital
Department of Medical oncology, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
SSD Medical Oncology Addarii, Via Pietro Albertoni 15, 40138, Bologna
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Complex Structure of Clinical and Experimental Oncology in Innovative and High-Dose Thera, Via Piero Maroncelli 40, 47014, Meldola
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Hematology, Via Del Vespro 129, 90127, Palermo
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Hematology, Via Francesco Sforza 28, 20122, Milan
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
Haematology Department, Viale Luigi Borri N 57, 21100, Varese
Azienda Ospedaliera Ordine Mauriziano Di Torino
SCDU Ematologia e Terapie cellulari, Via Ferdinando Magellano 1, 10128, Turin
Azienda Ospedaliera Ospedali Riuniti Marche Nord
Hematology and Stem Cell Transplant Centre, Piazzale Carlo Cinelli 4, 61121, Pesaro
Fondazione IRCCS Policlinico San Matteo
Oncohematology, Operative Unit of Hematology, Viale Camillo Golgi 19, 27100, Pavia
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Hematology, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department of clinical and biological sciences, Regione Gonzole 10, 10043, Orbassano
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi
Department of Oncohematology, Via Filippo Corridoni 11, 60123, Ancona
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Department of Hematology, Ul. Kornela Ujejskiego 75, 85-168, Bydgoszcz
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie
Oddział Kliniczny Hematologii i Chorób Wewnętrznych z Ośrodkiem Transplantacji Szpiku, Al. Wojska Polskiego 37, 10-228, Olsztyn
Pratia Hematologia Sp. z o.o.
Pratia Onkologia Katowice, Ul. Tadeusza Kosciuszki 92, 40-519, Katowice
"InterHem" Katarzyna Mazgajska-Barczyk, Marek Milewski, Jarosław Piszcz, Piotr Radziwon Sp. j
Oddział Hematologiczny Nowotworów Krwi, Choroszczanska 24, 15-732, Białystok
Szpital Specjalistyczny Im. Jedrzeja Sniadeckiego W Nowym Saczu SPZOZ
Oddział Hematologiczny, Ul. Mlynska 5, 33-300, Nowy Sacz
Clinical Best Solutions Sp. z o.o. S.K.
N/A, Ul. Ludwika Idzikowskiego 16, 00-710, Warsaw
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego
Oddział Hematologiczny, Ul. Alfreda Sokolowskiego 4, 58-309, Walbrzych
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Poradnia Hematologiczna, Ul. Macieja Jakubowskiego 2, 30-688, Cracow
Uniwersyteckie Centrum Kliniczne
Klinika Hematologii, Transplantologii i Terapii Komórkowych, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu
Oddział Hematologii, Ul. Sw. Jozefa 53/59, 87-100, Torun
Centrum Medyczne Damiana Holding Sp. z o.o.
DOM LEKARSKI - AMBULATORIUM STRUGA, Ul. Andrzeja Struga 42, 70-784, Szczecin
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych, Ul. Wybrzeze Ludwika Pasteura 4, 50-367, Wroclaw
Aidport Sp. z o.o.
AIDPORT, Ul Ksiedza Stanisława Kozierowskiego 24, 60-185, Skorzewo
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
Oddział hematologiczny, Ul. Hubalczykow 1, 76-200, Slupsk
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Oddział Hematoonkologii i Chorób Wewnętrznych z Pododdziałem Chemioterapii Dziennej, Ul. Pabianicka 62, 93-513, Lodz
CCAB Centro Clinico Academico Braga Associacao
Oncology, Lugar De Sete Fontes S Victor, 4710-243, Braga
Unidade Local De Saude De Gaia/Espinho E.P.E.
Hematolgy, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia
Unidade Local De Saude Do Alto Minho E.P.E.
Hematology, Estrada De Santa Luzia, 4904-858, Viana Do Castelo
Unidade Local De Saude Da Regiao De Aveiro E.P.E.
Hematology, Avenida De Artur Ravara, 3814-501, Aveiro
Unidade Local De Saude De Lisboa Ocidental E.P.E.
Hematology, Estrada Forte Do Alto Duque, 1449-005, Lisbon
Unidade Local De Saude De Santa Maria E.P.E.
Hematolgy, Avenida Professor Egas Moniz, 1649-035, Lisbon
Spitalul Clinic Judetean De Urgenta Bihor
Hematology, Calea Coposu Corneliu Nr 12, 410469, Oradea
Spitalul Clinic Colentina Bucuresti
Hematology, Soseaua Stefan Cel Mare 19-21, 020125, Bucharest
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Hematology, Strada Republicii 34-36, 400015, Cluj-Napoca
Spitalul Clinic Judetean De Urgenta Targu Mures
Hematology, Strada Marinescu Gheorghe 50, 540136, Targu Mures
Onco Card S.R.L.
Hematology, Strada Carierei 65 A, 500052, Brasov
Hospital Universitario Virgen De La Victoria
Hematology, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Institut Catala D'oncologia
Hematology, Carretera Canyet S/n, 08916, Badalona
El Hospital Universitario De Gran Canaria Dr. Negrin
Hematology, Barranco De La Ballena S N, 35010, Las Palmas De Gran Canaria
Hospital Universitario Y Politecnico La Fe
Hematology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
University Hospital Son Espases
Hematology and Hemotherapy, Carretera Valldemossa 79, 07120, Palma
Institut Catala D'oncologia
Hematology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Ramon Y Cajal
Hematology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Clinico Universitario De Valencia
Hematology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario 12 De Octubre
Hematology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Quironsalud Zaragoza
Hematology, Paseo Renovales S/n, 50006, Zaragoza
Hospital Universitario De Salamanca
Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitari Vall D Hebron
Hematology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Del Mar
Hematology, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
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 | 2025-01-29 | 2025-03-04 | |||
| Belgium | 2024-10-25 | 2025-01-21 | |||
| Croatia | 2024-11-14 | 2024-11-19 | |||
| Czechia | 2025-02-28 | 2025-04-01 | |||
| France | 2025-01-30 | 2025-04-08 | |||
| Germany | 2025-01-10 | 2025-02-13 | |||
| Greece | 2025-03-24 | 2025-09-17 | |||
| Hungary | 2025-03-10 | 2025-05-19 | |||
| Italy | 2025-03-31 | 2025-04-28 | |||
| Poland | 2025-03-26 | 2025-03-28 | |||
| Portugal | 2025-03-20 | 2025-05-14 | |||
| Romania | 2024-12-30 | 2025-02-26 | |||
| Spain | 2024-10-16 | 2024-11-26 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 198 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol_2023-504724-25_GR_REDLINE from v AM1 | AM1.1 EU |
| Protocol (for publication) | D1_Protocol Clarification Memo ePRO collection_Redacted | N/A |
| Protocol (for publication) | D1_Protocol Clarification Memo_EOT_Redacted | N/A |
| Protocol (for publication) | D1_Protocol Clarification Memo_Serum Glucose_Redacted | N/A |
| Protocol (for publication) | D1_Protocol_2023-504724-25_Redacted | AM1.1 EU |
| Protocol (for publication) | D1_Protocol_2023-504724-25_Redacted_GR | AM1.1 EU |
| Protocol (for publication) | D1_Protocol_Clarification_Memo_Hepatitis B testing_Redacted | N/A |
| Protocol (for publication) | D4_Patient facing documents_PGIS_AT-DE | N/A |
| Protocol (for publication) | D4_Patient facing documents_PGIS_BE | N/A |
| Protocol (for publication) | D4_Patient facing documents_PGIS_BE-FR | N/A |
| Protocol (for publication) | D4_Patient facing documents_PGIS_CZ | N/A |
| Protocol (for publication) | D4_Patient facing documents_PGIS_DE | N/A |
| Protocol (for publication) | D4_Patient facing documents_PGIS_ES | N/A |
| Protocol (for publication) | D4_Patient facing documents_PGIS_FR | N/A |
| Protocol (for publication) | D4_Patient facing documents_PGIS_GR | N/A |
| Protocol (for publication) | D4_Patient facing documents_PGIS_HR | N/A |
| Protocol (for publication) | D4_Patient facing documents_PGIS_HU | N/A |
| Protocol (for publication) | D4_Patient facing documents_PGIS_IT | N/A |
| Protocol (for publication) | D4_Patient facing documents_PGIS_PL | N/A |
| Protocol (for publication) | D4_Patient facing documents_PGIS_PT | N/A |
| Protocol (for publication) | D4_Patient facing documents_PGIS_RO | N/A |
| Protocol (for publication) | D4_Patient facing documents_placeholder for publication | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedure | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedure | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed Consent Procedure_redline | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 4.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 4.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_public | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Redline | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Referral Contact Letter | 1.0 |
| Recruitment arrangements (for publication) | K1_Recuitment and Informed consent procedure | N/A |
| Recruitment arrangements (for publication) | K2_ Recruitment Material Study Postcard | 2 |
| Recruitment arrangements (for publication) | K2_ Recruitment Material Study_ Flyer | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment Material Website HCP | N/A |
| Recruitment arrangements (for publication) | K2_ Recruitment Material Website non HCP | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment Material POIESIS Website_HCP | NA |
| Recruitment arrangements (for publication) | K2_Recruitment Material POIESIS Website_Non HCP | NA |
| Recruitment arrangements (for publication) | K2_Recruitment Material Postcard | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Referral Contact Letter | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Referral Letter_public | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Study Flyer | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ Study Flyer | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Advertisement Schema Postcard | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Advertisement Study Flyer | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Advertisement Study Flyer Print | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Advertisement Study Flyer Print | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Advertisement Study Flyer Print_BE-FR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Advertisement Study Flyer Print_BE-NL | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Advertisement_Schema_Postcard | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Dr to Dr Letter | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_EU Referral Letter_BE-FR | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_EU Referral Letter_BE-NL | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_public | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_POIESIS Website HCP | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_POIESIS Website HCP_BE-FR | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_POIESIS Website HCP_BE-NL | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_POIESIS Website Non HCP | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_POIESIS Website Non HCP_BE-FR | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_POIESIS Website Non HCP_BE-NL | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_POIESIS Website_HCP | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_POIESIS Website_HCP | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_POIESIS Website_Non HCP | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_POIESIS Website_Non HCP | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_Referral Letter | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Referral Letter | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Referral Letter | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Referral Letter | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Referral letter | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Referral letter | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Referral Letter | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Referral letter | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Referral letter_Redline | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Schema Postcard | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Schema Postcard | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Schema Postcard | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Schema Postcard | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Schema Study Postcard | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Flyer | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Study Flyer | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Flyer Print | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Study Schema Postcard | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Website for Healthcare Professionals | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Website for Patient or Caregiver | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_Website HCP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Website HCP_public | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_Website Non HCP_public | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_Website_ HCP_No Date_IT | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_Website_Healthcare_Professionals | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment material_Website_Non HCP | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Website_non HCP_No Date_IT | NA |
| Recruitment arrangements (for publication) | K2_Recruitment material_Website_Non HCP_redline | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Website_Non_Healthcare_Professionals | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment Materials Referral Letter | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Advertisement Study Flyer Print | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Patient Referral Contact Letter | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Referral Letter | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Schema Postcard | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Study Flyer | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Study Post Card | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Website HCP | N/A |
| Recruitment arrangements (for publication) | K2_Recruitment materials_Website Non HCP | N/A |
| Subject information and informed consent form (for publication) | L1_centre-specific contact list_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF Genetic_EN_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF Genetic_HU_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Additional Optional_EN_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Additional Optional_HU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Additional Optional_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Additional_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF EU GDPR Sheet for pregnancy FU_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF EU GDPR Sheet_for public | N/A |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research_for public | N/A |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research_HR | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Future Research_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_EN_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_EN_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_HR_redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_HU_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Additional_EN_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Additional_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Additional_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy Follow_up_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy Follow-Up_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy FU_EN_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy FU_for public | N/A |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy FU_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_EN_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_HU_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_HR_redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Subject_HR_redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Additional ICF_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Additional Optional_BE-FR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Additional Optional_BE-NL_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Additional Optional_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Additional_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Additional_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Additional_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Additonal ICF_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_HIV Testing | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_BE-FR_Redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_BE-NL_Redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Additional ICF_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Additional_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Personal Data Use_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy Follow Up_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS Genetic_EN_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS Genetic_HU_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GP Information Letter_Redacted | 3.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Reimbursement Form_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Patient card | 3.0 |
| Subject information and informed consent form (for publication) | L2_Patient Card_EN_public | 3.0 |
| Subject information and informed consent form (for publication) | L2_Patient Card_HU_public | 3.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_Pregnancy_BE-FR | 3.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_Pregnancy_BE-NL | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Ruxolitinib | N/A |
| Synopsis of the protocol (for publication) | D1_Synopsis for laypersons_AT-DE_2023-504724-25 | Am1 |
| Synopsis of the protocol (for publication) | D1_Synopsis for laypersons_BE-DE_2023-504724-25 | Am1 |
| Synopsis of the protocol (for publication) | D1_Synopsis for laypersons_BE-FR_2023-504724-25 | Am1 |
| Synopsis of the protocol (for publication) | D1_Synopsis for laypersons_BE-NL_2023-504724-25 | Am1 |
| Synopsis of the protocol (for publication) | D1_Synopsis for laypersons_CZ_2023-504724-25 | Am1 |
| Synopsis of the protocol (for publication) | D1_Synopsis for laypersons_ENG_2023-504724-25 | Am1 |
| Synopsis of the protocol (for publication) | D1_Synopsis for laypersons_ES_2023-504724-25 | Am1 |
| Synopsis of the protocol (for publication) | D1_Synopsis for laypersons_FR_2023-504724-25 | Am1 |
| Synopsis of the protocol (for publication) | D1_Synopsis for laypersons_GR_2023-504724-25 | Am1 |
| Synopsis of the protocol (for publication) | D1_Synopsis for laypersons_HR_2023-504724-25 | Am1 |
| Synopsis of the protocol (for publication) | D1_Synopsis for laypersons_HU_2023-504724-25 | Am1 |
| Synopsis of the protocol (for publication) | D1_Synopsis for laypersons_IT_2023-504724-25 | Am1 |
| Synopsis of the protocol (for publication) | D1_Synopsis for laypersons_PL_2023-504724-25 | Am1 |
| Synopsis of the protocol (for publication) | D1_Synopsis for laypersons_PT_2023-504724-25 | Am1 |
| Synopsis of the protocol (for publication) | D1_Synopsis for laypersons_RO_2023-504724-25 | Am1 |
Application history
18 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-24 | Austria | Acceptable 2024-09-16
|
2024-09-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-01 | Austria | Acceptable | 2024-12-15 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-02 | Acceptable | 2024-12-02 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-10-04 | Acceptable | 2024-11-12 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-10-04 | Acceptable | 2024-11-13 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-10-11 | Acceptable | 2024-10-30 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-11-15 | Acceptable | 2025-01-09 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-01-10 | Acceptable | 2025-01-10 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-01-13 | Austria | Acceptable 2025-03-17
|
2025-03-17 |
| 10 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-04-30 | Austria | Acceptable 2025-08-05
|
2025-08-06 |
| 11 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-08-19 | Austria | Acceptable | 2025-10-06 |
| 12 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-08-25 | Acceptable | 2025-10-02 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-13 | 2025-08-29 | Acceptable | 2025-09-11 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-14 | 2025-09-04 | Acceptable | 2025-09-30 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-09-05 | Acceptable | 2025-10-01 | |
| 16 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-10-06 | Acceptable | 2025-10-06 | |
| 17 | SUBSTANTIAL MODIFICATION | SM-15 | 2026-02-19 | Austria | Acceptable 2026-04-27
|
2026-04-27 |
| 18 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2026-06-02 | Acceptable 2026-04-27
|
2026-06-02 |