KRT-232 Versus Best Available Therapy for the Treatment of Subjects With Myelofibrosis Who Are Relapsed or Refractory to JAK Inhibitor Treatment (BOREAS)

2024-513912-89-00 Protocol KRT-232-101 Phase II and Phase III (Integrated) Ongoing, recruitment ended

Start 13 Dec 2018 · Status Ongoing, recruitment ended · 13 EU/EEA countries · 51 sites · Protocol KRT-232-101

Overview

Sponsor-declared trial summary

Phase Phase II and Phase III (Integrated)
Status Ongoing, recruitment ended
Participants planned 447
Countries 13
Sites 51

Primary Or Secondary (Post-PV MF or Post-ET-MF) Myelofibrosis (MF) With Intermediate Or High-Risk TP53 Wild-Type (TP53 WT) Who Are Relapsed Or Refractory to Janus Kinase (JAK) - Inhibitor Treatment

Part A: To determine spleen response. Part B: To compare the spleen volume reduction (SVR) at Week 24 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
13 Dec 2018 → ongoing
Decision date (initial)
2024-11-15
Transition trial
Yes
Low-intervention
No
Rare-disease indication
Yes
Vulnerable population
Yes
Funding sources
Kartos Therapeutics, Inc.

External identifiers

EU CT number
2024-513912-89-00
EudraCT number
2018-001671-21
WHO UTN
U1111-1308-4867
ClinicalTrials.gov
NCT03662126

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Pharmacodynamic, Pharmacogenetic, Therapy, Pharmacokinetic

Part A: To determine spleen response.
Part B: To compare the spleen volume reduction (SVR) at Week 24 between Arm 1 and Arm 2.

Secondary objectives 11

  1. Part A: To determine the change in modified MPN-SAF Total Symptom Score (TSS) at Week 24 and Week 48
  2. Part A: To determine the duration of spleen response (DoR-spleen); and spleen size reduction as measured by palpation
  3. Part A: To determine RBC transfusion usage
  4. Part A: To determine the clinical response rate at Week 24; and overall survival (OS) rate
  5. Part A: To determine the safety and tolerability of KRT-232 and PK/PD profile of KRT-232
  6. Part B: Compare the improvement of TSS at Week 24 between Arm 1 and Arm 2
  7. Part B: Compare the OS and progression free survival (PFS) between Arm 1 and Arm 2
  8. Part B: Compare the overall SVR at any time in each study arm, and evaluate the spleen response duration between Arm 1 and 2
  9. Part B: Compare the rate of conversion from RBC transfusion dependent to independent at Week 24 between Arm 1 and Arm 2
  10. Part B: Evaluate the safety between Arm 1 and Arm 2
  11. Part B: Monitor the PK of KRT-232 (Arm 1 only)

Conditions and MedDRA coding

Primary Or Secondary (Post-PV MF or Post-ET-MF) Myelofibrosis (MF) With Intermediate Or High-Risk TP53 Wild-Type (TP53 WT) Who Are Relapsed Or Refractory to Janus Kinase (JAK) - Inhibitor Treatment

VersionLevelCodeTermSystem organ class
21.0 LLT 10074690 Post essential thrombocythemia myelofibrosis 10029104
21.0 LLT 10074689 Post polycythemia vera myelofibrosis 10029104
20.0 PT 10077161 Primary myelofibrosis 100000004864

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

  1. Part A: Adults ≥18 years of age
  2. Part A: Confirmed diagnosis of PMF, post-PV MF or post-ET MF (WHO)
  3. Part A: High, intermediate-2, or intermediate-1 risk Dynamic International Prognostic System (DIPSS)
  4. Part A: Failure of prior treatment with JAK inhibitor
  5. Part A: ECOG ≤ 2
  6. Part B: Adults >18 years of age
  7. Part B: Confirmed diagnosis of PMF, post PV-MF, or post-ET-MF (WHO)
  8. Part B: High, intermediate-2, or intermediate-1 risk Dynamic International Prognostic System (DIPSS)
  9. Part B: Subjects with p53WT MF by central laboratory testing
  10. Part B: Failure of prior treatment with JAK inhibitor
  11. Part B: ECOG ≤ 2

Exclusion criteria 18

  1. Part A: Subjects who are positive for P53 mutations
  2. Part A: Splenic irradiation within 3 months prior to randomization
  3. Part A: History of major hemorrhage or intracranial hemorrhage within 6 months prior to randomization
  4. Part A: History of stroke, reversible ischemic neurological defect or transient ischemic attack within 6 months prior to randomization
  5. Part A: Prior MDM2 inhibitor therapy or p53-directed therapy
  6. Part A: Prior allogeneic stem-cell transplant or plans for allogeneic stem cell transplant
  7. Part B: History of major organ transplant
  8. Part B: Grade 2 or higher QTc prolongation (>480 milliseconds per NCI- CTCAE criteria, version 5.0)
  9. Part A: History of major organ transplant
  10. Part A: Grade 2 or higher QTc prolongation (> 480 milliseconds per NCI-CTCAE criteria, version 5.0)
  11. Part B: Prior splenectomy
  12. Part B: Splenic irradiation within 12 weeks of randomization
  13. Part B: Prior allogeneic stem-cell transplantation or plans for allogeneic stem cell transplantation
  14. Part B: Prior MDM2 inhibitor therapy or p53-directed therapy
  15. Part B: JAK-, PI3k-, SYK-, BTK-, BET- or MTOR inhibitor treatment within 28 days prior to the Screening MRI/CT scan
  16. Part A: Prior splenectomy
  17. Part B: History of major hemorrhage or intracranial hemorrhage within 6 months prior to randomization
  18. Part B: History of stroke, reversible ischemic neurological defect or transient ischemic attack within 6 months prior to randomization

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

  1. Part A: The proportion of subjects achieving a ≥35% spleen volume reduction from Baseline to Week 24, as assessed by magnetic resonance imaging (MRI) or computed tomography (CT) scan.
  2. Part B: The proportion of subjects in each arm achieving SVR of ≥ 35% at Week 24 by MRI/CT scan (central review)

Secondary endpoints 13

  1. Part A: Proportion of subjects with a reduction in total symptom score
  2. Part A: To determine the duration of reduction of spleen volume
  3. Part A: To determine the need for red blood cell (RBC) transfusion
  4. Part A: The proportion of subjects who have RBC transfusion independence at week 24
  5. Part A: To determine complete and partial remission of treated subjects
  6. Part A: To determine time to death from any cause in treated subjects
  7. Part A: To determine the pharmacokinetic/pharmacodynamic (PK/PD) profile of KRT-232
  8. Part B: The proportion of subjects with reduction from Baseline to Week 24 in the total symptom score
  9. Part B: Time from randomization to death from any cause
  10. Part B: Progression free survival (PFS): time from randomization to either first occurrence of disease progression or death due to any cause
  11. Part B: The proportion of subjects in each arm achieving spleen volume reduction
  12. Part B: Time from initial spleen volume reduction until the first occurrence of disease progression
  13. Part B: The proportion of subjects who have red blood cell transfusion independence at week 24

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 6

Navtemadlin 25-60

PRD10314829 · Product

Active substance
Navtemadlin
Other product name
AMG 232
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
240 mg milligram(s)
Max total dose
240 mg milligram(s)
Max treatment duration
54 Month(s)
Authorisation status
Not Authorised
MA holder
KARTOS THERAPEUTICS INC.
Paediatric formulation
No
Orphan designation
No

Navtemadlin 10-15

PRD10314825 · Product

Active substance
Navtemadlin
Other product name
AMG 232
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
360 mg milligram(s)
Max total dose
360 mg milligram(s)
Max treatment duration
72 Month(s)
Authorisation status
Not Authorised
MA holder
KARTOS THERAPEUTICS INC.
Paediatric formulation
No
Orphan designation
No

Navtemadlin 25-15

PRD10314827 · Product

Active substance
Navtemadlin
Other product name
AMG 232
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
240 mg milligram(s)
Max total dose
240 mg milligram(s)
Max treatment duration
54 Month(s)
Authorisation status
Not Authorised
MA holder
KARTOS THERAPEUTICS INC.
Paediatric formulation
No
Orphan designation
No

Navtemadlin 10-60

PRD10314826 · Product

Active substance
Navtemadlin
Other product name
AMG 232
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
360 mg milligram(s)
Max total dose
360 mg milligram(s)
Max treatment duration
72 Month(s)
Authorisation status
Not Authorised
MA holder
KARTOS THERAPEUTICS INC.
Paediatric formulation
No
Orphan designation
No

Navtemadlin 25-120

PRD10314830 · Product

Active substance
Navtemadlin
Other product name
AMG 232
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
240 mg milligram(s)
Max total dose
240 mg milligram(s)
Max treatment duration
54 Month(s)
Authorisation status
Not Authorised
MA holder
KARTOS THERAPEUTICS INC.
Paediatric formulation
No
Orphan designation
No

Navtemadlin 25-30

PRD10314828 · Product

Active substance
Navtemadlin
Other product name
AMG 232
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
240 mg milligram(s)
Max total dose
240 mg milligram(s)
Max treatment duration
54 Month(s)
Authorisation status
Not Authorised
MA holder
KARTOS THERAPEUTICS INC.
Paediatric formulation
No
Orphan designation
No

Comparator 6

Prednison 10 mg GALEN®

PRD3166920 · Product

Active substance
Prednisone
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
54 Month(s)
Authorisation status
Authorised
ATC code
H02AB07 — PREDNISONE
Marketing authorisation
90895.00.00
MA holder
GALENPHARMA GMBH
MA country
Germany
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Danatrol 50 mg capsule rigide

PRD426017 · Product

Active substance
Danazol
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
54 Month(s)
Authorisation status
Authorised
ATC code
G03XA01 — DANAZOL
Marketing authorisation
025021066
MA holder
SANOFI S.R.L.
MA country
Italy
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

HYDREA 500 mg capsule

PRD10833408 · Product

Active substance
Hydroxycarbamide
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
54 Month(s)
Authorisation status
Authorised
ATC code
L01XX05 — HYDROXYCARBAMIDE
Marketing authorisation
11474/2019/01
MA holder
BRISTOL-MYERS SQUIBB KFT.
MA country
Romania
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

DANAZOL POLFARMEX, 200 mg, tabletki

PRD1162594 · Product

Active substance
Danazol
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
54 Month(s)
Authorisation status
Authorised
ATC code
G03XA01 — DANAZOL
Marketing authorisation
9253
MA holder
POLFARMEX S.A.
MA country
Poland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Pegasys 180 micrograms solution for injection in pre-filled syringe

PRD9188897 · Product

Active substance
Peginterferon ALFA-2A
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS
Max daily dose
00 Aµg/ml microgram(s)/millilitre
Max total dose
00 Aµg/ml microgram(s)/millilitre
Max treatment duration
54 Month(s)
Authorisation status
Authorised
ATC code
L03AB11 — PEGINTERFERON ALFA-2A
Marketing authorisation
EU/1/02/221/007
MA holder
PHARMAAND GMBH
MA country
Norway
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Lenalidomide Accord 5 mg hard capsules

PRD6845269 · Product

Active substance
Lenalidomide
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL USE
Max daily dose
00 mg milligram(s)
Max total dose
00 mg milligram(s)
Max treatment duration
54 Month(s)
Authorisation status
Authorised
ATC code
L04AX04 — -
Marketing authorisation
EU/1/18/1316/004
MA holder
ACCORD HEALTHCARE S.L.U.
MA country
Liechtenstein
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Kartos Therapeutics Inc.

4 Total trials 1 Recruiting 3 Ended
Commercial
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
John Mei

Public contact point

Organisation
Kartos Therapeutics Inc.
Contact name
John Mei

Third parties 14

OrganisationCity, countryDuties
Excelya Greece CRO Single Member S.A.
ORG-100009224
 Nea Filadelfia, Greece On site monitoring, Code 12, Interactive response technologies (IRT), E-data capture
Fisher Clinical Services GmbH
ORG-100017323
 Weil Am Rhein, Germany Other
Eurofins Central Laboratory B.V.
ORG-100036990
 Breda, Netherlands Other
Pharmaceutical Product Development LLC
ORG-100016999
 Richmond, United States Other
Aperio Clinical Outcomes LLC
ORG-100046387
 Durham, United States Data management
Greenphire LLC
ORG-100041621
 King Of Prussia, United States Other
PAREXEL International GmbH
ORG-100008131
 Berlin, Germany Other
Parexel International (IRL) Limited
ORG-100022780
 Dublin 2, Ireland On site monitoring, Code 12, Code 2, Data management, Code 8
Perceptive Informatics Inc.
ORG-100013171
 Billerica, United States Other
Endpoint Clinical Inc.
ORG-100040567
 Wakefield, United States Interactive response technologies (IRT)
Signant Health Management Limited
ORG-100040504
 Reading, United Kingdom Other
Primevigilance USA Inc.
ORG-100047266
 Raleigh, United States Code 8
Flagship Biosciences Inc.
ORG-100043268
 Morrisville, United States Other
Celerion Inc.
ORG-100029202
 Lincoln, United States Other

Locations

13 EU/EEA countries · 51 investigational sites

By country

CountryMS statusPlanned subjectsSites
Bulgaria Ongoing, recruitment ended 12 2
Croatia Ongoing, recruitment ended 9 2
Czechia Ongoing, recruitment ended 2 2
France Ongoing, recruitment ended 30 6
Germany Ongoing, recruitment ended 28 6
Greece Ended 3 1
Hungary Ongoing, recruitment ended 26 3
Italy Ongoing, recruitment ended 23 8
Lithuania Ongoing, recruitment ended 5 1
Poland Ongoing, recruitment ended 50 5
Portugal Ended 4 1
Romania Ongoing, recruitment ended 31 5
Spain Ongoing, recruitment ended 30 9
Rest of world
Taiwan, Russian Federation, Turkey, Philippines, Thailand, Australia, Brazil, Mexico, United States, Argentina, Hong Kong, United Kingdom, Israel, Canada, Korea, Republic of
 — 194 —

Investigational sites

Bulgaria

2 sites · Ongoing, recruitment ended
Acibadem City Clinic Tokuda University Hospital EAD
2301: Department of Clinical Hematology, Bulevard Nikola Yonkov Vaptsarov 51b, 1407, Sofiya
Specialized Hospital For Active Treatment Of Hematological Diseases EAD
Clinic of Clinical Hematology – Third Department, Bulevard Kliment Ohridski 1a, 1797, Sofiya

Croatia

2 sites · Ongoing, recruitment ended
Klinicka bolnica Merkur
#8701;Hematologija, Ulica Ivana Zajca 19, 10000, Zagreb
Klinicki bolnicki centar Sestre milosrdnice
#8703;Dermatologija, Vinogradska Cesta 29, Zagreb, Grad Zagreb

Czechia

2 sites · Ongoing, recruitment ended
Fakultni Nemocnice Hradec Kralove
#3005:IV. interni hematologicka klinika, Sokolska 581, 500 03, Novy Hradec Kralove
University Hospital Olomouc
#3003:Hemato-onkologicka klinika, Zdravotniku 248/7, 779 00, Olomouc

France

6 sites · Ongoing, recruitment ended
Oncopole Claudius Regaud
#4004: Service d’hématologie, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Hospitalier Regional Universitaire De Tours
#4013: Hématologie, 2 Boulevard Tonnelle, 37044, Tours Cedex 9
Hopital Saint Louis
#4000: Centre d'Investigations cliniques, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Universitaire Amiens Picardie
#4008: Hématologie Clinique, 30 Avenue De La Croix Jourdain, 80054, Amiens Cedex 1
Centre Hospitalier Universitaire De Caen Normandie
#4007: Service Hématologie Clinique, Avenue De La Cote De Nacre, 14000, Caen
Centre Hospitalier Regional Et Universitaire De Brest
#4003 Département d’hématologie clinique, Boulevard Tanguy Prigent, 29200, Brest

Germany

6 sites · Ongoing, recruitment ended
Kliniken Ostalb gemeinnuetzige kommunale Anstalt des oeffentlichen Rechts
#5006:Zentrum Für Innere Medizin, Wetzgauer Strasse 85, 73557, Mutlangen
Universitaetsklinikum Aachen AöR
#5007:Onkologie und Haematologie, Pauwelsstrasse 30, 52074, Aachen
Universitaetsklinikum Halle (Saale) AöR
#5005:Klinik für Innere Medizin IV, Hämatologie und Onkologie, Ernst-Grube-Strasse 40, Kroellwitz, Halle Saale
Universitaetsklinikum Jena KöR
#5004:Hämatologie und Onkologie, Am Klinikum 1, Lobeda, Jena
Gemeinschaftspraxis Haematologie Onkologie
#5008:Jacobasch, Illmer, Wolf, Arnoldstrasse 18, Johannstadt-Nord, Dresden
Klinikum rechts der Isar der TU Muenchen AöR
#5001:III. Medizinische Klinik, Ismaninger Strasse 22, Au-Haidhausen, Munich

Greece

1 site · Ended
University General Hospital Of Thessaloniki Ahepa
#9305;1st Propeudetic Internal Medicine Clinic, Hematology Department, 1st St Kiriakidis Str, 546 36, Thessaloniki

Hungary

3 sites · Ongoing, recruitment ended
University Of Szeged
#6001: Belgyógyászati Klinika, Semmelweis Utca 8, 6725, Szeged
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
#6004: Hematológiai Osztály, Szent Istvan Utca 68, 4400, Nyiregyhaza
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
#6006; Hematológiai és Őssejt-transzplantációs Osztály, Albert Florian Ut 5-7, 1097, Budapest IX

Italy

8 sites · Ongoing, recruitment ended
ASST Grande Ospedale Metropolitano Niguarda
3116: Ematologia, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
3102:S.C.Ematologia U S.S.D. Clinical Trial in Oncoematologia e Mieloma Multiplo, Corso Bramante 88, 10126, Turin
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
3104: Servizio e DH di Ematologia, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
3113: S.C. Ematologia, Via Venezia 16, 15121, Alexandria
Azienda Ospedaliero Universitaria Delle Marche
3107: SOD Clinica Ematologica, Via Conca 71, 60126, Ancona
Azienda USL IRCCS Di Reggio Emilia
3108: Ematologia, Via Giovanni Amendola 2, 42122, Reggio Emilia
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
3109: Ematologia, Via Piero Maroncelli 40, 47014, Meldola
Azienda Ospedaliera S Maria Di Terni
3105: S.C. di Oncologia Medica e Translazionale / Dipartimento di Oncologia, Viale Tristano Di Joannuccio 1, 05100, Terni

Lithuania

1 site · Ongoing, recruitment ended
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
#8601; Hematology, Eiveniu G. 2, Kauno M. Sav., Kaunas

Poland

5 sites · Ongoing, recruitment ended
Pratia S.A.
#8009; Centrum Medyczne Pratia Poznan, Ul. Poznanska 14, 60-185, Skorzewo
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
#8007; Oddzial Hematologiczny, Ul. Hubalczykow 1, 76-200, Slupsk
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
#8005; Oddzial Hematologiczny, Ul. Grabiszynska 105, 53-439, Wroclaw
Szpital Wojewodzki W Opolu Sp. z o.o.
#8002; Oddzial Kliniczny Hematologii, Onkologii Hematologicznej i Chorob Wewnetrznych, Ul. Katowicka 64, 45-061, Opole
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
#8004; Laboratorium Analityczne, Ul. Strzelcow Bytomskich 11, 41-500, Chorzow

Portugal

1 site · Ended
Unidade Local De Saude Da Regiao De Aveiro E.P.E.
#7100:Dermatologia, Avenida De Artur Ravara, 3814-501, Aveiro

Romania

5 sites · Ongoing, recruitment ended
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
3307: Hematology, Strada Republicii 34-36, 400015, Cluj-Napoca
Spitalul Clinic Coltea
3301: Hematology, Bulevardul Bratianu C. Ion 1-3, 030171, Bucharest
Spitalul Clinic Municipal Filantropia Craiova
3305: Hematology, Strada Filantropiei No 1, 200143, Craiova
Institutul Regional De Oncologie Iasi
3304: Hematology, Strada G-Ral Berthelot 2-4, 700483, Iasi
Spitalul Clinic Colentina Bucuresti
3302: Hematology, Soseaua Stefan Cel Mare 19-21, 020125, Bucharest

Spain

9 sites · Ongoing, recruitment ended
Hospital Universitario Puerta De Hierro De Majadahonda
#7007: Hematología y Hemoterapia, Calle De Manuel De Falla 1, 28222, Majadahonda
Institut Catala D'oncologia
#7000: Hematología, Carretera Canyet S/n, 08916, Badalona
Hospital General Universitario Dr. Balmis
#7009: Hematología, Avinguda Del Pintor Baeza 12, 03010, Alicante
Hospital Quironsalud Zaragoza
#7013: Oncologia Medica, Paseo Renovales S/n, 50006, Zaragoza
University Hospital Son Espases
#7014: Oftalmología, Carretera Valldemossa 79, 07120, Palma
Hospital Universitario De Navarra
#7010: Hematología, Irunlarrea Kalea 3, 31008, Pamplona
El Hospital Universitario De Gran Canaria Dr. Negrin
#7003: Hematologia y Transfusión, Barranco De La Ballena S N, 35010, Las Palmas De Gran Canaria
Hospital Universitario Dr Peset Aleixandre
#7008: Hematología, Avinguda De Gaspar Aguilar 90, 46017, Valencia
Hospital San Pedro De Alcantara
#7015: Unidad de Ensayos Clinicos, Avenida De Pablo Naranjo Porras S/n, 10002, Caceres

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Bulgaria 2020-02-13 2020-07-21 2023-09-01
Croatia 2022-03-22 2022-03-28 2023-09-01
Czechia 2019-01-16 2019-07-17 2023-09-01
France 2019-02-04 2019-03-11 2023-09-01
Germany 2019-01-21 2019-03-06 2023-09-01
Greece 2023-03-22 2025-03-31 2023-07-25 2023-09-01
Hungary 2018-12-13 2019-02-19 2023-09-01
Italy 2021-06-21 2021-11-17 2023-09-01
Lithuania 2022-01-30 2023-03-29 2023-09-01
Poland 2019-02-12 2019-03-14 2023-09-01
Portugal 2022-05-11 2024-09-17 2022-07-12 2023-09-01
Romania 2022-09-07 2022-10-03 2023-09-01
Spain 2019-02-14 2019-03-18 2023-09-01

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 96 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol Main 2024-513912-89-00 English KRT-232-101 Public 11.1 EU
Protocol (for publication) D1_Protocol Main 2024-513912-89-00 Greek KRT-232-101 Public 11.1 EU
Recruitment arrangements (for publication) K1_POL Regulatory Filenote Recruitment arrangements KRT-232-101 NA
Recruitment arrangements (for publication) K1_Recruitment arrangements ICF Patient Procedure Place holder KRT-232-101 NA
Recruitment arrangements (for publication) K1_Recruitment arrangements Regulatory filenote English_KRT-232-101_Public NA
Recruitment arrangements (for publication) K1_Recruitment arrangements Regulatory filenote English_KRT-232-101_Public NA
Recruitment arrangements (for publication) K1_Recruitment arrangements Regulatory Filenote KRT-232-101 NA
Recruitment arrangements (for publication) K1_Recruitment arrangements Regulatory Filenote Public_ KRT-232-101 NA
Recruitment arrangements (for publication) K1_Recruitment arrangements Regulatory Filenote Public_KRT-232-101 NA
Recruitment arrangements (for publication) K1_Recruitment arrangements Regulatory Filenote Public_KRT-232-101 NA
Recruitment arrangements (for publication) K1_Recruitment arrangements_Placeholder_Public NA
Recruitment arrangements (for publication) K1_Recruitment arrangements_Regulatory Filenote KRT-232-101 NA
Recruitment arrangements (for publication) K1_Recruitment arrangements_Transition Placeholder NA
Recruitment arrangements (for publication) K1_Recruitment arrangements_Transition placeholder_Public NA
Recruitment arrangements (for publication) K1_Regulatory Filenote_End of Recruitment KRT-232-101 NA
Recruitment arrangements (for publication) K2_ Recruitment material Regulatory Filenote Public_ KRT-232-101 NA
Subject information and informed consent form (for publication) L1_BGR Country ICF Other Pregnant Partner Bulgarian KRT-232-101 Public 5.0
Subject information and informed consent form (for publication) L1_BGR Country ICF Other Pregnant Partner English KRT-232-101 Public 1.0
Subject information and informed consent form (for publication) L1_CZE Country ICF Main Adult already enrolled Czech KRT-232-101 Public 4.0
Subject information and informed consent form (for publication) L1_CZE Country ICF Main Adult Czech KRT-232-101 Public 4.0
Subject information and informed consent form (for publication) L1_CZE Country ICF Other Pregnancy Czech KRT-232-101 Public 1.0
Subject information and informed consent form (for publication) L1_DEU ICF Future Research Part B German KRT-232-101 Public 1.1
Subject information and informed consent form (for publication) L1_DEU ICF Main Adult Part B German KRT-232-101 Public 4.1
Subject information and informed consent form (for publication) L1_DEU ICF Main Part A German KRT-232-101 Public 11.1
Subject information and informed consent form (for publication) L1_DEU ICF Other Pregnant Partner Part A German KRT-232-101 Public 4.0
Subject information and informed consent form (for publication) L1_DEU ICF Other Pregnant Partner Part B German KRT-232-101 Public 1.1
Subject information and informed consent form (for publication) L1_ESP Country ICF Main KRT-232-101 Public 5.0
Subject information and informed consent form (for publication) L1_ESP Country ICF Other Pregant Partner Spanish KRT-232-101 Public 1.0
Subject information and informed consent form (for publication) L1_FRA Country ICF Main Part A French KRT-232-101 Public 9.0
Subject information and informed consent form (for publication) L1_FRA Country ICF Main Part B French KRT-232-101 Public 6.0
Subject information and informed consent form (for publication) L1_FRA Country ICF Other Pregnant Partner French KRT-232-101 Public 1.1
Subject information and informed consent form (for publication) L1_FRA Country ICF Part B Patient Information Sheet Pre-Screening French KRT-232-101 Public 1.1
Subject information and informed consent form (for publication) L1_GRC Country ICF Other Pregnant Partner English KRT-232-101 Public 1.1
Subject information and informed consent form (for publication) L1_GRC Country ICF Other Pregnant Partner Greek KRT-232-101 Public 1.1
Subject information and informed consent form (for publication) L1_GRC Country ICF Screening Adult English KRT-232-101 Public 1.1
Subject information and informed consent form (for publication) L1_GRC Country ICF Screening Adult Greek KRT-232-101 Public 1.1
Subject information and informed consent form (for publication) L1_HRV Country ICF Main Croatian KRT-232-101 Public 8.0
Subject information and informed consent form (for publication) L1_HRV Country ICF Other Pregnant Participant Croatian KRT-232-101 Public 2.0
Subject information and informed consent form (for publication) L1_HRV Country ICF Other Pregnant Partner Croatian KRT-232-101 Public 2.0
Subject information and informed consent form (for publication) L1_ICF Data Protection Adult Czech KRT-232-101 Public 1
Subject information and informed consent form (for publication) L1_ICF IRB-IEC Additional-Amendment Approval_Italian_KRT-232-101_Public NA
Subject information and informed consent form (for publication) L1_ICF Main Adult English KRT-232-101 Public 4.1
Subject information and informed consent form (for publication) L1_ICF Main Adult Greek KRT-232-101 Public 4.1
Subject information and informed consent form (for publication) L1_ICF Main Part B Bulgarian KRT-232-101 Public 6.0
Subject information and informed consent form (for publication) L1_ICF Main Part B English KRT-232-101 Public 6.0
Subject information and informed consent form (for publication) L1_ICF Main Part B_Hungarian_KRT-232-101_Public 6.1
Subject information and informed consent form (for publication) L1_ICF Main Patient Information Sheet Part A Hungarian KRT-232-101 Public 9.0
Subject information and informed consent form (for publication) L1_ICF Main Patient Information Sheet Part B Hungarian KRT-232-101 Public 5.0
Subject information and informed consent form (for publication) L1_ICF Main Romanian KRT-232-101 Public 6.1
Subject information and informed consent form (for publication) L1_ICF Other Pregnant Partner Information Sheet Part A Hungarian KRT-232-101 Public 5.0
Subject information and informed consent form (for publication) L1_ICF Other Pregnant Partner Information Sheet Part B Hungarian KRT-232-101 Public 1.0
Subject information and informed consent form (for publication) L1_ICF Other Pregnant Partner Part A Hungarian KRT-232-101 Public 5.0
Subject information and informed consent form (for publication) L1_ICF Other Pregnant Partner Part B Hungarian KRT-232-101 Public 1.0
Subject information and informed consent form (for publication) L1_ICF Research Adult Czech KRT-232-101 Public 2
Subject information and informed consent form (for publication) L1_ICF_Genetic Research Part A_Hungarian_KRT-232-101_Public 5.0
Subject information and informed consent form (for publication) L1_ICF_Genetic Research Part B_Hungarian_KRT-232-101_Public 2.0
Subject information and informed consent form (for publication) L1_ICF_Genetic Research Patient Information Sheet Part A_Hungarian_KRT-232-101_Public 5.0
Subject information and informed consent form (for publication) L1_ICF_Genetic Research Patient Information Sheet Part B_Hungarian_KRT-232-101_Public 2.0
Subject information and informed consent form (for publication) L1_ICF_Main Part A_Hungarian_KRT-232-101_Public 10.1
Subject information and informed consent form (for publication) L1_IRB-IEC Initial Approval_Italian_KRT-232-101_Public NA
Subject information and informed consent form (for publication) L1_ITA Country ICF Main Italian KRT-232-101 Public 6.1
Subject information and informed consent form (for publication) L1_ITA Country ICF Pregnant Partner Italian KRT-232-101 Public 1.0
Subject information and informed consent form (for publication) L1_LTU Country ICF Main Lithuanian KRT-232-101 Public 5.0
Subject information and informed consent form (for publication) L1_LTU Country ICF Other Pregnant Partner Lithuanian KRT-232-101 Public 1.0
Subject information and informed consent form (for publication) L1_POL ICF Main Part A Polish KRT-232-101 Public 12.0
Subject information and informed consent form (for publication) L1_POL ICF Main Part B Polish KRT-232-101 Public 7.0
Subject information and informed consent form (for publication) L1_POL ICF Other Pregnant Partner Part A Polish KRT-232-101 Public 4.0
Subject information and informed consent form (for publication) L1_POL ICF Other Pregnant Partner Part B Polish KRT-232-101 Public 1.0
Subject information and informed consent form (for publication) L1_PRT ICF Main Portuguese KRT-232-101 Public 3.0
Subject information and informed consent form (for publication) L1_PRT ICF Other Pregnant Participant Portuguese KRT-232-101 Public 1.0
Subject information and informed consent form (for publication) L1_PRT ICF Other Pregnant Partner Portuguese KRT-232-101 Public 1.0
Subject information and informed consent form (for publication) L1_ROU Country ICF Other Pregnant Partner Romanian KRT-232-101 Public 1.0
Subject information and informed consent form (for publication) L2_ICF_Subject Participation Card_Patient ID Card Part B_KRT-232-101_Public 1.0
Subject information and informed consent form (for publication) L2_ICF_Subject Participation Card_Patient ID Justification Letter_KRT-232-101 Public 1.0
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Danatrol English Public N/A
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Danatrol Italian Public N/A
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Danazol English Public N/A
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Danazol Polish Public N/A
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Hydrea English Public N/A
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Hydrea Romanian Public N/A
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Lenalidomide English Public N/A
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Pegasys English Public N/A
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Pegasys zr Pharma English Public N/A
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Prednison English Public N/A
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Prednison German Public N/A
Synopsis of the protocol (for publication) D1_Lay Protocol Synopsis Main Bulgarian KRT-232-101 Public 1.0
Synopsis of the protocol (for publication) D1_Lay Protocol Synopsis Main Czech KRT-232-101 Public 1.0
Synopsis of the protocol (for publication) D1_Lay Protocol Synopsis Main English KRT-232-101 Public 1.0
Synopsis of the protocol (for publication) D1_Lay Protocol Synopsis Main French KRT-232-101 Public 1.0
Synopsis of the protocol (for publication) D1_Lay Protocol Synopsis Main Greek KRT-232-101 Public 1.0
Synopsis of the protocol (for publication) D1_Lay Protocol Synopsis Main Hungarian KRT-232-101 Public 1.0
Synopsis of the protocol (for publication) D1_Lay Protocol Synopsis Main Italian KRT-232-101 Public 1.0
Synopsis of the protocol (for publication) D1_Lay Protocol Synopsis Main Lithuanian KRT-232-101 Public 1.0
Synopsis of the protocol (for publication) D1_Lay Protocol Synopsis Main Polish KRT-232-101 Public 1.0
Synopsis of the protocol (for publication) D1_Lay Protocol Synopsis Main Romanian KRT-232-101 Public 1.0
Synopsis of the protocol (for publication) D1_Lay Protocol Synopsis Main Spanish KRT-232-101 Public 1.0

Application history

5 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-10-08 Italy Acceptable
2024-11-13
 2024-11-14
2 NON SUBSTANTIAL MODIFICATION NSM-1 2025-01-23 Acceptable
2024-11-13
 2025-01-23
3 SUBSTANTIAL MODIFICATION SM-1 2025-03-21 Italy Acceptable
2025-06-30
 2025-07-01
4 SUBSTANTIAL MODIFICATION SM-2 2025-08-05 Acceptable 2025-09-10
5 NON SUBSTANTIAL MODIFICATION NSM-2 2025-09-17 Acceptable 2025-09-17

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