Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma (EPCORE™FL-2)

2023-506906-38-00 Protocol M22-003 Therapeutic confirmatory (Phase III) Ongoing, recruitment ended

Start 23 May 2024 · Status Ongoing, recruitment ended · 17 EU/EEA countries · 97 sites · Protocol M22-003

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruitment ended
Participants planned 906
Countries 17
Sites 97

Follicular Lymphoma

The primary objective of the study is to demonstrate that epcoritamab with R2 followed by epcoritamab maintenance (ER2 + E- Arm A1) will improve CR30 rates and PFS using Lugano criteria by IRC compared to chemoimmunotherapy followed by anti-CD20 maintenance therapy (CIT + maintenance - Arm B) in subjects with previousl…

Key facts

Sponsor
AbbVie Deutschland GmbH & Co. KG
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
23 May 2024 → ongoing
Decision date (initial)
2024-04-30
Transition trial
No
Low-intervention
No
Rare-disease indication
Yes
Vulnerable population
Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

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

The primary objective of the study is to demonstrate that epcoritamab with R2 followed by epcoritamab maintenance (ER2 + E- Arm A1) will improve CR30 rates and PFS using Lugano criteria by IRC compared to chemoimmunotherapy followed by anti-CD20 maintenance therapy (CIT + maintenance - Arm B) in subjects with previously untreated FL.

Secondary objectives 3

  1. Demonstrate that ER2 will improve OS compared to CIT in subjects with previously untreated FL in Arm A1 (ER2) versus Arm B (CIT).
  2. Demonstrate that ER2 will improve MRD negativity rate at C3D1/mid-induction compared to CIT in subjects with previously untreated FL in Arm A1 (ER2) versus Arm B (CIT).
  3. Demonstrate that subjects treated with ER2 will report higher Physical Functioning scores (using the Physical Functioning Scale of the EORTC-QLQC30) compared to CIT in subjects with previously untreated FL in Arm A1 (ER2) at Week 21 versus Arm B (CIT) at Week 21/22.

Conditions and MedDRA coding

Follicular Lymphoma

VersionLevelCodeTermSystem organ class
23.1 LLT 10084346 B-cell non-Hodgkin´s lymphoma 100000004848
24.0 PT 10085128 Follicular lymphoma 100000004864

Regulatory references

Scientific advice from competent authorities
European Medicines Agency, Food And Drug Administration, European Medicines Agency, Pharmaceuticals And Medical Devices Agency
Plan to share IPD
Yes
IPD plan description
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information. To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/ For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

  1. Diagnosis of follicular lymphoma (FL).
  2. Have CD20+, histologically confirmed classic FL (previously Grade 1 to 3a FL) at most recent representative tumor biopsy based on the local pathology report, according to the 5th edition of World Health Organization (WHO) Classification of Haematolymphoid Tumours.
  3. Are willing and able to comply with procedures required in this protocol.
  4. Must have stage II, III or IV disease.
  5. Must be in need of systemic treatment per investigator, as evidenced by meeting at least one of the Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria.
  6. Has one or more target lesions: (a) A positron emission tomography (PET)/computerized tomography (CT) scan demonstrating PET-positive lesion(s), and (b) >=1 measurable nodal lesion (long axis >1.5cm) or >=1 measurable extra-nodal lesion (long axis >1.0 cm) on CT scan or MRI
  7. Eastern Cooperative Oncology Group (ECOG) performance status 0–2.
  8. Able to receive at least one of the standard of care CIT treatment regimens (Arm B) at the discretion of the Investigator, and R2 (Arm C)

Exclusion criteria 2

  1. Had major surgery within 4 weeks prior to randomization.
  2. Have active cytomegalovirus (CMV) disease.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. The primary endpoint is the Complete Response rate at 30 months/120 weeks (CR30) in Arm A1 (ER2) versus Arm B (CIT), as determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.

Secondary endpoints 3

  1. OS
  2. MRD negativity rate
  3. PROs: Change from baseline in physical functioning (assessed by the physical functioning scale of the EORTC QLQ-C30) at Week 21 for Arm A1 and Week 21 (G/R-Benda regimen)/22 (G/R-CHOP regimen) for Arm B.

Investigational products

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

Test 6

Revlimid 5 mg hard capsules

PRD9264284 · Product

Active substance
Lenalidomide
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
72 Week(s)
Authorisation status
Authorised
ATC code
L04AX04 — -
Marketing authorisation
EU/1/07/391/001
MA holder
BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Revlimid 20 mg hard capsules

PRD9264267 · Product

Active substance
Lenalidomide
Pharmaceutical form
CAPSULE, HARD
Route of administration
ORAL
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
72 Week(s)
Authorisation status
Authorised
ATC code
L04AX04 — -
Marketing authorisation
EU/1/07/391/009
MA holder
BRISTOL-MYERS SQUIBB PHARMA EEIG
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Truxima 500 mg concentrate for solution for infusion

PRD4797328 · Product

Active substance
Rituximab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
0 mg/m2 milligram(s)/square meter
Max total dose
0 mg/m2 milligram(s)/square meter
Max treatment duration
120 Week(s)
Authorisation status
Authorised
ATC code
L01FA01 — -
Marketing authorisation
EU/1/16/1167/001
MA holder
CELLTRION HEALTHCARE HUNGARY KFT
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Truxima 100 mg concentrate for solution for infusion

PRD5065907 · Product

Active substance
Rituximab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
0 mg/m2 milligram(s)/square meter
Max total dose
0 mg/m2 milligram(s)/square meter
Max treatment duration
120 Week(s)
Authorisation status
Authorised
ATC code
L01FA01 — -
Marketing authorisation
EU/1/16/1167/002
MA holder
CELLTRION HEALTHCARE HUNGARY KFT
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Epcoritamab (GEN3013)

PRD10556501 · Product

Active substance
Epcoritamab
Substance synonyms
Anti-CD3E x Anti-MS4A1 IgG1 monoclonal antibody, Anti-(CD3 epsilon) and anti-(membrane-spanning 4-domains subfamily A member 1) IgG1 monoclonal antibody, GEN3013
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SUBCUTANEOUS INJECTION
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
120 Week(s)
Authorisation status
Not Authorised
MA holder
ABBVIE DEUTSCHLAND GMBH & CO. KG
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/22/2634

Epcoritamab (GEN3013)

PRD10556500 · Product

Active substance
Epcoritamab
Substance synonyms
Anti-CD3E x Anti-MS4A1 IgG1 monoclonal antibody, Anti-(CD3 epsilon) and anti-(membrane-spanning 4-domains subfamily A member 1) IgG1 monoclonal antibody, GEN3013
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
SOLUTION FOR INJECTION
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
120 Week(s)
Authorisation status
Not Authorised
MA holder
ABBVIE DEUTSCHLAND GMBH & CO. KG
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/22/2634

Comparator 6

Doxorubicin 2 mg/ml Solution for Injection.

PRD631907 · Product

Active substance
Doxorubicin Hydrochloride
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS
Max daily dose
0 mg/m2 milligram(s)/square meter
Max total dose
0 mg/m2 milligram(s)/square meter
Max treatment duration
18 Week(s)
Authorisation status
Authorised
ATC code
L01DB01 — DOXORUBICIN
Marketing authorisation
PL 00057/ 0970
MA holder
PFIZER LIMITED
MA country
XI
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Bendamustine 100 mg Powder for concentrate for Solution for Infusion

PRD1992113 · Product

Active substance
Bendamustine Hydrochloride
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
0 mg/m2 milligram(s)/square meter
Max total dose
0 mg/m2 milligram(s)/square meter
Max treatment duration
24 Week(s)
Authorisation status
Authorised
ATC code
L01AA09 — -
Marketing authorisation
PA2315/077/002
MA holder
ACCORD HEALTHCARE IRELAND LIMITED
MA country
Ireland
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Vincristine Sulfate 1 mg/ml solution for injection

PRD993268 · Product

Active substance
Vincristine Sulfate
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS
Max daily dose
0 mg/m2 milligram(s)/square meter
Max total dose
0 mg/m2 milligram(s)/square meter
Max treatment duration
18 Week(s)
Authorisation status
Authorised
ATC code
L01CA02 — VINCRISTINE
Marketing authorisation
PL 04515/0008
MA holder
HOSPIRA UK LIMITED
MA country
XI
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

PREDNISONE BIOGARAN 20 mg, scored tablet

PRD9819272 · Product

Active substance
Prednisone
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
18 Week(s)
Authorisation status
Authorised
ATC code
H02AB07 — PREDNISONE
Marketing authorisation
AA1218/01402
MA holder
BIOGARAN
MA country
Malta
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Cyclophosphamide Injection 500 mg.

PRD347229 · Product

Active substance
Cyclophosphamide
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRAVENOUS
Max daily dose
0 mg/m2 milligram(s)/square meter
Max total dose
0 mg/m2 milligram(s)/square meter
Max treatment duration
18 Week(s)
Authorisation status
Authorised
ATC code
L01AA01 — CYCLOPHOSPHAMIDE
Marketing authorisation
PL 00116/0387
MA holder
BAXTER HEALTHCARE LTD.
MA country
XI
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Gazyvaro 1,000 mg concentrate for solution for infusion.

PRD1753415 · Product

Active substance
Obinutuzumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
120 Week(s)
Authorisation status
Authorised
ATC code
L01XC15 — -
Marketing authorisation
EU/1/14/937/001
MA holder
ROCHE REGISTRATION GMBH
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Auxiliary 1

RoActemra 20 mg/mL concentrate for solution for infusion

PRD366304 · Product

Active substance
Tocilizumab
Pharmaceutical form
SOLUTION FOR INFUSION
Route of administration
INTRAVENOUS
Max daily dose
0 mg milligram(s)
Max total dose
0 mg milligram(s)
Max treatment duration
2 Day(s)
Authorisation status
Authorised
ATC code
L04AC07 — -
Marketing authorisation
EU/1/08/492/001
MA holder
ROCHE REGISTRATION GMBH
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

138 Total trials 54 Recruiting 80 Ended
Commercial
Sponsor organisation
AbbVie Deutschland GmbH & Co. KG
Address
Knollstrasse
City
Ludwigshafen Am Rhein
Postcode
67061
Country
Germany

Scientific contact point

Organisation
AbbVie Deutschland GmbH & Co. KG
Contact name
Global Clinial Trial Helpdesk

Public contact point

Organisation
AbbVie Deutschland GmbH & Co. KG
Contact name
Global Clinial Trial Helpdesk

Third parties 11

OrganisationCity, countryDuties
Greenphire LLC
ORG-100041621
 King Of Prussia, United States Other
Endpoint Clinical Inc.
ORG-100040567
 Wakefield, United States Interactive response technologies (IRT)
Q Squared Solutions Holdings LLC
ORG-100043288
 Durham, United States Laboratory analysis
Clinical Trial Media Inc.
ORG-100046339
 Hauppauge, United States Code 2
Cytel Inc.
ORG-100042560
 Waltham, United States Other
Medable Inc.
ORG-100043083
 Palo Alto, United States Other
Veeva Systems Inc.
ORG-100006053
 Pleasanton, United States E-data capture
Labcorp Central Laboratory Services S.a.r.l.
ORG-100011524
 Meyrin, Switzerland Laboratory analysis
Labcorp
ORG-100042736
 Mechelen, Belgium Laboratory analysis
Medical Equipment Supplies And Management Limited
ORG-100044212
 Chorley, United Kingdom Other
Perceptive Informatics Inc.
ORG-100013171
 Billerica, United States Other

Locations

17 EU/EEA countries · 97 investigational sites

By country

CountryMS statusPlanned subjectsSites
Belgium Ongoing, recruitment ended 22 7
Bulgaria Ongoing, recruitment ended 20 4
Croatia Ongoing, recruitment ended 28 7
Czechia Ongoing, recruitment ended 14 3
Denmark Ongoing, recruitment ended 11 5
France Ongoing, recruitment ended 31 10
Germany Ongoing, recruitment ended 20 6
Greece Ongoing, recruitment ended 15 5
Hungary Ongoing, recruitment ended 15 5
Italy Ongoing, recruitment ended 25 7
Netherlands Ongoing, recruitment ended 38 9
Poland Ongoing, recruitment ended 20 5
Portugal Ongoing, recruitment ended 14 4
Romania Ongoing, recruitment ended 13 4
Slovakia Ongoing, recruitment ended 10 2
Spain Ongoing, recruitment ended 46 12
Sweden Ended 15 2
Rest of world
Serbia, United States, Brazil, Canada, Puerto Rico, Japan, South Africa, China, Israel, Turkey, Australia, United Kingdom, Taiwan, Korea, Republic of, New Zealand
 — 549 —

Investigational sites

Belgium

7 sites · Ongoing, recruitment ended
Algemeen Ziekenhuis Klina
Hematology, Augustijnslei 100, 2930, Brasschaat
Cliniques Universitaires Saint-Luc
Hematology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
CHC MontLegia
Hematology, Boulev. De Patience Et Beajonc 2, 4000, Liege
Universitair Ziekenhuis Gent
Hematology, Corneel Heymanslaan 10, 9000, Gent
Algemeen Ziekenhuis Delta
Hematology, Deltalaan 1, 8800, Roeselare
Antwerp University Hospital
Hematology, Drie Eikenstraat 655, 2650, Edegem
UZ Leuven
Hematology, Herestraat 49, 3000, Leuven

Bulgaria

4 sites · Ongoing, recruitment ended
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Clinic of Clinical Hematology, Ulitsa Georgi Kochev 8-A, 5803, Pleven
Tokuda Hospital
Department of Clinical Hematology in Clinic of Hematology, Bul.nikola Yonkov Vaptsarov, 1407, Sofia
Specialized Hospital For Active Treatment Of Hematological Diseases EAD
Clinic of Clinical Hematology, Bulevard Kliment Ohridski 1a, 1797, Sofiya
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Department of Clinical Hematology in Clinic of Clinical Hematology, Boulevard Akademik Ivan Evstratiev Geshov 15, 1431, Sofia

Croatia

7 sites · Ongoing, recruitment ended
Zadar General Hospital
Department for hematology, Ulica Boze Pericica 5, 23000, Zadar
Clinical Hospital Centre Rijeka
Department for hematology, Kresimirova 42, 51000, Rijeka
KBC Split
Department for hematology, Spinciceva 1, 21000, Split
Klinicki bolnicki centar Sestre milosrdnice
Department for hematology, Vinogradska Cesta 29, Zagreb, Grad Zagreb
KBC Zagreb
Department for hematology, Ulica Mije Kispatica 12, Zagreb, Grad Zagreb
Clinical Hospital Dubrava
Department for hematology, Avenija Gojka Suska 6, Zagreb, Grad Zagreb
Clinical Hospital Merkur
Department for hematology, Zajceva 19, 10000, Zagreb

Czechia

3 sites · Ongoing, recruitment ended
Fakultni Nemocnice Hradec Kralove
IV. interní hematologická klinika, Sokolska 581, 500 03, Novy Hradec Kralove
Fakultni Nemocnice Brno
Interní hematologická a onkologická klinika, Jihlavska 340/20, Bohunice, Brno
Fakultni Nemocnice Kralovske Vinohrady
Interní hematologická klinika, Srobarova 1150/50, Vinohrady, Prague 10

Denmark

5 sites · Ongoing, recruitment ended
Region Midtjylland
Klinik for Blodsygdomme, Hospitalsparken 15, 7400, Herning
Sygehus Lillebaelt Vejle Sygehus
Department of Medicine, Kabbeltoft 25, 7100, Vejle
Odense University Hospital
Hæmatologisk Afdeling, J B Winsloews Vej 4, 5000, Odense C
Region Sjaelland
Hæmatologisk Afdeling, Sygehusvej 10, 4000, Roskilde
Rigshospitalet
Department of Hematology, Blegdamsvej 9, 2100, Copenhagen Oe

France

10 sites · Ongoing, recruitment ended
Groupe Hospitalier Saint Vincent
Hématologie-oncologie, 182 Route De La Wantzenau, 67000, Strasbourg
Centre Hospitalier Universitaire De Caen Normandie
Département d'hématologie clinique, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Hopital Saint Louis
Service onco-hématologie, 1 Avenue Claude Vellefaux, 75010, Paris
L'Hopital Prive Du Confluent
Service d'hématologie, 4 Rue Eric Tabarly, 44277, Nantes Cedex 2
Centre Hospitalier Le Mans
Cancérologie, 194 Avenue Rubillard, 72037, Le Mans Cedex 9
Centre Hospitalier General De Libourne
Département d'hématologie, 112 Rue De La Marne, Bp 199, Libourne Cedex
Centre Hospitalier D Avignon
hématologie, 305 Rue Raoul Follereau, 84000, Avignon
Groupe D’Etude Des Lymphomes De L’Adulte
Service d'hématologie, 165 Chemin Du Grand Revoyet, 69495, Pierre Benite Cedex
Centre Hospitalier Regional Et Universitaire De Brest
Service hématologie, Boulevard Tanguy Prigent, 29200, Brest
Hopital Prive D Antony
hematologie, 1 Rue Velpeau, 92160, Antony

Germany

6 sites · Ongoing, recruitment ended
Klinikum Kassel GmbH
Klinik fuer Haematologie, Onkologie und Immunologie, Moenchebergstrasse 41-43, Fasanenhof, Kassel
Staedtisches Klinikum Karlsruhe gGmbH
Medizinische Klinik III, Moltkestrasse 90, Weststadt, Karlsruhe
Goethe University Frankfurt
Department of Medicine II Hematology/Oncology, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Otto Von Guericke Universitaet Magdeburg
Medizinische Fakultaet, Leipziger Strasse 44, Leipziger Str., Magdeburg
St.-Antonius-Hospital gGmbH
Klinik fuer Haematologie und Onkologie, Dechant-Deckers-Strasse 8, 52249, Eschweiler
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
NA, Bremserstrasse 79, Friesenheim, Ludwigshafen Am Rhein

Greece

5 sites · Ongoing, recruitment ended
Laiko General Hospital Of Athens
Hematology Clinic and Βone Μarrow Τransplantation Unit, NKUA, Sevastoupoleos 16, 115 26, Athens
University General Hospital Attikon
2nd Propaedeutic Internal Medicine Clinic, Hematology Unit, Rimini Street 1, 124 62, Athens
University General Hospital Of Alexandroupoli
Department of Haematology, 6th Km Alex Polis Makris, Dragana, Alexandroupoli
Evaggelismos Hospital
Hematology-Lymphomas Department and BMT Unit, Ipsiladou 45-47, 106 76, Athens
Olympion General Clinic Patras P.C.
Hematology & Oncology Clinic, Volou And Meilichou, Kato Sichena, Patras

Hungary

5 sites · Ongoing, recruitment ended
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Hematologiai es ossejt-transzplantacios Osztaly, Albert Florian Ut 5-7, 1097, Budapest IX
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
II. Belgyogyaszat - Hematologia, Vasvari Pal Utca 2-4, 9024, Gyor
Orszagos Onkologiai Intezet
Gyogyszerterapias Kozpont Hematologia es Lymphoma Osztaly, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
Vas Varmegyei Markusovszky Egyetemi Oktatokorhaz
Haematologiai es Haemosztazeologiai Osztaly, Markusovszky Str. 5, 9700, Szombathely
Tolna Varmegyei Balassa Janos Korhaz
Hematologiai Osztaly, Beri Balogh Adam Utca 5-7, 7100, Szekszard

Italy

7 sites · Ongoing, recruitment ended
Humanitas Research Hospital
UO di Oncologia Medica ed Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
Medical Oncology, Strada Provinciale 142 Km 3,95, 10060, Candiolo
Fondazione Policlinico Universitario Campus Bio-Medico
Hematology, Via Alvaro Del Portillo N 200, 00128, Rome
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
OncoHematology, Via Trabucco 180, 90146, Palermo
Azienda USL IRCCS Di Reggio Emilia
Oncology and Advanced Technologies, SC Hematology, Viale Risorgimento 80, 42123, Reggio Emilia
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
Division of Hematology and Bone Marrow Trasplantation, Via Santa Sofia 78, 95123, Catania
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Dipartimento Malattie Oncologiche ed Ematologiche, Via Pietro Albertoni 15, 40138, Bologna

Netherlands

9 sites · Ongoing, recruitment ended
Universitair Medisch Centrum Groningen
N/A, Hanzeplein 1, 9713 GZ, Groningen
Bravis Ziekenhuis
Oncology, Boerhaaveplein 1, 4624 VT, Bergen Op Zoom
Haga Hospital
Hematology, Els Borst-Eilersplein 275, 2545 AA, 's-Gravenhage
Academisch Ziekenhuis Leiden
Oncology, Albinusdreef 2, 2333 ZA, Leiden
OLVG Stichting
Oncology, Oosterpark 9, 1091 AC, Amsterdam
Sint Franciscus Vlietland Groep Stichting
Hematology, Vlietlandplein 2, 3118 JH, Schiedam
St. Antonius Ziekenhuis
Oncology, Koekoekslaan 1, 3435 CM, Nieuwegein
St. Elisabeth Hospital Tilburg
Hematology, Hilvarenbeekseweg 60, 5022 GC, Tilburg
Rijnstate Ziekenhuis Stichting
Oncology, Wagnerlaan 55, 6815 AD, Arnhem

Poland

5 sites · Ongoing, recruitment ended
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworow Ukladu Chlonnego, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Klinika Hematologii i Transplantacji Szpiku, Ul. Prezydenta Stefana Artwinskiego 3, 25-734, Kielce
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Oddzial Hematoonkologii z Pododzialem Chemioterapii Dziennej, Ul. Pabianicka 62, 93-513, Lodz
Aidport Sp. z o.o.
N/A, Ul Ksiedza Stanisława Kozierowskiego 24, 60-185, Skorzewo
Pratia S.A.
N/A, Ul. Pana Tadeusza 2, 30-727, Cracow

Portugal

4 sites · Ongoing, recruitment ended
Centro Hospitalar De Vila Nova De Gaia/Espinho E.P.E.
Hematology, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia
Hospital De Santa Maria E.P.E.
Hematology, Avenida Professor Egas Moniz Piso 3, 1649-028, Lisbon
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Hematology, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Champalimaud Clinical Centre
Hematology, Avenida Brasilia S/n, 1400-038, Lisbon

Romania

4 sites · Ongoing, recruitment ended
Institutul Regional De Oncologie Iasi
Hematologie, Strada G-Ral Berthelot 2-4, 700483, Iasi
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Hematologie, Strada Republicii 34-36, 400015, Cluj-Napoca
Spitalul Clinic Coltea
Hematologie, Bulevardul Bratianu C. Ion 1-3, 030171, Bucharest
Institutul Clinic Fundeni
Clinica de Hematologie II, Soseaua Fundeni 258, 022328, Bucharest

Slovakia

2 sites · Ongoing, recruitment ended
Jessenius Medical School Comenius University
Klinika hematologie a transuyiologie, Kollarova 2, Jahodniky, Martin
National Oncology Institute
klinika onkohematologie, Klenova 1, 833 10, Bratislava

Spain

12 sites · Ongoing, recruitment ended
Hospital Universitario De Salamanca
Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
Institut Catala D'oncologia
Hematology, Carretera Canyet S/n, 08916, Badalona
Clinica Universidad De Navarra
Hematology, Avenue Pio XII 36, 31008, Pamplona
MD Anderson Cancer Center
Hematology, Calle De Arturo Soria Nº 270, 28033, Madrid
Clinica Universidad De Navarra
Hematology, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Universitario Fundacion Jimenez Diaz
Hematology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Clinic De Barcelona
Hematology, Calle Villarroel 170, 08036, Barcelona
Hospital De La Santa Creu I Sant Pau
Hematology, Carrer De San Quinti 89, 08041, Barcelona
Institut Catala D'oncologia
Hematology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario Marques De Valdecilla
Hematology, Avenida Valdecilla Sn, 39008, Santander
Hospital San Pedro De Alcantara
Hematology, Avenida De Pablo Naranjo Porras S/n, 10002, Caceres
Hospital Universitari Vall D Hebron
Hematology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona

Sweden

2 sites · Ended
Sodra Alvsborg Hospital-Vastra Gotalandsregionen
Hematolog dagvård, Brämhultsvägen 53, 501 82 Borås, Bramhultsvagen 53, Boras Gustav Adolf, Boras
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Section of Hematology and Coagulation, 5th floor, Bla Straket 5, Goteborgs Annedal, Goteborg

Country notifications

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

Country Trial startTrial end Recruitment startRecruitment end Early termination
Belgium 2024-07-30 2024-09-06 2025-12-10
Bulgaria 2024-08-21 2024-08-22 2025-12-10
Croatia 2024-06-21 2024-10-10 2025-12-10
Czechia 2024-06-13 2024-06-19 2025-12-10
Denmark 2024-08-27 2024-11-04 2025-12-10
France 2024-06-13 2024-06-17 2025-12-10
Germany 2024-06-12 2024-06-18 2025-12-10
Greece 2024-08-08 2024-08-19 2025-12-10
Hungary 2024-07-17 2024-08-29 2025-12-10
Italy 2024-06-28 2024-07-03 2025-12-10
Netherlands 2024-07-01 2024-08-23 2025-12-10
Poland 2024-06-27 2024-07-11 2025-12-10
Portugal 2024-07-03 2024-07-17 2025-12-10
Romania 2024-05-23 2024-06-05 2025-12-10
Slovakia 2024-09-30 2024-11-26 2025-12-10
Spain 2024-05-31 2024-06-03 2025-12-10
Sweden 2024-09-24

Results and documents

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

Documents 181 files

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

TypeTitleVersion
Protocol (for publication) D1_M22-003 - Protocol -EL-GR-redacted-public 5.1
Protocol (for publication) D1_M22-003_EORTC IL19 - PRO_merged-all-languages-san_MS 1
Protocol (for publication) D1_M22-003-protocol-redacted-public 5.1
Recruitment arrangements (for publication) K1 M22-003 PT Recruitment and ICF Procedures _Public 2.0
Recruitment arrangements (for publication) K2 M22-003 BE Doctor to Patient Email Dutch_Public 2.0
Recruitment arrangements (for publication) K2 M22-003 BE Doctor to Patient Email English_Public 2.0
Recruitment arrangements (for publication) K2 M22-003 BE Doctor to Patient Email French_Public 2.0
Recruitment arrangements (for publication) K2 M22-003 BE Doctor to Patient Email German_Public 2.0
Recruitment arrangements (for publication) K2 M22-003 BE Doctor to Patient Letter Dutch_Public 2.0
Recruitment arrangements (for publication) K2 M22-003 BE Doctor to Patient Letter English_Public 2.0
Recruitment arrangements (for publication) K2 M22-003 BE Doctor to Patient Letter French_Public 2.0
Recruitment arrangements (for publication) K2 M22-003 BE Doctor to Patient Letter German_Public 2.0
Recruitment arrangements (for publication) K2 M22-003 BE Recruitment Brochure Dutch_Public 2.0
Recruitment arrangements (for publication) K2 M22-003 BE Recruitment Brochure English_Public 2.0
Recruitment arrangements (for publication) K2 M22-003 BE Recruitment Brochure French_Public 2.0
Recruitment arrangements (for publication) K2 M22-003 BE Recruitment Brochure German_Public 2.0
Recruitment arrangements (for publication) K2 M22-003 ES Recruitment material_Study-specific Website copy_Clean_Public 3
Recruitment arrangements (for publication) K2 M22-003 FR Recruitment Brochure Track Changes_MS 2.0
Recruitment arrangements (for publication) K2 M22-003 PT Doctor to Patient Email_Public 2.1
Recruitment arrangements (for publication) K2 M22-003 PT Doctor to Patient Letter_Public 2.1
Recruitment arrangements (for publication) K2 M22-003 PT Recruitment Brochure_Public 2.1
Recruitment arrangements (for publication) K2_M22-003 CZ Recruitment Material_Recruitment Brochure_Public 1
Recruitment arrangements (for publication) K2_M22-003 FR Recruitment Brochure_Public 2.0
Recruitment arrangements (for publication) K2_M22-003 IT Caregiver Booklet_Public 3.2
Recruitment arrangements (for publication) K2_M22-003 IT Doctor to Patient Email_Public 2.1
Recruitment arrangements (for publication) K2_M22-003 IT Doctor to Patient Letter_Public 2.1
Recruitment arrangements (for publication) K2_M22-003 IT Patient Downloadable Study Guide_Public 2
Recruitment arrangements (for publication) K2_M22-003 IT Patient-Doctor Discussion Guide_Public 1
Recruitment arrangements (for publication) K2_M22-003 IT Recruitment Brochure_Public 2
Recruitment arrangements (for publication) K2_M22-003 IT Website Copy_Public 3
Recruitment arrangements (for publication) K2_M22-003 IT Website Prescreener_Public 2
Recruitment arrangements (for publication) K2_M22-003 IT Website_Public 2.1
Recruitment arrangements (for publication) K2_M22-003 SE Recruitment Material_Doctor to Patient Email_Public 2.0
Recruitment arrangements (for publication) K2_M22-003 SE Recruitment Material_Doctor to Patient letter_Public 2.0
Recruitment arrangements (for publication) K2_M22-003 SE Recruitment Material_Epcore Website Copy_Public 2.0
Recruitment arrangements (for publication) K2_M22-003 SE Recruitment Material_Patient Downloadable study guide_Public 2.0
Recruitment arrangements (for publication) K2_M22-003 SE Recruitment Material_Patient-Doctor Discussion Guide_Public 1.1
Recruitment arrangements (for publication) K2_M22-003 SE Recruitment Material_Recruitment Brochure_Public 2.0
Recruitment arrangements (for publication) K2_M22-003 SE Recruitment Material_Study Website copy_Public 3.0
Recruitment arrangements (for publication) K2_M22-003 SE Recruitment Material_Web-based Pre-screening_Public 2.0
Recruitment arrangements (for publication) K2_M22-003 SK Recruitment Material_Doctor to Patient Email_Public 2.1
Recruitment arrangements (for publication) K2_M22-003 SK Recruitment Material_Doctor to Patient Letter_Public 2.1
Recruitment arrangements (for publication) K2_M22-003 SK Recruitment Material_Participant Study Guide_Public 3.2
Recruitment arrangements (for publication) K2_M22-003 SK Recruitment Material_Recruitment Brochure_Public 3.1
Recruitment arrangements (for publication) K2_M22-003_BG_Recruitment Brochure_Public Redacted 2.0
Recruitment arrangements (for publication) K2_M22-003_DE_Recruitment material Doctor to Patient Email_German_Public 2
Recruitment arrangements (for publication) K2_M22-003_DE_Recruitment material Doctor to Patient Letter_German_Public 2
Recruitment arrangements (for publication) K2_M22-003_DE_Recruitment material Recruitment Brochure_German_Public 2
Recruitment arrangements (for publication) K2_M22-003_ES_Recruitment material_Digital ads_Public 1
Recruitment arrangements (for publication) K2_M22-003_ES_Recruitment material_Patient Downloadable Study Guide_Public 2.1
Recruitment arrangements (for publication) K2_M22-003_ES_Recruitment material_Patient-doctor discussion guide_Public 1
Recruitment arrangements (for publication) K2_M22-003_ES_Recruitment material_Program-level Website copy_Public 2
Recruitment arrangements (for publication) K2_M22-003_ES_Recruitment material_Recruitment brochure_Clean_Public 2.1
Recruitment arrangements (for publication) K2_M22-003_ES_Recruitment material_Search ads_Public 1
Recruitment arrangements (for publication) K2_M22-003_ES_Recruitment material_Website Prescreener_Public 2
Recruitment arrangements (for publication) K2_M22-003_NL_ Recruitment Material Doctor to Patient Email_Public 2.0
Recruitment arrangements (for publication) K2_M22-003_NL_ Recruitment Material Doctor to Patient Letter_Public 2.0
Recruitment arrangements (for publication) K2_M22-003_NL_ Recruitment Material Recruitment Brochure_Public 2.0
Recruitment arrangements (for publication) K2_M22-003_NL_ Recruitment Material Website text IKNL_Public 4
Recruitment arrangements (for publication) K2_M22-003_RO_Recruitment Brochure_Public 2.0
Recruitment arrangements (for publication) M22-003 BE Recruitment and ICF Procedures_Public 1
Recruitment arrangements (for publication) M22-003 BG Recruitment and ICF Procedures_Public Redacted 1
Recruitment arrangements (for publication) M22-003 CZ Recruitment and ICF Procedures_Public 1
Recruitment arrangements (for publication) M22-003 DE Recruitment and ICF Procedures_Public 1
Recruitment arrangements (for publication) M22-003 DK Recruitment and ICF Procedures_Public 2
Recruitment arrangements (for publication) M22-003 FR Recruitment and ICF Procedures_Public 1
Recruitment arrangements (for publication) M22-003 GR Recruitment and ICF Procedures_Public 1
Recruitment arrangements (for publication) M22-003 HR Recruitment and ICF Procedures_Public 1
Recruitment arrangements (for publication) M22-003 HU Recruitment and ICF Procedures_Public 1
Recruitment arrangements (for publication) M22-003 IT Recruitment and ICF Procedures_Public 1.1
Recruitment arrangements (for publication) M22-003 NL Recruitment and ICF Procedures_Public 1
Recruitment arrangements (for publication) M22-003 PL Recruitment and ICF Procedures_Public 1
Recruitment arrangements (for publication) M22-003 RO Recruitment and ICF Procedures - Public 1
Recruitment arrangements (for publication) M22-003 SE Recruitment and ICF Procedures_Public 1
Recruitment arrangements (for publication) M22-003 SK EU CTR Part II Recruitment and ICF Procedures Public Only 2.0
Recruitment arrangements (for publication) M22-003_ES Recruitment and ICF Procedures_Public 1
Subject information and informed consent form (for publication) L1 M22-003 - PT ICF Combined Main and Optional EN public 6.0
Subject information and informed consent form (for publication) L1 M22-003 GR ICF Preg Part Greek_Public 2
Subject information and informed consent form (for publication) L1 M22-003 HU Main PIS and ICF_Public redacted 5.0
Subject information and informed consent form (for publication) L1 M22-003 HU Pregnant Parter PIS and ICF_Public 2.1
Subject information and informed consent form (for publication) L1 M22-003 PT ICF Pregnant Participant Data Release EN Public 2.0
Subject information and informed consent form (for publication) L1 M22-003 PT ICF Combined Main and Optional EN Public 9.0
Subject information and informed consent form (for publication) L1 M22-003 PT ICF Pregnant Participant Data Release_Public Redacted 2.0
Subject information and informed consent form (for publication) L1 M22-003 RO Main ICF Clean Public 6.1
Subject information and informed consent form (for publication) L1 M22-003 RO Main ICF Clean Public 6.1
Subject information and informed consent form (for publication) L1 M22-003_FR_Participant Letter_Change address AbbVie France_Public 1
Subject information and informed consent form (for publication) L1_M22-003 BE ICF Main Dutch_public_clean 8.0
Subject information and informed consent form (for publication) L1_M22-003 BE ICF Main English_public_clean 8.0
Subject information and informed consent form (for publication) L1_M22-003 BE ICF Main French_public_clean 8.0
Subject information and informed consent form (for publication) L1_M22-003 BE ICF Other Dutch_public_clean 5.0
Subject information and informed consent form (for publication) L1_M22-003 BE ICF Other English_public_clean 5.0
Subject information and informed consent form (for publication) L1_M22-003 BE ICF Other French_public_clean 5.0
Subject information and informed consent form (for publication) L1_M22-003 BE ICF Preg Part Dutch_public_clean 2.0
Subject information and informed consent form (for publication) L1_M22-003 BE ICF Preg Part English_public_clean 2.0
Subject information and informed consent form (for publication) L1_M22-003 BE ICF Preg Part French_public_clean 2.0
Subject information and informed consent form (for publication) L1_M22-003 CZ ICF Main Public 5.1
Subject information and informed consent form (for publication) L1_M22-003 CZ ICF Optional Public 4
Subject information and informed consent form (for publication) L1_M22-003 CZ ICF PPA Public 3
Subject information and informed consent form (for publication) L1_M22-003 CZ ICF Privacy Czech _Public 5
Subject information and informed consent form (for publication) L1_M22-003 DK ICF Main_Public 5
Subject information and informed consent form (for publication) L1_M22-003 DK ICF Pregnant Partner_Public 2
Subject information and informed consent form (for publication) L1_M22-003 ES Pregnant Partner ICF_Clean_Public 2.0
Subject information and informed consent form (for publication) L1_M22-003 FR ICF Preg Part_Public 2.0
Subject information and informed consent form (for publication) L1_M22-003 FR Main ICF Clean_Public 5.0
Subject information and informed consent form (for publication) L1_M22-003 GR ICF Main_Public 5
Subject information and informed consent form (for publication) L1_M22-003 GR ICF Optional Greek_Public 3
Subject information and informed consent form (for publication) L1_M22-003 HR ICF Main clean Public 8.0
Subject information and informed consent form (for publication) L1_M22-003 HR ICF Optional_Public 3.0
Subject information and informed consent form (for publication) L1_M22-003 HR ICF Pregnant Partner Clean_Public 4.0
Subject information and informed consent form (for publication) L1_M22-003 HR ICF Pregnant Subject Clean_Public 4.0
Subject information and informed consent form (for publication) L1_M22-003 IT ICF Main Italian_Public 5.1
Subject information and informed consent form (for publication) L1_M22-003 IT ICF Opt reasearch Italian_Public 4
Subject information and informed consent form (for publication) L1_M22-003 IT ICF Other Italian Pregn_Public 2.1
Subject information and informed consent form (for publication) L1_M22-003 PL ICF Main_Public 7
Subject information and informed consent form (for publication) L1_M22-003 PL ICF Pregnancy 2
Subject information and informed consent form (for publication) L1_M22-003 PT ICF Combined Main and Optional_Public 9.0
Subject information and informed consent form (for publication) L1_M22-003 SE ICF Main_Public 4
Subject information and informed consent form (for publication) L1_M22-003 SE ICF Summary_Public 2.1
Subject information and informed consent form (for publication) L1_M22-003 SK Main ICF_Public 7.0
Subject information and informed consent form (for publication) L1_M22-003 SK Optional ICF_Public 3.0
Subject information and informed consent form (for publication) L1_M22-003 SK Pregnant Partner ICF_Public 3.0
Subject information and informed consent form (for publication) L1_M22-003 SK Privacy ICF_Public 3.0
Subject information and informed consent form (for publication) L1_M22-003_BG_ICF Main Bulgarian Clean_Public Redacted 4.0
Subject information and informed consent form (for publication) L1_M22-003_BG_ICF Main English Clean_Public Redacted 4.0
Subject information and informed consent form (for publication) L1_M22-003_BG_ICF Pregnant Partner Bulgarian Clean_Public Redacted 2.0
Subject information and informed consent form (for publication) L1_M22-003_BG_ICF Pregnant Partner English Clean_Public Redacted 2.0
Subject information and informed consent form (for publication) L1_M22-003_DE_ICF Main_German_Public 4
Subject information and informed consent form (for publication) L1_M22-003_DE_ICF Pregnant Partner_German_Public 4
Subject information and informed consent form (for publication) L1_M22-003_ES_Main ICF_clean_Public 5.0
Subject information and informed consent form (for publication) L1_M22-003_ES_Optional Research ICF_clean_Public 4.0
Subject information and informed consent form (for publication) L1_M22-003_NL_ ICF Main_Public 5.0
Subject information and informed consent form (for publication) L1_M22-003_RO_Pregnant Partner ICF - Public 3.0
Subject information and informed consent form (for publication) L1_M22-003_RO_Pregnant Partner ICF_Public 3.0
Subject information and informed consent form (for publication) L2_M22-003_HU_EU-CTR blank document Subject Participation Card Public 1
Subject information and informed consent form (for publication) L2_M22-003_HU_EU-CTR blank document Subject Participation Card_Public 1
Subject information and informed consent form (for publication) M22-003 CZ ICF Main Czech Arm A _Public 1
Subject information and informed consent form (for publication) M22-003 CZ ICF Main Czech Arm B-Benda _Public 1
Subject information and informed consent form (for publication) M22-003 CZ ICF Main Czech Arm B-CHOP _Public 1
Subject information and informed consent form (for publication) M22-003 CZ ICF Main Czech Arm C _Public 1
Subject information and informed consent form (for publication) M22-003 DK ICF Optional_Public 1
Subject information and informed consent form (for publication) M22-003 DK Your rights as a study participant_Public 1
Subject information and informed consent form (for publication) M22-003 HU PharmacoGenetic ICF_Public 1
Subject information and informed consent form (for publication) M22-003 HU PharmacoGenetic PIS_Public Redacted 1
Subject information and informed consent form (for publication) M22-003 IT ICF Privacy Main Italian_public 1.2
Subject information and informed consent form (for publication) M22-003 IT ICF Privacy Opt Research Italian_public 1.2
Subject information and informed consent form (for publication) M22-003 NL ICF Pregnancy_Public 2.0
Subject information and informed consent form (for publication) M22-003 NL ICF Optional_Public 1
Subject information and informed consent form (for publication) M22-003 PL ICF Optional_Public 3
Subject information and informed consent form (for publication) M22-003 SE ICF Pregnant Partner_Public 2.0
Subject information and informed consent form (for publication) M22-003 SK ICF Privacy Country Sample Slovak Public 2.0
Subject information and informed consent form (for publication) M22-003 SK ICF Genetic Country Sample Slovak Public 1
Subject information and informed consent form (for publication) M22-003 SK ICF Pregnant Partner Country Sample Slovak Public 1
Summary of Product Characteristics (SmPC) (for publication) E2_Bendamustine hydrochloride 180 mg_4 ml Concentrate For Solution For Infusion-SmPC 1.0
Summary of Product Characteristics (SmPC) (for publication) E2_Cyclophosphamide Injection 500 mg - Summary of Product Characteristics 1
Summary of Product Characteristics (SmPC) (for publication) E2_M22-003_BENDAMUSTINEFRESENIUSKABI-powderforconcentrateforsolutionforinfusion 1
Summary of Product Characteristics (SmPC) (for publication) E2_M22-003_PREDNISONEBIOGARAN20mg scoredtablet 1
Summary of Product Characteristics (SmPC) (for publication) E2_Prednisolone 25mg Tablets - Summary of Product Characteristics 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Bendamustine hydrochloride 180 mg_4 ml Concentrate For Solution For Infusion_redlines 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Doxorubicin Solution for Injection_redlines 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_Vincristine Sulfate 1 mg_ml Injection_redlines 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC- Doxorubicin hydrochloride_2mg_ml_sol_for_inj 1.0
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC-Gazyvaro_1000 mg_conc_for_sol_for_ Inf 1
Summary of Product Characteristics (SmPC) (for publication) EE2_SmPC-Vincristine Sulfate_1 mg_ml _Sol_for_ Inj 1.0
Synopsis of the protocol (for publication) D1_m22003-EU CTR synopsis_EN-EN 1
Synopsis of the protocol (for publication) D1_m22003-EU CTR synopsis-BG-BG 1
Synopsis of the protocol (for publication) D1_m22003-EU CTR synopsis-CS-CZ 1
Synopsis of the protocol (for publication) D1_m22003-EU CTR synopsis-DE-BE 1
Synopsis of the protocol (for publication) D1_m22003-EU CTR synopsis-EL-GR 1
Synopsis of the protocol (for publication) D1_m22003-EU CTR synopsis-ES-ES 1
Synopsis of the protocol (for publication) D1_m22003-EU CTR synopsis-FR-BE 1
Synopsis of the protocol (for publication) D1_m22003-EU CTR synopsis-FR-FR 1
Synopsis of the protocol (for publication) D1_m22003-EU CTR synopsis-HU-HU 1
Synopsis of the protocol (for publication) D1_m22003-EU CTR synopsis-IT-IT 1
Synopsis of the protocol (for publication) D1_m22003-EU CTR synopsis-NL-BE 1
Synopsis of the protocol (for publication) D1_m22003-EU CTR synopsis-NL-NL 1
Synopsis of the protocol (for publication) D1_m22003-EU CTR synopsis-PL-PL 1
Synopsis of the protocol (for publication) D1_m22003-EU CTR synopsis-PT-PT 1
Synopsis of the protocol (for publication) D1_m22003-EU CTR synopsis-RO-RO 1
Synopsis of the protocol (for publication) D1_m22003-EU CTR synopsis-SK-SK 1
Synopsis of the protocol (for publication) D1_m22003-EU CTR synopsis-SV-SE 1
Synopsis of the protocol (for publication) D1_m22003-protocol synopsis-redacted_HU-HU 5.1

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-01-05 Czechia Acceptable with conditions
2024-04-26
 2024-04-29
2 SUBSTANTIAL MODIFICATION SM-3 2024-05-07 Acceptable with conditions 2024-07-08
3 SUBSTANTIAL MODIFICATION SM-1 2024-05-08 Acceptable with conditions 2024-08-07
4 SUBSTANTIAL MODIFICATION SM-2 2024-05-10 Acceptable with conditions 2024-08-16
5 SUBSTANTIAL MODIFICATION SM-5 2024-08-27 Czechia Acceptable with conditions
2024-11-29
 2024-11-29
6 SUBSTANTIAL MODIFICATION SM-6 2024-12-20 Czechia Acceptable
2025-05-28
 2025-05-28
7 NON SUBSTANTIAL MODIFICATION NSM-1 2025-06-18 Acceptable
2025-05-28
 2025-06-18
8 SUBSTANTIAL MODIFICATION SM-7 2025-06-19 Acceptable 2025-07-02
9 SUBSTANTIAL MODIFICATION SM-8 2025-06-19 Acceptable 2025-08-27
10 SUBSTANTIAL MODIFICATION SM-10 2025-06-19 Acceptable 2025-06-24
11 SUBSTANTIAL MODIFICATION SM-11 2025-06-19 Acceptable 2025-07-25
12 SUBSTANTIAL MODIFICATION SM-12 2025-06-19 Acceptable 2025-09-02
13 SUBSTANTIAL MODIFICATION SM-9 2025-06-23 Czechia Acceptable 2025-07-10
14 SUBSTANTIAL MODIFICATION SM-13 2025-06-23 Acceptable 2025-07-16
15 SUBSTANTIAL MODIFICATION SM-14 2025-07-11 Acceptable 2025-08-08
16 SUBSTANTIAL MODIFICATION SM-15 2025-08-07 Acceptable 2025-08-26
17 SUBSTANTIAL MODIFICATION SM-16 2025-09-25 Czechia Acceptable
2026-01-15
 2026-01-15

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