Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
977
Countries
16
Sites
149
Diffuse Large B-Cell Lymphoma (DLBCL)
The primary objective of this study is to evaluate whether the addition of epcoritamab to 6 cycles of standard R-CHOP followed by 2 cycles of epcoritamab can prolong progression-free survival (PFS) compared with 6 cycles of standard R-CHOP alone followed by 2 cycles of rituximab in subjects with newly diagnosed DLBCL w…
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
- 26 Jan 2023 → ongoing
- Decision date (initial)
- 2024-04-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- AbbVie Inc.
External identifiers
- EU CT number
- 2023-505277-32-00
- EudraCT number
- 2021-000168-31
- ClinicalTrials.gov
- NCT05578976
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
The primary objective of this study is to evaluate whether the addition of epcoritamab to 6 cycles of standard R-CHOP followed by 2 cycles of epcoritamab can prolong progression-free survival (PFS) compared with 6 cycles of standard R-CHOP alone followed by 2 cycles of rituximab in subjects with newly diagnosed DLBCL with an IPI of 3-5.
Secondary objectives 1
- The first secondary objective is to evaluate and compare PFS between the two treatment arms in subjects with newly diagnosed DLBCL with an IPI of 2-5 (i.e., all randomized subjects). The other secondary objectives are to evaluate and compare each key secondary endpoint for both the subset of subjects with an IPI of 3-5 and all randomized subjects per the hierarchical order specified in protocol Section 7.7.
Conditions and MedDRA coding
Diffuse Large B-Cell Lymphoma (DLBCL)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | PT | 10012818 | Diffuse large B-cell lymphoma | 100000004864 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines 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 3
- Age ≥ 18 years old and < 80 years old, with a life expectancy of ≥ 12 months.
- Subject is planned to receive treatment with 6 cycles of standard R CHOP per investigator determination.
- Subject must have an IPI score of 2-5. The number of subjects with an IPI 2 of will not exceed approximately 30% of the overall sample size.
Exclusion criteria 2
- Subject with history of prior systemic anti-lymphoma therapy for DLBCL (including any definitive radiotherapy with curative intent) other than corticosteroids with or without vincristine during pre-phase treatment, or non-curative intent palliative radiotherapy with the stipulation that radiated lesions cannot be selected as target lesion for response assessment.
- Subject has clinically significant cardiovascular disease, including: • Myocardial infarction or stroke within 6 months prior to enrollment. OR • The following conditions within 3 months prior to enrollment: unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart Association Class III IV), uncontrolled cardiac arrhythmia OR • Screening 12-lead electrocardiogram showing a baseline QT interval as corrected by Fridericia's formula > 470 msec (male) or > 480 msec (female) OR • Other clinically significant ECG abnormalities within 6 months prior to enrollment unless deemed stable and appropriately treated.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- The primary endpoint is PFS defined as the duration from the date of randomization to the date of any of the following (whichever occurs first). The primary analysis population is the subset of subjects with an IPI of 3-5
- Death due to any causes.
- Disease progression based on the independent review committee (IRC) assessment per Lugano criteria.
Secondary endpoints 4
- PFS in all randomized subjects.
- CR on or after the EOT based on the IRC assessment per Lugano criteria, where EOT is defined as treatment completion or early treatment discontinuation.
- OS, defined as time from randomization until death due to any causes.
- MRD negativity.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
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
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/22/2581
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
- 24 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/22/2581
Comparator 6
Doxorubicinhydrochlorid Bendalis 2 mg/ml Injektionslösung
PRD6567464 · Product
- Active substance
- Doxorubicin Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 50 mg/m2 milligram(s)/square meter
- Max total dose
- 300 mg/m2 milligram(s)/square meter
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01DB01 — DOXORUBICIN
- Marketing authorisation
- 51199.00.00
- MA holder
- BENDALIS GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Vincristine Sulfate 1 mg/ml solution for injection
PRD4322472 · Product
- Active substance
- Vincristine Sulfate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 2 mg/ml milligram(s)/millilitre
- Max total dose
- 12 mg/ml milligram(s)/millilitre
- 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
Truxima 100 mg concentrate for solution for infusion
PRD5065907 · Product
- Active substance
- Rituximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 375 mg/m2 milligram(s)/square meter
- Max total dose
- 3000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 24 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
Truxima 500 mg concentrate for solution for infusion
PRD4797328 · Product
- Active substance
- Rituximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 375 mg/m2 milligram(s)/square meter
- Max total dose
- 3000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 24 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
Cyclophosphamide Injection 500 mg.
PRD347229 · Product
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 750 mg/m2 milligram(s)/square meter
- Max total dose
- 4500 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
Prednisone Zentiva 5 mg compresse
PRD3766368 · Product
- Active substance
- Prednisone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 3000 mg milligram(s)
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- H02AB07 — PREDNISONE
- Marketing authorisation
- 043410012
- MA holder
- PHARMACARE SRL
- MA country
- Italy
- 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
- 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
| Organisation | City, country | Duties |
|---|---|---|
| Clinical Trial Media Inc. ORG-100046339
|
Hauppauge, United States | Code 2 |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Avantor Inc. ORG-100050885
|
Claremont, United States | Other |
| Q Squared Solutions Limited ORG-100042527
|
Reading, United Kingdom | Laboratory analysis |
| Perceptive Informatics Inc. ORG-100013171
|
Billerica, United States | Other |
| Endpoint Clinical Inc. ORG-100040567
|
Wakefield, United States | Interactive response technologies (IRT) |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Other |
| Labcorp ORG-100042736
|
Mechelen, Belgium | Laboratory analysis |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Cytel Inc. ORG-100042560
|
Waltham, United States | Other |
Locations
16 EU/EEA countries · 149 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 27 | 4 |
| Belgium | Ongoing, recruitment ended | 22 | 12 |
| Bulgaria | Ongoing, recruitment ended | 8 | 2 |
| Croatia | Ongoing, recruitment ended | 8 | 4 |
| Czechia | Ongoing, recruitment ended | 25 | 6 |
| Denmark | Ongoing, recruitment ended | 22 | 5 |
| France | Ongoing, recruitment ended | 70 | 25 |
| Greece | Ongoing, recruitment ended | 15 | 7 |
| Hungary | Ongoing, recruitment ended | 24 | 8 |
| Italy | Ongoing, recruitment ended | 57 | 16 |
| Netherlands | Ongoing, recruitment ended | 53 | 26 |
| Poland | Ongoing, recruitment ended | 16 | 7 |
| Portugal | Ongoing, recruitment ended | 12 | 4 |
| Slovakia | Ended | 21 | 2 |
| Spain | Ongoing, recruitment ended | 52 | 16 |
| Sweden | Ongoing, recruitment ended | 3 | 5 |
| Rest of world
Taiwan, Australia, Puerto Rico, Turkey, Mexico, Brazil, Israel, Argentina, United States, China, New Zealand, United Kingdom, Switzerland, South Africa, Canada, Japan, Korea, Republic of
|
— | 542 | — |
Investigational sites
Noe LGA Gesundheit Region Mitte GmbH
Clinical Department of Internal Medicine I, Dunant-Platz 1, 3100, St. Poelten
SCRI CCCIT Ges.m.b.H.
Department of Internal Medicine III, Muellner Hauptstrasse 48, 5020, Salzburg
Stadt Wien Wiener Gesundheitsverbund
1st Medical Department, Montleartstrasse 37, Ottakring, Vienna
Medical University Of Vienna
Department of Hematology and Hemostaseology, Waehringer Guertel 18-20, Alsergrund, Vienna
Az St-Jan Brugge-Oostende A.V.
N/A, Ruddershove 10, 8000, Brugge
UZ Leuven
N/A, Herestraat 49, 3000, Leuven
CHU Helora
NA, Rue Ferrer 159 Boite 1, 7100, La Louviere
CHU UCL Namur
N/A, Avenue Dr-Gaston-Therasse 1, 5530, Yvoir
Cliniques Universitaires Saint-Luc
N/A, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Vitaz
N/A, Moerlandstraat 1, 9100, Sint-Niklaas
Het Ziekenhuisnetwerk Antwerpen
N/A, Lindendreef 1, 2020, Antwerp
Az Delta
N/A, Deltalaan 1, 8800, Roeselare
Universitair Ziekenhuis Gent
N/A, Corneel Heymanslaan 10, 9000, Gent
Institut Jules Bordet
Hematology, Mijlenmeersstraat 90, 1070, Brussels
CHU De Liege
Hematology, Avenue De L'hopital 1, 4000, Liege
Het Ziekenhuisnetwerk Antwerpen
NA, Kempenstraat 100, 2030, Antwerp
National Specialised Hospital For Active Treatment Of Haematological Diseases
First department of Clinical Hematology, Ul.plovdivsko Pole 6, 1756, Sofia
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Clinic of Clinical Hematology, Bulevard Vasil Aprilov 15a, 4002, Plovdiv
Clinical Hospital Centre Rijeka
Department for hematology, Kresimirova 42, 51000, Rijeka
KBC Zagreb
Department for hematology, Ulica Mije Kispatica 12, Zagreb, Grad Zagreb
Klinicka bolnica Merkur
Department for hematology, Ulica Ivana Zajca 19, 10000, Zagreb
KBC Split
Department for hematology, Spinciceva 1, 21000, Split
Vseobecna Fakultni Nemocnice V Praze
N/A, U Nemocnice 499/2, Nove Mesto, Prague 2
Fakultni Nemocnice Kralovske Vinohrady
N/A, Srobarova 1150/50, Vinohrady, Prague 10
Fakultni Nemocnice Brno
NA, Jihlavska 340/20, Bohunice, Brno
Fakultni Nemocnice Motol A Homolka
NA, V Uvalu 84/1, Motol, Prague
Fakultni Nemocnice Hradec Kralove
N/A, Sokolska 581, 500 03, Novy Hradec Kralove
Fakultni Nemocnice Ostrava
N/A, 17. Listopadu 1790/5, 708 00, Poruba
Lillebaelt Hospital
N/A, Beriderbakken 4, 7100, Vejle
Region Midtjylland
N/A, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Odense University Hospital
N/A, J B Winsloews Vej 4, 5000, Odense C
Rigshospitalet
N/A, Blegdamsvej 9, 2100, Copenhagen Oe
Zealand University Hospital
N/A, Sygehusvej 10, 4000, Roskilde
Centre Henri Becquerel
N/A, 1 Rue D Amiens, 76000, Rouen
Institut Universitaire Du Cancer Toulouse-Oncopole
N/A, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Hospitalier Universitaire De Caen Normandie
N/A, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
University Hospitals Pitie Salpetriere Charles Foix
N/A, 47 To 83 Boulevard De L Hopital, 75013, Paris
CHRU De Nancy
N/A, Rue Du Morvan, 54500, Vandoeuvre Les Nancy
Centre Hospitalier Universitaire Grenoble Alpes
N/A, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Centre Hospitalier Universitaire De Limoges
N/A, 2 Avenue Martin Luther King, 87042, Limoges Cedex 1
Centre Hospitalier Universitaire De Lille
N/A, Rue Michel Polonovski, 59037, Lille Cedex
Institut Curie
N/A, 35 Rue Dailly, 92210, Saint-Cloud
Centre Hospitalier Departemental Vendee
N/A, Boulevard Stephane Moreau, 85925, La Roche Sur Yon Cedex 9
Assistance Publique Hopitaux De Paris
N/A, 51 Av Du Mal De Lattre De Tassigny, 94000, Creteil
Centre Hospitalier Universitaire Amiens Picardie
N/A, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
Institut Gustave Roussy
N/A, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Universitaire De Nantes
N/A, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Nice
N/A, 151 Route De Saint Antoine, 06200, Nice
Centre Hospitalier Universitaire D Angers
N/A, 4 Rue Larrey, 49100, Angers
Centre Hospitalier Universitaire De Rennes
N/A, 2 Rue Henri Le Guilloux, 35000, Rennes
Groupe D’Etude Des Lymphomes De L’Adulte
N/A, 165 Chemin Du Grand Revoyet, 69495, Pierre Benite Cedex
University Hospital Of Clermont-Ferrand
N/A, 1 Place Lucie Et Raymond Aubrac, 63100, Clermont-Ferrand
Centre Hospitalier De La Cote Basque
N/A, 13 Avenue Interne Jacques Loeb, 64100, Bayonne
Hopital Saint Louis
N/A, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Universitaire De Montpellier
N/A, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Institut Paoli-Calmettes
N/A, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Centre Hospitalier Universitaire De Poitiers
N/A, 2 Rue De La Miletrie, 86000, Poitiers
Centre Hospitalier Universitaire De Dijon
N/A, 14 Rue Paul Gaffarel, 21000, Dijon
Evaggelismos Hospital
Hematology-Lymphomas Department and BMT Unit, Ipsiladou 45-47, 106 76, Athens
University General Hospital Attikon
2nd Department of Internal Medicine - Propaedeutic, Hematology Unit, Rimini Street 1, 124 62, Athens
Alexandra Hospital
Plasma Cell Dyscrasias Unit, Department of Clinical Therapeutics, Vassilissas Sofias Avenue 80, 115 28, Athens
University General Hospital Of Ioannina
Hematology Department, Niarchou Stavrou Avenue, 455 00, Ioannina
University General Hospital Of Thessaloniki Ahepa
1st Department of Internal Medicine, Division of Hematology, 1st St Kiriakidis Str, 546 36, Thessaloniki
Laiko General Hospital Of Athens
Haematology Clinic and Βone Μarrow Τransplantation Unit, NKUA, Agiou Thoma (goudi) 17, 115 27, Athens
Theageneio Cancer Hospital
Hematology Department, Papanastassiou Alexandrou 11, 546 39, Thessaloniki
Tolna Megyei Balassa Janos Korhaz
N/A, Beri Balogh Adam Utca 5-7, 7100, Szekszard
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
N/A, Vasvari Pal Utca 2-4, 9024, Gyor
University Of Szeged
N/A, Semmelweis Utca 8, 6725, Szeged
University Teaching Hospital Markusovszky
N/A, Markusovszky Str. 5, 9700, Szombathely
University Of Debrecen
N/A, Nagyerdei Korut 98, 4032, Debrecen
Somogy Varmegyei Kaposi Mor Oktato Korhaz
N/A, Tallian Gyula Utca 20-32, 7400, Kaposvar
Orszagos Onkologiai Intezet
N/A, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
Semmelweis University
N/A, Szentkiralyi Utca 46, VIII Kerulet, Budapest VIII
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
N/A, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Unita Sanitaria Locale Della Romagna
N/A, Via Alcide De Gasperi 8, 48121, Ravenna
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
N/A, Via Trabucco 180, 90146, Palermo
Casa Sollievo Della Sofferenza
N/A, Viale Convento Cappuccini 1, 71013, San Giovanni Rotondo
Azienda Ospedaliero-Universitaria Maggiore Della Carita
N/A, Corso Giuseppe Mazzini 18, 28100, Novara
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
N/A, Strada Provinciale 142 Orba Km 3,95, 10060, Candiolo
Centro Di Riferimento Oncologico Di Aviano
N/A, Via Franco Gallini 2, 33081, Aviano
Azienda Ospedaliera Universitaria Federico II Di Napoli
N/A, Via Sergio Pansini 5, 80131, Naples
Istituto Tumori Bari Giovanni Paolo II
N/A, Viale Orazio Flacco 65, 70124, Bari
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
N/A, Via Piero Maroncelli 40, 47014, Meldola
Azienda Ospedaliero Universitaria Pisana
N/A, Via Roma 67, 56126, Pisa
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
N/A, Corso Bramante 88, 10126, Turin
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
N/A, Via Pietro Albertoni 15, 40138, Bologna
European Institute Of Oncology S.r.l.
N/A, Via Giuseppe Ripamonti 435, 20141, Milan
Azienda Ospedaliera Nazionale Ss Antonio E Biagio E C Arrigo Alessandria
N/A, Via Venezia 16, 15121, Alexandria
Ospedale San Raffaele S.r.l.
N/A, Via Olgettina 60, 20132, Milan
Academisch Ziekenhuis Leiden
N/A, Albinusdreef 2, 2333 ZA, Leiden
University Medical Center Groningen
N/A, Hanzeplein 1, 9713 GZ, Groningen
Medical Center Haaglanden
N/A, Lijnbaan 32, 2512 VA, 's-Gravenhage
St Antonius Hospital
N/A, Koekoekslaan 1, 3435 CM, Nieuwegein
Dijklander Ziekenhuis
N/A, Maelsonstraat 3, 1624 NP, Hoorn Nh
Noordwest Ziekenhuisgroep Stichting
N/A, Wilhelminalaan 12, 1815 JD, Alkmaar
Deventer Ziekenhuis
N/A, Nico Bolkesteinlaan 75, 7416 SE, Deventer
Catharina Ziekenhuis Stichting
N/A, Michelangelolaan 2, 5623 EJ, Eindhoven
Medisch Spectrum Twente
N/A, Koningsplein 1, 7512 KZ, Enschede
Zaans Medisch Centrum Stichting
N/A, Koningin Julianaplein 58, 1502 DV, Zaandam
Canisius Wilhelmina Hospital
N/A, Weg Door Jonkerbos 100, 6532 SZ, Nijmegen
Spaarne Gasthuis
N/A, Spaarnepoort 1, 2134 TM, Hoofddorp
Diakonessenhuis Stichting
N/A, Bosboomstraat 1, 3582 KE, Utrecht
Maxima Medisch Centrum
N/A, De Run 4600, 5504 DB, Veldhoven
Gelre Hospitals
N/A, Albert Schweitzerlaan 31, 7334 DZ, Apeldoorn
University Hospital Maastricht
N/A, P Debyelaan 25, 6229 HX, Maastricht
Flevoziekenhuis Stichting
N/A, Hospitaalweg 1, 1315 RA, Almere
Albert Schweitzer Ziekenhuis
N/A, Albert Schweitzerplaats 25, 3318 AT, Dordrecht
Tergooiziekenhuizen
N/A, Van Riebeeckweg 212, 1213 XZ, Hilversum
Meander Medisch Centrum Stichting
N/A, Maatweg 3, 3813 TZ, Amersfoort
Jeroen Bosch Ziekenhuis
N/A, Henri Dunantstraat 1, 5223 GZ, 's-Hertogenbosch
Amsterdam UMC
N/A, De Boelelaan 1117, 1081 HV, Amsterdam
OLVG Stichting
N/A, Oosterpark 9, 1091 AC, Amsterdam
Medisch Centrum Leeuwarden B.V.
N/A, Henri Dunantweg 2, 8934 AD, Leeuwarden
St. Elisabeth Hospital Tilburg
N/A, Hilvarenbeekseweg 60, 5022 GC, Tilburg
Amphia Hospital
N/A, Molengracht 21, 4818 CK, Breda
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
Oddzial Hematologiczny, Ul. Hubalczykow 1, 76-200, Slupsk
Szpital Wojewodzki W Opolu Sp. z o.o.
Oddzial Kliniczny Hematologii, Onkologii Hematologicznej i Chorob Wewnetrznych, Ul. Katowicka 64, 45-061, Opole
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Klinika Hematologii i Transplantacji Szpiku, Ul. Prezydenta Stefana Artwinskiego 3, 25-734, Kielce
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie
Oddzal Kliniczny Hematologii i Chorob Wewnetrznych z Osrodkiem Transplantacji Szpiku, Al. Wojska Polskiego 37, 10-228, Olsztyn
Pratia S.A.
N/A, Ul. Poznanska 14, 60-185, Skorzewo
Aidport Sp. z o.o.
N/A, Ul Ksiedza Stanisława Kozierowskiego 24, 60-185, Skorzewo
Ars Medical Sp. z o.o.
Oddzial Hematologii, Al. Wojska Polskiego 43, 64-920, Pila
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
N/A, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Centro Hospitalar Universitario De Lisboa Norte E.P.E.
N/A, Avenida Professor Egas Moniz, 1649-035, Lisbon
CCAB Centro Clinico Academico Braga Associacao
N/A, Lugar De Sete Fontes S Victor, 4710-243, Braga
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
N/A, Rua Professor Lima Basto, 1099-023, Lisbon
Narodny Onkologicky Ustav
N/A, Klenova 1, Nove Mesto, Bratislava
Univerzitna Nemocnica Martin
N/A, Kollarova 2, 036 01, Martin
Institut Catala D'oncologia
N/A, Carretera Canyet S/n, 08916, Badalona
Clinica Universidad De Navarra
N/A, Calle Marquesado De Santa Marta 1, 28027, Madrid
Hospital Del Mar
N/A, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Hospital Universitario Fundacion Jimenez Diaz
Haematology Service, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Clinica Universidad De Navarra
N/A, Avenue Pio XII 36, 31008, Pamplona
Hospital Universitario Reina Sofia
N/A, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Clinic De Barcelona
N/A, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario 12 De Octubre
N/A, Bloque D, Avenida De Cordoba S/n, Madrid
Hospital De La Santa Creu I Sant Pau
N/A, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital Universitario Ramon Y Cajal
N/A, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
University Clinical Hospital Virgen De La Arrixaca
N/A, Carretera De Cartagena Sn, El Palmar, Murcia
Hospital Universitario Infanta Leonor
N/A, Avenida Gran Via Del Este 80, 28031, Madrid
Hospital Universitari Vall D Hebron
N/A, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Institut Catala D'oncologia
N/A, Avinguda Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Clinico Universitario De Valencia
N/A, Avenida Blasco Ibanez 17, 46010, Valencia
MD Anderson Cancer Center
N/A, Calle De Arturo Soria Nº 270, 28033, Madrid
Sodra Alvsborg Hospital-Vastra Gotalandsregionen
Medicinkliniken, Hematologens Kliniska Provningar, Hiss E plan 7, Bramhultsvagen 53, Boras Gustav Adolf, Boras
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Sahlgrenska University Hospital, Section of Hematology and Coagulation, Bruna Straket 5, Bla Straket 5, 413 46, Goteborg
Linkoping University Hospital Region Ostergotland
Department of Hematology, O-huset, Universitetssjukhuset I Linkoping, 581 85, Linkoping
Karolinska University Hospital
Karolinska Universitetssjukhuset Solna, Hematologiskt centrum, Eugeniavagen 3, 171 76 Solna, Eugeniavagen 3, 171 64, Solna
Region Skane Skanes Universitetssjukhus
Hematology clinic, Entregatan 7, Lunds Allhelgonafors, Lund
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2023-04-14 | 2023-05-24 | 2024-05-15 | ||
| Belgium | 2023-04-03 | 2023-04-24 | 2024-05-15 | ||
| Bulgaria | 2023-05-19 | 2023-07-05 | 2024-05-09 | ||
| Croatia | 2023-06-01 | 2023-06-29 | 2024-05-15 | ||
| Czechia | 2023-05-26 | 2023-05-30 | 2024-05-15 | ||
| Denmark | 2023-05-08 | 2023-07-14 | 2024-05-15 | ||
| France | 2023-04-12 | 2023-05-15 | 2024-05-16 | ||
| Greece | 2023-04-05 | 2023-04-19 | 2024-05-15 | ||
| Hungary | 2023-03-23 | 2023-04-14 | 2024-05-10 | ||
| Italy | 2023-04-28 | 2023-05-09 | 2024-05-15 | ||
| Netherlands | 2023-04-03 | 2023-05-03 | 2024-05-21 | ||
| Poland | 2023-03-30 | 2023-04-26 | 2024-05-07 | ||
| Portugal | 2023-08-23 | 2024-01-26 | 2024-05-15 | ||
| Slovakia | 2024-04-24 | 2024-05-15 | |||
| Spain | 2023-01-26 | 2023-02-08 | 2024-05-15 | ||
| Sweden | 2023-03-31 | 2023-04-19 | 2024-05-17 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 124 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_M20-621-protocol_redacted | 6.0 |
| Protocol (for publication) | D1_M20-621-protocol-admin-change3_Public | 3 |
| Protocol (for publication) | D1_M20-621-protocol-admin-change4_Public | 4 |
| Protocol (for publication) | D1_M20-621-protocol-redacted_EL-GR | 6.0 |
| Recruitment arrangements (for publication) | EU-CTR blank document | 1 |
| Recruitment arrangements (for publication) | EU-CTR blank document | 1 |
| Recruitment arrangements (for publication) | EU-CTR blank document | 1 |
| Recruitment arrangements (for publication) | EU-CTR blank document | 1 |
| Recruitment arrangements (for publication) | K1 M20-621 SE EU-CTR blank document | 1 |
| Recruitment arrangements (for publication) | K1_Blank Document_Recruitment and ICF Procedures | 1.0 |
| Recruitment arrangements (for publication) | K1_Blank Document_Recruitment and ICF Procedures | 1.0 |
| Recruitment arrangements (for publication) | K1_Blank Document_Recruitment and ICF Procedures | 2 |
| Recruitment arrangements (for publication) | K1_EU CTR Blank Document_Recruitment and ICF Procedures | 1.0 |
| Recruitment arrangements (for publication) | K1_EU-CTR blank document | 1 |
| Recruitment arrangements (for publication) | K1_EU-CTR blank document_recruitment and ICF procedures | 2 |
| Recruitment arrangements (for publication) | K1_EU-CTR blank document_recruitment and ICF procedures | 1.0 |
| Recruitment arrangements (for publication) | K1_M20-621 ES Blank Document_Recruitment and ICF Procedures | 1.0 |
| Recruitment arrangements (for publication) | K1_M20-621 PT Blank Document_Recruitment and ICF Procedures | 2.0 |
| Recruitment arrangements (for publication) | K1_M20-621_EU CTR Blank Document_Recruitment and ICF Procedures | 1.0 |
| Recruitment arrangements (for publication) | K1_M20-621_EU CTR Blank Document_Recruitment and ICF Procedures | 1 |
| Recruitment arrangements (for publication) | M1 20-621 EU-CTR blank document Recruitment and ICF Procedures | 2 |
| Recruitment arrangements (for publication) | M20-621 DK Danish Protocol Addendum V1 | 1 |
| Subject information and informed consent form (for publication) | L1 M20-621 BE AUMC Optional ICF Dutch_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1 M20-621 CZ Main ICF_Public | 5 |
| Subject information and informed consent form (for publication) | L1 M20-621 CZ Optional AUMC ICF_Public | 2 |
| Subject information and informed consent form (for publication) | L1 M20-621 CZ Optional ICF_Public | 2 |
| Subject information and informed consent form (for publication) | L1 M20-621 CZ Preg Part ICF_Public | 3 |
| Subject information and informed consent form (for publication) | L1 M20-621 CZ Privacy ICF_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1 M20-621 FR ICF Optional Research_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1 M20-621 FR ICF Main_Public | 7.0 |
| Subject information and informed consent form (for publication) | L1 M20-621 FR ICF Pregnant Partner_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1 M20-621 FR Pregnant Participant ICF_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1 M20-621 SE ICF Main_Public | 6.0 |
| Subject information and informed consent form (for publication) | L1 M20-621 SE ICF Optional_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1 M20-621 SE ICF Pregnant partner_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1 M22-574 FR Addendum ICF French_Public | 1 |
| Subject information and informed consent form (for publication) | L1_ M20-621 GR Optional AUMC ICF _Public | 2 |
| Subject information and informed consent form (for publication) | L1_M20-621 AT ICF Main_Public_Redacted | 6.1 |
| Subject information and informed consent form (for publication) | L1_M20-621 AT ICF Optional AUMC Sub study_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M20-621 AT ICF Optional_Public_Redacted | 6.1 |
| Subject information and informed consent form (for publication) | L1_M20-621 AT ICF Pregnancy_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M20-621 BE AUMC Optional ICF English_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M20-621 BE AUMC Optional ICF French_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M20-621 BE Main ICF Dutch_public_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_M20-621 BE Main ICF English_public_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_M20-621 BE Main ICF French_public_Redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_M20-621 BE Optional ICF Dutch_public_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_M20-621 BE Optional ICF English_public_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_M20-621 BE Optional ICF French_public_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_M20-621 BE Pregnancy ICF Dutch_public | 5.0 |
| Subject information and informed consent form (for publication) | L1_M20-621 BE Pregnancy ICF English_public | 5.0 |
| Subject information and informed consent form (for publication) | L1_M20-621 BE Pregnancy ICF French_public | 5.0 |
| Subject information and informed consent form (for publication) | L1_M20-621 BG ICF Main Bulgarian_Public_Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_M20-621 BG ICF Main English_Public_Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_M20-621 BG ICF Pregnant partner Bulgarian_Public_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_M20-621 BG ICF Pregnant partner English_Public_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_M20-621 BG Optional AUMC ICF Bulgarian_Public_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_M20-621 BG Optional AUMC ICF English_Public_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_M20-621 DK ICF Pregnant Partner Public | 2 |
| Subject information and informed consent form (for publication) | L1_M20-621 DK Leaflet - Your rights as a subject in clinical drug trials | 1 |
| Subject information and informed consent form (for publication) | L1_M20-621 DK Main ICF_Public | 6 |
| Subject information and informed consent form (for publication) | L1_M20-621 ES Main ICF | 6.0 |
| Subject information and informed consent form (for publication) | L1_M20-621 ES Optional AUMC ICF | 2.0 |
| Subject information and informed consent form (for publication) | L1_M20-621 ES Optional ICF | 2.0 |
| Subject information and informed consent form (for publication) | L1_M20-621 ES Pregnant Partner ICF | 3.0 |
| Subject information and informed consent form (for publication) | L1_M20-621 GR Main ICF_Public | 6 |
| Subject information and informed consent form (for publication) | L1_M20-621 GR Optional ICF_Public | 5 |
| Subject information and informed consent form (for publication) | L1_M20-621 GR Pregnant Partner ICF_Public | 4 |
| Subject information and informed consent form (for publication) | L1_M20-621 HR AUMC Optional Biomarker ICF clean Public | 3 |
| Subject information and informed consent form (for publication) | L1_M20-621 HR Main ICF_Public | 8 |
| Subject information and informed consent form (for publication) | L1_M20-621 HR Optional Biomarker ICF clean Public | 4 |
| Subject information and informed consent form (for publication) | L1_M20-621 HR Optional Tumor Biopsy ICF clean Public | 4 |
| Subject information and informed consent form (for publication) | L1_M20-621 HR Pregnant Partner ICF clean Public | 5 |
| Subject information and informed consent form (for publication) | L1_M20-621 HR Pregnant Subject ICF clean Public | 5 |
| Subject information and informed consent form (for publication) | L1_M20-621 HU_Pregnant Partner_PIS_ICF_clean_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_M20-621 IT ICF Main_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_M20-621 IT ICF Optional AUMC_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M20-621 IT ICF Optional_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M20-621 IT ICF Pregnant Authorization_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_M20-621 PL ICF Main_Public | 7 |
| Subject information and informed consent form (for publication) | L1_M20-621 PL ICF Optional Substudy_Public | 2 |
| Subject information and informed consent form (for publication) | L1_M20-621 PL ICF Optional_Public | 2 |
| Subject information and informed consent form (for publication) | L1_M20-621 PL ICF Pregnant Partner_Public | 2 |
| Subject information and informed consent form (for publication) | L1_M20-621 PT Combined Main and Optional ICF_public redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_M20-621 PT ICF Main_public redacted_Already approved by EC | 4.0 |
| Subject information and informed consent form (for publication) | L1_M20-621 PT ICF Pregnant partner _public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M20-621 PT ICF Sub-Study AUMC HOVON Public Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_M20-621_HU_Main PIS_ICF_clean_Public Redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_M20-621_HU_Optional AUMC_ PIS_clean_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M20-621_HU_Optional AUMC_ICF_clean_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M20-621_NL ICF Main_Public | 5.1 |
| Subject information and informed consent form (for publication) | L1_M20-621_NL ICF Substudy AUMC_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M20-621_NL_ICF Optional_Public | 2.1 |
| Subject information and informed consent form (for publication) | L1_M20-621_NL_ICF Pregnancy_Public | 2.0 |
| Subject information and informed consent form (for publication) | L2_M20-621_AT blank document_ICF site contact details_Public | 1 |
| Subject information and informed consent form (for publication) | M20-621 HU ICF Mandatory Genetic Hungarian_Public | 1.0 |
| Subject information and informed consent form (for publication) | M20-621 HU PIS Main Hungarian_Public Redacted | 4.0 |
| Subject information and informed consent form (for publication) | M20-621 HU PIS Mandatory Genetic Hungarian_Public Redacted | 1.0 |
| Subject information and informed consent form (for publication) | M20-621 HU PIS Pregnant Partner Hungarian_Public | 1.0 |
| Subject information and informed consent form (for publication) | M20-621 PT ICF Optional Portuguese_public | 1 |
| Subject information and informed consent form (for publication) | M20-621 SK ICF Confidentiality and data protection Slovak Public | 1 |
| Subject information and informed consent form (for publication) | M20-621 SK ICF Optional Slovak Public | 1 |
| Subject information and informed consent form (for publication) | M20-621 SK ICF Pregnant partner Slovak Public | 1 |
| Subject information and informed consent form (for publication) | M20-621 SK Informed Consent Main Slovak Public Redacted | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_CyclophosphamideInjection500Mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Truxima_Rituximab_100mg_500mg_Sol-for-infusion | 26 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC- Doxorubicin hydrochloride_2mg_ml_sol_for_inf. | 12 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC-Prednisolone 5mg Tablets | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC-Vincristine Sulfate_1 mg_ml _Sol_for_ Inj | 21 |
| Synopsis of the protocol (for publication) | D1_m20621-EU CTR synopsis | 1 |
| Synopsis of the protocol (for publication) | D1_m20621-EU CTR synopsis_BG-BG | 1 |
| Synopsis of the protocol (for publication) | D1_m20621-EU CTR synopsis_DE-AT | 1 |
| Synopsis of the protocol (for publication) | D1_m20621-EU CTR synopsis_DE-BE | 1 |
| Synopsis of the protocol (for publication) | D1_m20621-EU CTR synopsis_EL-GR | 1 |
| Synopsis of the protocol (for publication) | D1_m20621-EU CTR synopsis_ES-ES | 1 |
| Synopsis of the protocol (for publication) | D1_m20621-EU CTR synopsis_FR-BE | 1 |
| Synopsis of the protocol (for publication) | D1_m20621-EU CTR synopsis_FR-FR | 1 |
| Synopsis of the protocol (for publication) | D1_m20621-EU CTR synopsis_HU-HU | 1 |
| Synopsis of the protocol (for publication) | D1_m20621-EU CTR synopsis_IT-IT | 1 |
| Synopsis of the protocol (for publication) | D1_m20621-EU CTR synopsis_NL-BE | 1 |
| Synopsis of the protocol (for publication) | D1_m20621-EU CTR synopsis_NL-NL | 1 |
| Synopsis of the protocol (for publication) | D1_m20621-EU CTR synopsis_PL-PL | 1 |
| Synopsis of the protocol (for publication) | D1_m20621-EU CTR synopsis_PT-PT | 1 |
| Synopsis of the protocol (for publication) | D1_m20621-EU CTR synopsis_SV-SE | 1 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-29 | Netherlands | Acceptable 2024-04-08
|
2024-04-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-12 | Netherlands | Acceptable 2025-01-07
|
2025-01-07 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-20 | Netherlands | Acceptable 2025-05-21
|
2025-05-21 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-07-21 | Netherlands | Acceptable 2025-10-27
|
2025-10-27 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-11-13 | Acceptable | 2025-12-10 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-11 | 2025-12-11 | ||
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-03-10 | Acceptable 2026-05-28
|
2026-05-28 |