Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
1,130
Countries
7
Sites
56
Large B-Cell Lymphoma
To evaluate the efficacy of glofitamab in combination with Pola-R-CHP compared with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) based on the progression-free survival (PFS)
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 22 Sep 2023 → ongoing
- Decision date (initial)
- 2023-08-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- F. Hoffmann La Roche
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others, Efficacy, Safety, Pharmacokinetic
To evaluate the efficacy of glofitamab in combination with Pola-R-CHP compared with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) based on the progression-free survival (PFS)
Secondary objectives 6
- To evaluate the efficacy of glofitamab in combination with Pola-R-CHP compared with Pola-R-CHP on the basis of PFS, event-free survival–efficacy causes (EFSeff), complete response (CR) rate at the end of treatment by fluorodeoxyglucose positron emission tomography (FDG-PET), objective response rate (ORR) at treatment completion or discontinuation, overall survival (OS), duration of response (DOR), duration of complete response (DOCR), and disease-free survival (DFS)
- To evaluate the efficacy of glofitamab in combination with Pola-R-CHP compared with Pola-R-CHP in participants with international prognostic index (IPI) 3-5 based on the PFS
- To evaluate the safety of glofitamab in combination with Pola-R-CHP compared with Pola-R-CHP
- To characterize the glofitamab pharmacokinetic (PK) profile in combination with Pola-R-CHP
- To evaluate the immunogenicity of glofitamab in combination with Pola-R CHP
- To evaluate the health-related quality of life (HRQoL) of participants treated with glofitamab in combination with Pola-R-CHP
Conditions and MedDRA coding
Large B-Cell Lymphoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10080211 | T-cell/histiocyte-rich large B-cell lymphoma | 10029104 |
| 20.1 | LLT | 10080218 | High-grade B-cell lymphoma NOS | 10029104 |
| 21.0 | PT | 10012818 | Diffuse large B-cell lymphoma | 100000004864 |
Regulatory references
- EMA paediatric investigation plan (PIP)
- EMEA-002648-PIP01-09
- Plan to share IPD
- No
- IPD plan description
- N/A
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Previously untreated participants with cluster of differentiation 20 (CD20)- positive large B-cell lymphoma (LBCL), including diagnoses by 2022 world health organization (WHO) classification of lymphoid neoplasms
- Ability to provide tumor tissue; archival or freshly collected
- IPI score 2-5
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Life expectancy >= 6 months
- Adequate hematologic function
- Negative human immunodeficiency virus (HIV) test at screening
Exclusion criteria 6
- Contraindication to any of the individual components of Pola-R-CHP or glofitamab, including prior receipt of anthracyclines, or history of severe allergic or anaphylactic reactions to humanized or murine mAbs, or known sensitivity or allergy to murine products
- Prior solid organ transplantation
- History of indolent lymphoma
- Active autoimmune disease requiring treatment
- Positive test results for chronic hepatitis B infection, hepatitis C (hepatitis C virus [HCV] antibody serology testing) and human T lymphotropic virus type 1 (HTLV-1)
- Participants with a history of progressive multifocal leukoencephalopathy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- PFS, as determined by the IRF
Secondary endpoints 21
- PFS, as determined by the investigator
- EFSeff
- CR rate at the end of treatment by FDG-PET
- ORR at treatment completion or discontinuation
- OS
- DOR
- DOCR
- DFS
- PFS in participants with IPI score 3-5
- Incidence and severity of adverse events, with severity determined according to the national cancer institute common terminology criteria for adverse events version 5.0 (NCI CTCAE v5.0) grading scale, including cytokine release syndrome (CRS), with severity determined according to the american society for transplantation and cellular therapy (ASTCT) CRS grading criteria (Lee et al. 2019)
- Change from baseline in targeted vital signs
- Change from baseline in targeted clinical laboratory test results
- Tolerability, as assessed by dose interruptions, dose reductions, and dose intensity, and study treatment discontinuation because of adverse events
- Serum concentration of glofitamab at specified timepoints
- Prevalence of anti-drug antibodies (ADAs) of glofitamab at baseline and incidence of ADAs during the study and follow up period
- Proportion of participants experiencing a clinically meaningful improvement in physical functioning and fatigue [european organisation for research and treatment of cancer quality of life questionnaire (EORTC QLQ-C30)], and lymphoma symptoms [functional assessment of cancer therapy lymphoma subscale (FACT Lym LymS)]
- Proportion of participants experiencing a clinically meaningful improvement in fatigue (EORTC QLQ-C30)
- Proportion of participants experiencing a clinically meaningful improvement in lymphoma symptoms (FACT-Lym LymS)
- Time to deterioration in physical functioning and fatigue (EORTC QLQ-C30), and lymphoma symptoms (FACT-Lym LymS)
- Time to deterioration in fatigue (EORTC QLQ-C30)
- Time to deterioration in lymphoma symptoms (FACT-Lym LymS)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
—
PRD9870862 · Product
- Authorisation status
- Not Authorised
- MA holder
- F. HOFFMANN-LA ROCHE LTD
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/21/2497
—
PRD7856215 · Product
- Substance synonyms
- RO5541077
- Authorisation status
- Authorised
- Marketing authorisation
- EU/1/19/1388/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/18/2013
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Label modified for clinical trial use
Comparator 1
—
PRD2154043 · Product
- Substance synonyms
- CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
- Authorisation status
- Authorised
- Marketing authorisation
- EU/1/98/067/002
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Label modified for clinical trial use
Auxiliary 15
—
SCP6153324 · ATC
- Substance synonyms
- L-VALINE ESTER WITH 9-((2-HYDROXYETHOXY)METHYL)GUANINE
- Authorisation status
- Authorised
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP132446 · ATC
- Substance synonyms
- (8S,9S,10S,11S,13S,14S,17R)-11,17-DIHYDROXY-17-(2-HYDROXYACETYL)-10,13-DIMETHYL-7,8,9,11,12,14,15,16-OCTAHYDRO-6H-CYCLOPENTA[A]PHENANTHREN-3-ONE, GLPG0303, DELTA-HYDROCORTISONE, 1,2-DEHYDROHYDROCORTISONE, METACORTANDRALONE
- Authorisation status
- Authorised
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
R06A · Product
- Authorisation status
- Authorised
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP1728208 · ATC
- Authorisation status
- Authorised
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP813954 · ATC
- Substance synonyms
- NT100H, FILGRASTIM (GENETICAL RECOMBINATION)
- Authorisation status
- Authorised
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP1977137 · ATC
- Authorisation status
- Authorised
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
J06BA · Product
- Authorisation status
- Authorised
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP1989046 · ATC
- Authorisation status
- Authorised
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
N02A · Product
- Authorisation status
- Authorised
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
PRD2154622 · Product
- Authorisation status
- Authorised
- Marketing authorisation
- EU/1/08/492/003
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Label modified for clinical trial use
—
PRD2154623 · Product
- Authorisation status
- Authorised
- Marketing authorisation
- EU/1/08/492/004
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Label modified for clinical trial use
—
SCP1712543 · ATC
- Substance synonyms
- ADRIAMYCIN
- Authorisation status
- Authorised
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP31288914 · ATC
- Substance synonyms
- FLUDEOXYGLUCOSE F 18, FLUORODEOXYGLUCOSE F18, ALPHA-D-GLUCOPYRANOSE, 2-DEOXY-2-(FLUORO-18F), 18F-FLUDEOXYGLUCOSE
- Authorisation status
- Authorised
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP20117599 · ATC
- Substance synonyms
- ACYCLOVIR
- Authorisation status
- Authorised
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP8268998 · ATC
- Authorisation status
- Authorised
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel
- Postcode
- 4058
- Country
- Switzerland
Scientific contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Head of CTRM Clinical Trial Regulatory Management, Product Development Regulatory
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Head of CTRM Clinical Trial Regulatory Management, Product Development Regulatory
Third parties 8
| Organisation | City, country | Duties |
|---|---|---|
| Cellcarta ORG-100039881
|
Antwerp, Belgium | Other |
| Iqvia Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
| WCG Clinical Inc. ORG-100040730
|
Washington, United States | Other |
| Bioclinica Inc. ORG-100033079
|
Princeton, United States | Other |
| Labcorp Central Laboratory Services S.a.r.l. ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Other |
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | Data management |
Locations
7 EU/EEA countries · 56 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 30 | 4 |
| Denmark | Ongoing, recruitment ended | 33 | 3 |
| France | Ongoing, recruitment ended | 60 | 10 |
| Germany | Ongoing, recruitment ended | 110 | 16 |
| Italy | Ongoing, recruitment ended | 45 | 9 |
| Poland | Ongoing, recruitment ended | 90 | 6 |
| Spain | Ongoing, recruitment ended | 35 | 8 |
| Rest of world
Turkey, United States, Korea, Republic of, United Kingdom, Brazil, Taiwan, Switzerland, Mexico, Argentina, Canada, China, Australia
|
— | 727 | — |
Investigational sites
Institut Jules Bordet
Hematology, Mijlenmeersstraat 90, 1070, Brussels
Algemeen Ziekenhuis Groeninge
Hematology, President Kennedylaan 4, 8500, Kortrijk
UZ Brussel
Hematology, Laarbeeklaan 101, 1090, Jette
CHU De Liege
Hematology, Avenue De L'hopital 1, 4000, Liege
Aarhus University
Hematology, Palle Juul-Jensens Boulevard 82, 8200, Aarhus N
Regionshospitalet Gødstrup
Medicinsk afdeling, Hospitalsparken 15, Gødstrup, Herning
Aalborg University Hospital
Hematology, Moelleparkvej 4, 9000, Aalborg
Centre Hospitalier Universitaire De Rennes
Service d’Hématologie, 2 Rue Henri Le Guilloux, 35000, Rennes
University Hospital Of Montpellier
Hématologie clinique, 191 Avenue Du Doyen Gaston Giraud, 34295, Montpellier Cedex 5
Centre Henri Becquerel
Hématologie, 1 Rue D Amiens, 76000, Rouen
Centre Hospitalier Universitaire De Toulouse
Service d'Hématologie, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Centre Hospitalier Universitaire De Bordeaux
Service d’Hématologie et de thérapie cellulaire, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Lyon Sud
Service Hématologie Clinique, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Centre Hospitalier Universitaire De Nantes
Hématologie clinique, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Lille
Service des Maladies du sang, Rue Michel Polonowski, 59000, Lille
Institut Paoli-Calmettes
Hématologie, 232 Boulevard De Sainte Marguerite, Bp 156, Marseille
Les Hopitaux Universitaires De Strasbourg
Hématologie, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Otto Von Guericke Universitaet Magdeburg
Otto von Guericke Uni Magdeburg Uniklinik; Hämatologie/Onkologie, Leipziger Strasse 44, Leipziger Str., Magdeburg
Klinikum Ernst Von Bergmann gGmbH
Klinikum Ernst von Bergman; Klinik für Hämatologie, Onkologie und Palliativmedizin, Charlottenstrasse 72, Noerdliche Innenstadt, Potsdam
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Klinik f. Hämatologie, Onkologie u. Palliativmedizin, Kriegsbergstrasse 60, Mitte, Stuttgart
Universitaetsklinikum Ulm AöR
Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo., Albert-Einstein-Allee 23, Eselsberg, Ulm
University Hospital Cologne AöR
Klinik I für Innere Medizin - Onkologie, Hämatologie, Kerpener Strasse 62, Lindenthal, Cologne
University Medical Center Hamburg-Eppendorf
Zentrum für Onkologie II. Medizinische Klinik und Poliklinik, Martinistrasse 52, Eppendorf, Hamburg
Universitaetsklinikum Muenster AöR
Facharzt für Innere Medizin, Hämatologie und Onkologie, Albert-Schweitzer-Strasse 33, 48149, Muenster
University Of Luebeck
Universitaetsklinikum Schleswig Holstein - Campus Luebeck; Haematologie, Onkologie, Ratzeburger Allee 160, Strecknitz, Lübeck
Universitaetsklinikum Essen AöR
Klinik für Hämatologie und Stammzellentransplantation, Hufelandstrasse 55, Holsterhausen, Essen
Universitaetsklinikum Frankfurt AöR
Medizinische Klinik II; Hämatologie/Onkologie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Universitaetsklinikum Duesseldorf AöR
Klinik für Hämatologie, Onkologie und Klinische Immunologie, Moorenstrasse 5, Bilk, Duesseldorf
Universitaetsklinikum Wuerzburg AöR
Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Universitaetsklinikum Erlangen AöR
Medizinische Klinik 5, Krankenhausstrasse 12, Innenstadt, Erlangen
Charite Universitaetsmedizin Berlin KöR
CAMPUS BENJAMIN FRANKLIN CharitéCentrum 14 Med.Klinik f.Hämatologie u.Onkologie, Hindenburgdamm 30, Lichterfelde, Berlin
Gesundheitszentrum Brandenburg An Der Havel GmbH
Staedisches Klinikum Brandenburg, Hochstrasse 29, Altstadt, Brandenburg An Der Havel
Klinikum Chemnitz gGmbH
Klinik für Innere Medizin III Hämatologie, Onkologie und Zelltherapie, Flemmingstrasse 2, Altendorf, Chemnitz
Azienda Unita' Locale Socio Sanitaria N. 8 Berica
Dipartimento di Oncologia Medica, UOC Ematologia, Viale Ferdinando Rodolfi 37, 36100, Vicenza
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Divisione di Ematologia e Trapianto Midollo Osseo, Via Santa Sofia 78, 95123, Catania
Humanitas Research Hospital
Dipartimento di Scienze Biomediche, Via Alessandro Manzoni 56, 20089, Rozzano
Fondazione IRCCS Istituto Nazionale Dei Tumori
SC Ematologia - Trapianto di Midollo Osseo Allogenico, Via Giacomo Venezian 1, 20133, Milan
Azienda Ospedaliera Papa Giovanni XXIII
Dipartimento di Oncologia ed Ematologia, Piazza Oms 1, 24127, Bergamo
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
Azienda Ospedaliero Universitaria Di Modena
Dipartimento di Oncologia ed Ematologia, Largo Del Pozzo 71, 41124, Modena
IRCCS Istituto Nazionale Tumori Fondazione Pascale
SC di Ematologia Oncologica e Trapianto di Cellule Staminali, Via Mariano Semmola 52, 80131, Naples
IRCCS Ospedale Policlinico San Martino
S.C. Ematologia e Terapie Cellulari, Largo Rosanna Benzi 10, 16132, Genoa
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych, Ul. Wybrzeze Ludwika Pasteura 4, 50-367, Wroclaw
Pratia Hematologia Sp. z o.o.
n/a, Ul. Ligocka 103, 40-568, Katowice
Pratia MCM Krakow
n/a, Ul. Pana Tadeusza 2, 30-727, Cracow
Uniwersyteckie Centrum Kliniczne
Klinika Hematologii i Transplantologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Oddział Hematologii Onkologicznej z Pododdziałem Transplantologii Klinicznej, Ul. Ks. Jozefa Bielawskiego 18, 36-200, Brzozow
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Klinika Hematologii i Transplantacji Szpiku, Ul. Prezydenta Stefana Artwinskiego 3, 25-734, Kielce
Hospital Universitari Vall D Hebron
Servicio de Hematologia, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Quironsalud Madrid
Servicio de Hematologia, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Complexo Hospitalario Universitario De Santiago
Servicio de Hematologia, Calle Choupana Da S/n, 15706, Santiago De Compostela
Clinica Universidad De Navarra
Servicio de Hematologia, Avenue Pio XII 36, 31008, Pamplona
Hospital General Universitario Gregorio Maranon
Servicio de Hematologia, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Clinico Universitario De Valencia
Servicio de Hematologia, Avenida Blasco Ibanez 17, 46010, Valencia
Clinica Universidad De Navarra
Servicio de Hematologia, Calle Marquesado De Santa Marta 1, 28027, Madrid
University Hospital Virgen Del Rocio S.L.
Servicio de Hematologia, Avenida De Manuel Siurot S/n, 41013, Sevilla
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 |
|---|---|---|---|---|---|
| Belgium | 2023-11-06 | 2023-12-11 | 2024-11-18 | ||
| Denmark | 2023-12-04 | 2024-01-25 | 2024-11-20 | ||
| France | 2023-10-20 | 2023-10-23 | 2024-11-20 | ||
| Germany | 2023-11-10 | 2024-01-11 | 2024-11-20 | ||
| Italy | 2023-10-18 | 2023-10-18 | 2024-11-20 | ||
| Poland | 2024-01-09 | 2024-01-26 | 2024-11-20 | ||
| Spain | 2023-09-22 | 2023-10-20 | 2024-11-20 |
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_protocol-2023-504028-24-00-redacted | 5 |
| Protocol (for publication) | D4_Patient facing documents_CTCAE_BE-NL | 1 |
| Protocol (for publication) | D4_Patient facing documents_CTCAE_DE-DE | 1 |
| Protocol (for publication) | D4_Patient facing documents_CTCAE_EN | 1 |
| Protocol (for publication) | D4_Patient facing documents_CTCAE_ES-ES | 1 |
| Protocol (for publication) | D4_Patient facing documents_CTCAE_FR-FR | 1 |
| Protocol (for publication) | D4_Patient facing documents_CTCAE_IT-IT | 1 |
| Protocol (for publication) | D4_Patient facing documents_EQ5D5L_BE-DE | 1 |
| Protocol (for publication) | D4_Patient facing documents_EQ5D5L_BE-FR | 1 |
| Protocol (for publication) | D4_Patient facing documents_EQ5D5L_BE-NL | 1 |
| Protocol (for publication) | D4_Patient facing documents_EQ5D5L_DE-DE | 1 |
| Protocol (for publication) | D4_Patient facing documents_EQ5D5L_EN | 1 |
| Protocol (for publication) | D4_Patient facing documents_EQ5D5L_ES-ES | 1 |
| Protocol (for publication) | D4_Patient facing documents_EQ5D5L_FR-FR | 1 |
| Protocol (for publication) | D4_Patient facing documents_EQ5D5L_IT-IT | 1 |
| Protocol (for publication) | D4_Patient facing documents_FACTLYM_BE-NL | 4 |
| Protocol (for publication) | D4_Patient facing documents_FACTLYM_DE-DE | 4 |
| Protocol (for publication) | D4_Patient facing documents_FACTLYM_EN | 4 |
| Protocol (for publication) | D4_Patient facing documents_FACTLYM_ES-ES | 4 |
| Protocol (for publication) | D4_Patient facing documents_FACTLYM_FR-FR | 4 |
| Protocol (for publication) | D4_Patient facing documents_FACTLYM_IT-IT | 4 |
| Protocol (for publication) | D4_Patient facing documents_GP5_BE-NL | 4 |
| Protocol (for publication) | D4_Patient facing documents_GP5_DE-DE | 4 |
| Protocol (for publication) | D4_Patient facing documents_GP5_EN | 4 |
| Protocol (for publication) | D4_Patient facing documents_GP5_ES-ES | 4 |
| Protocol (for publication) | D4_Patient facing documents_GP5_FR-FR | 4 |
| Protocol (for publication) | D4_Patient facing documents_GP5_IT-IT | 4 |
| Protocol (for publication) | D4_Patient facing documents_QLQC30_BE-NL | 3 |
| Protocol (for publication) | D4_Patient facing documents_QLQC30_DE-DE | 3 |
| Protocol (for publication) | D4_Patient facing documents_QLQC30_EN | 3 |
| Protocol (for publication) | D4_Patient facing documents_QLQC30_ES-ES | 3 |
| Protocol (for publication) | D4_Patient facing documents_QLQC30_FR-FR | 3 |
| Protocol (for publication) | D4_Patient facing documents_QLQC30_IT-IT | 3 |
| Recruitment arrangements (for publication) | 2023-504028-24-00_Document additionnel_GO44145_Redacted | 1 |
| Recruitment arrangements (for publication) | 2023-504028-24-00_Recruitment and Informed consent procedure_GO44145 | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangement | 1 |
| Recruitment arrangements (for publication) | K1_GO44145_DEU_Recruitment and Informed Consent Procedure | 1 |
| Recruitment arrangements (for publication) | K1_recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 5.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements NOT REDACTED | 1 |
| Subject information and informed consent form (for publication) | 2023-504028-24-00_NIFC_Enfant_ne_GO44145 | 1 |
| Subject information and informed consent form (for publication) | 2023-504028-24-00_NIFC_Partenaire_enceinte_GO44145 | 1 |
| Subject information and informed consent form (for publication) | 2023-504028-24-00_NIFC_RBR_GO44145 | 1 |
| Subject information and informed consent form (for publication) | L1 Pregnant Partner ICF | 1 |
| Subject information and informed consent form (for publication) | L1_Appendix 1 to ICFs | 4 |
| Subject information and informed consent form (for publication) | L1_General Pratictioner Letter_placeholder | N/A |
| Subject information and informed consent form (for publication) | L1_GO44145_DEU_ICF_RBR | 1 |
| Subject information and informed consent form (for publication) | L1_GO44145_DEU_ICF_Treatment Continuation | 1 |
| Subject information and informed consent form (for publication) | L1_Infant Authorization Form | 1 |
| Subject information and informed consent form (for publication) | L1_Main ICF_Clean_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_Main ICF_REDACTED | 5 |
| Subject information and informed consent form (for publication) | L1_Mobile Nursing ICF_FILE NOTE | 1 |
| Subject information and informed consent form (for publication) | L1_Optional Biopsy and Plasma | 2 |
| Subject information and informed consent form (for publication) | L1_Optional biospy ICF_Clean | 2 |
| Subject information and informed consent form (for publication) | L1_Privacy consent form other subjects | N/A |
| Subject information and informed consent form (for publication) | L1_Pseudo-progression ICF_clean | 1 |
| Subject information and informed consent form (for publication) | L1_RBR ICF | 3 |
| Subject information and informed consent form (for publication) | L1_S13 Genomforskning_Retten til ikke-viden | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF IAF NOT REDACTED | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF infant and Privacy sheet | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF main and Appendix 1_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_AR_NtF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_EN_REDACTED | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_FR_REDACTED | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_NL_REDACTED | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Mobile Nursing_EN_REDACTED | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Mobile Nursing_FR_REDACTED | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Mobile Nursing_NL_REDACTED | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Mobile Nursing_note file | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Biopsy | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA NOT REDACTED | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PPA_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF pregnant partner and Privacy sheet | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RBR NOT REDACTED | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment Continuation NOT REDACTED | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IAF_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IAF_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IAF_GO44145 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IAF_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_GO44145 | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Mobile Nursing_Note to File_GO44145 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_optional Biopsy_GO44145 | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PPA_GO44145 | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment continuation_EN | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment continuation_FR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment continuation_NL | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_General_EN | NA |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_General_REDACTED | 5 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_IAF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_mobile nursing_EN | NA |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_mobile nursing_REDACTED | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_optional biopsy | 2 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_optional biopsy_EN | NA |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_PPA | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_RBR | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_RBR_EN | NA |
| Subject information and informed consent form (for publication) | L1_Treatment Continuation after Apparent Disease Worsening | 1 |
| Subject information and informed consent form (for publication) | L2_Dine rettigheder som forsgsperson i forsg med medicin | 1 |
| Subject information and informed consent form (for publication) | L2_Informed consent form procedure | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Lay CTD_NOTE | 1 |
| Subject information and informed consent form (for publication) | L2_Sponsor statement on use of ICF model | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC MABTHERA | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC POLIVY | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol Clarification Letter 2023-504028-24-00 DEC2023 Redacted | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol Clarification Letter 2023-504028-24-00 MAR2024 Redacted | NA |
| Synopsis of the protocol (for publication) | D1_Protocol Clarification Letter 2023-504028-24-00 SEP2023 Redacted | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-DE 2023-504028-24-00_Redacted | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-FR 2023-504028-24-00_Redacted | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_BE-NL 2023-504028-24-00_Redacted | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_DE-DE 2023-504028-24-00 | 1 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_eng-2023-504028-24-00 | 4 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_eng-2023-504028-24-00 tc | NA |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_es-2023-504028-24-00 | 4 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_es-2023-504028-24-00 tc | NA |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_fr-fr-2023-504028-24-00 | 4 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_fr-fr-2023-504028-24-00 tc | NA |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_it-2023-504028-24-00 | 4 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_it-2023-504028-24-00 tc | NA |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_pl-2023-504028-24-00 | 4 |
| Synopsis of the protocol (for publication) | d1_protocol-synopsis_pl-2023-504028-24-00 tc | NA |
Application history
17 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-08 | Denmark | Acceptable 2023-08-28
|
2023-08-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-09-05 | Acceptable | 2023-10-12 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-10-04 | Acceptable | 2023-11-17 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-11-23 | Denmark | 2023-11-23 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-03-04 | Denmark | 2024-03-04 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-04-24 | Denmark | Acceptable 2024-07-09
|
2024-07-09 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2024-07-22 | Denmark | Acceptable 2024-07-09
|
2024-07-22 |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-08-07 | Acceptable | 2024-09-11 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-08-09 | 2024-09-23 | ||
| 10 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-01-17 | Denmark | Acceptable 2025-04-14
|
2025-04-14 |
| 11 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-06-05 | Acceptable | 2025-06-17 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-08-18 | Denmark | Acceptable 2025-10-29
|
2025-10-30 |
| 13 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-11-04 | Acceptable | 2025-12-05 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-11-06 | Acceptable | 2025-12-04 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-11 | 2026-01-22 | Denmark | Acceptable 2026-03-02
|
2026-03-02 |
| 16 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2026-04-02 | Acceptable 2026-03-02
|
2026-04-02 | |
| 17 | SUBSTANTIAL MODIFICATION | SM-12 | 2026-05-08 | Acceptable | 2026-06-03 |