Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Ongoing, recruitment ended
Participants planned
555
Countries
10
Sites
41
Lymphoma of B-cell origin
Dose Escalation Phase: Evaluate the safety and tolerability of epcoritamab in combination with other agents Expansion Phase: Arms 1-6 and 8-10: Assess the preliminary anti-tumor activity of epcoritamab in combination with other agents Arm 7: Evaluate the safety and tolerability of epcoritamab following standard of care…
Key facts
- Sponsor
- Genmab A/S
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 22 Oct 2020 → ongoing
- Decision date (initial)
- 2024-01-31
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Genmab US, Inc. · Genmab A/S
External identifiers
- EU CT number
- 2023-504805-35-00
- EudraCT number
- 2020-000845-15
- ClinicalTrials.gov
- NCT04623541
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacodynamic, Pharmacokinetic, Safety
Dose Escalation Phase: Evaluate the safety and tolerability of epcoritamab in combination with other agents
Expansion Phase: Arms 1-6 and 8-10: Assess the preliminary anti-tumor activity of epcoritamab in combination with other agents
Arm 7: Evaluate the safety and tolerability of epcoritamab following standard of care (SOC)
Secondary objectives 2
- Dose Escalation Phase: - Characterize the pharmacokinetic (PK) properties of epcoritamab - Evaluate pharmacodynamic markers linked to efficacy and mechanism of action of epcoritamab - Evaluate immunogenicity - Assess the preliminary anti-tumor activity of epcoritamab in combination with other agents
- Expansion Phase: - Further assess the preliminary anti-tumor activity of epcoritamab as a component of a treatment regimen - Further evaluate the safety and tolerability of epcoritamab in combination with other agents - Characterize the PK properties of epcoritamab - To evaluate pharmacodynamic markers linked to efficacy and mechanism of action of epcoritamab - Evaluate immunogenicity
Conditions and MedDRA coding
Lymphoma of B-cell origin
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLGT | 10025320 | Lymphomas non-Hodgkin's B-cell | 10029104 |
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Part I Dose Escalation
|
Not Applicable | None | Arm 1: Epcoritamab + rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in subjects with previously untreated diffuse large B-cell lymphoma (DLBCL), with high-risk features (International Prognostic Index [IPI] 3-5) Arm 2: Epcoritamab + rituximab and lenalidomide (R2) in subjects with relapsed/refractory (R/R) follicular lymphoma (FL) Arm 3: Epcoritamab + rituximab and bendamustine (BR) in subjects with previously untreated FL Arm 4: Epcoritamab + rituximab, dexamethasone, cytarabine, and oxaliplatin/carboplatin(R-DHAX/C) in subjects with R/R DLBCL eligible for autologous stem cell transplant (ASCT) Arm 5: Epcoritamab + gemcitabine and oxaliplatin (GemOx) in subjects with R/R DLBCL ineligible for ASCT due to age, performance status (PS), or comorbidity Arm 10: Epcoritamab + rituximab, ifosfamide, carboplatin, and etoposide phosphate (R-ICE) in subjects with R/R DLBCL eligible for ASCT |
|
| 2 | Part II Expansion
|
Not Applicable | None | Arm 1: Epcoritamab + rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in subjects with previously untreated diffuse large B-cell lymphoma (DLBCL), with high-risk features (International Prognostic Index [IPI] 3-5) Arm 2: Epcoritamab + rituximab and lenalidomide (R2) in subjects with relapsed/refractory (R/R) follicular lymphoma (FL) Arm 3: Epcoritamab + rituximab and bendamustine (BR) in subjects with previously untreated FL Arm 4: Epcoritamab + rituximab, dexamethasone, cytarabine, and oxaliplatin/carboplatin (R-DHAX/C) in subjects with R/R DLBCL eligible for autologous stem cell transplant (ASCT) Arm 5: Epcoritamab + gemcitabine and oxaliplatin (GemOx) in subjects with R/R DLBCL ineligible for ASCT due to age, performance status (PS), or comorbidity Arm 6: Epcoritamab + R2 (12 cycles of SOC in combination with epcoritamab followed by epcoritamab monotherapy for a total of 2 years) in subjects with previously untreated FL Arm 7: Epcoritamab maintenance (up to 13 cycles of epcoritamab) in subjects with FL in CR or PR following first- or second-line SOC treatment Arm 8: Epcoritamab + reduced dose schedule of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-mini-CHOP) (6 cycles of SOC in combination with epcoritamab followed by 2 cycles of epcoritamab monotherapy) in subjects with previously untreated DLBCL who are ineligible to receive full-dose anthracycline Arm 9: Epcoritamab + lenalidomide for second-line treatment in subjects with FL who progressed within 24 months of initiation of first-line anti-CD20-containing immunochemotherapy Arm 10: Epcoritamab + rituximab, ifosfamide, carboplatin, and etoposide phosphate (R-ICE) in subjects with R/R DLBCL eligible for ASCT |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- Subject must sign an ICF
- At least 18 years of age
- Measurable disease defined as ≥1 measurable nodal lesion (long axis >1.5 cm and short axis >1.0 cm) or ≥1 measurable extra-nodal lesion (long axis >1.0 cm) on CT or MRI
- ECOG PS score of 0, 1 or 2
- Acceptable organ function at screening
- CD20-positive NHL at most recent representative tumor biopsy
- If of childbearing potential subject must practicing a highly effective method of birth control
- A man who is sexually active with a woman of childbearing potential must agree to use a barrier method of birth control
- Life expectancy >2 months with SOC treatment. Arm 1: One of these confirmed histologies: - DLBCL, NOS - T-cell/histiocyte rich DLBCL - "double-hit" or "triple-hit" DLBCL - FL Grade 3B Arm 2 and Arm 9: R/R FL Arm 3: Newly diagnosed, previously untreated FL grade 1-3A Arm 4 and Arm 10: One of these confirmed histologies and eligible for HDT-ASCT - DLBCL, NOS - T-cell/histiocyte rich DLBCL - "double-hit" or "triple-hit" DLBCL - FL Grade 3B Arm 5: One of these confirmed histologies and ineligible for HDT-ASCT - DLBCL, NOS - T-cell/histiocyte rich DLBCL - "double-hit" or "triple-hit" DLBCL - FL Grade 3B Arm 6: previously untreated CD20+ FL Arm 7: FL and in CR or PR per Lugano criteria following first-line or second-line treatment with SOC regiment at last treatment received, and last dose of SOC within 6 months prior to enrollment Arm 8: One of these confirmed histologies: - DLBCL, NOS - T-cell/histiocyte rich DLBCL - "double-hit" or "triple-hit" DLBCL -FL Grade 3B For Arm8, subjects must be ineligible to receive full-dose anthracycline (as part of R-CHOP) per eligibility criteria Arm 9: Must have received only 1 prior line of therapy. This first-line therapy must have included an anti-CD20 antibody in combination with chemotherapy. Progressed within 24 months of initiating first-line treatment
Exclusion criteria 10
- Chemotherapy, radiation therapy, or major surgery within 4 weeks prior to the first dose of epcoritamab
- Any prior treatment with a bispecific antibody targeting CD3 and CD20.
- Treatment with CAR-T therapy within 100 days prior to first dose of epcoritamab
- Clinically significant cardiovascular disease
- Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
- Primary CNS lymphoma or known CNS involvement by lymphoma at screening as confirmed by MRI/CT scan of the brain and, if clinically indicated, by lumbar puncture
- Active HBV or HCV (DNA PCR positive infection)
- Known history of seropositivity for human immunodeficiency virus (HIV)
- Active tuberculosis or history of completed treatment for active tuberculosis within the past 12 months
- Subject has current seizure disorder requiring anti-epileptic therapy
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Dose Escalation Phase: - Incidence of dose-limiting toxicities - Incidence and severity of adverse events (AEs) - Incidence and severity of changes in laboratory values - Incidence of dose interruptions and delays
- Expansion Phase: Arms 1-6 and 8-10: - ORR determined by Lugano criteria Arm 7: - Incidence and severity of AEs - Incidence and severity of changes in laboratory values - Incidence of dose interruptions and delays
Secondary endpoints 6
- Dose Escalation Phase:- PK parameters- Pharmacodynamic markers in blood samples and within tumor (ontreatment biopsy)- Incidence of anti-drug antibodies (ADAs) to epcoritamab- ORR determined by Lugano criteria- Duration of response (DOR) determined by Lugano criteria- Time to response (TTR) determined by Lugano criteria- Progression-free survival (PFS) determined by Lugano criteria- Overall survival (OS)- TTNT- Rate and duration of minimal residual disease (MRD) negativity
- Expansion Phase:-DOR determined by Lugano criteria (Arms 1-6 and 8-10)-TTR determined by Lugano criteria (Arms 1-6 and 8-10)-PFS determined by Lugano criteria (Arms 1-6 and 8-10)-CR rate (Arm 1-10 except Arm 7 subjects in CR at baseline)-OS (Arms 1-10)-TTNT (Arms 1-10)-Rate and duration of MRD negativity (Arms 1-10)-Rate of conversion from MRD positivity to MRD negativity (Arm 7)-CR rate (Arm 7 subjects in PR at baseline)-TTCR (Arms 1-10 except Arm 7 subjects in CR at baseline)-DoCR (Arms 1-10)
- Incidence and severity of AEs (Arms 1-6, and 8-10) -Incidence and severity of changes in laboratory values (Arms 1-6, and 8-10) -Incidence of dose interruptions and delays (Arms 1-6, and 8-10)
- PK parameters
- Pharmacodynamic markers in blood samples and within tumor (on treatment biopsy)
- Incidence of ADAs to epcoritamab
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 16
SCP167667 · ATC
- Active substance
- Dexamethasone Isonicotinate
- Route of administration
- INTRAVENOUS
- Authorisation status
- Authorised
- ATC code
- D07AB19 — DEXAMETHASONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP100376572 · ATC
- Active substance
- Etoposide
- Route of administration
- INTRAVENOUS
- Authorisation status
- Authorised
- ATC code
- L01CB01 — ETOPOSIDE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP106382672 · ATC
- Active substance
- Cyclophosphamide
- Route of administration
- INTRAVENOUS
- Authorisation status
- Authorised
- ATC code
- L01AA01 — CYCLOPHOSPHAMIDE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP20211730 · ATC
- Active substance
- Bendamustine Hydrochloride
- Route of administration
- INTRAVENOUS
- Authorisation status
- Authorised
- ATC code
- L01AA09 — BENDAMUSTINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP872361 · ATC
- Active substance
- Rituximab
- Substance synonyms
- CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
- Route of administration
- INTRAVENOUS
- Authorisation status
- Authorised
- ATC code
- L01FA01 — RITUXIMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1137788 · ATC
- Active substance
- Vinorelbine
- Route of administration
- INTRAVENOUS
- Authorisation status
- Authorised
- ATC code
- L01CA02 — VINCRISTINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1128788 · ATC
- Active substance
- Gemcitabine Hydrochloride
- Substance synonyms
- 4-AMINO-1-[(2R,4R,5R)-3,3-DIFLUORO-4-HYDROXY-5-(HYDROXYMETHYL)OXOLAN-2-YL]PYRIMIDIN-2-ONE HYDROCHLORIDE
- Route of administration
- INTRAVENOUS
- Authorisation status
- Authorised
- ATC code
- L01BC05 — GEMCITABINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP10337134 · ATC
- Active substance
- Carboplatin
- Route of administration
- INTRAVENOUS
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP149173 · ATC
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- L04AX04 — LENALIDOMIDE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD10899078 · Product
- Active substance
- Epcoritamab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Authorisation status
- Not Authorised
- MA holder
- GENMAB
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/22/2581
SCP107216203 · ATC
- Active substance
- Prednisolone
- 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
- Route of administration
- INTRAVENOUS
- Authorisation status
- Authorised
- ATC code
- H02AB07 — PREDNISONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD5599809 · Product
- Active substance
- Epcoritamab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Authorisation status
- Not Authorised
- MA holder
- GENMAB
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/22/2581
SCP119562649 · ATC
- Active substance
- Doxorubicin Hydrochloride
- Route of administration
- INTRAVENOUS
- Authorisation status
- Authorised
- ATC code
- L01DB01 — DOXORUBICIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP128961 · ATC
- Active substance
- Oxaliplatin
- Route of administration
- INTRAVENOUS
- Authorisation status
- Authorised
- ATC code
- L01XA03 — OXALIPLATIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP142361 · ATC
- Active substance
- Cytarabine
- Substance synonyms
- ARA-C, CYTOSINE ARABINOSIDE
- Route of administration
- INTRAVENOUS
- Authorisation status
- Authorised
- ATC code
- L01BC01 — CYTARABINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP11431448 · ATC
- Active substance
- Ifosfamide
- Route of administration
- INTRAVENOUS
- Authorisation status
- Authorised
- ATC code
- L01AA06 — IFOSFAMIDE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 6
SCP1081917 · ATC
- Active substance
- Buclizine Hydrochloride
- Substance synonyms
- Buclizine dihydrochloride
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- N02BE01 — PARACETAMOL
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- N/A
- Modified vs. Marketing Authorisation
- No
Betamethasone Sodium Phosphate
SCP1158234 · ATC
- Active substance
- Betamethasone Sodium Phosphate
- Substance synonyms
- BETAMETHASONE DISODIUM PHOSPHATE
- Route of administration
- ORAL
- Authorisation status
- Authorised
- ATC code
- H02AB06 — PREDNISOLONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP1159503 · ATC
- Route of administration
- INTRAVENOUS USE
- Authorisation status
- Authorised
- ATC code
- R06AA02 — DIPHENHYDRAMINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP176238 · ATC
- Active substance
- Tocilizumab
- Substance synonyms
- RO4877533, BIIB800, ATLIZUMAB, TOCILIZUMABUM
- Route of administration
- INTRAVENOUS
- Authorisation status
- Authorised
- ATC code
- L04AC07 — TOCILIZUMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP183367 · ATC
- Active substance
- Anakinra
- Route of administration
- SUBCUTANEOUS
- Authorisation status
- Authorised
- ATC code
- L04AC03 — ANAKINRA
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- N/A
—
SCP274031 · ATC
- Route of administration
- INTRAVENOUS
- Authorisation status
- Authorised
- ATC code
- L04AC11 — SILTUXIMAB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Genmab A/S
- Sponsor organisation
- Genmab A/S
- Address
- Kalvebod Brygge 43
- City
- Copenhagen V
- Postcode
- 1560
- Country
- Denmark
Scientific contact point
- Organisation
- Genmab A/S
- Contact name
- Trial Information
Public contact point
- Organisation
- Genmab A/S
- Contact name
- Trial Information
Third parties 13
| Organisation | City, country | Duties |
|---|---|---|
| Fortrea Development Limited ORG-100009463
|
Maidenhead, United Kingdom | Code 8 |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring, Code 11, Code 12, Other, Code 2, Code 5, E-data capture |
| Klifo A/S ORG-100016474
|
Glostrup, Denmark | Code 14 |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Laboratory analysis |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Other |
| Clinipace Inc. ORG-100042162
|
Morrisville, United States | Code 10 |
| Adaptive Biotechnologies Corp. ORG-100044428
|
Seattle, United States | Other, Laboratory analysis |
| CellCarta ORG-100039881
|
Antwerp, Belgium | Other, Laboratory analysis |
| Endpoint Clinical Inc. ORG-100040567
|
Wakefield, United States | Interactive response technologies (IRT) |
| Perceptive Informatics Inc. ORG-100013171
|
Billerica, United States | Other |
| Q Squared Solutions Limited ORG-100042527
|
Reading, United Kingdom | Laboratory analysis |
| Bioagilytix Labs LLC ORG-100013030
|
Durham, United States | Laboratory analysis |
| ICON Bioanalytical Laboratories ORL-000000518
|
Assen, Netherlands | Other |
Locations
10 EU/EEA countries · 41 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 29 | 3 |
| Czechia | Ongoing, recruitment ended | 53 | 4 |
| Denmark | Ongoing, recruitment ended | 45 | 4 |
| Finland | Ended | 11 | 2 |
| France | Ended | 17 | 4 |
| Italy | Ongoing, recruitment ended | 41 | 7 |
| Netherlands | Ongoing, recruitment ended | 55 | 6 |
| Norway | Ongoing, recruitment ended | 10 | 1 |
| Spain | Ongoing, recruitment ended | 66 | 5 |
| Sweden | Ongoing, recruitment ended | 40 | 5 |
| Rest of world
Australia, United States, United Kingdom
|
— | 188 | — |
Investigational sites
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Hematology, Avenue Docteur Gaston Therasse 1, 5530, Yvoir
Az St-Jan Brugge-Oostende A.V.
Hematology, Ruddershove 10, 8000, Brugge
Universitair Ziekenhuis Gent
Hematology, Corneel Heymanslaan 10, 9000, Gent
Vseobecna Fakultni Nemocnice V Praze
I. interní klinika – hematologie, U Nemocnice 499/2, Nove Mesto, Prague 2
Fakultni Nemocnice Hradec Kralove
IV. interní hematologická klinika, Sokolska 581, 500 03, Novy Hradec Kralove
Fakultni Nemocnice V Motole
Onkologická klinika, V Uvalu 84/1, Motol, Prague 5
Fakultni Nemocnice Ostrava
Klinika hematoonkologie, 17. Listopadu 1790/5, 708 00, Poruba
Rigshospitalet
Department of Hematology, Blegdamsvej 9, 2100, Copenhagen Oe
Odense University Hospital
Department of Hematology, Kloevervaenget 47, 5000, Odense C
Sygehus Lillebaelt Vejle Sygehus
Department of Hematology, Kabbeltoft 25, 7100, Vejle
Aarhus Universitetshospital
Department of Hematology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Kuopio University Hospital
Department of Oncology, Puijonlaaksontie 2, P. O. Box 1777, Kuopio
HUS-Yhtymae
Department of Oncology, Haartmaninkatu 4, 00290, Helsinki
Assistance Publique Hopitaux De Marseille
Phase I, 264 Rue Saint Pierre, 13005, Marseille
Assistance Publique Hopitaux De Paris
Oncology-Hematology, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Universitaire De Lille
Blood Diseases, Rue Michel Polonowski, 59000, Lille
Centre Hospitalier Lyon Sud
Clinical Hematology, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Ematologia, Via Piero Maroncelli 40, 47014, Meldola
Fondazione IRCCS Policlinico San Matteo
Ematologia, Viale Camillo Golgi 19, 27100, Pavia
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
U.O.C. Ematologia, Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliera Papa Giovanni XXIII
U.O. di Ematologia, Piazza Oms 1, 24127, Bergamo
Azienda USL IRCCS Di Reggio Emilia
Ematologia, Viale Risorgimento 80, 42123, Reggio Emilia
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS
Div. di Oncologia Medica ed Ematologia, Strada Provinciale 142 Km 3,95, 10060, Candiolo
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Hematology, Via Francesco Sforza 35, 20122, Milan
Utrecht University
Hematology, Heidelberglaan 100, 3584 CX, Utrecht
Academisch Ziekenhuis Leiden
Hematology, Albinusdreef 2, 2333 ZA, Leiden
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Hematology, Wytemaweg 80, 3015 CN, Rotterdam
Amsterdam UMC
Hematology, De Boelelaan 1117, 1081 HV, Amsterdam
Universitair Medisch Centrum Groningen
Hematology, Hanzeplein 1, 9713 GZ, Groningen
Universiteit Maastricht
Hematology, P Debyelaan 25, 6229 HX, Maastricht
Oslo University Hospital HF
Oslo Universitetssykehus HF, Radiumhospitalet, Montebello, Ullernchausséen 70, Oslo
Institut Catala D'oncologia
Hematology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Universitario De Salamanca
Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario Fundacion Jimenez Diaz
Oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario La Paz
Hematology, Paseo Castellana 261, 28046, Madrid
Hospital Universitari Vall D Hebron
Hematology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Region Skane Skanes Universitetssjukhus
Department of Oncology, Entregatan 7, 222 42, Lund
Uppsala University Hospital
Kliniska forsknings- och utvecklingsenheten, Akademiska Sjukhuset, 751 85, Uppsala
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Sektionen för Hematologi och Koagulation, Forskningsenhet Hematologi, Bruna Straket 16, 413 46, Gothenburg
Karolinska University Hospital
Studiebehandlingsenheten B8:09, Eugeniavagen 3, 171 64, Solna
Sodra Alvsborg Hospital-Vastra Gotalandsregionen
Hematolog dagvård, Bramhultsvagen 53, Boras Gustav Adolf, Boras
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 | 2021-03-18 | 2021-03-29 | 2024-09-20 | ||
| Czechia | 2021-03-01 | 2021-03-03 | 2024-09-20 | ||
| Denmark | 2020-11-03 | 2020-11-03 | 2024-09-20 | ||
| Finland | 2021-03-31 | 2021-05-04 | 2024-09-20 | ||
| France | 2021-02-16 | 2021-04-02 | 2024-09-20 | ||
| Italy | 2021-07-09 | 2021-08-16 | 2024-09-20 | ||
| Netherlands | 2020-10-22 | 2021-05-03 | 2024-09-20 | ||
| Norway | 2021-05-18 | 2021-06-10 | 2024-09-20 | ||
| Spain | 2021-02-25 | 2021-04-26 | 2024-09-20 | ||
| Sweden | 2021-01-08 | 2021-01-29 | 2024-09-20 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 160 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-504805-35_red_san | 13.0 |
| Protocol (for publication) | D4_Patient facing documents Fact-Lym_eCOA Tablet_CZ_san | 1 |
| Protocol (for publication) | D4_Patient facing documents Fact-Lym_eCOA Tablet_DK_san | 1 |
| Protocol (for publication) | D4_Patient facing documents Fact-Lym_eCOA Tablet_EN_san | 1 |
| Protocol (for publication) | D4_Patient facing documents Fact-Lym_eCOA Tablet_ES_san | 1 |
| Protocol (for publication) | D4_Patient facing documents Fact-Lym_eCOA Tablet_FI_san | 1 |
| Protocol (for publication) | D4_Patient facing documents Fact-Lym_eCOA Tablet_FR_san | 1 |
| Protocol (for publication) | D4_Patient facing documents Fact-Lym_eCOA Tablet_frBE_san | 1 |
| Protocol (for publication) | D4_Patient facing documents Fact-Lym_eCOA Tablet_IT_san | 1 |
| Protocol (for publication) | D4_Patient facing documents Fact-Lym_eCOA Tablet_NL_san | 1 |
| Protocol (for publication) | D4_Patient facing documents Fact-Lym_eCOA Tablet_nlBE_san | 1 |
| Protocol (for publication) | D4_Patient facing documents Fact-Lym_eCOA Tablet_NO_san | 1 |
| Protocol (for publication) | D4_Patient facing documents Fact-Lym_eCOA Tablet_SE_san | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_san | NA |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_san | 1.0 |
| Recruitment arrangements (for publication) | K1__Recruitment and ICF Form_san | 1 |
| Recruitment arrangements (for publication) | K1_2023-504805-35_Recruitment Arrangements_san | N/A |
| Recruitment arrangements (for publication) | K1_2023-504805-35_Recruitment Arrangements_san | 1.0 |
| Recruitment arrangements (for publication) | K1_GCT3013-02_Recruitment and Informed Consent Procedure_NLD | v1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_BE_San | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_CEC submisssion_red and san | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_IT | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_san | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_san | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_SE | V1.0 |
| Recruitment arrangements (for publication) | K2_other subject information material_Referral Letter | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material - Referral Letter for Arm 9_san | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Physician Referral Letter_EN_San | 02 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Referral Letter | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Referral Letter_IT | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Referral Letter_san | 2.0 |
| Subject information and informed consent form (for publication) | Cover_letter_15Mar2024 | NA |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_Main ICF APPENDIX Group 2b_san | 11.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_Main ICF APPENDIX Group 6_san | 10.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_Main ICF APPENDIX Group 7_san | 11.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_Main ICF APPENDIX Group 8_san | 10.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_2023-504805-35_ICF_PP ICF_TC | 6.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_2023-504805-35_Main ICF_Arms 1_2a_3_5_8_10_san | 18.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_2023-504805-35-00_PP ICF_san | 6.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_GCT3013-02_Main ICF Groups 1-5 and 10_red-san | V18.0NL2.0 |
| Subject information and informed consent form (for publication) | L1_GCT3013-02_Main ICF groups 2b 6-9_red-san | V11.0NL2.0 |
| Subject information and informed consent form (for publication) | L1_GCT3013-02_Pregnancy ICF_red-san | V6.0NLD2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Czech_Main_Arm 1_TC_san | 17.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum to Appendix Main Adult Groups 1-5 and 10_san_clean | 2.0FIN1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum to Appendix Main Adult Groups 2b 6-8 and 9_san_clean | 2.0FIN1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum to Main Adult Groups 1-5 and 10_san | 2.0FIN1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum to Main Adult Groups 2b 6 7 8 and 9_san | 2.0FIN1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main 2b 7-9_san | 11.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Adult Groups 1-5 and 10_san | 18.0FIN1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Adult Groups 2b 6 7 8 and 9_san | 11.0FIN1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Appendix Groups 1-5 and 10_san | 18.0FIN1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Appendix Groups 2b 6 7 8 and 9_san | 11.0FIN1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF APPENDIX Group 1 part 1_san | 17.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF APPENDIX Group 1 part 2_san | 17.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF Appendix Group 10 part 1_san | 17.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF Appendix Group 10 part 2_san | 17.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF APPENDIX Group 2 part 1_san | 18.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF APPENDIX Group 2 part 2_san | 18.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF APPENDIX Group 3 part 1_san | 18.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF Appendix Group 3 part 2_san | 18.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF Appendix Group 4 part 1_san | 17.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF Appendix Group 4 part 2_san | 17.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF Appendix Group 5 part 1_san | 17.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF Appendix Group 5 part 2_san | 17.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF Arm 1-5 and 10_san | V18SWE1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF Arm 2b 6-8 9_san | V11SWE1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF group 1-5 and 10_san | V18.0NOR1. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main ICF group 2b and 6-9_san | 11.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_san | 18.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PP_clean_red-san | V6-0ITA2-0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF PP_san_clean | V6-0ITA2-0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_san | V6.0SWE1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_san | V6.0FIN3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_san | V6.0NOR2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Privacy_san_clean | V3-0ITA1-0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Data protection ICF_Czech_enrolled subject_san | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Data protection_Czech_clean_san | 7.00 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Genomics addendum on the right to non-knowledge_san_clean | V1.0DNK1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF 2b 6 7 8 and 9_san | 11.0DNK1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF APPENDIX Group 9_san | 11.0NOR1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF dose escalation and expansion_san | 18.0DNK1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Czech_Arm 1_clean_san | V18.0CZE1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Czech_Arm 1_enrolled subject_san | 17.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Czech_Arm 10_clean_san | V18.0CZE1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Czech_Arm 10_enrolled patient_san | 17.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Czech_Arm 2_clean_san | V18.0CZE1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Czech_Arm 2_enrolled subject_san | 17.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Czech_Arm 2b_clean_san | V11.0CZE1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Czech_Arm 2b_enrolled subject_san | 10.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Czech_Arm 3_clean_san | 14.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Czech_Arm 3_enrolled patient_san | 14.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Czech_Arm 4_clean_san | 14.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Czech_Arm 4_enrolled patient_san | 14.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Czech_Arm 5_clean_san | V18.0CZE1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Czech_Arm 5_enrolled subject_san | 17.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Czech_Arm 6_clean_san | V11.0CZE1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Czech_Arm 6_enrolled patient_san | 10.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Czech_Arm 8_clean_san | V11.0CZE1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Czech_Arm 8_enrolled subject_san | 10.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Czech_Arm 9_clean_san | V11.0CZE1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Czech_Arm 9_enrolled subject_san | 10.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Groups 1-5 and 10_EN_san | 18.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Groups 1-5 and 10_FR_san | 18.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Groups 1-5 and 10_NL_san | 18.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Groups 2b678 9_EN_san | 11.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Groups 2b678 9_FR_san | 11.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Groups 2b678 9_NL_san | 11.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PP_clean_san | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PP_Data Protection_Czech_clean_san | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PP_for already enrolled subject_san | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PP_TC_san | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF Clean_san_red | V6.0DNK1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_EN_san | 6.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_FR_san | 6.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF_NL_san | 6.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and Main ICF Group 2b 6 - 9_cl_red | 11.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_SIS_Pregnant Partner ICF_cl_red | V6.0ESP1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_CZ_Patient ID Card_san | V01 CZ |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_eCOA Tablet_TrainingModule_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_Fact-Lym_eCOA Tablet_san | 1.0 |
| Subject information and informed consent form (for publication) | L2_2023-504805-35-00_Patient ID Card_san | V01FRA2.0 |
| Subject information and informed consent form (for publication) | L2_List of documents_san | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material GP Letter_clean | V10-0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material ID card_san | V01 |
| Subject information and informed consent form (for publication) | L2_other subject information material ID Card_san | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Data processing description_san | V2.0 |
| Subject information and informed consent form (for publication) | L2_other subject information material_Fact-Lym eCOA Tablet Screenshots_san | 1 |
| Subject information and informed consent form (for publication) | L2_other subject information material_Training Module eCOA Tablet Screenshot_san | 1 |
| Subject information and informed consent form (for publication) | L2_Patient-ID-Card_en_san | 1 |
| Subject information and informed consent form (for publication) | L2_Patient-ID-Card_fr_san | 1 |
| Subject information and informed consent form (for publication) | L2_Patient-ID-Card_nl_san | 1 |
| Subject information and informed consent form (for publication) | LI_SIS_Main ICF Group 1-5 10_cl_red | 18.0ESP1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Bendamustine | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_blank_san | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_blank_san | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Carboplatin | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cyclophosphamide | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cytarabine | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Dexamethasone | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Doxorubicin | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Etoposide | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Gemcitabine | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Ifosfamide | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Lenalidomide | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Oxaliplatin | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Prednisone | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Rituximab | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Vincristine | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol Full Synopsis_2023-504805-35_IT_san | 13.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-504805-35_BE_de_san | 13.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-504805-35_BE_fr_san | 13.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-504805-35_BE_nl_san | 13.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-504805-35_CZ_san | 13.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-504805-35_ES_san | 13.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-504805-35_FR_san | 13.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-504805-35_IT_san | 13.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-504805-35_NL_san | 13.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-504805-35_NO_san | 13.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-504805-35_SE_san | 13.0 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-01 | Denmark | Acceptable 2024-01-23
|
2024-01-23 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-03-18 | Acceptable 2024-01-23
|
2024-03-18 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-06 | Denmark | Acceptable 2024-07-02
|
2024-07-05 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-08-30 | Acceptable 2024-07-02
|
2024-08-30 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-17 | Denmark | Acceptable 2025-05-09
|
2025-05-10 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-06-11 | Acceptable 2025-05-09
|
2025-06-11 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-11 | Denmark | Acceptable 2025-09-26
|
2025-09-26 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-11-14 | Acceptable 2025-09-26
|
2025-11-14 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-12-22 | Denmark | Acceptable 2026-03-27
|
2026-03-27 |