Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
358
Countries
11
Sites
54
Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)
The primary objective of this study is to evaluate whether epcoritamab plus lenalidomide (E-Len) can improve outcomes as measured by progression-free survival (PFS) versus rituximab plus gemcitabine and oxaliplatin (R-GemOx) in relapsed or refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL).
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
- 3 Sep 2024 → ongoing
- Decision date (initial)
- 2024-08-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
- Funding sources
- AbbVie Inc.
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The primary objective of this study is to evaluate whether epcoritamab plus lenalidomide (E-Len) can improve outcomes as measured by progression-free survival (PFS) versus rituximab plus gemcitabine and oxaliplatin (R-GemOx) in relapsed or refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL).
Secondary objectives 1
- Key secondary objectives are to evaluate whether E-Len can improve outcomes as measured by the following versus R-GemOx in R/R DLBCL: • Complete Response Rate (CRR) determined by Lugano 2014 criteria, as assessed by an independent review committee (IRC) • Overall survival (OS) • Minimal residual disease (MRD) negativity rate
Conditions and MedDRA coding
Relapsed or Refractory (R/R) 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 5
- Subject must have histologically confirmed CD20+ DLBCL and documented in the most recent representative pathology report, inclusive of the following according to the 5th edition of the WHO (2022) Classification of Haematolymphoid Tumours: Lymphoid Neoplasms: • DLBCL, NOS including de novo or histologically transformed from an earlier diagnosis of FL or MZL • DLBCL/HGBCL with MYC and BCL2 rearrangements • Follicular large B-cell lymphoma (FLBL; previously FL Grade 3B) • T-cell/histiocyte-rich large B-cell lymphoma • Epstein Barr Virus-positive DLBCL
- Subject must have R/R disease and have been previously treated with at least 1 line of systemic antineoplastic therapy including anti-CD20 mAb-containing combination chemotherapy since DLBCL diagnosis. Note: Relapsed disease is defined as disease that has recurred ≥ 6 months after completion of therapy. Refractory disease is defined as disease that either progressed during therapy, failed to achieve an objective response to prior therapy, or progressed within 6 months after completion of therapy (including maintenance therapy).
- Subject must meet at least 1 of the following criteria: • Failed prior ASCT, defined as relapsed after ASCT or been refractory to ASCT • Not be considered a candidate for ASCT due to age, performance status, comorbidities and/or insufficient response to prior treatment, or have refused ASCT • Be ineligible for or unable to receive CAR-T meeting at least 1 of the following criteria: • Unable to receive CAR-T therapy due to fitness and/or comorbidity • Lymphocyte apheresis failure • Unwilling to receive CAR-T therapy • Unable to receive CAR-T therapy due to financial, geographic, insurance, access, and/or manufacturing constraints • Relapsed/progressed after having achieved at least a PR or CR while on prior CAR-T therapy
- Subject must have measurable disease defined as: • ≥ 1 measurable nodal lesion (long axis > 1.5 cm) or ≥ 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT or MRI AND •F-FDG PET scan positive
- Subject must have an Eastern Cooperative Oncology Group Performance status score of 0 to 2.
Exclusion criteria 5
- Prior treatment with a bispecific antibody targeting CD3 and CD20 or prior treatment with R-GemOx or GemOx.
- Lenalidomide exposure within 12 months prior to screening or history of documented refractoriness to lenalidomide with refractoriness defined as: • best response SD or PD, or • PD within 6 months of completion of the therapy
- Best response to prior CAR-T therapy of SD or PD. Subject should not have received any treatment with CAR-T therapy within 90 days prior to randomization; any CAR-T related toxicity should have been resolved for at least 30 days.
- Current evidence of primary CNS lymphoma or known CNS involvement by lymphoma including leptomeningeal disease, at screening
- Current autoimmune disease requiring immunosuppressive therapy except for up to 20 mg daily prednisone or equivalent.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Progression-free survival (PFS)
Secondary endpoints 3
- Percentage of Participants Who Achieve Complete response (CR)
- Overall Survival (OS)
- Percentage of Participants Who Achieve Minimal Residual Disease (MRD) Negativity Rate
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
PRD9264271 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 6300 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/004
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9264284 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 6300 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9264267 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 6300 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/009
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
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
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 12 Month(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
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 12 Month(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 5
Oxaliplatin 5mg/ml Concentrate for Solution for Infusion
PRD1785472 · Product
- Active substance
- Oxaliplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 100 mg/m2 milligram(s)/square meter
- Max total dose
- 800 mg/m2 milligram(s)/square meter
- Max treatment duration
- 4 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XA03 — OXALIPLATIN
- Marketing authorisation
- PA 2315/114/001
- MA holder
- ACCORD HEALTHCARE IRELAND LIMITED
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Gemcitabine 38 mg/ml Concentrate for Solution for Infusion
PRD3925612 · Product
- Active substance
- Gemcitabine
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 1000 mg/m2 milligram(s)/square meter
- Max total dose
- 8000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 4 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BC05 — GEMCITABINE
- Marketing authorisation
- MA 505/08802
- MA holder
- PFIZER HELLAS A.E.
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Gemcitabine 38 mg/ml Concentrate for Solution for Infusion
PRD3925613 · Product
- Active substance
- Gemcitabine
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 1000 mg/m2 milligram(s)/square meter
- Max total dose
- 8000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 4 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BC05 — GEMCITABINE
- Marketing authorisation
- MA 505/08803
- MA holder
- PFIZER HELLAS A.E.
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Truxima 100 mg concentrate for solution for infusion
PRD5065907 · Product
- Active substance
- Rituximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 375 mg/m2 milligram(s)/square meter
- Max total dose
- 3000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 4 Month(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
- INTRAVENOUS INFUSION
- Max daily dose
- 375 mg/m2 milligram(s)/square meter
- Max total dose
- 3000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 4 Month(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
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 Clinical Trials Helpdesk
Public contact point
- Organisation
- AbbVie Deutschland GmbH & Co. KG
- Contact name
- Global Clinical Trials Helpdesk
Third parties 13
| Organisation | City, country | Duties |
|---|---|---|
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | E-data capture |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Perceptive Informatics Inc. ORG-100013171
|
Billerica, United States | Other |
| SC Abbvie SRL ORL-000007966
|
Bucharest, Romania | On site monitoring, Other |
| Altasciences Compagnie Inc. ORG-100037610
|
Laval, Canada | Laboratory analysis |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | Interactive response technologies (IRT) |
| Clinical Trial Media Inc. ORG-100046339
|
Hauppauge, United States | Other |
| Q Squared Solutions Limited ORG-100042527
|
Livingston, United Kingdom | Laboratory analysis |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Personalis Inc. ORG-100043141
|
Fremont, United States | Laboratory analysis |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Other |
| Cytel Inc. ORG-100042560
|
Waltham, United States | Other |
| CellCarta ORG-100039881
|
Antwerp, Belgium | Laboratory analysis |
Locations
11 EU/EEA countries · 54 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 5 | 5 |
| Bulgaria | Ongoing, recruitment ended | 13 | 4 |
| Croatia | Ongoing, recruitment ended | 10 | 6 |
| Czechia | Ongoing, recruitment ended | 8 | 4 |
| France | Ongoing, recruitment ended | 13 | 7 |
| Greece | Ongoing, recruitment ended | 14 | 5 |
| Hungary | Ongoing, recruitment ended | 16 | 7 |
| Netherlands | Ongoing, recruitment ended | 8 | 5 |
| Poland | Ongoing, recruitment ended | 12 | 4 |
| Portugal | Ongoing, recruitment ended | 5 | 3 |
| Romania | Ongoing, recruitment ended | 12 | 4 |
| Rest of world
Korea, Republic of, South Africa, Taiwan, Singapore, Turkey, United States, United Kingdom, Canada, Mexico, Japan, Brazil, Argentina, Australia, China, Chile, Serbia
|
— | 242 | — |
Investigational sites
Algemeen Ziekenhuis Delta
Hematology, Deltalaan 1, 8800, Roeselare
Centre Hospitalier EPICURA
Hematology, Rue De Mons 63, 7301, Boussu
UZ Leuven
Hematology, Herestraat 49, 3000, Leuven
CHU UCL Namur - site Godinne
Hematology, Avenue Gaston Therasse 1, 5530, Yvoir
UZ Brussel
Hematology, Laarbeeklaan 101, 1090, Jette
University Hospital St Marina Varna
Clinic of Clinical Hematology, Hristo Smirnenski St 1, 9010, Varna
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
Department of Clinical Hematology, Boulevard Akademik Ivan Evstratiev Geshov 15, 1431, Sofia
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Clinic of Clinical Hematology, Bulevard Vasil Aprilov 15a, 4002, Plovdiv
National Specialised Hospital For Active Treatment Of Haematological Diseases
First department of Clinical Hematology, Ul.plovdivsko Pole 6, 1756, Sofia
KBC Zagreb
Department for hematology, Ulica Mije Kispatica 12, Zagreb, Grad Zagreb
KBC Split
Department for hematology, Spinciceva 1, 21000, Split
Clinical Hospital Centre Rijeka
Department for hematology, Kresimirova 42, 51000, Rijeka
Klinicki bolnicki centar Sestre milosrdnice
Department for hematology, Vinogradska Cesta 29, Zagreb, Grad Zagreb
Klinicki Bolnicki Centar Osijek
Department for hematology, Ulica Josipa Huttlera 4, 31000, Osijek
University Hospital Merkur
Department for hematology, Zajčeva 19, 10000, Zagreb
University Hospital Olomouc
Hemato-onkologicka klinika, Zdravotniku 248/7, 779 00, Olomouc
Fakultni Nemocnice Hradec Kralove
IV. interni hematologicka klinika, Sokolska 581, 500 03, Novy Hradec Kralove
Fakultni Nemocnice Kralovske Vinohrady
-, Srobarova 1150/50, Vinohrady, Prague
Fakultni Nemocnice Motol A Homolka
NA, V Uvalu 84/1, Motol, Prague
Centre Hospitalier De La Cote Basque
Service d'Hématologie, 13 Avenue Interne Jacques Loeb, 64100, Bayonne
Centre Hospitalier Regional Universitaire De Tours
Service d'Hématologie et Thérapie Cellulaire, 2 Boulevard Tonnelle, 37000, Tours
Groupement Des Hopitaux De L'Institut Catholique De Lille
Département d'Onco-Hématologie, Boulevard De Belfort, P. O. Box 387, Lille Cedex
Centre Hospitalier Universitaire De Caen Normandie
Département d'Hématologie, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Centre Hospitalier D Avignon
Département d'Oncologie-Hématologie, 305 Rue Raoul Follereau, 84000, Avignon
Les Hopitaux Universitaires De Strasbourg
Département d'Hématologie, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Centre Hospitalier Universitaire De Poitiers
Service d'Hématologie et Thérapie Cellulaire, 2 Rue De La Miletrie, 86000, Poitiers
Evaggelismos Hospital
Haematology Department, Ipsiladou 45-47, 106 76, Athens
Theageneio Cancer Hospital
Hematology Department, Simeonidi Alex 2, 546 39, Thessaloniki
University General Hospital Attikon
2nd Department of Internal Medicine - Propaedeutic, Hematology Unit, Rimini Street 1, 124 62, Athens
Laiko General Hospital Of Athens
Hematology Clinic and Βone Μarrow Τransplantation Unit, NKUA, Sevastoupoleos 16, 115 26, Athens
University General Hospital Of Thessaloniki Ahepa
1st Department of Internal Medicine, Division of Hematology, 1st St Kiriakidis Str, 546 36, Thessaloniki
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Hematologiai es Ossejt-transzplantacios Osztaly, Albert Florian Ut 5-7, 1097, Budapest IX
University Of Debrecen
Belgyogyaszati Klinika, Hematologia, Nagyerdei Korut 98, 4032, Debrecen
University Of Pecs
I. szamu Belgyogyaszati Klinika, Ifjusag Utja 13, 7624, Pecs
Orszagos Onkologiai Intezet
Gyogyszerterapias Kozpont Hematologia es Lymphoma Osztaly, Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
Semmelweis University
Belgyogyaszati es Hematologiai Klinika, Szentkiralyi Utca 46, VIII Kerulet, Budapest VIII
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Hematologiai Osztaly, Szent Istvan Utca 68, 4400, Nyiregyhaza
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
II. Belgyogyaszat - Hematologia, Vasvari Pal Utca 2-4, 9024, Gyor
Albert Schweitzer Ziekenhuis
Interne geneeskunde, Albert Schweitzerplaats 25, 3318 AT, Dordrecht
Stichting OLVG
Hematologie Oncologie, Oosterpark 9, 1091 AC, Amsterdam
Medisch Centrum Leeuwarden B.V.
Oncology, Henri Dunantweg 2, 8934 AD, Leeuwarden
Sint Antonius Ziekenhuis Stichting
Interne Geneeskunde, Koekoekslaan 1, 3435 CM, Nieuwegein
Jeroen Bosch Ziekenhuis
Oncology, Henri Dunantstraat 1, 5223 GZ, 'S-Hertogenbosch
Pratia S.A.
NA, Ul. Pana Tadeusza 2, 30-727, Cracow
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Klinika Hematologii i Transplantacji Szpiku, Ul. Prezydenta Stefana Artwinskiego 3, 25-734, Kielce
Aidport Sp. z o.o.
NA, Ul Ksiedza Stanisława Kozierowskiego 24, 60-185, Skorzewo
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Nowotworów Układu Chłonnego, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Hospital Da Luz S.A.
Hematology, Avenida Lusiada 100, 1500-650, Lisbon
Unidade Local de Saude de Sao Joao E.P.E.
Hematology, Alameda Professor Hernani Monteiro, 4200-319, Porto
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Hematology, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Hematologie, Strada Republicii 34-36, 400015, Cluj-Napoca
Institutul Clinic Fundeni
Hematologie II, Soseaua Fundeni 258, 022328, Bucharest
Institutul Regional De Oncologie Iasi
Hematologie, Strada G-Ral Berthelot 2-4, 700483, Iasi
Spitalul Clinic Coltea
Hematologie, Bulevardul Bratianu C. Ion 1-3, 030171, Bucharest
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 | 2024-09-24 | 2024-09-26 | 2026-03-06 | ||
| Bulgaria | 2024-09-26 | 2024-09-27 | 2026-03-06 | ||
| Croatia | 2024-09-12 | 2024-09-19 | 2026-03-06 | ||
| Czechia | 2025-02-11 | 2025-11-25 | 2026-02-09 | ||
| France | 2024-09-17 | 2024-10-03 | 2026-03-06 | ||
| Greece | 2024-11-14 | 2024-11-15 | 2026-03-06 | ||
| Hungary | 2024-09-12 | 2024-10-14 | 2026-03-06 | ||
| Netherlands | 2024-11-29 | 2025-03-05 | 2026-03-06 | ||
| Poland | 2024-09-23 | 2024-10-02 | 2026-03-06 | ||
| Portugal | 2024-09-03 | 2024-11-21 | 2026-03-06 | ||
| Romania | 2024-09-25 | 2024-11-07 | 2026-03-06 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 119 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_M22-128-protocol_EL-GR_Redacted | 4.1 |
| Protocol (for publication) | D1_M22-128-Protocol_Redacted | 4.1 |
| Recruitment arrangements (for publication) | K1 M22-128 EU CTR Recruitment and ICF Procedures Public | 2.1 |
| Recruitment arrangements (for publication) | K1 M22-128 PL Recruitment and ICF Procedures_Public | 3 |
| Recruitment arrangements (for publication) | K1_M22-128 CZE Recruitment and ICF Procedures_Public | 2 |
| Recruitment arrangements (for publication) | K1_M22-128 FR Recruitment and ICF Procedures_Public | 1.1 |
| Recruitment arrangements (for publication) | K1_M22-128 HR Recruitment and ICF Procedures_Public | 2 |
| Recruitment arrangements (for publication) | K1_M22-128 HR Recruitment and ICF Procedures_Redline | 1 |
| Recruitment arrangements (for publication) | K1_M22-128 PT Recruitment and ICF Procedures_Public | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and ICF Procedures | 1 |
| Recruitment arrangements (for publication) | K2 M22-128 PT Caregiver booklet_Public | 2.1 |
| Recruitment arrangements (for publication) | K2 M22-128 PT Recruitment Brochure_Public | 2.1 |
| Recruitment arrangements (for publication) | K2_ M22-128_CZ_ Doctor to Patient Email_Public | 2 |
| Recruitment arrangements (for publication) | K2_ M22-128_CZ_Cargiver Booklet_public | 2 |
| Recruitment arrangements (for publication) | K2_ M22-128_CZ_Docter to Patient Letter_Public | 2 |
| Recruitment arrangements (for publication) | K2_ M22-128_CZ_Recruitment Brochure_Public | 2 |
| Recruitment arrangements (for publication) | K2_ M22-128_PT_ Doctor to Patient email_Public | 2.1 |
| Recruitment arrangements (for publication) | K2_ M22-128_PT_Doctor to Patient Letter_Public | 2.1 |
| Recruitment arrangements (for publication) | K2_M22-128 BG Caregiver Booklet_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-128 BG EPCORE Program Website Copy_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-128 BG EPCORE Program WS Prescreener_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-128 BG Patient Downloadable Guide_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-128 BG Patient-Doctor Discussion Guide_Public | 1 |
| Recruitment arrangements (for publication) | K2_M22-128 BG Recruitment Brochure_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-128 BG Website Copy_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-128_BE_Caregiver Booklet Dutch | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-128_BE_Caregiver Booklet English | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-128_BE_Caregiver Booklet French | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-128_BE_Doctor to Patient Email Dutch | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-128_BE_Doctor to Patient Email English | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-128_BE_Doctor to Patient Email French | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-128_BE_Doctor to Patient Letter Dutch | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-128_BE_Doctor to Patient Letter English | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-128_BE_Doctor to Patient Letter French | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-128_BE_Recruitment Brochure Dutch | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-128_BE_Recruitment Brochure English | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-128_BE_Recruitment Brochure French | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-128_HU_Recruitment Material_Caregiver Booklet_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-128_HU_Recruitment Material_Doctor to Patient Email_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_M22-128_HU_Recruitment Material_Doctor to Patient Letter_Public | 1.0 |
| Recruitment arrangements (for publication) | K2_M22-128_HU_Recruitment Material_Recruitment Brochure_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-128_NL_recruitment material_Caregiver Booklet_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-128_NL_recruitment material_Docter to patient email_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_M22-128_NL_recruitment material_Docter to patient letter_Public | 1.1 |
| Recruitment arrangements (for publication) | K2_M22-128_NL_recruitment material_Recruitment Brochure_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-128_RO_recruitment material_Caregiver Booklet_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-128_RO_recruitment material_Doctor to patient email_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-128_RO_recruitment material_Doctor to patient letter_Public | 2.0 |
| Recruitment arrangements (for publication) | K2_M22-128_RO_recruitment material_Recruitment Brochure_Public | 2.0 |
| Recruitment arrangements (for publication) | M22-128 BG Recruitment and ICF Procedures | 2.0 |
| Recruitment arrangements (for publication) | M22-128 HU Recruitment and ICF Procedures_Public | 2.0 |
| Recruitment arrangements (for publication) | M22-128 NL Recruitment and ICF Procedures | 1.1 |
| Recruitment arrangements (for publication) | M22-128 RO Recruitment and ICF Procedures | 1 |
| Subject information and informed consent form (for publication) | L1 M22-128 FR Pregnancy Data Release ICF French_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1 M22-128 FR Main ICF French_Public Redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1 M22-128 FR Preg Part ICF French_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1 M22-128 GR ICF Pregnant Partner Public | 2 |
| Subject information and informed consent form (for publication) | L1 M22-128 GR Main ICF_ Public | 4 |
| Subject information and informed consent form (for publication) | L1 M22-128 PL ICF Main_Public redacted | 4 |
| Subject information and informed consent form (for publication) | L1 M22-128 PL ICF Optional_Public | 3 |
| Subject information and informed consent form (for publication) | L1 M22-128 PL ICF Pregnancy_Public | 2 |
| Subject information and informed consent form (for publication) | L1_ M22-128 BG Combined ICF Bulgarian_Public Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_ M22-128 BG Combined ICF English_Public Redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_M22-128 BG ICF Pregnant Partner Bulgarian_Public redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_M22-128 BG ICF Pregnant Partner English_Public redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_M22-128 CZ ICF Main_Public | 4 |
| Subject information and informed consent form (for publication) | L1_M22-128 CZ ICF Optional_Public | 3 |
| Subject information and informed consent form (for publication) | L1_M22-128 CZ ICF Pregnancy_Public | 2 |
| Subject information and informed consent form (for publication) | L1_M22-128 GR ICF Optional Public | 3 |
| Subject information and informed consent form (for publication) | L1_M22-128 HR ICF Main_MS | 1 |
| Subject information and informed consent form (for publication) | L1_M22-128 HR ICF Main_Public | 6 |
| Subject information and informed consent form (for publication) | L1_M22-128 HR ICF Optional_Public | 5 |
| Subject information and informed consent form (for publication) | L1_M22-128 HR ICF Pregnant Partner_Public | 5 |
| Subject information and informed consent form (for publication) | L1_M22-128 HR ICF Pregnant Subject_Public | 5 |
| Subject information and informed consent form (for publication) | L1_M22-128 HU ICF PIS Pregnant Partner Hungarian_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_M22-128 NL ICF Main_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M22-128 NL ICF Optional_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_M22-128 PT Pregnant Partner ICF | 2.0 |
| Subject information and informed consent form (for publication) | L1_M22-128 PT_ICF Main and Optional_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_M22-128 RO ICF Main Combined English Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_M22-128 RO ICF Main Combined Romanian Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_M22-128 RO ICF Pregnant Partner English Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M22-128 RO ICF Pregnant Partner Romanian Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_M22-128_BE_Main ICF Dutch_Public | 6.0 |
| Subject information and informed consent form (for publication) | L1_M22-128_BE_Main ICF English_Public | 6.0 |
| Subject information and informed consent form (for publication) | L1_M22-128_BE_Main ICF French_Public | 6.0 |
| Subject information and informed consent form (for publication) | L1_M22-128_BE_Optional ICF Dutch | 4.0 |
| Subject information and informed consent form (for publication) | L1_M22-128_BE_Optional ICF English | 4.0 |
| Subject information and informed consent form (for publication) | L1_M22-128_BE_Optional ICF French | 4.0 |
| Subject information and informed consent form (for publication) | L1_M22-128_BE_Preg Part ICF Dutch | 3.0 |
| Subject information and informed consent form (for publication) | L1_M22-128_BE_Preg Part ICF English | 3.0 |
| Subject information and informed consent form (for publication) | L1_M22-128_BE_Preg Part ICF French | 3.0 |
| Subject information and informed consent form (for publication) | L1_M22-128_HU_ICF PIS Main_Hungarian_Public redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_M22-128_NL_ICF Pregnancy_Public | 2.0 |
| Subject information and informed consent form (for publication) | L2_M22-128 HU Patient ID Card_ARM C_Public | 1.0 |
| Subject information and informed consent form (for publication) | M22-128 CZ ICF GDPR | 1.0 |
| Subject information and informed consent form (for publication) | M22-128 HU ICF Mandatory Genetic Hungarian_Public | 1 |
| Subject information and informed consent form (for publication) | M22-128 HU ICF Optional Genetic Hungarian_Public | 1 |
| Subject information and informed consent form (for publication) | M22-128 HU Patient ID Card_Public | 1 |
| Subject information and informed consent form (for publication) | M22-128 HU PIS Mandatory Genetic Hungarian_Public | 1 |
| Subject information and informed consent form (for publication) | M22-128 HU PIS Optional Genetic Hungarian_Public | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_EPAR-revlimid-Lenalidomide-hard-capsule | 54 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_M22-128_Gemcitabine 38 mg_ml Concentrate for Solution for Infusion-SmPC | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_M22-128_Oxaliplatin 5mg_ml concentrate for solution for infusion-SmPC | 9 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_M22-128_truxima-epar-product-information_en | 26 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC-Gemcitabine-38 mg_ml Concentrate for sol for Infusion-TC | 1.0 |
| Synopsis of the protocol (for publication) | D1_m22128-EUCTR-synopsis-BG-BG | 1 |
| Synopsis of the protocol (for publication) | D1_m22128-EUCTR-synopsis-CS-CZ | 1 |
| Synopsis of the protocol (for publication) | D1_m22128-EUCTR-synopsis-DE-BE | 1 |
| Synopsis of the protocol (for publication) | D1_m22128-EUCTR-synopsis-EL-GR | 1 |
| Synopsis of the protocol (for publication) | D1_m22128-EUCTR-synopsis-EN-EN | 1 |
| Synopsis of the protocol (for publication) | D1_m22128-EUCTR-synopsis-FR-BE | 1 |
| Synopsis of the protocol (for publication) | D1_m22128-EUCTR-synopsis-FR-FR | 1 |
| Synopsis of the protocol (for publication) | D1_m22128-EUCTR-synopsis-HU-HU | 1 |
| Synopsis of the protocol (for publication) | D1_m22128-EUCTR-synopsis-NL-BE | 1 |
| Synopsis of the protocol (for publication) | D1_m22128-EUCTR-synopsis-NL-NL | 1 |
| Synopsis of the protocol (for publication) | D1_m22128-EUCTR-synopsis-PL-PL | 1 |
| Synopsis of the protocol (for publication) | D1_m22128-EUCTR-synopsis-PT-PT | 1 |
| Synopsis of the protocol (for publication) | D1_m22128-EUCTR-synopsis-RO-RO | 1 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-29 | Belgium | Acceptable with conditions 2024-08-19
|
2024-08-19 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-22 | Belgium | Acceptable with conditions 2024-08-19
|
2024-08-22 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-07 | Belgium | Acceptable 2025-02-14
|
2025-02-14 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-02-26 | Acceptable 2025-02-14
|
2025-02-26 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-04 | Belgium | Acceptable with conditions 2025-07-07
|
2025-07-07 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-08-06 | Belgium | Acceptable 2025-09-18
|
2025-09-18 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-10-07 | Acceptable | 2025-10-17 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-11-19 | Belgium | Acceptable | 2025-12-12 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-12-15 | 2025-12-15 | ||
| 10 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-03-11 | Belgium | Acceptable 2026-05-27
|
2026-05-27 |