Clinical trial • Phase III • Oncology
EPCORITAMAB for Diffuse large B-cell lymphoma | Relapsed or refractory diffuse large B-cell lymphoma
Phase III trial of EPCORITAMAB for Diffuse large B-cell lymphoma | Relapsed or refractory diffuse large B-cell lymphoma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Diffuse large B-cell lymphoma | Relapsed or refractory diffuse large B-cell lymphoma
- Trial Stage
- Phase III
- Drug Modality
- Bispecific antibody | Small molecule | Monoclonal antibody
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 29-04-2024
- First CTIS Authorization Date
- 19-08-2024
Trial design
Randomised, open-label, test arm: epcoritamab (gen3013) (subcutaneous) plus lenalidomide (revlimid oral capsules) — doses/schedule not specified in ctis record; comparator arm: rituximab (truxima, iv) plus gemcitabine (iv) and oxaliplatin (iv) (r‑gemox) — routes provided, doses/schedule not specified in ctis record.-controlled Phase III trial in Croatia, Greece, Hungary and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Test arm: Epcoritamab (GEN3013) (subcutaneous) plus Lenalidomide (Revlimid oral capsules) — doses/schedule not specified in CTIS record; Comparator arm: Rituximab (Truxima, IV) plus Gemcitabine (IV) and Oxaliplatin (IV) (R‑GemOx) — routes provided, doses/schedule not specified in CTIS record.
- Target Sample Size
- 242
Eligibility
Recruits 242 No vulnerable populations selected; trial enrols adults only; informed consent obtained from participants; no assent or other vulnerable-population procedures specified..
- Vulnerable Population
- No vulnerable populations selected; trial enrols adults only; informed consent obtained from participants; no assent or other vulnerable-population procedures specified.
Inclusion criteria
- {"criterion_text":"- 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"}
- {"criterion_text":"- 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)."}
- {"criterion_text":"- 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"}
- {"criterion_text":"- 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"}
- {"criterion_text":"- Subject must have an Eastern Cooperative Oncology Group Performance status score of 0 to 2."}
Exclusion criteria
- {"criterion_text":"- Prior treatment with a bispecific antibody targeting CD3 and CD20 or prior treatment with R-GemOx or GemOx."}
- {"criterion_text":"- 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"}
- {"criterion_text":"- 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."}
- {"criterion_text":"- Current evidence of primary CNS lymphoma or known CNS involvement by lymphoma including leptomeningeal disease, at screening"}
- {"criterion_text":"- Current autoimmune disease requiring immunosuppressive therapy except for up to 20 mg daily prednisone or equivalent."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Progression-free survival (PFS)","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Percentage of Participants Who Achieve Complete response (CR)","definition_or_measurement_approach":"Complete Response Rate (CRR) determined by Lugano 2014 criteria, as assessed by an independent review committee (IRC)."}
- {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Percentage of Participants Who Achieve Minimal Residual Disease (MRD) Negativity Rate","definition_or_measurement_approach":""}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 242
- Recruitment Window Months
- 41
- Consent Approach
- Informed consent obtained from adult participants. Subject information and informed consent forms (ICFs) are provided for each participating country and in multiple languages (documents show ICFs and translations in English, French, Dutch, Hungarian, Polish, Portuguese, Romanian, Bulgarian, Greek, Czech and country-specific versions). There are also specific ICFs for pregnant partners and pregnancy-related information listed. No assent procedures are specified (participants are adults).
Methods
- Doctor-to-patient email/letter — channel: email or printed letter from treating physician to potential patients; target audience: patients; country-specific materials available (documents titled 'Doctor to Patient Email'/'Doctor to Patient Letter' present for multiple countries including Hungary, Portugal, Netherlands, Poland, Belgium, Romania, Czechia, etc.).
- Recruitment brochure — channel: printed/digital brochure for patients; target audience: patients and caregivers; country-specific brochures available (documents titled 'Recruitment Brochure' present for multiple countries).
- Caregiver booklet — channel: printed/digital booklet for caregivers; target audience: caregivers; country-specific caregiver booklets present (e.g., Belgium, Hungary, Portugal, Romania, Bulgaria, Netherlands, etc.).
- Website copy / online prescreener / program pages (EPCORE Program Website Copy, Website Copy) — channel: web pages and online prescreener; target audience: patients seeking trial information; country-specific website materials available (e.g., Belgium, Bulgaria).
- Patient downloadable guide and patient-doctor discussion guide — channel: downloadable PDF materials and discussion aids; target audience: patients and clinicians; country-specific versions present (e.g., Bulgaria).
- Prescreener / Doctor-to-patient email templates — channel: electronic prescreening and digital outreach; target audience: potential participants identified by clinicians; country-specific templates present.
Geography
- Total Number Of Sites
- 56
- Total Number Of Participants
- 116
Croatia
- Earliest CTIS Part Ii Submission Date
- 26-07-2024
- Latest Decision Or Authorization Date
- 20-08-2024
- Processing Time Days
- 25
- Number Of Sites
- 6
- Number Of Participants
- 10
Sites
- Site Name
- KBC Zagreb
- Department Name
- Department for hematology
- Principal Investigator Name
- Igor Aurer
- Principal Investigator Email
- kbc-zagreb@kbc-zagreb.hr
- Contact Person Name
- Igor Aurer
- Contact Person Email
- kbc-zagreb@kbc-zagreb.hr
- Site Name
- KBC Split
- Department Name
- Department for hematology
- Principal Investigator Name
- Viktor Blaslov
- Principal Investigator Email
- hematodb@kbsplit.hr
- Contact Person Name
- Viktor Blaslov
- Contact Person Email
- hematodb@kbsplit.hr
- Site Name
- Clinical Hospital Centre Rijeka
- Department Name
- Department for hematology
- Principal Investigator Name
- Neven Franjic
- Principal Investigator Email
- interna-rijeka@kbc-rijeka.hr
- Contact Person Name
- Neven Franjic
- Contact Person Email
- interna-rijeka@kbc-rijeka.hr
- Site Name
- Klinicki bolnicki centar Sestre milosrdnice
- Department Name
- Department for hematology
- Principal Investigator Name
- Petar Gacina
- Principal Investigator Email
- tajnistvo.interne@kbcsm.hr
- Contact Person Name
- Petar Gacina
- Contact Person Email
- tajnistvo.interne@kbcsm.hr
- Site Name
- Klinicki Bolnicki Centar Osijek
- Department Name
- Department for hematology
- Principal Investigator Name
- Jasminka Sincic Petricevic
- Principal Investigator Email
- hematologija.nalazi@kbco.hr
- Contact Person Name
- Jasminka Sincic Petricevic
- Contact Person Email
- hematologija.nalazi@kbco.hr
- Site Name
- University Hospital Merkur
- Department Name
- Department for hematology
- Principal Investigator Name
- Karla Misura Jakobac
- Principal Investigator Email
- interna@kb-merkur.hr
- Contact Person Name
- Karla Misura Jakobac
- Contact Person Email
- interna@kb-merkur.hr
Greece
- Earliest CTIS Part Ii Submission Date
- 17-05-2024
- Latest Decision Or Authorization Date
- 22-08-2024
- Processing Time Days
- 97
- Number Of Sites
- 5
- Number Of Participants
- 14
Sites
- Site Name
- Evaggelismos Hospital
- Department Name
- Haematology Department
- Principal Investigator Name
- Maria Bouzani
- Principal Investigator Email
- mbouzani@yahoo.com
- Contact Person Name
- Maria Bouzani
- Contact Person Email
- mbouzani@yahoo.com
- Site Name
- Theageneio Cancer Hospital
- Department Name
- Hematology Department
- Principal Investigator Name
- Eirini Katodritou
- Principal Investigator Email
- theagenio@otenet.gr
- Contact Person Name
- Eirini Katodritou
- Contact Person Email
- theagenio@otenet.gr
- Site Name
- University General Hospital Attikon
- Department Name
- 2nd Department of Internal Medicine - Propaedeutic, Hematology Unit
- Principal Investigator Name
- Panagiotis Tsirigotis
- Principal Investigator Email
- panagtsirigotis@gmail.com
- Contact Person Name
- Panagiotis Tsirigotis
- Contact Person Email
- panagtsirigotis@gmail.com
- Site Name
- Laiko General Hospital Of Athens
- Department Name
- Hematology Clinic and Βone Μarrow Τransplantation Unit, NKUA
- Principal Investigator Name
- Theodoros Vassilakopoulos
- Principal Investigator Email
- clinicaltrial.tvassilakopoulos@gmail.com
- Contact Person Name
- Theodoros Vassilakopoulos
- Contact Person Email
- clinicaltrial.tvassilakopoulos@gmail.com
- Site Name
- University General Hospital Of Thessaloniki Ahepa
- Department Name
- 1st Department of Internal Medicine, Division of Hematology
- Principal Investigator Name
- Evdoxia Hatjiharissi
- Principal Investigator Email
- ehatjiharissi@gmail.com
- Contact Person Name
- Evdoxia Hatjiharissi
- Contact Person Email
- ehatjiharissi@gmail.com
Hungary
- Earliest CTIS Part Ii Submission Date
- 08-07-2024
- Latest Decision Or Authorization Date
- 26-08-2024
- Processing Time Days
- 49
- Number Of Sites
- 8
- Number Of Participants
- 16
Sites
- Site Name
- Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
- Department Name
- Hematologiai es Ossejt-transzplantacios Osztaly
- Principal Investigator Name
- Otto Csacsovszki
- Principal Investigator Email
- csacsotto@gmail.com
- Contact Person Name
- Otto Csacsovszki
- Contact Person Email
- csacsotto@gmail.com
- Site Name
- University Of Debrecen
- Department Name
- Belgyogyaszati Klinika, Hematologia
- Principal Investigator Name
- Arpad Illes
- Principal Investigator Email
- illesarpaddr@gmail.com
- Contact Person Name
- Arpad Illes
- Contact Person Email
- illesarpaddr@gmail.com
- Site Name
- University Of Pecs
- Department Name
- I. szamu Belgyogyaszati Klinika
- Principal Investigator Name
- Hussain Alizadeh
- Principal Investigator Email
- alizadeh.hussain@pte.hu
- Contact Person Name
- Hussain Alizadeh
- Contact Person Email
- alizadeh.hussain@pte.hu
- Site Name
- Orszagos Onkologiai Intezet
- Department Name
- Gyogyszerterapias Kozpont Hematologia es Lymphoma Osztaly
- Principal Investigator Name
- Andras Masszi
- Principal Investigator Email
- masszi.andras@oncol.hu
- Contact Person Name
- Andras Masszi
- Contact Person Email
- masszi.andras@oncol.hu
- Site Name
- Semmelweis University
- Department Name
- Belgyogyaszati es Hematologiai Klinika
- Principal Investigator Name
- Zsolt Nagy
- Principal Investigator Email
- nagy.zsolt@med.semmelweis-univ.hu
- Contact Person Name
- Zsolt Nagy
- Contact Person Email
- nagy.zsolt@med.semmelweis-univ.hu
- Site Name
- Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
- Department Name
- Hematologiai Osztaly
- Principal Investigator Name
- Laszlo Rejto
- Principal Investigator Email
- lrejto@med.unideb.hu
- Contact Person Name
- Laszlo Rejto
- Contact Person Email
- lrejto@med.unideb.hu
- Site Name
- Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
- Department Name
- II. Belgyogyaszat - Hematologia
- Principal Investigator Name
- Zsolt Lazar
- Principal Investigator Email
- lazarzsolt1982@gmail.com
- Contact Person Name
- Zsolt Lazar
- Contact Person Email
- lazarzsolt1982@gmail.com
- Site Name
- Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz (duplicate entry not expected)
- Department Name
- Hematologiai Osztaly
- Principal Investigator Name
- Laszlo Rejto
- Principal Investigator Email
- lrejto@med.unideb.hu
- Contact Person Name
- Laszlo Rejto
- Contact Person Email
- lrejto@med.unideb.hu
Poland
- Earliest CTIS Part Ii Submission Date
- 29-07-2024
- Latest Decision Or Authorization Date
- 26-08-2024
- Processing Time Days
- 28
- Number Of Sites
- 4
- Number Of Participants
- 12
Sites
- Site Name
- Pratia S.A.
- Principal Investigator Name
- Wojciech Jurczak
- Principal Investigator Email
- wojciech.jurczak@pratia.com
- Contact Person Name
- Wojciech Jurczak
- Contact Person Email
- wojciech.jurczak@pratia.com
- Site Name
- Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
- Department Name
- Klinika Hematologii i Transplantacji Szpiku
- Principal Investigator Name
- Pawel Steckiewicz
- Principal Investigator Email
- badania.kliniczne@onkol.kielce.pl
- Contact Person Name
- Pawel Steckiewicz
- Contact Person Email
- badania.kliniczne@onkol.kielce.pl
- Site Name
- Aidport Sp. z o.o.
- Principal Investigator Name
- Michal Kwiatek
- Principal Investigator Email
- michal.kwiatek@aidport.pl
- Contact Person Name
- Michal Kwiatek
- Contact Person Email
- michal.kwiatek@aidport.pl
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Klinika Nowotworów Układu Chłonnego
- Principal Investigator Name
- Ewa Paszkiewicz-Kozik
- Principal Investigator Email
- ewa.paszkiewicz-kozik@nio.gov.pl
- Contact Person Name
- Ewa Paszkiewicz-Kozik
- Contact Person Email
- ewa.paszkiewicz-kozik@nio.gov.pl
Portugal
- Earliest CTIS Part Ii Submission Date
- 15-07-2024
- Latest Decision Or Authorization Date
- 21-08-2024
- Processing Time Days
- 37
- Number Of Sites
- 3
- Number Of Participants
- 5
Sites
- Site Name
- Hospital Da Luz S.A.
- Department Name
- Hematology
- Principal Investigator Name
- José Carda
- Principal Investigator Email
- jose.nascimento.carda@hospitaldaluz.pt
- Contact Person Name
- José Carda
- Contact Person Email
- jose.nascimento.carda@hospitaldaluz.pt
- Site Name
- Unidade Local de Saude de Sao Joao E.P.E.
- Department Name
- Hematology
- Principal Investigator Name
- Ana Carneiro
- Principal Investigator Email
- ana.carneiro@chsj.min-saude.pt
- Contact Person Name
- Ana Carneiro
- Contact Person Email
- ana.carneiro@chsj.min-saude.pt
- Site Name
- Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
- Department Name
- Hematology
- Principal Investigator Name
- Rita Coutinho
- Principal Investigator Email
- rita.coutinho@ipoporto.min-saude.pt
- Contact Person Name
- Rita Coutinho
- Contact Person Email
- rita.coutinho@ipoporto.min-saude.pt
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 29-07-2024
- Latest Decision Or Authorization Date
- 26-08-2024
- Processing Time Days
- 28
- Number Of Sites
- 4
- Number Of Participants
- 13
Sites
- Site Name
- University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD
- Department Name
- Department of Clinical Hematology
- Principal Investigator Name
- Atanas Radinoff
- Principal Investigator Email
- aradinoff@hotmail.com
- Contact Person Name
- Atanas Radinoff
- Contact Person Email
- aradinoff@hotmail.com
- Site Name
- University Hospital St Marina Varna
- Department Name
- Clinic of Clinical Hematology
- Principal Investigator Name
- Ilina Micheva
- Principal Investigator Email
- ilinamicheva@gmail.com
- Contact Person Name
- Ilina Micheva
- Contact Person Email
- ilinamicheva@gmail.com
- Site Name
- University Multiprofile Hospital For Active Treatment Saint Georgi EAD
- Department Name
- Clinic of Clinical Hematology
- Principal Investigator Name
- Vasko Grklanov
- Principal Investigator Email
- dr.grklanov@yahoo.com
- Contact Person Name
- Vasko Grklanov
- Contact Person Email
- dr.grklanov@yahoo.com
- Site Name
- National Specialised Hospital For Active Treatment Of Haematological Diseases
- Department Name
- First department of Clinical Hematology
- Principal Investigator Name
- Tanya Yankova
- Principal Investigator Email
- t.yankova@hematology.bg
- Contact Person Name
- Tanya Yankova
- Contact Person Email
- t.yankova@hematology.bg
Czechia
- Earliest CTIS Part Ii Submission Date
- 29-07-2024
- Latest Decision Or Authorization Date
- 20-08-2024
- Processing Time Days
- 22
- Number Of Sites
- 4
- Number Of Participants
- 8
Sites
- Site Name
- Fakultni Nemocnice V Motole
- Department Name
- Onkologicka klinika 2. LF UK a FN Motol
- Principal Investigator Name
- Katerina Kopeckova
- Principal Investigator Email
- katerina.kopeckova@fnmotol.cz
- Contact Person Name
- Katerina Kopeckova
- Contact Person Email
- katerina.kopeckova@fnmotol.cz
- Site Name
- University Hospital Olomouc
- Department Name
- Hemato-onkologicka klinika
- Principal Investigator Name
- Vit Prochazka
- Principal Investigator Email
- vit.prochazka@fnol.cz
- Contact Person Name
- Vit Prochazka
- Contact Person Email
- vit.prochazka@fnol.cz
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- IV. interni hematologicka klinika
- Principal Investigator Name
- David Belada
- Principal Investigator Email
- david.belada@fnhk.cz
- Contact Person Name
- David Belada
- Contact Person Email
- david.belada@fnhk.cz
- Site Name
- Fakultni Nemocnice Kralovske Vinohrady
- Department Name
- -
- Principal Investigator Name
- Jan Novak
- Principal Investigator Email
- jan.novak@fnkv.cz
- Contact Person Name
- Jan Novak
- Contact Person Email
- jan.novak@fnkv.cz
Netherlands
- Earliest CTIS Part Ii Submission Date
- 29-07-2024
- Latest Decision Or Authorization Date
- 22-08-2024
- Processing Time Days
- 24
- Number Of Sites
- 6
- Number Of Participants
- 8
Sites
- Site Name
- Albert Schweitzer Ziekenhuis
- Department Name
- Interne geneeskunde
- Principal Investigator Name
- Eva de Jongh
- Principal Investigator Email
- wetenschap@asz.nl
- Contact Person Name
- Eva de Jongh
- Contact Person Email
- wetenschap@asz.nl
- Site Name
- Stichting OLVG
- Department Name
- Hematologie Oncologie
- Principal Investigator Name
- Wim Terpstra
- Principal Investigator Email
- mailtrialbureau@olvg.nl
- Contact Person Name
- Wim Terpstra
- Contact Person Email
- mailtrialbureau@olvg.nl
- Site Name
- Medisch Centrum Leeuwarden B.V.
- Department Name
- Oncology
- Principal Investigator Name
- Rozemarijn van Rijn
- Principal Investigator Email
- Wetenschap@mclacademie.nl
- Contact Person Name
- Rozemarijn van Rijn
- Contact Person Email
- Wetenschap@mclacademie.nl
- Site Name
- Sint Antonius Ziekenhuis Stichting
- Department Name
- Interne Geneeskunde
- Principal Investigator Name
- Inger Nijhof
- Principal Investigator Email
- i.nijhof@antoniusziekenhuis.nl
- Contact Person Name
- Inger Nijhof
- Contact Person Email
- i.nijhof@antoniusziekenhuis.nl
- Site Name
- Jeroen Bosch Ziekenhuis
- Department Name
- Oncology
- Principal Investigator Name
- Djamila Issa
- Principal Investigator Email
- Researchoncologie@jbz.nl
- Contact Person Name
- Djamila Issa
- Contact Person Email
- Researchoncologie@jbz.nl
- Site Name
- Medisch Centrum Leeuwarden B.V. (duplicate entry possibility)
- Department Name
- Oncology
- Principal Investigator Name
- Rozemarijn van Rijn
- Principal Investigator Email
- Wetenschap@mclacademie.nl
- Contact Person Name
- Rozemarijn van Rijn
- Contact Person Email
- Wetenschap@mclacademie.nl
Romania
- Earliest CTIS Part Ii Submission Date
- 17-05-2024
- Latest Decision Or Authorization Date
- 26-08-2024
- Processing Time Days
- 101
- Number Of Sites
- 4
- Number Of Participants
- 12
Sites
- Site Name
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
- Department Name
- Hematologie
- Principal Investigator Name
- Delia Dima
- Principal Investigator Email
- office@iocn.ro
- Contact Person Name
- Delia Dima
- Contact Person Email
- office@iocn.ro
- Site Name
- Institutul Clinic Fundeni
- Department Name
- Hematologie II
- Principal Investigator Name
- Daniel Coriu
- Principal Investigator Email
- hematologie2@icfundeni.ro
- Contact Person Name
- Daniel Coriu
- Contact Person Email
- hematologie2@icfundeni.ro
- Site Name
- Institutul Regional De Oncologie Iasi
- Department Name
- Hematologie
- Principal Investigator Name
- Catalin-Doru Danaila
- Principal Investigator Email
- manager@iroiasi.ro
- Contact Person Name
- Catalin-Doru Danaila
- Contact Person Email
- manager@iroiasi.ro
- Site Name
- Spitalul Clinic Coltea
- Department Name
- Hematologie
- Principal Investigator Name
- Andrei Colita
- Principal Investigator Email
- secretariat@coltea.ro
- Contact Person Name
- Andrei Colita
- Contact Person Email
- secretariat@coltea.ro
Belgium
- Earliest CTIS Part Ii Submission Date
- 23-07-2024
- Latest Decision Or Authorization Date
- 19-08-2024
- Processing Time Days
- 27
- Number Of Sites
- 5
- Number Of Participants
- 5
Sites
- Site Name
- Algemeen Ziekenhuis Delta
- Department Name
- Hematology
- Principal Investigator Name
- Caressa Meert
- Principal Investigator Email
- caressa.meert@azdelta.be
- Contact Person Name
- Caressa Meert
- Contact Person Email
- caressa.meert@azdelta.be
- Site Name
- Centre Hospitalier EPICURA
- Department Name
- Hematology
- Principal Investigator Name
- Géraldine Claes
- Principal Investigator Email
- geraldine.claes@epicura.be
- Contact Person Name
- Géraldine Claes
- Contact Person Email
- geraldine.claes@epicura.be
- Site Name
- UZ Leuven
- Department Name
- Hematology
- Principal Investigator Name
- Sherida Woei-A-Jin
- Principal Investigator Email
- sherida.woei-a-jin@uzleuven.be
- Contact Person Name
- Sherida Woei-A-Jin
- Contact Person Email
- sherida.woei-a-jin@uzleuven.be
- Site Name
- CHU UCL Namur - site Godinne
- Department Name
- Hematology
- Principal Investigator Name
- Gilles Crochet
- Principal Investigator Email
- gilles.crochet@chuuclnamur.uclouvain.be
- Contact Person Name
- Gilles Crochet
- Contact Person Email
- gilles.crochet@chuuclnamur.uclouvain.be
- Site Name
- UZ Brussel
- Department Name
- Hematology
- Principal Investigator Name
- Veerle Beckers
- Principal Investigator Email
- veerle.beckers@uzbrussel.be
- Contact Person Name
- Veerle Beckers
- Contact Person Email
- veerle.beckers@uzbrussel.be
France
- Earliest CTIS Part Ii Submission Date
- 09-08-2024
- Latest Decision Or Authorization Date
- 23-08-2024
- Processing Time Days
- 14
- Number Of Sites
- 7
- Number Of Participants
- 13
Sites
- Site Name
- Centre Hospitalier De La Cote Basque
- Department Name
- Service d'Hématologie
- Principal Investigator Name
- Sophie Bernard
- Principal Investigator Email
- sbernard@ch-cotebasque.fr
- Contact Person Name
- Sophie Bernard
- Contact Person Email
- sbernard@ch-cotebasque.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Service d'Hématologie et Thérapie Cellulaire
- Principal Investigator Name
- Emmanuel Gyan
- Principal Investigator Email
- e.gyan@chu-tours.fr
- Contact Person Name
- Emmanuel Gyan
- Contact Person Email
- e.gyan@chu-tours.fr
- Site Name
- Groupement Des Hopitaux De L'Institut Catholique De Lille
- Department Name
- Département d'Onco-Hématologie
- Principal Investigator Name
- Sandy Amorim
- Principal Investigator Email
- Amorim.sandy@ghicl.net
- Contact Person Name
- Sandy Amorim
- Contact Person Email
- Amorim.sandy@ghicl.net
- Site Name
- Centre Hospitalier Universitaire De Caen Normandie
- Department Name
- Département d'Hématologie
- Principal Investigator Name
- Gandhi Laurent Damaj
- Principal Investigator Email
- damaj-gl@chu-caen.fr
- Contact Person Name
- Gandhi Laurent Damaj
- Contact Person Email
- damaj-gl@chu-caen.fr
- Site Name
- Centre Hospitalier D Avignon
- Department Name
- Département d'Oncologie-Hématologie
- Principal Investigator Name
- Hacene Zerazhi
- Principal Investigator Email
- hzerazhi@ch-avignon.fr
- Contact Person Name
- Hacene Zerazhi
- Contact Person Email
- hzerazhi@ch-avignon.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Département d'Hématologie
- Principal Investigator Name
- Luc-Matthieu Fornecker
- Principal Investigator Email
- lm.fornecker@icans.eu
- Contact Person Name
- Luc-Matthieu Fornecker
- Contact Person Email
- lm.fornecker@icans.eu
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Service d'Hématologie et Thérapie Cellulaire
- Principal Investigator Name
- Stéphanie Guidez
- Principal Investigator Email
- stephanie.guidez@chu-poitiers.fr
- Contact Person Name
- Stéphanie Guidez
- Contact Person Email
- stephanie.guidez@chu-poitiers.fr
Sponsor
Primary sponsor
- Full Name
- AbbVie Deutschland GmbH & Co. KG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Contract research organisations
- Name
- Q Squared Solutions Limited
- Name
- IQVIA Limited
- Name
- Altasciences Compagnie Inc.
- Name
- Perceptive Informatics Inc.
- Responsibilities
- Imaging
Third parties
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Romania","full_name":"SC Abbvie SRL","duties_or_roles":"local national activities","organisation_type":"Industry"}
- {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Imaging","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Altasciences Compagnie Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Personalis Inc.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Clinical Trial Media Inc.","duties_or_roles":"Recruitment material, website creation, shipping subject materials","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Cytel Inc.","duties_or_roles":"iDMC","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient reimbursement","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"ePRO management","organisation_type":"Non-Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Epcoritamab (GEN3013)
- Active Substance
- EPCORITAMAB
- Modality
- Bispecific antibody
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- prodAuthStatus: 1
- Orphan Designation
- Yes
- Investigational Product Name
- Revlimid (Lenalidomide) 5/20/25 mg hard capsules
- Active Substance
- LENALIDOMIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- prodAuthStatus: 2
- Investigational Product Name
- Truxima (Rituximab) 100 mg / 500 mg concentrate for solution for infusion
- Active Substance
- RITUXIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- prodAuthStatus: 2
- Investigational Product Name
- Gemcitabine 38 mg/ml Concentrate for Solution for Infusion
- Active Substance
- GEMCITABINE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- prodAuthStatus: 2
- Investigational Product Name
- Oxaliplatin 5mg/ml Concentrate for Solution for Infusion
- Active Substance
- OXALIPLATIN
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Authorisation Status
- prodAuthStatus: 2
- Combination Treatment
- Yes
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