Clinical trial • Phase III • Oncology
ZILOVERTAMAB VEDOTIN for Diffuse large B-cell lymphoma
Phase III trial of ZILOVERTAMAB VEDOTIN for Diffuse large B-cell lymphoma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Diffuse large B-cell lymphoma
- Trial Stage
- Phase III
- Drug Modality
- ADC|Monoclonal antibody|Small molecule|Biological
Key dates
- Initial CTIS Submission Date
- 09-10-2024
- First CTIS Authorization Date
- 11-02-2025
Trial design
Randomised, open-label, r-chop (rituximab + cyclophosphamide + doxorubicin + vincristine + prednisone) vs experimental arm: zilovertamab vedotin (mk-2140) in combination with r-chp (rituximab + cyclophosphamide + doxorubicin + prednisone). doses available in product listings: zilovertamab vedotin up to 1.75 mg/kg (doseuom mg/kg; maxdailydoseamount 1.75; maxtotaldoseamount 10.5); rituximab listed with 375 mg/m2 (doseuom mg/m2; maxdailydoseamount 375); cyclophosphamide listed with 750 mg/m2; doxorubicin listed with 50 mg/m2; vincristine listed with 2 mg/m2; prednisone/prednisolone listed with max daily 100 mg. specific schedule (cycle length and administration schedule) not specified in the ctis metadata.-controlled Phase III trial in Netherlands, Hungary, Romania and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- R-CHOP (rituximab + cyclophosphamide + doxorubicin + vincristine + prednisone) vs experimental arm: Zilovertamab vedotin (MK-2140) in combination with R-CHP (rituximab + cyclophosphamide + doxorubicin + prednisone). Doses available in product listings: Zilovertamab vedotin up to 1.75 mg/kg (doseUOM mg/kg; maxDailyDoseAmount 1.75; maxTotalDoseAmount 10.5); Rituximab listed with 375 mg/m2 (doseUOM mg/m2; maxDailyDoseAmount 375); Cyclophosphamide listed with 750 mg/m2; Doxorubicin listed with 50 mg/m2; Vincristine listed with 2 mg/m2; Prednisone/prednisolone listed with max daily 100 mg. Specific schedule (cycle length and administration schedule) not specified in the CTIS metadata.
- Target Sample Size
- 888
Eligibility
Recruits 888 No vulnerable populations selected; informed consent is obtained from participants. No assent procedures for minors are specified..
- Vulnerable Population
- No vulnerable populations selected; informed consent is obtained from participants. No assent procedures for minors are specified.
Inclusion criteria
- {"criterion_text":"- Has histologically confirmed diagnosis of diffuse large B-cell lymphoma (DLBCL), by prior biopsy, according to the WHO classification of neoplasms of the hematopoietic and lymphoid tissues.\n- Has positron emission tomography (PET) positive disease at screening, defined as 4 to 5 on the Lugano 5-point scale.\n- Has received no prior treatment for their DLBCL.\n- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 assessed within 7 days before randomization.\n- Has an ejection fraction ≥45% as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA)\n- Human immunodeficiency virus (HIV) infected participants must have well controlled HIV on antiretroviral therapy (ART)\n- Who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy and have undetectable HBV viral load prior to randomization\n- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening."}
Exclusion criteria
- {"criterion_text":"- Has a history of transformation of indolent disease to DLBCL\n- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n- Known additional malignancy that is progressing or has required active treatment within the past 2 years\n- Known active central nervous system (CNS) lymphoma.\n- Has active autoimmune disease that has required systemic treatment in the past 2 years\n- Has active infection requiring systemic therapy.\n- Has concurrent active HBV (defined as HBsAg positive and detectable HBV DNA) and HCV (defined as anti-HCV antibody positive and detectable HCV ribonucleic acid (RNA)) infection.\n- Has history of allogeneic tissue/solid organ transplant\n- Has received a diagnosis of primary mediastinal B-cell lymphoma (PMBCL) or Grey zone lymphoma\n- Has Ann Arbor Stage I DLBCL\n- Has clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (<6 months prior to enrollment), myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class ≥II), or serious cardiac arrhythmia requiring medication\n- Has clinically significant pericardial or pleural effusion.\n- Has ongoing Grade >1 peripheral neuropathy.\n- Has a demyelinating form of Charcot-Marie-Tooth disease.\n- HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease.\n- Has ongoing corticosteroid therapy"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Progression-free Survival (PFS) per Lugano Response Criteria","definition_or_measurement_approach":"PFS assessed per Lugano Response Criteria (primary objective specifies assessment by Blinded Independent Central Review (BICR))."}
Secondary endpoints
- {"endpoint_text":"- Complete Response (CR) at End of Treatment (EOT) per Lugano Response Criteria","definition_or_measurement_approach":"CR at EOT assessed per Lugano Response Criteria (secondary objectives indicate assessment by BICR)."}
- {"endpoint_text":"- Overall Survival (OS)","definition_or_measurement_approach":"Time from randomization to death from any cause (Overall Survival)."}
- {"endpoint_text":"- Event-free Survival (EFS) per Lugano Response Criteria","definition_or_measurement_approach":"EFS assessed per Lugano Response Criteria."}
- {"endpoint_text":"- Duration of CR","definition_or_measurement_approach":"Duration of complete response measured from time of documented CR to time of progression or relapse."}
- {"endpoint_text":"- Number of Participants Who Experienced At Least One Adverse Event (AE)","definition_or_measurement_approach":"Count of participants with ≥1 AE (safety reporting per study definitions)."}
- {"endpoint_text":"- Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)","definition_or_measurement_approach":"Count of participants who permanently discontinued study treatment because of an AE."}
- {"endpoint_text":"- Change From Baseline in Health-Related Quality Of Life (HRQoL) on Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) Trial Outcome Index (TOI) Score","definition_or_measurement_approach":"Change from baseline in FACT-Lym TOI score (patient-reported outcome)."}
- {"endpoint_text":"- Change From Baseline in HRQoL on FACT-Lym Total Score","definition_or_measurement_approach":"Change from baseline in FACT-Lym total score (patient-reported outcome)."}
- {"endpoint_text":"- Change From Baseline in HRQoL on FACT-Lym Physical Wellbeing (PWB) score","definition_or_measurement_approach":"Change from baseline in FACT-Lym PWB subscore (patient-reported outcome)."}
- {"endpoint_text":"- Change From Baseline in HRQoL on Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) Neurotoxicity Subscale Score","definition_or_measurement_approach":"Change from baseline in FACT/GOG-NTX neurotoxicity subscale (patient-reported neurotoxicity assessment)."}
Recruitment
- Digital Remote Recruitment
- True; recruitment materials include a country-specific 'Website' document (Poland) and other electronic patient materials; multiple countries have published recruitment documents that could be used digitally.
- Planned Sample Size
- 888
- Recruitment Window Months
- 84
- Consent Approach
- Informed consent is obtained from participants. Subject information and informed consent forms (L1_ICF_Main consent and related ICFs) are provided per country and in local languages (examples in CTIS documents: Dutch/English, Hungarian, Romanian, Greek, Italian, Portuguese, English, French, Spanish, Polish, Danish). Optional consent modules (e.g., genetic consent, pregnancy follow-up, optional Greenphire) are provided where applicable. No age-specific assent procedures for minors are specified in the CTIS metadata.
Methods
- Country-specific recruitment arrangements documents (K1_Recruitment Arrangements and IC Procedure) — e.g., Netherlands, Hungary, Romania, Greece, Italy, Portugal, Belgium, France, Poland, Denmark, Spain (documents listed in CTIS).
- Patient brochures (K2_Recruitment Doc Patient Brochure) — country-specific patient-facing brochures listed for multiple countries.
- Patient visit guides (K2_Recruitment Doc Patient Visit Guide) — country-specific visit guides listed.
- Posters (K2_Recruitment Doc Poster) — country-specific posters listed.
- Website-based recruitment (K2_Recruitment Doc Website) — explicit document present for Poland indicating use of a recruitment website.
Geography
- Total Number Of Sites
- 73
- Total Number Of Participants
- 258
Netherlands
- Earliest CTIS Part Ii Submission Date
- 06-02-2025
- Latest Decision Or Authorization Date
- 30-09-2025
- Processing Time Days
- 236
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Albert Schweitzer Ziekenhuis
- Department Name
- Hematology
- Principal Investigator Name
- Eva de Jongh
- Principal Investigator Email
- p.a.dezeeuw@asz.nl
- Contact Person Name
- Eva de Jongh
- Contact Person Email
- p.a.dezeeuw@asz.nl
- Site Name
- Meander Medisch Centrum
- Department Name
- Hematology
- Principal Investigator Name
- Rob Fijnheer
- Principal Investigator Email
- researchhematologie@meandermc.nl
- Contact Person Name
- Rob Fijnheer
- Contact Person Email
- researchhematologie@meandermc.nl
Hungary
- Earliest CTIS Part Ii Submission Date
- 05-12-2024
- Latest Decision Or Authorization Date
- 03-10-2025
- Processing Time Days
- 302
- Number Of Sites
- 5
- Number Of Participants
- 20
Sites
- Site Name
- University Of Debrecen
- Department Name
- Belgyógyászati Klinika (Hematológia)
- Principal Investigator Name
- Árpád Illés
- Principal Investigator Email
- illes.arpad@med.unideb.hu
- Contact Person Name
- Árpád Illés
- Contact Person Email
- illes.arpad@med.unideb.hu
- Site Name
- Tolna Varmegyei Balassa Janos Korhaz
- Department Name
- Hematológiai Osztály
- Principal Investigator Name
- Renáta Csalódi
- Principal Investigator Email
- csalodi.renata@tmkorhaz.hu
- Contact Person Name
- Renáta Csalódi
- Contact Person Email
- csalodi.renata@tmkorhaz.hu
- Site Name
- Semmelweis University
- Department Name
- Belgyógyászati és Hematológiai 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
- Hematológia Osztály
- Principal Investigator Name
- László Rejtő
- Principal Investigator Email
- dr.rejto.laszlo@szszbmk.hu
- Contact Person Name
- László Rejtő
- Contact Person Email
- dr.rejto.laszlo@szszbmk.hu
- Site Name
- Orszagos Onkologiai Intezet
- Department Name
- Gyógyszerterápiás központ, Hematológia és Lymphoma Osztály "Kemoterápia A"
- Principal Investigator Name
- András Masszi
- Principal Investigator Email
- masszi.andras@oncol.hu
- Contact Person Name
- András Masszi
- Contact Person Email
- masszi.andras@oncol.hu
Romania
- Earliest CTIS Part Ii Submission Date
- 23-10-2024
- Latest Decision Or Authorization Date
- 06-10-2025
- Processing Time Days
- 349
- Number Of Sites
- 7
- Number Of Participants
- 23
Sites
- Site Name
- Spitalul Clinic Colentina Bucuresti
- Department Name
- Hematology
- Principal Investigator Name
- Georgeta-Daniela Georgescu
- Principal Investigator Email
- secretariat@spitalulcolentia.ro
- Contact Person Name
- Georgeta-Daniela Georgescu
- Contact Person Email
- secretariat@spitalulcolentia.ro
- Site Name
- Spitalul Clinic Judetean De Urgenta Sibiu
- Department Name
- Hematology
- Principal Investigator Name
- Alina Catana
- Principal Investigator Email
- secretariat@scjus.ro
- Contact Person Name
- Alina Catana
- Contact Person Email
- secretariat@scjus.ro
- Site Name
- Onco Card S.R.L.
- Department Name
- Hematologie
- Principal Investigator Name
- Mihaela - Cornelia Lazaroiu
- Principal Investigator Email
- office@medlife.ro
- Contact Person Name
- Mihaela - Cornelia Lazaroiu
- Contact Person Email
- office@medlife.ro
- Site Name
- Institutul Regional De Oncologie Iasi
- Department Name
- Hematology
- Principal Investigator Name
- Catalin Danaila
- Principal Investigator Email
- secretariat@scjus.ro
- Contact Person Name
- Catalin Danaila
- Contact Person Email
- secretariat@scjus.ro
- Site Name
- Spitalul Clinic Coltea
- Department Name
- Hematologie
- Principal Investigator Name
- Gabriela Borsaru
- Principal Investigator Email
- secretariat@coltea.ro
- Contact Person Name
- Gabriela Borsaru
- Contact Person Email
- secretariat@coltea.ro
- Site Name
- Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
- Department Name
- Hematology
- Principal Investigator Name
- Ionut Ciprian Tomuleasa
- Principal Investigator Email
- office@iocn.ro
- Contact Person Name
- Ionut Ciprian Tomuleasa
- Contact Person Email
- office@iocn.ro
- Site Name
- Spitalul Clinic Colentina Bucuresti (additional listed site)
- Department Name
- Hematology
- Principal Investigator Name
- Georgeta-Daniela Georgescu
- Principal Investigator Email
- secretariat@spitalulcolentia.ro
- Contact Person Name
- Gabriela Borsaru
- Contact Person Email
- secretariat@spitalulcolentia.ro
Greece
- Earliest CTIS Part Ii Submission Date
- 23-10-2024
- Latest Decision Or Authorization Date
- 03-10-2025
- Processing Time Days
- 315
- Number Of Sites
- 4
- Number Of Participants
- 16
Sites
- Site Name
- Laiko General Hospital Of Athens
- Department Name
- Hematology Department
- 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 Alexandroupoli
- Department Name
- Hematology Department, Thalassemia Unit
- Principal Investigator Name
- Ioannis Kotsianidis
- Principal Investigator Email
- jankots@yahoo.gr
- Contact Person Name
- Ioannis Kotsianidis
- Contact Person Email
- jankots@yahoo.gr
- Site Name
- University General Hospital Attikon
- Department Name
- 2nd Propaedeutic Pathology Clinic, Department of Hematology
- Principal Investigator Name
- Vasiliki Pappa
- Principal Investigator Email
- vas_pappa@yahoo.com
- Contact Person Name
- Vasiliki Pappa
- Contact Person Email
- vas_pappa@yahoo.com
- Site Name
- Evangelismos S.A.
- Department Name
- Hematology and Lymphoma Department
- Principal Investigator Name
- Maria Bouzani
- Principal Investigator Email
- mbouzani@yahoo.com
- Contact Person Name
- Maria Bouzani
- Contact Person Email
- mbouzani@yahoo.com
Italy
- Earliest CTIS Part Ii Submission Date
- 23-10-2024
- Latest Decision Or Authorization Date
- 03-10-2025
- Processing Time Days
- 315
- Number Of Sites
- 11
- Number Of Participants
- 33
Sites
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- ISTITUTO DI EMATOLOGIA
- Principal Investigator Name
- Stefan Hohaus
- Principal Investigator Email
- stefan.hohaus@policlinicogemelli.it
- Contact Person Name
- Stefan Hohaus
- Contact Person Email
- stefan.hohaus@policlinicogemelli.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- U.O. Ematologia
- Principal Investigator Name
- Monica Tani
- Principal Investigator Email
- monica.tani@auslromagna.it
- Contact Person Name
- Monica Tani
- Contact Person Email
- monica.tani@auslromagna.it
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- Divisione di Oncoematologia
- Principal Investigator Name
- Enrico Derenzini
- Principal Investigator Email
- enrico.derenzini@ieo.it
- Contact Person Name
- Enrico Derenzini
- Contact Person Email
- enrico.derenzini@ieo.it
- Site Name
- Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
- Department Name
- U.O.C. Oncoematologia
- Principal Investigator Name
- Caterina Patti
- Principal Investigator Email
- k.patti@villasofia.it
- Contact Person Name
- Caterina Patti
- Contact Person Email
- k.patti@villasofia.it
- Site Name
- Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
- Department Name
- Day Hospital Oncologia Medica
- Principal Investigator Name
- Umberto Vitolo
- Principal Investigator Email
- umberto.vitolo@ircc.it
- Contact Person Name
- Umberto Vitolo
- Contact Person Email
- umberto.vitolo@ircc.it
- Site Name
- Azienda Ospedaliero-Universitaria Maggiore Della Carita
- Department Name
- SCDU di Ematologia
- Principal Investigator Name
- Riccardo Bruna
- Principal Investigator Email
- riccardo.bruna@uniupo.it
- Contact Person Name
- Riccardo Bruna
- Contact Person Email
- riccardo.bruna@uniupo.it
- Site Name
- Azienda Ospedaliero Universitaria Delle Marche
- Department Name
- Clinica Ematologica
- Principal Investigator Name
- Guido Gini
- Principal Investigator Email
- guido.gini@ospedaliriuniti.marche.it
- Contact Person Name
- Guido Gini
- Contact Person Email
- guido.gini@ospedaliriuniti.marche.it
- Site Name
- Istituto Di Ricovero E Cura A Carattere Scientifico Centro Di Riferimento Oncologico Della Basilicata
- Department Name
- UO Ematologia e Trapianto cellule staminali
- Principal Investigator Name
- Giuseppe Pietrantuono
- Principal Investigator Email
- giuseppe.pietrantuono@crob.it
- Contact Person Name
- Giuseppe Pietrantuono
- Contact Person Email
- giuseppe.pietrantuono@crob.it
- Site Name
- Fondazione IRCCS San Gerardo Dei Tintori
- Department Name
- Ematologia Adulti
- Principal Investigator Name
- Carlo Gambacorti Passerini
- Principal Investigator Email
- carlo.gambacorti@unimib.it
- Contact Person Name
- Carlo Gambacorti Passerini
- Contact Person Email
- carlo.gambacorti@unimib.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Dipartimento di Onco-ematologia - Unità Linfomi
- Principal Investigator Name
- Andrés José María Ferreri
- Principal Investigator Email
- ferreri.andres@hsr.it
- Contact Person Name
- Andrés José María Ferreri
- Contact Person Email
- ferreri.andres@hsr.it
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- SC Ematologia
- Principal Investigator Name
- Alessandra Tucci
- Principal Investigator Email
- alessandra.tucci@asst-spedalicivili.it
- Contact Person Name
- Alessandra Tucci
- Contact Person Email
- alessandra.tucci@asst-spedalicivili.it
Portugal
- Earliest CTIS Part Ii Submission Date
- 23-10-2024
- Latest Decision Or Authorization Date
- 05-12-2025
- Processing Time Days
- 409
- Number Of Sites
- 3
- Number Of Participants
- 14
Sites
- Site Name
- CCAB Centro Clinico Academico Braga Associacao
- Department Name
- Centro Clínico Académico - Braga, Associação (2CA-Braga)
- Principal Investigator Name
- Teresa Ribeiro
- Principal Investigator Email
- teresa.garcia.ribeiro@hb.min-saude.pt
- Contact Person Name
- Teresa Ribeiro
- Contact Person Email
- teresa.garcia.ribeiro@hb.min-saude.pt
- Site Name
- Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
- Department Name
- Serviço de Hematologia e Transplantação de Medula Óssea
- Principal Investigator Name
- Mário Pimenta
- Principal Investigator Email
- clinicalstudies@ipoporto.min-saude.pt
- Contact Person Name
- Mário Pimenta
- Contact Person Email
- clinicalstudies@ipoporto.min-saude.pt
- Site Name
- Unidade Local De Saude De Santa Maria E.P.E.
- Department Name
- Serviçode Hematologia e Transplantação de Medula Óssea
- Principal Investigator Name
- Daniela Alves
- Principal Investigator Email
- daniela.p.alves@ulssm.min-saude.pt
- Contact Person Name
- Daniela Alves
- Contact Person Email
- daniela.p.alves@ulssm.min-saude.pt
Belgium
- Earliest CTIS Part Ii Submission Date
- 29-01-2025
- Latest Decision Or Authorization Date
- 15-12-2025
- Processing Time Days
- 319
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Emmaues
- Department Name
- Hematology
- Principal Investigator Name
- Toine Mercier
- Principal Investigator Email
- toine.mercier@emmaus.be
- Contact Person Name
- Toine Mercier
- Contact Person Email
- toine.mercier@emmaus.be
- Site Name
- CHU Helora
- Department Name
- Hematology
- Principal Investigator Name
- Justine Deuson
- Principal Investigator Email
- justine.deuson@helora.be
- Contact Person Name
- Justine Deuson
- Contact Person Email
- justine.deuson@helora.be
France
- Earliest CTIS Part Ii Submission Date
- 29-01-2025
- Latest Decision Or Authorization Date
- 04-12-2025
- Processing Time Days
- 309
- Number Of Sites
- 14
- Number Of Participants
- 74
Sites
- Site Name
- HIA Sainte Anne
- Department Name
- Oncologie-Hématologie
- Principal Investigator Name
- Laurys BOUDIN
- Principal Investigator Email
- laurys.boudin@intradef.gouv.fr
- Contact Person Name
- Laurys BOUDIN
- Contact Person Email
- laurys.boudin@intradef.gouv.fr
- Site Name
- Centre Hospital Region Metz Thionville
- Department Name
- Hématologie
- Principal Investigator Name
- Philippe CARASSOU
- Principal Investigator Email
- philippe.carassou@chr-metz-thionville.fr
- Contact Person Name
- Philippe CARASSOU
- Contact Person Email
- philippe.carassou@chr-metz-thionville.fr
- Site Name
- Centre Hospitalier De La Cote Basque
- Department Name
- Oncologie
- 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 Henri Becquerel
- Department Name
- Department of Hematology
- Principal Investigator Name
- Fabrice Jardin
- Principal Investigator Email
- fabrice.jardin@chb.unicancer.fr
- Contact Person Name
- Fabrice Jardin
- Contact Person Email
- fabrice.jardin@chb.unicancer.fr
- Site Name
- Centre Hospitalier Et Universitaire De Limoges
- Department Name
- Hématologie Clinique et Thérapie Cellulaire
- Principal Investigator Name
- Julie ABRAHAM
- Principal Investigator Email
- julie.abraham@chu-limoges.fr
- Contact Person Name
- Julie ABRAHAM
- Contact Person Email
- julie.abraham@chu-limoges.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- Department of Hematology
- Principal Investigator Name
- Fabien Claves
- Principal Investigator Email
- Fclaves@chu-grenoble.fr
- Contact Person Name
- Fabien Claves
- Contact Person Email
- Fclaves@chu-grenoble.fr
- Site Name
- Centre Antoine Lacassagne
- Department Name
- Oncologie Médicale
- Principal Investigator Name
- Luca INCHIAPPA
- Principal Investigator Email
- inchiappal@ipc.unicancer.fr
- Contact Person Name
- Luca INCHIAPPA
- Contact Person Email
- inchiappal@ipc.unicancer.fr
- Site Name
- Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis
- Department Name
- Hématologie
- Principal Investigator Name
- Anne CORBY
- Principal Investigator Email
- anne.corby@ght-atlantique17.fr
- Contact Person Name
- Anne CORBY
- Contact Person Email
- anne.corby@ght-atlantique17.fr
- Site Name
- University Hospital Of Clermont-Ferrand
- Department Name
- Hématologie et Thérapie Cellulaire Adultes
- Principal Investigator Name
- Sebastien BAILLY
- Principal Investigator Email
- s-bailly@chu-clermontferrand.fr
- Contact Person Name
- Sebastien BAILLY
- Contact Person Email
- s-bailly@chu-clermontferrand.fr
- Site Name
- L’Hopital Alexandra Lepeve
- Department Name
- Hématologie
- Principal Investigator Name
- Sarah BARBIEUX
- Principal Investigator Email
- sarah.barbieux@ch-dunkerque.fr
- Contact Person Name
- Sarah BARBIEUX
- Contact Person Email
- sarah.barbieux@ch-dunkerque.fr
- Site Name
- Institut Curie
- Department Name
- Oncologie
- Principal Investigator Name
- Clémentine SARKOZY
- Principal Investigator Email
- clementine.sarkozy@curie.fr
- Contact Person Name
- Clémentine SARKOZY
- Contact Person Email
- clementine.sarkozy@curie.fr
- Site Name
- Centre Hospitalier D Avignon
- Department Name
- Hématologie clinique et Oncologie médicale
- Principal Investigator Name
- Borhane SLAMA
- Principal Investigator Email
- bslama@ch-avignon.fr
- Contact Person Name
- Borhane SLAMA
- Contact Person Email
- bslama@ch-avignon.fr
- Site Name
- Centre Hospitalier Departemental Vendee
- Department Name
- Onco-Hematologie
- Principal Investigator Name
- Bruno VILLEMAGNE
- Principal Investigator Email
- bruno.villemagne@ght85.fr
- Contact Person Name
- Bruno VILLEMAGNE
- Contact Person Email
- bruno.villemagne@ght85.fr
- Site Name
- Centre Hospitalier Universitaire De Dijon
- Department Name
- Hématologie
- Principal Investigator Name
- Cédric ROSSI
- Principal Investigator Email
- cedric.rossi@chu-dijon.fr
- Contact Person Name
- Cédric ROSSI
- Contact Person Email
- cedric.rossi@chu-dijon.fr
Poland
- Earliest CTIS Part Ii Submission Date
- 04-02-2025
- Latest Decision Or Authorization Date
- 23-12-2025
- Processing Time Days
- 322
- Number Of Sites
- 8
- Number Of Participants
- 20
Sites
- Site Name
- Pratia S.A.
- Department Name
- Onkologia
- Principal Investigator Name
- Elżbieta Kalicińska
- Principal Investigator Email
- biuro.onkologia.wroclaw@pratia.pl
- Contact Person Name
- Elżbieta Kalicińska
- Contact Person Email
- biuro.onkologia.wroclaw@pratia.pl
- Site Name
- Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie
- Department Name
- Oddział Kliniczny Hematologii z Ośrodkiem Transplantacji Szpiku
- Principal Investigator Name
- Janusz Hałka
- Principal Investigator Email
- clinicaltrialsoffice@poliklinika.net
- Contact Person Name
- Janusz Hałka
- Contact Person Email
- clinicaltrialsoffice@poliklinika.net
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Warsaw)
- 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
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy (Gliwice)
- Department Name
- Klinika Transplantacji Szpiku i Onkohematologii
- Principal Investigator Name
- Sebastian Giebel
- Principal Investigator Email
- ktsbadaniakliniczne@gliwice.nio.gov.pl
- Contact Person Name
- Sebastian Giebel
- Contact Person Email
- ktsbadaniakliniczne@gliwice.nio.gov.pl
- Site Name
- Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
- Department Name
- Oddział Hematologiczny
- Principal Investigator Name
- Wojciech Homenda
- Principal Investigator Email
- hematologia@szpital.slupsk.pl
- Contact Person Name
- Wojciech Homenda
- Contact Person Email
- hematologia@szpital.slupsk.pl
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
- Department Name
- Oddział Kliniczny Hematologii i Chorób Wewnętrznych
- Principal Investigator Name
- Agnieszka Giza
- Principal Investigator Email
- badaniakliniczne@su.krakow.pl
- Contact Person Name
- Agnieszka Giza
- Contact Person Email
- badaniakliniczne@su.krakow.pl
- Site Name
- Pratia Hematologia Sp. z o.o.
- Department Name
- Pratia Onkologia Katowice
- Principal Investigator Name
- Sebastian Grosicki
- Principal Investigator Email
- kontakt.onkologia.katowice@pratia.com
- Contact Person Name
- Sebastian Grosicki
- Contact Person Email
- kontakt.onkologia.katowice@pratia.com
- Site Name
- Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
- Department Name
- Klinika Hematoonkologii i Transplantacji Szpiku
- Principal Investigator Name
- Marek Hus
- Principal Investigator Email
- hematoonkologia@usk1.pl
- Contact Person Name
- Marek Hus
- Contact Person Email
- hematoonkologia@usk1.pl
Denmark
- Earliest CTIS Part Ii Submission Date
- 16-01-2025
- Latest Decision Or Authorization Date
- 23-03-2026
- Processing Time Days
- 442
- Number Of Sites
- 4
- Number Of Participants
- 10
Sites
- Site Name
- Aalborg University Hospital
- Department Name
- Department of Hematology
- Principal Investigator Name
- Paw Jensen
- Principal Investigator Email
- paje@rn.dk
- Contact Person Name
- Paw Jensen
- Contact Person Email
- paje@rn.dk
- Site Name
- Region Midtjylland (Herning)
- Department Name
- Department of Medicine, Section of Hematology
- Principal Investigator Name
- Robert Schou Pedersen
- Principal Investigator Email
- Robert.Schou.Pedersen@goedstrup.rm.dk
- Contact Person Name
- Robert Schou Pedersen
- Contact Person Email
- Robert.Schou.Pedersen@goedstrup.rm.dk
- Site Name
- Region Midtjylland (Aarhus N)
- Department Name
- Department of Hematology
- Principal Investigator Name
- Judit Meszaros Jørgensen
- Principal Investigator Email
- Judit.Joergensen@aarhus.rm.dk
- Contact Person Name
- Judit Meszaros Jørgensen
- Contact Person Email
- Judit.Joergensen@aarhus.rm.dk
- Site Name
- Odense University Hospital
- Department Name
- Department of Hematology
- Principal Investigator Name
- Karen Juul-Jensen
- Principal Investigator Email
- ouh.ode.r.ctis@rsyd.dk
- Contact Person Name
- Karen Juul-Jensen
- Contact Person Email
- ouh.ode.r.ctis@rsyd.dk
Spain
- Earliest CTIS Part Ii Submission Date
- 30-01-2025
- Latest Decision Or Authorization Date
- 12-03-2026
- Processing Time Days
- 407
- Number Of Sites
- 13
- Number Of Participants
- 38
Sites
- Site Name
- Hospital Del Mar
- Department Name
- Hematology
- Principal Investigator Name
- Blanca Sanchez Gonzalez
- Principal Investigator Email
- 97894@parcdesalutmar.cat
- Contact Person Name
- Blanca Sanchez Gonzalez
- Contact Person Email
- 97894@parcdesalutmar.cat
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Hematology
- Principal Investigator Name
- Tycho Baumman
- Principal Investigator Email
- tycho.baumann@gmail.com
- Contact Person Name
- Tycho Baumman
- Contact Person Email
- tycho.baumann@gmail.com
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Hematology
- Principal Investigator Name
- Laura de la Torre Corona
- Principal Investigator Email
- laura.torre.corona.sspa@juntadeandalucia.es
- Contact Person Name
- Laura de la Torre Corona
- Contact Person Email
- laura.torre.corona.sspa@juntadeandalucia.es
- Site Name
- Complejo Hospitalario Universitario Insular Materno Infantil
- Department Name
- Oncology
- Principal Investigator Name
- Delvys Rodriguez Abreu
- Principal Investigator Email
- drodabr@gobiernodecanarias.org
- Contact Person Name
- Delvys Rodriguez Abreu
- Contact Person Email
- drodabr@gobiernodecanarias.org
- Site Name
- Hospital General Universitario Dr. Balmis
- Department Name
- Hematology
- Principal Investigator Name
- Pablo Manresa Manresa
- Principal Investigator Email
- manresa_pab@gva.es
- Contact Person Name
- Pablo Manresa Manresa
- Contact Person Email
- manresa_pab@gva.es
- Site Name
- Institut Catala D'oncologia
- Department Name
- Hematology
- Principal Investigator Name
- Eva Gonzalez Barca
- Principal Investigator Email
- e.gonzalez@iconcologia.net
- Contact Person Name
- Eva Gonzalez Barca
- Contact Person Email
- e.gonzalez@iconcologia.net
- Site Name
- Hospital Universitario Miguel Servet
- Department Name
- Hematology
- Principal Investigator Name
- Araceli Rubio Martínez
- Principal Investigator Email
- arubiom@salud.aragon.es
- Contact Person Name
- Araceli Rubio Martínez
- Contact Person Email
- arubiom@salud.aragon.es
- Site Name
- Hospital Universitario La Paz
- Department Name
- Hematology
- Principal Investigator Name
- Pilar Gomez Prieto
- Principal Investigator Email
- pgprieto@salud.madrid.org
- Contact Person Name
- Pilar Gomez Prieto
- Contact Person Email
- pgprieto@salud.madrid.org
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Oncology
- Principal Investigator Name
- Laura Galvez Carvajal
- Principal Investigator Email
- lauragalvezcarvajal@hotmail.com
- Contact Person Name
- Laura Galvez Carvajal
- Contact Person Email
- lauragalvezcarvajal@hotmail.com
- Site Name
- Hospital Universitario De Cabuenes
- Department Name
- Hematology
- Principal Investigator Name
- Ruben Fernandez Alvarez
- Principal Investigator Email
- ruben.fernandez@sespa.es
- Contact Person Name
- Ruben Fernandez Alvarez
- Contact Person Email
- ruben.fernandez@sespa.es
- Site Name
- Hospital Universitario De Cruces
- Department Name
- Hematology
- Principal Investigator Name
- Xabier Martin Martitegui
- Principal Investigator Email
- xabier.martinmartitegui@osakidetza.eus
- Contact Person Name
- Xabier Martin Martitegui
- Contact Person Email
- xabier.martinmartitegui@osakidetza.eus
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Hematology
- Principal Investigator Name
- Belén Navarro Matilla
- Principal Investigator Email
- mariabelen.navarro@salud.madrid.org
- Contact Person Name
- Belén Navarro Matilla
- Contact Person Email
- mariabelen.navarro@salud.madrid.org
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Hematology
- Principal Investigator Name
- Mariana Bastos Orteiro
- Principal Investigator Email
- marianabeatriz.bastos@salud.madrid.org
- Contact Person Name
- Mariana Bastos Orteiro
- Contact Person Email
- marianabeatriz.bastos@salud.madrid.org
Sponsor
Primary sponsor
- Full Name
- Merck Sharp & Dohme LLC
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- PPD Development LP
- Responsibilities
- Operational third party (sponsor duties code 4)
- Name
- Parexel International Corp.
- Responsibilities
- EUB Call center; Medical information (Physician Consulting)
- Name
- Bioclinica Inc.
- Responsibilities
- Collection and reconciliation of electrocardiograms (ECG); Central imaging (separate entries)
- Name
- Almac Clinical Services LLC
- Responsibilities
- Sponsor duties code 3
- Name
- PPD Global Central Labs
- Responsibilities
- Sponsor duties code 4
- Name
- Signant Health Global Solutions Limited
- Responsibilities
- Sponsor duties code 7
Third parties
- {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Sponsor duties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Collection and reconciliation of electrocardiograms (ECG)","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Bioclinica Inc. (central imaging)","duties_or_roles":"Central imaging","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB Call center; Medical information (Physician Consulting)","organisation_type":"Pharmaceutical company"}
- {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"Sponsor duties codes: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"Sponsor duties codes: 3","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Signant Health Global Solutions Limited","duties_or_roles":"Sponsor duties codes: 7","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Zilovertamab vedotin
- Active Substance
- ZILOVERTAMAB VEDOTIN
- Modality
- ADC
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Starting Dose
- 1.75 mg/kg
- Maximum Dose
- 10.5 mg/kg
- Investigational Product Name
- Rituximab
- Active Substance
- RITUXIMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Starting Dose
- 375 mg/m2
- Maximum Dose
- 3000 mg/m2
- Investigational Product Name
- Cyclophosphamide
- Active Substance
- CYCLOPHOSPHAMIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Maximum Dose
- 4500 mg/m2 (total); max daily 750 mg/m2
- Investigational Product Name
- Doxorubicin
- Active Substance
- DOXORUBICIN HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Maximum Dose
- 300 mg/m2 (total); max daily 50 mg/m2
- Investigational Product Name
- Vincristine
- Active Substance
- VINCRISTINE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Maximum Dose
- 12 mg (total); max daily 2 mg/m2
- Investigational Product Name
- Prednisone / Prednisolone
- Active Substance
- PREDNISOLONE (listed under product as PREDNISONE/PREDNISOLONE)
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Maximum Dose
- 3000 mg total; max daily 100 mg
- Investigational Product Name
- Betamethasone sodium phosphate
- Active Substance
- BETAMETHASONE SODIUM PHOSPHATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Maximum Dose
- 3000 mg total; max daily 100 mg
- Investigational Product Name
- Colony stimulating factors (auxiliary medicinal product)
- Active Substance
- -
- Modality
- Biological
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Maximum Dose
- 0 (document lists % (V/V) and 0 max amounts)
- Combination Treatment
- Yes
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