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Spots Global Cancer Trial Database for First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma

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Trial Identification

Brief Title: First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma

Official Title: A Phase 1/2, Open-label Safety Trial of GEN3013 in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma

Study ID: NCT03625037

Interventions

Epcoritamab

Study Description

Brief Summary: The purpose of this trial is to measure the following in participants with relapsed and/or refractory B-cell lymphoma who receive epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20): * The dose schedule for epcoritamab * The side effects seen with epcoritamab * What the body does with epcoritamab once it is administered * What epcoritamab does to the body once it is administered * How well epcoritamab works against relapsed and/or refractory B-cell lymphoma The trial consists of 3 parts: * a dose-escalation part \[Phase 1, first-in-human (FIH)\] * an expansion part (Phase 2a) * a dose-optimization part (OPT) (Phase 2a) The trial time for each participant depends on which trial part the participant enters: * For the dose-escalation part, each participant will be in the trial for approximately 1 year, which is made up of 21 days of screening, 6 months of treatment (the total time of treatment may be different for each participant), and 6 months of follow-up (the total time of follow-up may be different for each participant). * For the expansion and dose-OPT parts, each participant will be in the trial for approximately 1.5 years, which is made up of 21 days of screening, 1 year of treatment (the total time of treatment may be different for each participant), and 6 months of follow-up (the total time of follow-up may be different for each participant). Participation in the study will require visits to the sites. During the first month, participants must visit every day or every few days, depending on which trial part the participant enters. After that, participants must visit weekly, every other week, once a month, and once every 2 months, as trial participation ends. All participants will receive active drug, and no participants will be given placebo.

Detailed Description: The purpose of the dose-escalation part of the trial is to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D), as well as to establish the safety profile of epcoritamab in participants with relapsed or refractory B-cell lymphoma. In the expansion part, additional participants will be treated with epcoritamab, at the RP2D and the purpose is to further explore and determine the safety and efficacy of epcoritamab. The dose-OPT part will evaluate alternative priming and intermediate dose regimens of epcoritamab in participants with: * Diffuse large B-cell lymphoma (DLBCL) * Follicular lymphoma (FL) * Mantle cell lymphoma (MCL) All participants will receive epcoritamab at the RP2D.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Arizona Mayo Clinic, Phoenix, Arizona, United States

University of California at San Francisco, San Francisco, California, United States

Colorado Blood Cancer Institute, Denver, Colorado, United States

H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States

University of Iowa Hospital and Clinics, Iowa City, Iowa, United States

Ochsner Medical Center, New Orleans, Louisiana, United States

University of Michigan, Ann Arbor, Michigan, United States

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States

University of Nebraska Medical Center, Omaha, Nebraska, United States

Hackensack Meridian Health, Hackensack, New Jersey, United States

The Cleveland Clinic Foundation, Cleveland, Ohio, United States

OHSU Knight Cancer Institute, Portland, Oregon, United States

Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

Rhode Island Hospital, Providence, Rhode Island, United States

Medical University of South Carolina, Charleston, South Carolina, United States

UT Southwestern, Dallas, Texas, United States

MD Anderson Cancer Center, Houston, Texas, United States

Monash Health, Clayton, , Australia

Concord Hospital, Concord, , Australia

St. Vincent Hospital, Fitzroy, , Australia

Royal Brisbane and Women's Hospital, Herston, , Australia

Royal Hobart Hospital RHH, Hobart, , Australia

St. George Hospital, Kogarah, , Australia

Cabrini Hospital, Malvern, , Australia

Sir Charles Gairdner Hospital, Nedlands, , Australia

Gold Coast Hospital, Southport, , Australia

Westmead Hospital, Sydney, , Australia

Tom Baker Cancer Care, Calgary, , Canada

Toronto-Sunnybrook Regional Cancer Ctr, Toronto, , Canada

Rigshospitalet, Copenhagen, , Denmark

Odense University Hospital, Odense, , Denmark

Vejle Hospital, Vejle, , Denmark

Helsinki University Hospital, Helsinki, , Finland

Kuopio University Hospital, Kuopio, , Finland

Tampere University Hospital, Tampere, , Finland

Hopital Henri Mondor, Créteil, , France

CHU Montpellier, Montpellier, , France

Hospital Saint-Louis, Paris, , France

Hospices Civils de Lyon Centre Hospitalier Lyon Sud, Pierre-Bénite, , France

Centre Henri Becquerel, Rouen cedex, , France

CHU de Tours-Hopital Bretonneau, Tours, , France

Charite - Universitaetsmedizin Berlin, Berlin, , Germany

Klinik fur Innere Medizin Hamatologie and Onkologie, Berlin, , Germany

Universitaetsklinikum Koeln, Cologne, , Germany

Universitaetsklinikum Essen, Essen, , Germany

Johannes Gutenberg University, Mainz, , Germany

Der Universität Munchen Medizinische Klinik III LMU, München, , Germany

Ao Ss Antonio E Biagio Alessandria, Alessandria, , Italy

Policlinico S. Orsola-Ematologia LA Seragnoli, Bologna, , Italy

Istituto di Candiolo- Fondazione del Piemonte per l'Oncologia, Candiolo, , Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, , Italy

IRCCS Ospedale San Raffaele, Milan, , Italy

Dong-A University Hospital, Busan, , Korea, Republic of

Keimyung University Dongsan Medical Center, Daegu, , Korea, Republic of

National Cancer Center, Goyang-si, , Korea, Republic of

Chonbuk National University Hospital, Jeonju, , Korea, Republic of

Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of

Asan Medical Center, Seoul, , Korea, Republic of

Samsung Medical Center, Seoul, , Korea, Republic of

Seoul National University Hospital, Seoul, , Korea, Republic of

Severance Hospital, Yonsei University, Seoul, , Korea, Republic of

VU University Medical Center, Amsterdam, , Netherlands

Maastricht University Medical Center, Maastricht, , Netherlands

Erasmus MC Cancer Institute, Rotterdam, , Netherlands

Universitair Medisch Centrum Utrecht, Utrecht, , Netherlands

Szpital Uniwersytecki nr 2 im dr. Jana Biziela, Bydgoszcz, , Poland

Uniwersyteckie Centrum Kliniczne, Gdańsk, , Poland

Pratia-McM, Kraków, , Poland

Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka, Słupsk, , Poland

Maria Sklodowska-Curie Memorial Cancer Center and Institute, Warszawa, , Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego, Wrocław, , Poland

National University Hospital, Singapore, , Singapore

Singapore General Hospital, Singapore, , Singapore

Clinica Universidad de Navarra, Pamplona, Navarra, Spain

Hospital Germans Trias i Pujol, Badalona, , Spain

Hospital Universitario Vall dHebron, Barcelona, , Spain

Institut Catala de Oncologia, Barcelona, , Spain

Hospital Universitario Fundacin Jimnez Daz, Madrid, , Spain

Skåne University Hospital, Lund, , Sweden

Karolinska University Hospital Huddinge, Stockholm, , Sweden

Akademiska sjukhuset Uppsala University Hospital, Uppsala, , Sweden

The Christie NHS Foundation Trust, Manchester, , United Kingdom

Plymouth University School of Medicine- Derriford Hospital, Plymouth, , United Kingdom

University Hospital Southampton NHS Foundation Trust, Southampton, , United Kingdom

Royal Marsden NHS Foundation Trust, Sutton, , United Kingdom

Contact Details

Name: Study Official

Affiliation: Genmab

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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