Spots Global Cancer Trial Database for Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin Lymphoma
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Trial Identification
Brief Title: Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin Lymphoma
Official Title: A Phase 2, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin Lymphoma
Study ID: NCT04052997
Interventions
Study Description
Brief Summary: The purpose of this study is to evaluate the clinical efficacy and safety of Camidanlumab Tesirine (ADCT-301) in participants with relapsed or refractory Hodgkin Lymphoma (HL).
Detailed Description: This is a phase 2, multi-center, open-label, single-arm study of efficacy and safety of Camidanlumab Tesirine (ADCT-301) in participants with relapsed or refractory Hodgkin lymphoma. This study will enroll approximately 100 participants. Camidanlumab Tesirine (ADCT-301) is an antibody drug conjugate (ADC), composed of the human monoclonal antibody, HuMax®-TAC, which is directed against human CD25. The antibody is conjugated through a protease cleavable linker to SG3199, a pyrrolobenzodiazepine (PBD) dimer cytotoxin. For each participant the study will include a screening period (of up to 28 days), a treatment period (cycles of 3 weeks), and a follow-up period (approximately every 12-week visits) for up to 3 years after treatment discontinuation. Participants may continue treatment for up to 1 year or until disease progression, unacceptable toxicity, or other discontinuation criteria, whichever occurs first. Additionally, patients benefiting clinically at 1 year may continue treatment after a case by case review with the Sponsor.
Eligibility
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic - Arizona, Scottsdale, Arizona, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
UCSF Health - Hematology and Blood and Marrow Transplant Clinic, San Francisco, California, United States
Stanford University Medical Center, Stanford, California, United States
Baptist MD Anderson Cancer Center, Jacksonville, Florida, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida, United States
Northside Hospital - Atlanta, Atlanta, Georgia, United States
The University of Chicago Medicine, Chicago, Illinois, United States
Norton Cancer Institute - Saint Matthews, Louisville, Kentucky, United States
University of Minnesota, Minneapolis, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
Washington University School of Medicine in Saint Louis, Saint Louis, Missouri, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Memorial Sloan-Kettering Cancer Center - New York, New York, New York, United States
Stony Brook University Cancer Center, Stony Brook, New York, United States
University Hospitals Seidman Cancer Center, Cleveland, Ohio, United States
Cleveland Clinic - Taussig Cancer Center, Cleveland, Ohio, United States
The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Hollings Cancer Center, Charleston, South Carolina, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
The University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
Froedtert Hospital, Milwaukee, Wisconsin, United States
Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan, Brugge, , Belgium
Cliniques Universitaires Saint-Luc, Brussels, , Belgium
Grand Hôpital de Charleroi - Notre Dame, Charleroi, , Belgium
Hôpital de Jolimont, La Louvière, , Belgium
Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne, Yvoir, , Belgium
British Columbia Cancer Agency, Vancouver, British Columbia, Canada
The Ottawa Hospital - General Campus, Ottawa, , Canada
Princess Margaret Cancer Centre, Toronto, , Canada
Fakultní Nemocnice Brno, Brno, , Czechia
Vseobecna fakultni nemocnice v Praze, Prague, , Czechia
Fakultní Nemocnice Královské Vinohrady, Praha 10, , Czechia
Hôpitaux Universitaires Henri Mondor, Créteil, , France
Hôpital François Mitterrand, Dijon, , France
Clinique Victor Hugo Le Mans, Le Mans, , France
Hôpital Saint-Eloi, Montpellier, , France
Hôpital Haut-Lévêque, Pessac, , France
Centre Hospitalier Lyon-Sud, Pierre-Bénite, , France
Hôpital Pontchaillou, Rennes, , France
Centre de Lutte Contre le Cancer - Centre Henri-Becquerel, Rouen, , France
Universitätsklinikum Halle, Halle, , Germany
Debreceni Egyetem Klinikai Központ, Debrecen, , Hungary
Pécsi Tudományegyetem, Pécs, , Hungary
Azienda Ospedaliera Nazionale SS. Antonio e Biagio e C. Arrigo - Alessandria, Alessandria, , Italy
Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi, Bologna, , Italy
Istituto Clinico Humanitas, Milan, , Italy
Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, , Italy
Istituto Oncologico Veneto - IRCCS, Padova, , Italy
Szpital Wojewódzki w Opolu, Opole, , Poland
Dolnośląskie Centrum Transplantacji Komórkowych z Krajowym Bankiem Dawców Szpiku, Wrocław, , Poland
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Universitari Vall d'Hebrón, Barcelona, , Spain
Hospital Clínic de Barcelona, Barcelona, , Spain
Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet), Barcelona, , Spain
Hospital General Universitario Gregorio Marañón, Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Hospital Universitario HM Sanchinarro, Madrid, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Hospital Universitario Quirónsalud Madrid, Pozuelo De Alarcón, , Spain
Complejo Asistencial Universitario de Salamanca - Hospital Clínico, Salamanca, , Spain
Hospital Universitari i Politècnic La Fe, Valencia, , Spain
Hospital Clínico Universitario de Valencia, València, , Spain
NHS Greater Glasgow and Clyde, Glasgow, , United Kingdom
University College London Hospitals NHS Foundation Trust, London, , United Kingdom
The Royal Marsden NHS Foundation Trust, London, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Oxford University Hospitals NHS Foundation Trust, Oxford, , United Kingdom
University Hospitals Plymouth NHS Trust, Plymouth, , United Kingdom
Contact Details
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