Spots Global Cancer Trial Database for Safety and Efficacy Study of Loncastuximab Tesirine + Ibrutinib in Diffuse Large B-Cell or Mantle Cell Lymphoma
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Trial Identification
Brief Title: Safety and Efficacy Study of Loncastuximab Tesirine + Ibrutinib in Diffuse Large B-Cell or Mantle Cell Lymphoma
Official Title: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of Loncastuximab Tesirine and Ibrutinib in Patients With Advanced Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma (LOTIS-3)
Study ID: NCT03684694
Study Description
Brief Summary: The purpose of this Phase 1/2 study is to evaluate the safety and efficacy of Loncastuximab Tesirine (ADCT-402) in combination with Ibrutinib in participants with Advanced Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma.
Detailed Description: The Phase 1 portion of the study will cover the dose escalation portion of the study. This will then be followed by the Phase 2 portion of the study, which will treat participants with the dose of loncastuximab tesirine determined in the Phase 1 portion of the study. The ibrutinib dose of 560 mg daily, will remain the same throughout both phases of the study. A standard 3+3 dose escalation design will be used for the Phase 1 portion of the study. The dose-limiting toxicity (DLT) period will be the 21 days following the first dose of ibrutinib. The dose escalation cohort will receive loncastuximab tesirine for 2 cycles with concurrent ibrutinib (concomitant therapy) and may then continue ibrutinib therapy up to one year. The Phase 2 portion of the study will involve 3 cohorts: * Non-germinal center B-cell diffuse large B-cell lymphoma (Non-GCB DLBCL) cohort * Germinal center B-cell diffuse large B-cell lymphoma (GCB DLBCL) cohort * Mantle cell lymphoma (MCL) cohort Each of the cohorts will be treated with the recommended dose of loncastuximab tesirine determined in the Phase 1 portion of the study. The study will include a Screening Period (of up to 28 days), a Treatment Period (cycles of 3 to 4 weeks), and a Follow-up Period (approximately every 12 week visits for up to 2 years after treatment discontinuation).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California Irvine Health Chao Family Comprehensive Cancer Center, Orange, California, United States
Redlands Community Hospital, Redlands, California, United States
University of Miami, Miami, Florida, United States
Miami Cancer Institute, Miami, Florida, United States
The Blood and Marrow Transplant Group of Georgia, Atlanta, Georgia, United States
Georgia Cancer Center at Augusta University, Augusta, Georgia, United States
Norton Cancer Institute, St. Matthews Campus, Louisville, Kentucky, United States
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
University of Minnesota, Minneapolis, Minnesota, United States
Saint Vincent Healthcare, Billings, Montana, United States
Case Western Reserve University, Cleveland, Ohio, United States
GasthuisZusters Antwerpen Sint-Augustinus, Wilrijk, , Belgium
CHU UCL Namur (Site Godinne), Yvoir, , Belgium
Centre Hospitalier Universitaire de Rennes Hôpital Pontchailou, Bretagne, , France
Hôpital Hôtel-Dieu, Loiré, , France
Hôpital Saint-Eloi, Montpellier, , France
Hôpital Saint-Louis, Paris, , France
Centre Hospitalier Lyon Sud, Pierre-Bénite, , France
Centre Hospitalier Universitaire De Poitier - Hopital De La Miletrie - Hopital Jean Bernard, Poitiers, , France
IRCCS istituto Clinico Humanitas U.O. di Oncologia ed Ematologia, Via Manzoni, Rozzano, Italy
Azienda Ospedaliera Pap Giovanni XXIII, Bergamo, , Italy
Policlinico Sant'Orsola Malpighi, Bologna, , Italy
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia, Brescia, , Italy
Istituto Scientifico Rmagnolo per lo Studio e la Cura dei Tumori, Meldola FC, , Italy
Istituto Europeo di Oncologia, Milano, , Italy
Azienda Unita Sanitaria Locale de Ravenna, Ravenna, , Italy
Hospital Universitario Vall d'Hebrón, Barcelona, , Spain
Hospital Duran I Reynals, Barcelona, , Spain
Hospital General Universitario Gregorio Marañón, Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz, Madrid, , Spain
Hospital Universitario Marqués de Valdecilla, Santander, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Abertawe Bro Morgannwg University Health Board, Swansea, , United Kingdom
Contact Details
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