Spots Global Cancer Trial Database for Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL
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Trial Identification
Brief Title: Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL
Official Title: A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Lenalidomide Combined With MOR00208 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL)
Study ID: NCT02399085
Conditions
Study Description
Brief Summary: This is a Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Lenalidomide Combined with MOR00208 in Participants with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL).
Detailed Description: The aim of this single-arm, multicentre, open-label Phase II study is to evaluate the Lenalidomide (LEN) combined with Tafasitamab (MOR00208) in adult participants with DLBCL who had relapsed after or were refractory to at least one, but no more than three previous systemic regimens administered for the treatment of their DLBCL and who were not candidates for high-dose chemotherapy and subsequent Autologous stem cell transplants and were thus considered to have exhausted their therapeutic options. One prior therapy line had to include an anti-CD20 targeted therapy (e.g., rituximab \[RTX\]). MOR00208 and LEN were administered for up to 12 cycles (28 days each), followed by MOR00208 monotherapy until progression, in participants with at least stable disease or a better response.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center, Bakersfield, California, United States
UCLA - David Geffen School of Medicine, Los Angeles, California, United States
Cancer Care - Torrance Memorial Physician Network, Redondo Beach, California, United States
Central Coast Medical Oncology Corporation, Santa Maria, California, United States
St. Mary's Hospital And Regional Medical Center, Grand Junction, Colorado, United States
Norwalk Hospital, Norwalk, Connecticut, United States
St. Joseph Mercy Hospital Cancer Care Center, Ypsilanti, Michigan, United States
Ohio State University Medical Center, Columbus, Ohio, United States
Charleston Hematology Oncology Associates, Charleston, South Carolina, United States
Tyler Hematology-Oncology, Tyler, Texas, United States
ZNA Middelheim dep Klinische studies Hematologie, Antwerp, , Belgium
AZ Groeninge-Campus Maria's Voorzienigheid, Kortrijk, , Belgium
Centre Hospitalier Universitaire (CHU) de Liege, Liege, , Belgium
Clinique Universitaire de Mont Godinne, Yvoir, , Belgium
University Hospital Olomouc Hematoonkologicka klinika, Olomouc, , Czechia
CHU De Clermont Ferrand - Hopital Estaing Service Hematologie Clinique Et Thrapie Cellulaire, Clermont-Ferrand, , France
Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren, Limoges, , France
Centre Hospitalier Lyon-Sud (CHLS), Lyon, , France
Hopital Universitaire Necker Enfants Malades Service de Hematologie Adultes, Paris, , France
Universitatsklinikum Essen, Abteilung Haematologie, Essen, , Germany
Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF), Frankfurt, , Germany
Klinikum Grosshadern-Klinikum Der Ludwig-Maximilian Universitaet Muenchen, Munich, , Germany
Klinikum Nuernberg Nord Medizinische Klinik 5 Hamatologie, Nürnberg, , Germany
Universitaetsklinikum Wuerzburg, Würzburg, , Germany
Semmelweis Egyetem I. Sz. Belgyogyaszati Klinika-Semmelweis University, Budapest, , Hungary
National Institute of Oncology Hematological Department, Budapest, , Hungary
DEKK, Belgyogyaszati Klinika, Debrecen, , Hungary
Somogy Megyei Kaposi Mor Oktato Korhaz (Kaposi Mor County Hospital), Kaposvár, , Hungary
Azienda Ospedaliera Univerisitaria Policlinico Consorziale Di Bari UOC Ematologia con Trapianto, Bari, , Italy
Ist.Ematologia E Oncologia Medica L.E A.Seragnoli Azienda Ospedaliero-Universitaria, Policlinico S.Orsola-Malpighi, Bologna, , Italy
Azienda Ospedaliero Universitaria Careggi-S.O.D. Patologia Medica, Firenze, , Italy
Azienda Ospedaliero - Universitaria Policlinico di Modena Dip di Medicina Diagnostica, Clinica e di Sanità Pubblica, Modena, , Italy
AOU Maggiore della Cartia, Novara, , Italy
A .O. S. Maria della Misericordia, Perugia, , Italy
Tor Vergata University Department Of Hematology, Roma, , Italy
Az Ospedaliera Santa Maria Facolta di Medicina e Chirurgia, Terni, , Italy
A.O.U. Citta della Salute e della Scienza di Torino, Torino, , Italy
Pratia MCM Krakow, Krakow, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warmimsko, Olsztyn, , Poland
Szpital Wojewodzk I w Opolu SP ZOZ Oddzial Hematologii i Onkologii Hematologicznej, Opole, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych w Poznaniu im. prof. Ludwika Bierkowskiego, Poznan, , Poland
Szpital Wojewodzki Nr 1 im. Fryderyka Chopina w Rzeszowie, Rzeszow, , Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy, Warsaw, , Poland
MTZ Clinical Research Sp. z o.o, Warszawa, , Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Klinika Nowotworow Ukladu Chlonnego Ul., Warszawa, , Poland
Hospital Universitari Germans Trias i Pujol (HUGTP), Badalona, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Institut Catala D'Oncologia-Hospital Duran Y Reynals, Barcelona, , Spain
Hospital Universitario Fundacion Jimenez Diaz Servicio de Hematologia Unidad de Linformas Oncohealth Institute, Madrid, , Spain
Hospital Universitario Puerta de Hierro de Majadahonda, Madrid, , Spain
Complejo Hospitalario de Navarra (CHN), Pamplona, , Spain
Hospital Universitario Quiron Salud Madrid, Pozuelo De Alarcón, , Spain
Hospital Universitario Virgen del Rocio, Hospital de la Mujer Servicio de Hematologia, Sevilla, , Spain
The Royal Bournemouth & Christchurch Hospitals, Bournemouth, , United Kingdom
Royal Liverpool University Hospital - Liverpool University Hospitals NHS Foundation Trust, Liverpool, , United Kingdom
Sarah Cannon Research Institute, London, , United Kingdom
The Newcastle Hospitals NHS Foundation Trust, Newcastle, , United Kingdom
Contact Details
Name: Johannes Duell, MD
Affiliation: MorphoSys AG
Role: PRINCIPAL_INVESTIGATOR
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