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Brief Title: BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL)
Official Title: Pixantrone (BBR 2778) Versus Other Chemotherapeutic Agents for Third-line Single Agent Treatment of Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma: A Randomized, Controlled, Phase III Comparative Trial
Study ID: NCT00088530
Brief Summary: BBR 2778 is a novel aza-anthracenedione that has activity in experimental tumors and shows reduced potential for cardiotoxicity in animal models. This cytotoxic agent has structural similarities with mitoxantrone as well as general similarities with anthracyclines (such as the tricyclic central quinoid chromophore).
Detailed Description: The primary study objective is to compare the efficacy of BBR 2778 to a selection of single agents. Secondary objectives are to compare the safety and tolerability of BBR 2778 to a selection of single agents, and to assess the pharmacokinetic parameters of BBR 2778 in a subset of this patient population.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Robert A. Moss, M.D., FACP, Inc., Fountain Valley, California, United States
UCLA Medical Center, Los Angeles, California, United States
Watson Clinic for Cancer Care and Research, Lakeland, Florida, United States
Rush University Medical Center, Chicago, Illinois, United States
New Mexico Oncology/Hematology, Albuquerque, New Mexico, United States
SUNY Upstate Medical University, Syracuse, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Northwest Kaiser Permanente, Portland, Oregon, United States
Northern Utah Hematology Oncology, P.C., Ogden, Utah, United States
Clinica Modelo S.A., Parana, Entre Rios, Argentina
Instituto de Investigaciones Clinicas, Rosario, Santa Fe, Argentina
Centro Oncologico Rosario, Rosario, Santa Fe, Argentina
FUNDALEU - fundacion para combatir le Leucernia, Buenos Aires, , Argentina
Hospital Universitario Austral, Buenos Aires, , Argentina
Academia Nacional de Medicina, Caba, , Argentina
Hospital Privado Centro Medico de Cordoba S.A., Cordoba, , Argentina
ISIS Clinica Especializada, Santa Fe, , Argentina
University Gernal Hospital for Active Treatment "Alexandrovska" - Clinic of Hematology, Sofia, , Bulgaria
National Centre for Hemotransfusion, Sofia, , Bulgaria
University General Hospital for Active Treatment "St. Marina" Clinic of Hematology, Varna, , Bulgaria
Hospital CIMA San Jose, Escazu, , Costa Rica
Hospital Oncologico de Solca, Capilla Mauta, Guayaquil, Ecuador
Hospital Carlos Andrade Marin Oncologia, Quito,, Pinchincha, Ecuador
Hospital Solca Quito, Quito, , Ecuador
Tartu University Clinics, Hematology Oncology Clinic, Tartu, , Estonia
Institute Bergonie, Bordeaux, , France
Centre Hospitalier Lyo Sud, Service d'Hematologie et d'Oncologie, Pierre-Benite, , France
Hopitaux Universitaires de Strabourg - Hopital de Hautepierre, Strasbourg, , France
Staedtische Kliniken Hoechst, Frankfurt, HE, Germany
Charite, Campus Benjamin Franklin, Berlin, , Germany
Universitatklinik des Saarlandes, Innere Medzin I, Hamburg, , Germany
Westpfalzklinikum Kaiserslautern, Kaiserslautern, , Germany
Klinikum der Universitaet zu Koeln, Koeln, , Germany
Kliniken Maria Hilf GmbH, Moenchengladbach, , Germany
Mutterhaus der Borromaeerinne, Trier, , Germany
Szent Laszlo Korhaz, Budapest, , Hungary
Petz Aladar Megyei Okato Korhaz, Gyor, , Hungary
Bekes Megyei Pandy Kalman Korhaz, Gyula, , Hungary
Kaposi Mor Megyei Korhaz, Kaposvar, , Hungary
Pecsi Tudomanyegyetem, Pecs, , Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Orvos-es Gyogy II, Szeged, , Hungary
Indo-American Cancer Institute & Research Center, Hyderabaad, AndhPrad, India
Nizam's Institute of Medical Sciences, Panjagutta, Hyderabad, India
Manipal Hospital, Bangalore, Karnataka, India
Shirdi Sai Baba Cancer Hospital, K.M.C. Manipal, Manipala, Karna, India
Regional Cancer Center, Thiruvananthapuram, Kerla, India
Bhagwan Mahaveer Cancer Hospital & Research Center, Jaipur, Rajasthan, India
M.S. Ramaiah Medical College, Bangalore, , India
Tata Memorial Hospital, Mumbai, , India
Policlinico S. Orsola, Instituto di Ematologia, Bologna, , Italy
Ospedale Oncologico "A. Businco", Cagliari, , Italy
Ospedale S. Martino, Genova, , Italy
Universita degli Studi Perugia Policlinico Monteluce, Perugia, , Italy
Azienda ospedaliera Pisana "Santa Chiara", Pisa, , Italy
Azienda Ospedaliera Pisanan "Santana Chiara", Pisa, , Italy
Ospedale Oncolgoico Regionale della Basilicata, Rionero in Vulture, , Italy
Ospedale S. Eugenio, Roma, , Italy
Universita La Sapienza, Roma, , Italy
Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, , Italy
Policlinico S. Maria alle Scotte, Siena, , Italy
Presidio San Giuseppe Moscati, Taranto, , Italy
Ospedale Civile, Udine, , Italy
Fundacion Centro De Investigacion, Medellin, Columbia, Mexico
Medical Solutions, Guatimala, Guatemala, Mexico
Complejo Hospitalario "Arnulfo Arias Madrid, Panama, , Panama
Hospital Edgardo Rebagliati Martins, Lima, , Peru
Onococenter, San Borja, , Peru
Klinika Hematologii, Onkologii i Chorob Wewnetrznych, Gdansk, , Poland
Brasov Counthy Hospital, Brasov, , Romania
Colentina Clinical Hospital Hem Dept, Bucharest, , Romania
Fundei Clinical Institute, Bucharest, , Romania
Prof. Dr. Ian Chiricuta, Institute of Oncology, Radiotheraphy, Cluj Napoca, , Romania
Institutul Oncologic "Ion Chiricuta" Oncologie Medicala, Cluj-Napoca, , Romania
Mures County Clinical Hospital, Targu Mures, , Romania
State Medical Institution Altai Territorial Oncological Center, Barnaul, , Russian Federation
State Medical Institution Replubican Oncological Center, Bashkortostan, , Russian Federation
State Therapeutical & Prophlatic Institution: Cheylabinsk Regional Oncological Center, Chelyabinsk, , Russian Federation
State Medical Institution, Irkutsk, , Russian Federation
State Medical Institution: Clinical Oncological Center, Krasnodar, , Russian Federation
Russian Oncological Research Center n.a. N.N. Blokhin, Moscow, , Russian Federation
State Institution: Hematological Research Center under the Russian Academy of Medical Sciences, Moscow, , Russian Federation
State Institution: Moscow Regional Research Clinical institute n.a. M.F., Moscow, , Russian Federation
Semashko Central Clinical Hospital, Moscow, , Russian Federation
Medical Radiological Research Center under the Russian academey of Medical Sciences, Obninsk, , Russian Federation
Research Insitute of Hematology and Blood Transfusion, St. Petersburg, , Russian Federation
St. Petersburg Pavlov State Medical Clinic of Intensive Care & Bone Marrow Transplantation, St. Petersburg, , Russian Federation
St. Petersburg State Medical univ. n.a. I.P. Pavlov, St. Petersburg, , Russian Federation
St. Petersburg State Medical Institution: Municipal Hospital #31, St. Petersburg, , Russian Federation
Central Research Rontgenological and Radiological Institute, St. Petersburg, , Russian Federation
State Research Institution: Research Institute of Oncology, St. Petersburg, , Russian Federation
Institute of Clinical Radiology of the Research Center for Radiation Medicine under the UAMS, Kyiv, , Ukraine
Kyiv Bone Marrow Transplantation, Kyiv, , Ukraine
Institute of Blood Pathology & Transfusion Medicine under the UAMS, Lviv, , Ukraine
Zhtomyr O.F. Gerbachevsky Regional Hospital, Zhytomyr, , Ukraine
Beatson Oncology Centre, Western Infirmary, Glasgow, , United Kingdom
St. Georges Hospital, London, , United Kingdom
Weston Park Hospital, Sheffield, , United Kingdom
Hospital Maciel, Montevideo, , Uruguay
Hospital Policial de Montevideo, Poblado Montevideo Chico, , Uruguay
Name: Simran Singh
Affiliation: Sr. Director, Clinical Operations
Role: STUDY_DIRECTOR