BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL)
Lymphoma, Non-Hodgkin
About this trial
This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring Pixantrone, Non-Hodgkins lymphoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed aggressive [de novo or transformed] NHL according to REAL/WHO classification. At least one objectively measurable lesion as demonstrated by CT, spiral CT, or MRI and plain radiograph of the chest (chest x-ray, for chest lesions only) that can be followed for response as target lesion. Relapse after 2 or more prior regimens of chemotherapy ECOG performance status of 0, 1, or 2 Adequate hematologic, renal and hepatic function LVEF ≥50% determined by MUGA scan Exclusion Criteria: Prior treatment with a cumulative dose of doxorubicin or equivalent exceeding 450 mg/m² Prior allogenic stem cell transplant Histological diagnosis of Burkitt lymphoma, lymphoblastic lymphoma or Mantle cell lymphoma Active CNS lymphoma or HIV-related lymphoma. Any chemotherapy, radiotherapy, or other anticancer treatment (including corticosteroid, 10 or more mg/day of prednisone or equivalent) within the 2 weeks before randomization Pregnant women or nursing mothers
Sites / Locations
- Robert A. Moss, M.D., FACP, Inc.
- UCLA Medical Center
- Watson Clinic for Cancer Care and Research
- Rush University Medical Center
- New Mexico Oncology/Hematology
- SUNY Upstate Medical University
- Duke University Medical Center
- Northwest Kaiser Permanente
- Northern Utah Hematology Oncology, P.C.
- Clinica Modelo S.A.
- Instituto de Investigaciones Clinicas
- Centro Oncologico Rosario
- FUNDALEU - fundacion para combatir le Leucernia
- Hospital Universitario Austral
- Academia Nacional de Medicina
- Hospital Privado Centro Medico de Cordoba S.A.
- ISIS Clinica Especializada
- University Gernal Hospital for Active Treatment "Alexandrovska" - Clinic of Hematology
- National Centre for Hemotransfusion
- University General Hospital for Active Treatment "St. Marina" Clinic of Hematology
- Hospital CIMA San Jose
- Hospital Oncologico de Solca
- Hospital Carlos Andrade Marin Oncologia
- Hospital Solca Quito
- Tartu University Clinics, Hematology Oncology Clinic
- Institute Bergonie
- Centre Hospitalier Lyo Sud, Service d'Hematologie et d'Oncologie
- Hopitaux Universitaires de Strabourg - Hopital de Hautepierre
- Staedtische Kliniken Hoechst
- Charite, Campus Benjamin Franklin
- Universitatklinik des Saarlandes, Innere Medzin I
- Westpfalzklinikum Kaiserslautern
- Klinikum der Universitaet zu Koeln
- Kliniken Maria Hilf GmbH
- Mutterhaus der Borromaeerinne
- Szent Laszlo Korhaz
- Petz Aladar Megyei Okato Korhaz
- Bekes Megyei Pandy Kalman Korhaz
- Kaposi Mor Megyei Korhaz
- Pecsi Tudomanyegyetem
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Orvos-es Gyogy II
- Indo-American Cancer Institute & Research Center
- Nizam's Institute of Medical Sciences
- Manipal Hospital
- Shirdi Sai Baba Cancer Hospital, K.M.C. Manipal
- Regional Cancer Center
- Bhagwan Mahaveer Cancer Hospital & Research Center
- M.S. Ramaiah Medical College
- Tata Memorial Hospital
- Policlinico S. Orsola, Instituto di Ematologia
- Ospedale Oncologico "A. Businco"
- Ospedale S. Martino
- Universita degli Studi Perugia Policlinico Monteluce
- Azienda ospedaliera Pisana "Santa Chiara"
- Azienda Ospedaliera Pisanan "Santana Chiara"
- Ospedale Oncolgoico Regionale della Basilicata
- Ospedale S. Eugenio
- Universita La Sapienza
- Ospedale Casa Sollievo della Sofferenza
- Policlinico S. Maria alle Scotte
- Presidio San Giuseppe Moscati
- Ospedale Civile
- Fundacion Centro De Investigacion
- Medical Solutions
- Complejo Hospitalario "Arnulfo Arias Madrid
- Hospital Edgardo Rebagliati Martins
- Onococenter
- Klinika Hematologii, Onkologii i Chorob Wewnetrznych
- Brasov Counthy Hospital
- Colentina Clinical Hospital Hem Dept
- Fundei Clinical Institute
- Prof. Dr. Ian Chiricuta, Institute of Oncology, Radiotheraphy
- Institutul Oncologic "Ion Chiricuta" Oncologie Medicala
- Mures County Clinical Hospital
- State Medical Institution Altai Territorial Oncological Center
- State Medical Institution Replubican Oncological Center
- State Therapeutical & Prophlatic Institution: Cheylabinsk Regional Oncological Center
- State Medical Institution
- State Medical Institution: Clinical Oncological Center
- Russian Oncological Research Center n.a. N.N. Blokhin
- State Institution: Hematological Research Center under the Russian Academy of Medical Sciences
- State Institution: Moscow Regional Research Clinical institute n.a. M.F.
- Semashko Central Clinical Hospital
- Medical Radiological Research Center under the Russian academey of Medical Sciences
- Research Insitute of Hematology and Blood Transfusion
- St. Petersburg Pavlov State Medical Clinic of Intensive Care & Bone Marrow Transplantation
- St. Petersburg State Medical univ. n.a. I.P. Pavlov
- St. Petersburg State Medical Institution: Municipal Hospital #31
- Central Research Rontgenological and Radiological Institute
- State Research Institution: Research Institute of Oncology
- Institute of Clinical Radiology of the Research Center for Radiation Medicine under the UAMS
- Kyiv Bone Marrow Transplantation
- Institute of Blood Pathology & Transfusion Medicine under the UAMS
- Zhtomyr O.F. Gerbachevsky Regional Hospital
- Beatson Oncology Centre, Western Infirmary
- St. Georges Hospital
- Weston Park Hospital
- Hospital Maciel
- Hospital Policial de Montevideo
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Experimental Arm
Comparator Arm
Pixantrone (BBR2778)
To be chosen by the investigator, among vinorelbine, oxaliplatin, ifosfamide, etoposide or mitoxantrone