BBR 2778 for Relapsed, Aggressive Non-Hodgkin's Lymphoma (NHL)
NCT ID: NCT00088530
Last Updated: 2020-02-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
140 participants
INTERVENTIONAL
2004-07-31
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental Arm
Pixantrone (BBR2778)
pixantrone, cyclophosphamide, vincristine, rituximab, prednisone
Day 1: pixantrone (150 mg/m2), cyclophosphamide (750 mg/m2), vincristine (1.4 mg/m2), rituximab (375 mg/m2) Days 1-5: prednisone (100 mg/day)
Comparator Arm
To be chosen by the investigator, among vinorelbine, oxaliplatin, ifosfamide, etoposide or mitoxantrone
Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab
Day 1: cyclophosphamide (750 mg/m2), vincristine (1.4 mg/m2), rituximab (375 mg/m2) Days 1-5: prednisone (100 mg/day)
Interventions
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pixantrone, cyclophosphamide, vincristine, rituximab, prednisone
Day 1: pixantrone (150 mg/m2), cyclophosphamide (750 mg/m2), vincristine (1.4 mg/m2), rituximab (375 mg/m2) Days 1-5: prednisone (100 mg/day)
Vinorelbine, Oxalplatin, Ifosfasmide, Etoposide, Mitoxatrone, Gemcitabine or Rituximab
Day 1: cyclophosphamide (750 mg/m2), vincristine (1.4 mg/m2), rituximab (375 mg/m2) Days 1-5: prednisone (100 mg/day)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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CTI BioPharma
INDUSTRY
Responsible Party
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Principal Investigators
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Simran Singh
Role: STUDY_DIRECTOR
Sr. Director, Clinical Operations
Locations
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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.
Paraná, Entre Ríos Province, Argentina
Instituto de Investigaciones Clinicas
Rosario, Santa Fe Province, Argentina
Centro Oncologico Rosario
Rosario, Santa Fe Province, 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.
Córdoba, , 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
Escazú, , 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-Bénite, , France
Hopitaux Universitaires de Strabourg - Hopital de Hautepierre
Strasbourg, , France
Staedtische Kliniken Hoechst
Frankfurt am Main, Hesse, Germany
Charite, Campus Benjamin Franklin
Berlin, , Germany
Klinikum der Universitaet zu Koeln
Cologne, , Germany
Universitatklinik des Saarlandes, Innere Medzin I
Hamburg, , Germany
Westpfalzklinikum Kaiserslautern
Kaiserslautern, , Germany
Kliniken Maria Hilf GmbH
Mönchengladbach, , Germany
Mutterhaus der Borromaeerinne
Trier, , Germany
Szent Laszlo Korhaz
Budapest, , Hungary
Petz Aladar Megyei Okato Korhaz
Győr, , Hungary
Bekes Megyei Pandy Kalman Korhaz
Gyula, , Hungary
Kaposi Mor Megyei Korhaz
Kaposvár, , Hungary
Pecsi Tudomanyegyetem
Pécs, , 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
Manipal, 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
Medellín, Columbia, Mexico
Medical Solutions
Guatemala, Guatemala, Mexico
Complejo Hospitalario "Arnulfo Arias Madrid
Panama City, , 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
Institutul Oncologic "Ion Chiricuta" Oncologie Medicala
Cluj-Napoca, , Romania
Prof. Dr. Ian Chiricuta, Institute of Oncology, Radiotheraphy
Cluj-Napoca, , Romania
Mures County Clinical Hospital
Târgu Mureş, , Romania
State Medical Institution Altai Territorial Oncological Center
Barnaul, , Russia
State Medical Institution Replubican Oncological Center
Bashkortostan, , Russia
State Therapeutical & Prophlatic Institution: Cheylabinsk Regional Oncological Center
Chelyabinsk, , Russia
State Medical Institution
Irkutsk, , Russia
State Medical Institution: Clinical Oncological Center
Krasnodar, , Russia
Russian Oncological Research Center n.a. N.N. Blokhin
Moscow, , Russia
State Institution: Hematological Research Center under the Russian Academy of Medical Sciences
Moscow, , Russia
State Institution: Moscow Regional Research Clinical institute n.a. M.F.
Moscow, , Russia
Semashko Central Clinical Hospital
Moscow, , Russia
Medical Radiological Research Center under the Russian academey of Medical Sciences
Obninsk, , Russia
Research Insitute of Hematology and Blood Transfusion
Saint Petersburg, , Russia
St. Petersburg Pavlov State Medical Clinic of Intensive Care & Bone Marrow Transplantation
Saint Petersburg, , Russia
St. Petersburg State Medical univ. n.a. I.P. Pavlov
Saint Petersburg, , Russia
St. Petersburg State Medical Institution: Municipal Hospital #31
Saint Petersburg, , Russia
Central Research Rontgenological and Radiological Institute
Saint Petersburg, , Russia
State Research Institution: Research Institute of Oncology
Saint Petersburg, , Russia
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
Countries
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References
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Pettengell R, Coiffier B, Narayanan G, de Mendoza FH, Digumarti R, Gomez H, Zinzani PL, Schiller G, Rizzieri D, Boland G, Cernohous P, Wang L, Kuepfer C, Gorbatchevsky I, Singer JW. Pixantrone dimaleate versus other chemotherapeutic agents as a single-agent salvage treatment in patients with relapsed or refractory aggressive non-Hodgkin lymphoma: a phase 3, multicentre, open-label, randomised trial. Lancet Oncol. 2012 Jul;13(7):696-706. doi: 10.1016/S1470-2045(12)70212-7. Epub 2012 May 30.
Related Links
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CTI company website
Other Identifiers
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PIX301
Identifier Type: -
Identifier Source: org_study_id
NCT00101049
Identifier Type: -
Identifier Source: nct_alias
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