Spots Global Cancer Trial Database for Comparison of Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma or Follicular Grade 3 Lymphoma Who Have Relapsed After Therapy and Are Not Eligible for Stem Cell Transplant
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Trial Identification
Brief Title: Comparison of Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma or Follicular Grade 3 Lymphoma Who Have Relapsed After Therapy and Are Not Eligible for Stem Cell Transplant
Official Title: A Randomized Multicenter Study Comparing Pixantrone + Rituximab With Gemcitabine + Rituximab in Patients With Aggressive B-cell Non-Hodgkin Lymphoma Who Have Relapsed After Therapy With CHOP-R or an Equivalent Regimen and Are Ineligible for Stem Cell Transplant
Study ID: NCT01321541
Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy of Pixantrone + Rituximab compared to Gemcitabine + Rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), or follicular grade 3 lymphoma.
Detailed Description: Eligible patients will be randomized to treatment with pixantrone plus rituximab or gemcitabine plus rituximab in up to six 28-day cycles. At the time patients experience progressive disease during study treatment, early follow- up, or intermediate follow-up, they enter the survival follow up period. Patients who complete study treatment or discontinue study treatment for any other reason will participate in the follow-up periods. Early Follow-Up: After treatment completion or discontinuation, patient will enter a 24-week follow-up period. Intermediate Follow-Up: After completing the 24-week early follow-up period, patient will enter an additional 72-week follow-up period. Survival Follow-Up: All patients will be monitored for survival.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Arizona Clinical Research Center, Tucson, Arizona, United States
Arizona Oncology Associates, Tucson, Arizona, United States
Highlands Oncology Group, Bentonville, Arkansas, United States
Highlands Oncology Group, Fayetteville, Arkansas, United States
Rocky Mountain Cancer Centers, Aurora, Colorado, United States
Rocky Mountain Cancer Centers, Boulder, Colorado, United States
Rocky Mountain Cancer Centers, Denver, Colorado, United States
George Washington University Department of Medicine, Washington, District of Columbia, United States
Integrated Community Oncology Network-St. Vincent's, Jacksonville, Florida, United States
Integrated Community Oncology Network-Southside, Jacksonville, Florida, United States
Integrated Community Oncology Network, Orange Park, Florida, United States
Carle Physician Group, Danville, Illinois, United States
Cancer Care Specialists of Central Illinois, Decatur, Illinois, United States
Crossroads Cancer Center, Effingham, Illinois, United States
Carle Foundation Physician Services, Mattoon, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
Cancer Center of Kansas, Wichita, Kansas, United States
Cancer Center of Kansas, Wichita, Kansas, United States
Baptist Hospital East, Louisville, Kentucky, United States
Harry and Jeanette Weinberg Cancer Institute at Franklin Square, Baltimore, Maryland, United States
Center for Cancer and Blood Disorders, PC, Bethesda, Maryland, United States
Cancer & Hematology Center of Western Michigan, Grand Rapids, Michigan, United States
Metro Minnesota CCOP-Unity Hospital, Fridley, Minnesota, United States
Metro Minnesota CCOP-St. Johns, Maplewood, Minnesota, United States
Metro Minnesota Community Clinical Oncology Program, Saint Louis Park, Minnesota, United States
Metro Minnesota Community Clinical Oncology Program, Saint Louis Park, Minnesota, United States
Metro Minnesota CCOP-Regions Hospital, Saint Paul, Minnesota, United States
Missouri Cancer Associates, Columbia, Missouri, United States
Nebraska Hematology-Oncology, PC, Lincoln, Nebraska, United States
Hematology-Oncology Associates of Northern New Jersey, Morristown, New Jersey, United States
North Shore Hematology/Oncology Associates, East Setauket, New York, United States
Gabrail Cancer Center, Canton, Ohio, United States
Gabrail Cancer Center, Dover, Ohio, United States
Toledo Clinical Cancer Center, Toledo, Ohio, United States
Mercy Cancer Center at St. Anne's, Toledo, Ohio, United States
Toledo Clinic Cancer Center-Toledo, Toledo, Ohio, United States
Northwest Cancer Specialists, PC, Portland, Oregon, United States
Northwest Cancer Specialists, PC, Portland, Oregon, United States
Northwest Cancer Specialists, PC, Tualatin, Oregon, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Upstate Oncology Associates, Greenville, South Carolina, United States
South Carolina Cancer Specialists, Hardeeville, South Carolina, United States
South Carolina Cancer Specialists, Hilton Head Island, South Carolina, United States
Joe Arrington Cancer Research and Treatment Center, Lubbock, Texas, United States
Cancer Care Centers of South Texas-HOAST, New Braunfels, Texas, United States
Cancer Care Centers of South Texas-HOAST, San Antonio, Texas, United States
Blue Ridge Cancer Care, Roanoke, Virginia, United States
Northwest Cancer Specialists, PC, Vancouver, Washington, United States
Northwest Cancer Specialists, PC, Vancouver, Washington, United States
Saint Vincent Hospital Green Bay Oncology, Green Bay, Wisconsin, United States
Green Bay Oncology-St. Mary's Hospital MC, Green Bay, Wisconsin, United States
Medical University Innsbruck, Department of Internal Medicine V (Hematology and Oncology), Innsbruck, , Austria
Hospital Elisabethinen Linz, Internal Department 1 - Hemato-Oncology, Linz, , Austria
Hanusch Hospital, Department of Internal Medicine III, Vienna, , Austria
Saint Luc University Hospital, Department of Hematology, Brussels, , Belgium
General Hospital Delta, Hematology Department, Roeselare, , Belgium
General Hospital Turnhout, Hematology Department, Turnhout, , Belgium
UMHAT "Sveti Georgi", Plovdiv, Clinical Hematology Clinic, Plovdiv, , Bulgaria
UMHAT "Sveti Georgi", Plovdiv, Department of Medical Oncology, Plovdiv, , Bulgaria
MHAT "Tokuda Hospital Sofia", Hematology Clinic, Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Department of Clinical Hematology, Sofia, , Bulgaria
Specialized Hospital For Active Treatment Of Hematological Diseases, Sofia, Clinical Hematology Clinic, Sofia, , Bulgaria
MHAT Hristo Botev, Vratsa, First Department of Internal Medicine, Vratsa, , Bulgaria
University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology, Brno, , Czechia
University Hospital Hradec Kralove, 4th Department of Internal Medicne, Clinical Hematology, Hradec Kralove, , Czechia
University Hospital Ostrava, Institute of Clinical Hematology, Ostrava, , Czechia
University Hospital Kralovske Vinohrady, Department of Clinical Hematology, Prague, , Czechia
General University Hospital in Prague, 1st Department of Internal Medicine - Department of Hematology, Prague, , Czechia
Aalborg University Hospital, Department of Hematology, Aalborg, , Denmark
Service d'hématologie clinique, Avenue Laennec Salouel, Amiens, Cedex 1, , France
Centre hopitalier de la cote basque, Bayonne, , France
Centre hospitalier de Beziers, Beziers, , France
Polyclinique de Bordeaux nord Acquitaine, Bordeaux, , France
Centre hospitalier du Mans, Le Mans Cedex 03, , France
Centre hospitalier Lyon Sud, Pierre Benite Cedex, , France
Saint Quentin Hospital Center, Department of Oncology-Hematology, Saint-Quentin, , France
Hautepierre Hospital, Department of Hematology and Oncology, Strasbourg Cedex, , France
Gemeinschaftspraxis Drs. Klausmann, Aschaffenburg, , Germany
Klinikum Chemnitz gGmbH, Chemnitz, , Germany
Klinik für Innere Medizin III, Frankfurt (a.M.), , Germany
Universitaetsklinikum Halle, Halle (Saale), , Germany
St. Marien Hospital Hamm, Hamm, , Germany
Universitätsklinik Köln, Köln, , Germany
Klinikum Nürnberg Nord, Nürnberg, , Germany
Klinikum Mutterhaus der Borromäerinnen, Trier, , Germany
St. Istvan and St. Laszlo Hospital of Budapest, Budapest, , Hungary
University of Debrecen, Debrecen, , Hungary
Moritz Kaposi General Hospital, Kaposvár, , Hungary
University Hospital "Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi", Ancona, , Italy
Bologna University Hospital Authority St. Orsola-Malpighi Polyclinic, Bologna, , Italy
Scientific Institute of Romagna for the Study and Treatment of Cancer (I.R.S.T.) S.R.L., Meldola, , Italy
"Ospedali Riuniti Villa Sofia-Cervello" Hospital, Palermo, , Italy
Romagna Local Health Authority (AUSL Romagna) - "Santa Maria delle Croci", Ravenna, , Italy
Romagna Local Health Authority (AUSL Romagna) - "Infermi" Hospital, Rimini, , Italy
Siena University Hospital Authority Santa Maria alle Scotte Polyclinic, Siena, , Italy
Santa Maria Hospital, Terni, , Italy
A.O.U. Città della Salute e della Scienza di Torino, Torino, , Italy
Independent Public Healthcare Facility Municipal Hospital Group, Chorzów, , Poland
Marine Hospital of Polish Red Cross, Department of Chemotheraphy, Gdynia, , Poland
Silesia Medical University, Department of Hematology and Bone Marrow Transplantation, Katowice, , Poland
Malopolskie Medical Center S.C. , Department of Hematology, Krakow, , Poland
Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz, Lodz, , Poland
Oncology Center of Lublin Land, Department of Clinical Oncology, Lublin, , Poland
Institute of Hematology and Transfusion Medicine, Clinic of Hematology, Warsaw, , Poland
Wroclaw Medical University, Department and Clinic of Hematology, Blood Neoplasms and Bone Marrow Transplantation, Wroclaw, , Poland
Rapid Diagnosis Polyclinic SA, Brasov, , Romania
Fundeni Clinical Institute Center for Hematology and Bone Marrow Transplantation, Bucharest, , Romania
Bucharest University Emergency Hospital, Hematology Clinic, Bucharest, , Romania
State Budget Healthcare Institution of Sverdlovsk region: Sverdlovsk Regional Clinical Hospital #1, Ekaterinburg, , Russian Federation
Federal State Public Institution: Main Military Clinical Hospital n.a. N.N. Burdenko of the Russian Ministry of Defense, Moscow, , Russian Federation
Moscow State Budget Medical Institution: City Clinical Hospital n.a. S.P.Botkin, Moscow, , Russian Federation
State Medical Institution: Republican Hospital named after V.A. Baranov, Petrozavodsk, , Russian Federation
St. Petersburg Clinical Research and Practical Center for Specialized Types of Medical Care, St. Petersburg, , Russian Federation
State Healthcare Institution: Republican Clinical Oncology Center, Ufa, , Russian Federation
University Hospital with Outpatient Clinic F.D. Roosevelt Banska Bystrica, Department of Hematology, Banska Bystrica, , Slovakia
National Cancer Institute, Department of Hematology and Transfusiology, Bratislava, , Slovakia
University Hospital Martin, Department of Hematology and Transfusiology, Martin, , Slovakia
J. A. Reiman University Hospital with Polyclinic in Presov, Presov, , Slovakia
A Coruña University Hospital, A Coruña, , Spain
Hospital Universitario Vall Hebrón, Barcelona, , Spain
Hospital Iniversitario Puerta del Mar, Cadiz, , Spain
Institut Català de Oncologia (ICO), Hospital Dr Trueta, Girona, , Spain
Hospital Iniversitario La Paz, Madrid, , Spain
Hospital Universitario Araba, Vitoria, , Spain
Cherkasy Regional Oncology Center, Regional Treatment and Diagnostic Hematology Center, Cherkasy, , Ukraine
Kharkiv Regional Clinical Oncology Center, Kharkiv, , Ukraine
National Institute of Cancer, Kyiv, , Ukraine
State Institution: Institute of Blood Pathology and Transfusion Medicine, Lviv, , Ukraine
Beatson West of Scotland Cancer Center, Glasgow, , United Kingdom
St. George's Healthcare NHS Trust, London, , United Kingdom
Christie Hospital, Department of Medical Oncology, Manchester, , United Kingdom
Contact Details
Name: Simran B Singh, MS, GWCP
Affiliation: Sr. Director, Clinical Operations
Role: STUDY_DIRECTOR
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