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
Status: Completed
Location: See all (126) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Diagnosis of DLBCL (de novo DLBCL, or transformed from indolent lymphoma) or follicular grade 3 lymphoma on the basis of tissue biopsy.
• Patients with de novo DLBCL must have received 1-3 treatment regimens for DLBCL. Patients with follicular grade 3 lymphoma must have received 1-3 treatment regimens for follicular lymphoma (any grade). Patients with DLBCL transformed from indolent lymphoma must have received at least 1-4 treatment regimens for NHL.
• Received rituximab containing a multi-agent therapy for the treatment of NHL.
• Not eligible for high-dose chemotherapy and stem cell transplant.
• Patients with DLBCL transformed from indolent lymphoma must have had a complete or partial response to a therapy for NHL lasting at least 12 weeks.
Locations
United States
Arkansas
Highlands Oncology Group
Bentonville
Highlands Oncology Group
Fayetteville
Arizona
Arizona Clinical Research Center
Tucson
Arizona Oncology Associates
Tucson
Colorado
Rocky Mountain Cancer Centers
Aurora
Rocky Mountain Cancer Centers
Boulder
Rocky Mountain Cancer Centers
Denver
Washington, D.c.
George Washington University Department of Medicine
Washington
Florida
Integrated Community Oncology Network-Southside
Jacksonville
Integrated Community Oncology Network-St. Vincent's
Jacksonville
Integrated Community Oncology Network
Orange Park
Illinois
Carle Physician Group
Danville
Cancer Care Specialists of Central Illinois
Decatur
Crossroads Cancer Center
Effingham
Carle Foundation Physician Services
Mattoon
Carle Cancer Center
Urbana
Kansas
Cancer Center of Kansas
Wichita
Cancer Center of Kansas
Wichita
Kentucky
Baptist Hospital East
Louisville
Maryland
Harry and Jeanette Weinberg Cancer Institute at Franklin Square
Baltimore
Center for Cancer and Blood Disorders, PC
Bethesda
Michigan
Cancer & Hematology Center of Western Michigan
Grand Rapids
Minnesota
Metro Minnesota CCOP-Unity Hospital
Fridley
Metro Minnesota CCOP-St. Johns
Maplewood
Metro Minnesota Community Clinical Oncology Program
Saint Louis Park
Metro Minnesota Community Clinical Oncology Program
Saint Louis Park
Metro Minnesota CCOP-Regions Hospital
Saint Paul
Missouri
Missouri Cancer Associates
Columbia
Nebraska
Nebraska Hematology-Oncology, PC
Lincoln
New Jersey
Hematology-Oncology Associates of Northern New Jersey
Morristown
New York
North Shore Hematology/Oncology Associates
East Setauket
Ohio
Gabrail Cancer Center
Canton
Gabrail Cancer Center
Dover
Mercy Cancer Center at St. Anne's
Toledo
Toledo Clinic Cancer Center-Toledo
Toledo
Toledo Clinical Cancer Center
Toledo
Oregon
Northwest Cancer Specialists, PC
Portland
Northwest Cancer Specialists, PC
Portland
Northwest Cancer Specialists, PC
Tualatin
Pennsylvania
Fox Chase Cancer Center
Philadelphia
South Carolina
Upstate Oncology Associates
Greenville
South Carolina Cancer Specialists
Hardeeville
South Carolina Cancer Specialists
Hilton Head Island
Texas
Joe Arrington Cancer Research and Treatment Center
Lubbock
Cancer Care Centers of South Texas-HOAST
New Braunfels
Cancer Care Centers of South Texas-HOAST
San Antonio
Virginia
Blue Ridge Cancer Care
Roanoke
Washington
Northwest Cancer Specialists, PC
Vancouver
Northwest Cancer Specialists, PC
Vancouver
Wisconsin
Green Bay Oncology-St. Mary's Hospital MC
Green Bay
Saint Vincent Hospital Green Bay Oncology
Green Bay
Other Locations
Austria
Medical University Innsbruck, Department of Internal Medicine V (Hematology and Oncology)
Innsbruck
Hospital Elisabethinen Linz, Internal Department 1 - Hemato-Oncology
Linz
Hanusch Hospital, Department of Internal Medicine III
Vienna
Belgium
Saint Luc University Hospital, Department of Hematology
Brussels
General Hospital Delta, Hematology Department
Roeselare
General Hospital Turnhout, Hematology Department
Turnhout
Bulgaria
UMHAT Sveti Georgi, Plovdiv, Clinical Hematology Clinic
Plovdiv
UMHAT Sveti Georgi, Plovdiv, Department of Medical Oncology
Plovdiv
MHAT Tokuda Hospital Sofia, Hematology Clinic
Sofia
Specialized Hospital For Active Treatment Of Hematological Diseases, Sofia, Clinical Hematology Clinic
Sofia
University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski, Department of Clinical Hematology
Sofia
MHAT Hristo Botev, Vratsa, First Department of Internal Medicine
Vratsa
Denmark
Aalborg University Hospital, Department of Hematology
Aalborg
France
Service d'hématologie clinique, Avenue Laennec Salouel
Amiens, Cedex 1
Centre hopitalier de la cote basque
Bayonne
Centre hospitalier de Beziers
Beziers
Polyclinique de Bordeaux nord Acquitaine
Bordeaux
Centre hospitalier du Mans
Le Mans Cedex 03
Centre hospitalier Lyon Sud
Pierre Benite Cedex
Saint Quentin Hospital Center, Department of Oncology-Hematology
Saint-quentin
Hautepierre Hospital, Department of Hematology and Oncology
Strasbourg Cedex
Germany
Gemeinschaftspraxis Drs. Klausmann
Aschaffenburg
Klinikum Chemnitz gGmbH
Chemnitz
Klinik für Innere Medizin III
Frankfurt (a.m.)
Universitaetsklinikum Halle
Halle (saale)
St. Marien Hospital Hamm
Hamm
Universitätsklinik Köln
Köln
Klinikum Nürnberg Nord
Nürnberg
Klinikum Mutterhaus der Borromäerinnen
Trier
Hungary
St. Istvan and St. Laszlo Hospital of Budapest
Budapest
University of Debrecen
Debrecen
Moritz Kaposi General Hospital
Kaposvár
Italy
University Hospital Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi
Ancona
Bologna University Hospital Authority St. Orsola-Malpighi Polyclinic
Bologna
Scientific Institute of Romagna for the Study and Treatment of Cancer (I.R.S.T.) S.R.L.
Meldola
Ospedali Riuniti Villa Sofia-Cervello Hospital
Palermo
Romagna Local Health Authority (AUSL Romagna) - Santa Maria delle Croci
Ravenna
Romagna Local Health Authority (AUSL Romagna) - Infermi Hospital
Rimini
Siena University Hospital Authority Santa Maria alle Scotte Polyclinic
Siena
Santa Maria Hospital
Terni
A.O.U. Città della Salute e della Scienza di Torino
Torino
Poland
Independent Public Healthcare Facility Municipal Hospital Group
Chorzów
Marine Hospital of Polish Red Cross, Department of Chemotheraphy
Gdynia
Silesia Medical University, Department of Hematology and Bone Marrow Transplantation
Katowice
Malopolskie Medical Center S.C. , Department of Hematology
Krakow
Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz
Lodz
Oncology Center of Lublin Land, Department of Clinical Oncology
Lublin
Institute of Hematology and Transfusion Medicine, Clinic of Hematology
Warsaw
Wroclaw Medical University, Department and Clinic of Hematology, Blood Neoplasms and Bone Marrow Transplantation
Wroclaw
Romania
Rapid Diagnosis Polyclinic SA
Brasov
Bucharest University Emergency Hospital, Hematology Clinic
Bucharest
Fundeni Clinical Institute Center for Hematology and Bone Marrow Transplantation
Bucharest
Russian Federation
State Budget Healthcare Institution of Sverdlovsk region: Sverdlovsk Regional Clinical Hospital #1
Ekaterinburg
Federal State Public Institution: Main Military Clinical Hospital n.a. N.N. Burdenko of the Russian Ministry of Defense
Moscow
Moscow State Budget Medical Institution: City Clinical Hospital n.a. S.P.Botkin
Moscow
State Medical Institution: Republican Hospital named after V.A. Baranov
Petrozavodsk
St. Petersburg Clinical Research and Practical Center for Specialized Types of Medical Care
St. Petersburg
State Healthcare Institution: Republican Clinical Oncology Center
Ufa
Slovakia
University Hospital with Outpatient Clinic F.D. Roosevelt Banska Bystrica, Department of Hematology
Banska Bystrica
National Cancer Institute, Department of Hematology and Transfusiology
Bratislava
University Hospital Martin, Department of Hematology and Transfusiology
Martin
J. A. Reiman University Hospital with Polyclinic in Presov
Presov
Spain
A Coruña University Hospital
A Coruña
Hospital Universitario Vall Hebrón
Barcelona
Hospital Iniversitario Puerta del Mar
Cadiz
Institut Català de Oncologia (ICO), Hospital Dr Trueta
Girona
Hospital Iniversitario La Paz
Madrid
Hospital Universitario Araba
Vitoria
Ukraine
Cherkasy Regional Oncology Center, Regional Treatment and Diagnostic Hematology Center
Cherkasy
Kharkiv Regional Clinical Oncology Center
Kharkiv
National Institute of Cancer
Kyiv
State Institution: Institute of Blood Pathology and Transfusion Medicine
Lviv
United Kingdom
Beatson West of Scotland Cancer Center
Glasgow
St. George's Healthcare NHS Trust
London
Christie Hospital, Department of Medical Oncology
Manchester
Time Frame
Start Date: 2011-04-20
Completion Date: 2018-09-14
Participants
Target number of participants: 312
Treatments
Experimental: Pixantrone + Rituximab
Pixantrone and Rituximab
Active_comparator: Gemcitabine + Rituximab
Gemcitabine and Rituximab
Authors
Related Therapeutic Areas
Sponsors
Leads: CTI BioPharma