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
NCT ID: NCT01321541
Last Updated: 2021-11-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
312 participants
INTERVENTIONAL
2011-04-20
2018-09-14
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Pixantrone + Rituximab
Pixantrone and Rituximab
Pixantrone + Rituximab
Pixantrone + Rituximab: Rituximab 375 mg/m2 IV on day 1 and pixantrone 50 mg/m2 (equivalent to 85mg/m2 pixantrone dimaleate)IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered.
Gemcitabine + Rituximab
Gemcitabine and Rituximab
Gemcitabine + Rituximab
Gemcitabine + Rituximab: Rituximab 375 mg/m2 IV on day 1 and gemcitabine 1000 mg/m2 IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered.
Interventions
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Pixantrone + Rituximab
Pixantrone + Rituximab: Rituximab 375 mg/m2 IV on day 1 and pixantrone 50 mg/m2 (equivalent to 85mg/m2 pixantrone dimaleate)IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered.
Gemcitabine + Rituximab
Gemcitabine + Rituximab: Rituximab 375 mg/m2 IV on day 1 and gemcitabine 1000 mg/m2 IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered.
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Received rituximab containing a multi-agent therapy for the treatment of NHL.
4. Not eligible for high-dose chemotherapy and stem cell transplant.
5. 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.
Exclusion Criteria
2. Prior treatment with cumulative dose of doxorubicin or equivalent exceeding 450 mg/m2
3. Any experimental therapy ≤ 28 days prior to randomization
4. Other malignancy within last 5 years except for the following: curatively treated basal cell/squamous cell skin cancer, carcinoma in situ of the cervix, superficial transitional cell bladder carcinoma, or in situ ductal carcinoma of the breast after complete resection
5. Any contraindication or known allergy or hypersensitivity to any study drugs
6. Concomitant therapy with any anticancer agents, immunosuppressive agents, other investigational anticancer therapies. Low-dose corticosteroids for the treatment of non cancer-related illnesses are permitted.
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 B Singh, MS, GWCP
Role: STUDY_DIRECTOR
Sr. Director, Clinical Operations
Locations
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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 D.C., 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 Králové, , 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, , France
Centre hopitalier de la cote basque
Bayonne, , France
Centre hospitalier de Beziers
Béziers, , France
Polyclinique de Bordeaux nord Acquitaine
Bordeaux, , France
Centre hospitalier du Mans
Le Mans, , France
Centre hospitalier Lyon Sud
Pierre-Bénite, , France
Saint Quentin Hospital Center, Department of Oncology-Hematology
Saint-Quentin, , France
Hautepierre Hospital, Department of Hematology and Oncology
Strasbourg, , France
Gemeinschaftspraxis Drs. Klausmann
Aschaffenburg, , Germany
Klinikum Chemnitz gGmbH
Chemnitz, , Germany
Universitätsklinik Köln
Cologne, , Germany
Klinik für Innere Medizin III
Frankfurt (a.M.), , Germany
Universitaetsklinikum Halle
Halle, , Germany
St. Marien Hospital Hamm
Hamm, , Germany
Klinikum Nürnberg Nord
Nuremberg, , 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
Federal State Public Institution: Main Military Clinical Hospital n.a. N.N. Burdenko of the Russian Ministry of Defense
Moscow, , Russia
Moscow State Budget Medical Institution: City Clinical Hospital n.a. S.P.Botkin
Moscow, , Russia
State Medical Institution: Republican Hospital named after V.A. Baranov
Petrozavodsk, , Russia
St. Petersburg Clinical Research and Practical Center for Specialized Types of Medical Care
Saint Petersburg, , Russia
State Healthcare Institution: Republican Clinical Oncology Center
Ufa, , Russia
State Budget Healthcare Institution of Sverdlovsk region: Sverdlovsk Regional Clinical Hospital #1
Yekaterinburg, , Russia
University Hospital with Outpatient Clinic F.D. Roosevelt Banska Bystrica, Department of Hematology
Banská 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
Prešov, , 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-Gasteiz, , 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
Countries
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References
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Pettengell R, Dlugosz-Danecka M, Andorsky D, Belada D, Georgiev P, Quick D, Singer JW, Singh SB, Pallis A, Egorov A, Salles G. Pixantrone plus rituximab versus gemcitabine plus rituximab in patients with relapsed aggressive B-cell non-Hodgkin lymphoma not eligible for stem cell transplantation: a phase 3, randomized, multicentre trial (PIX306). Br J Haematol. 2020 Jan;188(2):240-248. doi: 10.1111/bjh.16255. Epub 2019 Dec 27.
Belada D, Georgiev P, Dakhil S, Inhorn LF, Andorsky D, Beck JT, Quick D, Pettengell R, Daly R, Dean JP, Pavlyuk M, Failloux N, Hubel K. Pixantrone-rituximab versus gemcitabine-rituximab in relapsed/refractory aggressive non-Hodgkin lymphoma. Future Oncol. 2016 Aug;12(15):1759-68. doi: 10.2217/fon-2016-0137. Epub 2016 Apr 20.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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PIX306 (PIX-R Trial)
Identifier Type: -
Identifier Source: org_study_id