- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01321541
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 (PIX-R)
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Innsbruck, Austria, 6020
- Medical University Innsbruck, Department of Internal Medicine V (Hematology and Oncology)
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Linz, Austria, 4020
- Hospital Elisabethinen Linz, Internal Department 1 - Hemato-Oncology
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Vienna, Austria, 1140
- Hanusch Hospital, Department of Internal Medicine III
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Brussels, Belgium, 1200
- Saint Luc University Hospital, Department of Hematology
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Roeselare, Belgium, 8800
- General Hospital Delta, Hematology Department
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Turnhout, Belgium, 2300
- General Hospital Turnhout, Hematology Department
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Plovdiv, Bulgaria, 4002
- UMHAT "Sveti Georgi", Plovdiv, Clinical Hematology Clinic
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Plovdiv, Bulgaria, 4002
- UMHAT "Sveti Georgi", Plovdiv, Department of Medical Oncology
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Sofia, Bulgaria, 1407
- MHAT "Tokuda Hospital Sofia", Hematology Clinic
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Sofia, Bulgaria, 1431
- University Multiprofile Hospital for Active Treatment "Sveti Ivan Rilski", Department of Clinical Hematology
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Sofia, Bulgaria, 1756
- Specialized Hospital For Active Treatment Of Hematological Diseases, Sofia, Clinical Hematology Clinic
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Vratsa, Bulgaria, 3000
- MHAT Hristo Botev, Vratsa, First Department of Internal Medicine
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Brno, Czechia, 62500
- University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology
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Hradec Kralove, Czechia, 500 05
- University Hospital Hradec Kralove, 4th Department of Internal Medicne, Clinical Hematology
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Ostrava, Czechia, 70852
- University Hospital Ostrava, Institute of Clinical Hematology
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Prague, Czechia, 10034
- University Hospital Kralovske Vinohrady, Department of Clinical Hematology
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Prague, Czechia, 128 20
- General University Hospital in Prague, 1st Department of Internal Medicine - Department of Hematology
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Aalborg, Denmark, 9100
- Aalborg University Hospital, Department of Hematology
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Amiens, Cedex 1, France, 80054
- Service d'hématologie clinique, Avenue Laennec Salouel
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Bayonne, France, 64190
- Centre hopitalier de la cote basque
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Beziers, France, 34500
- Centre Hospitalier de Beziers
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Bordeaux, France, 33077
- Polyclinique de Bordeaux nord Acquitaine
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Le Mans Cedex 03, France, 72037
- Centre Hospitalier Du Mans
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Pierre Benite Cedex, France, 69495
- Centre Hospitalier Lyon Sud
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Saint-Quentin, France
- Saint Quentin Hospital Center, Department of Oncology-Hematology
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Strasbourg Cedex, France, 97098
- Hautepierre Hospital, Department of Hematology and Oncology
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Aschaffenburg, Germany, 63739
- Gemeinschaftspraxis Drs. Klausmann
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Chemnitz, Germany, 09113
- Klinikum Chemnitz gGmbH
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Frankfurt (a.M.), Germany, 65929
- Klinik fur Innere Medizin III
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Halle (Saale), Germany, 06120
- Universitaetsklinikum Halle
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Hamm, Germany, 59071
- St. Marien Hospital Hamm
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Köln, Germany, 50924
- Universitätsklinik Köln
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Nürnberg, Germany, 90419
- Klinikum Nürnberg Nord
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Trier, Germany, 54290
- Klinikum Mutterhaus der Borromäerinnen
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Budapest, Hungary, H-1097
- St. Istvan and St. Laszlo Hospital of Budapest
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Debrecen, Hungary, H-4032
- University of Debrecen
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Kaposvár, Hungary, 7400
- Moritz Kaposi General Hospital
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Ancona, Italy, 70126
- University Hospital "Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi"
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Bologna, Italy, 40138
- Bologna University Hospital Authority St. Orsola-Malpighi Polyclinic
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Meldola, Italy, 47014
- Scientific Institute of Romagna for the Study and Treatment of Cancer (I.R.S.T.) S.R.L.
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Palermo, Italy, 90146
- "Ospedali Riuniti Villa Sofia-Cervello" Hospital
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Ravenna, Italy, 48121
- Romagna Local Health Authority (AUSL Romagna) - "Santa Maria delle Croci"
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Rimini, Italy, 47900
- Romagna Local Health Authority (AUSL Romagna) - "Infermi" Hospital
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Siena, Italy, 53100
- Siena University Hospital Authority Santa Maria alle Scotte Polyclinic
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Terni, Italy, 5100
- Santa Maria Hospital
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Torino, Italy, 10126
- A.O.U. Città della Salute e della Scienza di Torino
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Chorzów, Poland, 41-500
- Independent Public Healthcare Facility Municipal Hospital Group
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Gdynia, Poland, 81-519
- Marine Hospital of Polish Red Cross, Department of Chemotheraphy
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Katowice, Poland, 40-032
- Silesia Medical University, Department of Hematology and Bone Marrow Transplantation
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Krakow, Poland, 30-510
- Malopolskie Medical Center S.C. , Department of Hematology
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Lodz, Poland, 93-513
- Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz
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Lublin, Poland, 20-090
- Oncology Center of Lublin Land, Department of Clinical Oncology
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Warsaw, Poland, 02-776
- Institute of Hematology and Transfusion Medicine, Clinic of Hematology
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Wroclaw, Poland, 50-367
- Wroclaw Medical University, Department and Clinic of Hematology, Blood Neoplasms and Bone Marrow Transplantation
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Brasov, Romania
- Rapid Diagnosis Polyclinic SA
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Bucharest, Romania, 022328
- Fundeni Clinical Institute Center for Hematology and Bone Marrow Transplantation
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Bucharest, Romania, 050098
- Bucharest University Emergency Hospital, Hematology Clinic
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Ekaterinburg, Russian Federation, 620102
- State Budget Healthcare Institution of Sverdlovsk region: Sverdlovsk Regional Clinical Hospital #1
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Moscow, Russian Federation, 105229
- Federal State Public Institution: Main Military Clinical Hospital n.a. N.N. Burdenko of the Russian Ministry of Defense
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Moscow, Russian Federation
- Moscow State Budget Medical Institution: City Clinical Hospital n.a. S.P.Botkin
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Petrozavodsk, Russian Federation, 18500
- State Medical Institution: Republican Hospital named after V.A. Baranov
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St. Petersburg, Russian Federation, 197758
- St. Petersburg Clinical Research and Practical Center for Specialized Types of Medical Care
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Ufa, Russian Federation, 450054
- State Healthcare Institution: Republican Clinical Oncology Center
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Banska Bystrica, Slovakia, 975 17
- University Hospital with Outpatient Clinic F.D. Roosevelt Banska Bystrica, Department of Hematology
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Bratislava, Slovakia, 83310
- National Cancer Institute, Department of Hematology and Transfusiology
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Martin, Slovakia, 3659
- University Hospital Martin, Department of Hematology and Transfusiology
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Presov, Slovakia, 08181
- J. A. Reiman University Hospital with Polyclinic in Presov
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A Coruña, Spain, 15006
- A Coruña University Hospital
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Barcelona, Spain, 08035
- Hospital Universitario Vall Hebron
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Cadiz, Spain, 11009
- Hospital Iniversitario Puerta del Mar
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Girona, Spain, 17007
- Institut Català de Oncologia (ICO), Hospital Dr Trueta
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Madrid, Spain, 28046
- Hospital Iniversitario La Paz
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Vitoria, Spain, 01009
- Hospital Universitario Araba
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Cherkasy, Ukraine, 18009
- Cherkasy Regional Oncology Center, Regional Treatment and Diagnostic Hematology Center
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Kharkiv, Ukraine, 61070
- Kharkiv Regional Clinical Oncology Center
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Kyiv, Ukraine, 03022
- National Institute of Cancer
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Lviv, Ukraine, 79044
- State Institution: Institute of Blood Pathology and Transfusion Medicine
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Glasgow, United Kingdom, G12 0YN
- Beatson West of Scotland Cancer Center
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London, United Kingdom, SW17 0QT
- St. George's Healthcare NHS Trust
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Manchester, United Kingdom, M20 4BX
- Christie Hospital, Department of Medical Oncology
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Arizona
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Tucson, Arizona, United States, 85715
- Arizona Clinical Research Center
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Tucson, Arizona, United States, 85745
- Arizona Oncology Associates
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Arkansas
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Bentonville, Arkansas, United States, 72712
- Highlands Oncology Group
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Fayetteville, Arkansas, United States, 72703
- Highlands Oncology Group
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Colorado
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Aurora, Colorado, United States, 80012
- Rocky Mountain Cancer Centers
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Boulder, Colorado, United States, 80303
- Rocky Mountain Cancer Centers
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Denver, Colorado, United States, 80218
- Rocky Mountain Cancer Centers
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District of Columbia
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Washington, District of Columbia, United States, 20037
- George Washington University Department of Medicine
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Florida
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Jacksonville, Florida, United States, 32204
- Integrated Community Oncology Network-St. Vincent's
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Jacksonville, Florida, United States, 32207
- Integrated Community Oncology Network-Southside
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Orange Park, Florida, United States, 32073
- Integrated Community Oncology Network
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Illinois
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Danville, Illinois, United States, 61832
- Carle Physician Group
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Decatur, Illinois, United States, 62526
- Cancer Care Specialists of Central Illinois
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Effingham, Illinois, United States, 62401
- Crossroads Cancer Center
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Mattoon, Illinois, United States, 61938
- Carle Foundation Physician Services
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Urbana, Illinois, United States, 61801
- Carle Cancer Center
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Kansas
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Wichita, Kansas, United States, 67208
- Cancer Center of Kansas
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Wichita, Kansas, United States, 67215
- Cancer Center of Kansas
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Kentucky
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Louisville, Kentucky, United States, 40207
- Baptist Hospital East
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Maryland
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Baltimore, Maryland, United States, 21237
- Harry and Jeanette Weinberg Cancer Institute at Franklin Square
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Bethesda, Maryland, United States, 20817
- Center for Cancer and Blood Disorders, PC
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Michigan
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Grand Rapids, Michigan, United States, 49450
- Cancer & Hematology Center of Western Michigan
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Minnesota
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Fridley, Minnesota, United States, 55432
- Metro Minnesota CCOP-Unity Hospital
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Maplewood, Minnesota, United States, 55109
- Metro Minnesota CCOP-St. Johns
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Saint Louis Park, Minnesota, United States, 55426
- Metro Minnesota Community Clinical Oncology Program
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Saint Louis Park, Minnesota, United States, 55416
- Metro Minnesota Community Clinical Oncology Program
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Saint Paul, Minnesota, United States, 55101
- Metro Minnesota CCOP-Regions Hospital
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Missouri
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Columbia, Missouri, United States, 65201
- Missouri Cancer Associates
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Nebraska
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Lincoln, Nebraska, United States, 68506
- Nebraska Hematology-Oncology, PC
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New Jersey
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Morristown, New Jersey, United States, 07962
- Hematology-Oncology Associates of Northern New Jersey
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New York
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East Setauket, New York, United States, 11733
- North Shore Hematology/Oncology Associates
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Ohio
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Canton, Ohio, United States, 44718
- Gabrail Cancer Center
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Dover, Ohio, United States, 44622
- Gabrail Cancer Center
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Toledo, Ohio, United States, 43623
- Toledo Clinic Cancer center-Toledo
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Toledo, Ohio, United States, 43617
- Toledo Clinical Cancer Center
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Toledo, Ohio, United States, 43623
- Mercy Cancer Center at St. Anne's
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Oregon
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Portland, Oregon, United States, 97213
- Northwest Cancer Specialists, PC
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Portland, Oregon, United States, 97225
- Northwest Cancer Specialists, PC
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Tualatin, Oregon, United States, 97062
- Northwest Cancer Specialists, PC
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
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South Carolina
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Greenville, South Carolina, United States, 29615
- Upstate Oncology Associates
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Hardeeville, South Carolina, United States, 29927
- South Carolina Cancer Specialists
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Hilton Head Island, South Carolina, United States, 29926
- South Carolina Cancer Specialists
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Texas
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Lubbock, Texas, United States, 79410
- Joe Arrington Cancer Research and Treatment Center
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New Braunfels, Texas, United States, 78130
- Cancer Care Centers of South Texas-HOAST
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San Antonio, Texas, United States, 78229
- Cancer Care Centers of South Texas-HOAST
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Virginia
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Roanoke, Virginia, United States, 24014
- Blue Ridge Cancer Care
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Washington
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Vancouver, Washington, United States, 98684
- Northwest Cancer Specialists, PC
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Vancouver, Washington, United States, 98686
- Northwest Cancer Specialists, PC
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Wisconsin
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Green Bay, Wisconsin, United States, 54301
- Saint Vincent Hospital Green Bay Oncology
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Green Bay, Wisconsin, United States, 54303
- Green Bay Oncology-St. Mary's Hospital MC
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Primary refractory de novo DLBCL or primary refractory follicular grade 3 lymphoma, defined as documented progression within 12 weeks of the last cycle of the first-line multi-agent regimen.
- Prior treatment with cumulative dose of doxorubicin or equivalent exceeding 450 mg/m2
- Any experimental therapy ≤ 28 days prior to randomization
- 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
- Any contraindication or known allergy or hypersensitivity to any study drugs
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: Pixantrone + Rituximab
Pixantrone and Rituximab
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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.
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ACTIVE_COMPARATOR: Gemcitabine + Rituximab
Gemcitabine and Rituximab
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival (PFS)
Time Frame: From the date of randomization to the date of progressive disease or death due to any cause (whichever is first reported) (Up to 100 weeks)
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PFS is defined as the time of randomization to the date of disease progression or death due to any cause (whichever occurs first)
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From the date of randomization to the date of progressive disease or death due to any cause (whichever is first reported) (Up to 100 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Survival
Time Frame: From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks)
|
Overall survival is from randomization to death due to any cause
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From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks)
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Complete Response Rate
Time Frame: From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks)
|
CRR is defined as the proportion of patients who achieve a Complete Response (CR) without additional therapy.
CR is defined as the disappearance of all target lesions.
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From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks)
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Overall Response Rate
Time Frame: From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks)
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ORR is defined as the proportion of patients who achieve a CR or PR without additional therapy.
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From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks)
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Number of Treatment Emergent Adverse Events (TEAE) Related to Study Drug
Time Frame: From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks)
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The number of Participants with Treatment Emergent Adverse Events (TEAE) related to study drug (pixantrone or gemcitabine)
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From date of randomization to the date of the patient's death due to any cause (Up to 100 weeks)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Individual Concentration-time Profiles of Patients Will be Compared to Existing Data Using Simulations (Visual Predictive Checks)
Time Frame: within 1 hour of initiation of infusion to 24-48 hours after start of pixantrone infusion
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To characterize the PK profile of pixantrone when co-administered with rituximab.
Plasma samples for PK analysis will be collected relative to the D-1 dose of pixantrone in one of the 6 treatment cycles for each participating patient.
The goal is to enroll approx.
20 patients, active at 20 sites- Beatson West of Scotland Cancer Center, Uni.
Hospital Kralovske Vinohrady, Uni.
Hospital Hradec Kralove Hematooncology, Hospital Nuernberg, St. Marien Hospital Hamm, Puerta del Mar Hospital, Tokuda Hospital Sofia, National Center of Hematology & Transfusiology, UMHAT "SV.
IVAN RILSKI", Moritz Kaposi General Hospital, Uni. of Debrecen, Polish Red Cross Marine Hospital, Kharkiv Regional Clinical Oncology Center, National Inst. of Cancer Ukraine, Cherkasy Regional Oncology Center, Inst. of Blood Pathology & Transfusion Medicine, Uni.
Hospital Martin, National Onclogy Inst., Uni.
Hospital with Outpatient Clinic F.D. Roosevelt Banska Bystrica, Uni.
Hospital J.A. Reiman Presov
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within 1 hour of initiation of infusion to 24-48 hours after start of pixantrone infusion
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To Generate Individual Secondary PK Parameters (eg, Exposure, Half-life Etc.) Using Descriptive Statistics
Time Frame: within 1 hour of initiation of infusion to 24-48 hours after start of pixantrone infusion
|
To characterize the PK profile of pixantrone when co-administered with rituximab.
Plasma samples for PK analysis will be collected relative to the D-1 dose of pixantrone in one of the 6 treatment cycles for each participating patient.
The goal is to enroll approx.
20 patients, active at 20 sites- Beatson West of Scotland Cancer Center, Uni.
Hospital Kralovske Vinohrady, Uni.
Hospital Hradec Kralove Hematooncology, Hospital Nuernberg, St. Marien Hospital Hamm, Puerta del Mar Hospital, Tokuda Hospital Sofia, National Center of Hematology & Transfusiology, UMHAT "SV.
IVAN RILSKI", Moritz Kaposi General Hospital, Uni. of Debrecen, Polish Red Cross Marine Hospital, Kharkiv Regional Clinical Oncology Center, National Inst. of Cancer Ukraine, Cherkasy Regional Oncology Center, Inst. of Blood Pathology & Transfusion Medicine, Uni.
Hospital Martin, National Onclogy Inst., Uni.
Hospital with Outpatient Clinic F.D. Roosevelt Banska Bystrica, Uni.
Hospital J.A. Reiman Presov
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within 1 hour of initiation of infusion to 24-48 hours after start of pixantrone infusion
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Simran B Singh, MS, GWCP, Sr. Director, Clinical Operations
Publications and helpful links
General Publications
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Aggression
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
- Lymphoma, Non-Hodgkin
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Gemcitabine
- Rituximab
- Pixantrone
Other Study ID Numbers
- PIX306 (PIX-R Trial)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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