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

PHASE3CompletedINTERVENTIONAL
Enrollment

312

Participants

Timeline

Start Date

April 20, 2011

Primary Completion Date

June 28, 2018

Study Completion Date

September 14, 2018

Conditions
Diffuse Large B-cell Lymphomade Novo DLBCLDLBCL Transformed From Indolent LymphomaFollicular Grade 3 Lymphoma
Interventions
DRUG

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.

DRUG

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.

Trial Locations (131)

1140

Hanusch Hospital, Department of Internal Medicine III, Vienna

1200

Saint Luc University Hospital, Department of Hematology, Brussels

1407

"MHAT Tokuda Hospital Sofia, Hematology Clinic", Sofia

1431

"University Multiprofile Hospital for Active Treatment Sveti Ivan Rilski, Department of Clinical Hematology", Sofia

1756

Specialized Hospital For Active Treatment Of Hematological Diseases, Sofia, Clinical Hematology Clinic, Sofia

2300

General Hospital Turnhout, Hematology Department, Turnhout

3000

MHAT Hristo Botev, Vratsa, First Department of Internal Medicine, Vratsa

3659

University Hospital Martin, Department of Hematology and Transfusiology, Martin

4002

"UMHAT Sveti Georgi, Plovdiv, Clinical Hematology Clinic", Plovdiv

"UMHAT Sveti Georgi, Plovdiv, Department of Medical Oncology", Plovdiv

4020

Hospital Elisabethinen Linz, Internal Department 1 - Hemato-Oncology, Linz

5100

Santa Maria Hospital, Terni

6020

Medical University Innsbruck, Department of Internal Medicine V (Hematology and Oncology), Innsbruck

7400

Moritz Kaposi General Hospital, Kaposvár

8800

General Hospital Delta, Hematology Department, Roeselare

9100

Aalborg University Hospital, Department of Hematology, Aalborg

10034

University Hospital Kralovske Vinohrady, Department of Clinical Hematology, Prague

10126

A.O.U. Città della Salute e della Scienza di Torino, Torino

11009

Hospital Iniversitario Puerta del Mar, Cadiz

11733

North Shore Hematology/Oncology Associates, East Setauket

15006

A Coruña University Hospital, A Coruña

17007

Institut Català de Oncologia (ICO), Hospital Dr Trueta, Girona

18009

Cherkasy Regional Oncology Center, Regional Treatment and Diagnostic Hematology Center, Cherkasy

18500

State Medical Institution: Republican Hospital named after V.A. Baranov, Petrozavodsk

19111

Fox Chase Cancer Center, Philadelphia

20037

George Washington University Department of Medicine, Washington D.C.

20817

Center for Cancer and Blood Disorders, PC, Bethesda

21237

Harry and Jeanette Weinberg Cancer Institute at Franklin Square, Baltimore

24014

Blue Ridge Cancer Care, Roanoke

28046

Hospital Iniversitario La Paz, Madrid

29615

Upstate Oncology Associates, Greenville

29926

South Carolina Cancer Specialists, Hilton Head Island

29927

South Carolina Cancer Specialists, Hardeeville

32073

Integrated Community Oncology Network, Orange Park

32204

Integrated Community Oncology Network-St. Vincent's, Jacksonville

32207

Integrated Community Oncology Network-Southside, Jacksonville

33077

Polyclinique de Bordeaux nord Acquitaine, Bordeaux

34500

Centre hospitalier de Beziers, Béziers

40138

Bologna University Hospital Authority St. Orsola-Malpighi Polyclinic, Bologna

40207

Baptist Hospital East, Louisville

43617

Toledo Clinical Cancer Center, Toledo

43623

Mercy Cancer Center at St. Anne's, Toledo

Toledo Clinic Cancer Center-Toledo, Toledo

44622

Gabrail Cancer Center, Dover

44718

Gabrail Cancer Center, Canton

47014

Scientific Institute of Romagna for the Study and Treatment of Cancer (I.R.S.T.) S.R.L., Meldola

47900

"Romagna Local Health Authority (AUSL Romagna) - Infermi Hospital", Rimini

48121

"Romagna Local Health Authority (AUSL Romagna) - Santa Maria delle Croci", Ravenna

49450

Cancer & Hematology Center of Western Michigan, Grand Rapids

50924

Universitätsklinik Köln, Cologne

53100

Siena University Hospital Authority Santa Maria alle Scotte Polyclinic, Siena

54290

Klinikum Mutterhaus der Borromäerinnen, Trier

54301

Saint Vincent Hospital Green Bay Oncology, Green Bay

54303

Green Bay Oncology-St. Mary's Hospital MC, Green Bay

55101

Metro Minnesota CCOP-Regions Hospital, Saint Paul

55109

Metro Minnesota CCOP-St. Johns, Maplewood

55416

Metro Minnesota Community Clinical Oncology Program, Saint Louis Park

55426

Metro Minnesota Community Clinical Oncology Program, Saint Louis Park

55432

Metro Minnesota CCOP-Unity Hospital, Fridley

59071

St. Marien Hospital Hamm, Hamm

61070

Kharkiv Regional Clinical Oncology Center, Kharkiv

61801

Carle Cancer Center, Urbana

61832

Carle Physician Group, Danville

61938

Carle Foundation Physician Services, Mattoon

62401

Crossroads Cancer Center, Effingham

62500

University Hospital Brno, Clinic of Internal Medicine - Hematology and Oncology, Brno

62526

Cancer Care Specialists of Central Illinois, Decatur

63739

Gemeinschaftspraxis Drs. Klausmann, Aschaffenburg

64190

Centre hopitalier de la cote basque, Bayonne

65201

Missouri Cancer Associates, Columbia

65929

Klinik für Innere Medizin III, Frankfurt (a.M.)

67208

Cancer Center of Kansas, Wichita

67215

Cancer Center of Kansas, Wichita

68506

Nebraska Hematology-Oncology, PC, Lincoln

69495

Centre hospitalier Lyon Sud, Pierre-Bénite

70126

"University Hospital Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi", Ancona

70852

University Hospital Ostrava, Institute of Clinical Hematology, Ostrava

72037

Centre hospitalier du Mans, Le Mans

72703

Highlands Oncology Group, Fayetteville

72712

Highlands Oncology Group, Bentonville

78130

Cancer Care Centers of South Texas-HOAST, New Braunfels

78229

Cancer Care Centers of South Texas-HOAST, San Antonio

79044

State Institution: Institute of Blood Pathology and Transfusion Medicine, Lviv

79410

Joe Arrington Cancer Research and Treatment Center, Lubbock

80012

Rocky Mountain Cancer Centers, Aurora

80054

Service d'hématologie clinique, Avenue Laennec Salouel, Amiens

80218

Rocky Mountain Cancer Centers, Denver

80303

Rocky Mountain Cancer Centers, Boulder

83310

National Cancer Institute, Department of Hematology and Transfusiology, Bratislava

85715

Arizona Clinical Research Center, Tucson

85745

Arizona Oncology Associates, Tucson

90146

"Ospedali Riuniti Villa Sofia-Cervello Hospital", Palermo

90419

Klinikum Nürnberg Nord, Nuremberg

97062

Northwest Cancer Specialists, PC, Tualatin

97098

Hautepierre Hospital, Department of Hematology and Oncology, Strasbourg

97213

Northwest Cancer Specialists, PC, Portland

97225

Northwest Cancer Specialists, PC, Portland

98684

Northwest Cancer Specialists, PC, Vancouver

98686

Northwest Cancer Specialists, PC, Vancouver

105229

Federal State Public Institution: Main Military Clinical Hospital n.a. N.N. Burdenko of the Russian Ministry of Defense, Moscow

197758

St. Petersburg Clinical Research and Practical Center for Specialized Types of Medical Care, Saint Petersburg

450054

State Healthcare Institution: Republican Clinical Oncology Center, Ufa

620102

State Budget Healthcare Institution of Sverdlovsk region: Sverdlovsk Regional Clinical Hospital #1, Yekaterinburg

07962

Hematology-Oncology Associates of Northern New Jersey, Morristown

500 05

University Hospital Hradec Kralove, 4th Department of Internal Medicne, Clinical Hematology, Hradec Králové

128 20

General University Hospital in Prague, 1st Department of Internal Medicine - Department of Hematology, Prague

Unknown

Saint Quentin Hospital Center, Department of Oncology-Hematology, Saint-Quentin

Rapid Diagnosis Polyclinic SA, Brasov

Moscow State Budget Medical Institution: City Clinical Hospital n.a. S.P.Botkin, Moscow

09113

Klinikum Chemnitz gGmbH, Chemnitz

06120

Universitaetsklinikum Halle, Halle

H-1097

St. Istvan and St. Laszlo Hospital of Budapest, Budapest

H-4032

University of Debrecen, Debrecen

41-500

Independent Public Healthcare Facility Municipal Hospital Group, Chorzów

81-519

Marine Hospital of Polish Red Cross, Department of Chemotheraphy, Gdynia

40-032

Silesia Medical University, Department of Hematology and Bone Marrow Transplantation, Katowice

30-510

Malopolskie Medical Center S.C. , Department of Hematology, Krakow

93-513

Nicolaus Copernicus Memorial Provincial Specialist Hospital in Lodz, Lodz

20-090

Oncology Center of Lublin Land, Department of Clinical Oncology, Lublin

02-776

Institute of Hematology and Transfusion Medicine, Clinic of Hematology, Warsaw

50-367

Wroclaw Medical University, Department and Clinic of Hematology, Blood Neoplasms and Bone Marrow Transplantation, Wroclaw

022328

Fundeni Clinical Institute Center for Hematology and Bone Marrow Transplantation, Bucharest

050098

Bucharest University Emergency Hospital, Hematology Clinic, Bucharest

975 17

University Hospital with Outpatient Clinic F.D. Roosevelt Banska Bystrica, Department of Hematology, Banská Bystrica

08181

J. A. Reiman University Hospital with Polyclinic in Presov, Prešov

08035

Hospital Universitario Vall Hebrón, Barcelona

01009

Hospital Universitario Araba, Vitoria-Gasteiz

03022

National Institute of Cancer, Kyiv

G12 0YN

Beatson West of Scotland Cancer Center, Glasgow

SW17 0QT

St. George's Healthcare NHS Trust, London

M20 4BX

Christie Hospital, Department of Medical Oncology, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

CTI BioPharma

INDUSTRY

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 | Biotech Hunter | Biotech Hunter