A Study of Subcutaneous Versus Intravenous MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in Patients With Previously Untreated CD20-Positive Diffuse Large B-Cell Lymphoma

PHASE3CompletedINTERVENTIONAL
Enrollment

572

Participants

Timeline

Start Date

August 24, 2012

Primary Completion Date

October 21, 2014

Study Completion Date

September 16, 2016

Conditions
Lymphoma, Large B-Cell, Diffuse
Interventions
DRUG

CHOP

CHOP chemotherapy: cyclophosphamide, doxorubicin, vincristine, prednisone/prednisolone; 6 or 8 cycles

DRUG

rituximab [MabThera/Rituxan]

The first rituximab dose will be administered intravenously on Day of Cycle 1 at a dose of 375 mg/m2. Subsequent doses of 1400 mg are administered subcutaneously on Day 1 of each cycle, for a further 7 cycles

DRUG

rituximab [MabThera/Rituxan]

375 mg/m2 intravenously on Day 1 of each cycle, 8 cycles

Trial Locations (186)

7

Mater Misericordiae Uni Hospital; Oncology, Dublin

18

Instituto;Oncologico Miraflores, Lima

41

Oncosalud Sac; Oncología, Lima

1020

CHU Brugmann (Victor Horta), Brussels

Instituto de Oncologia y Hematologia UCV, Caracas

1070

Clin Univ de Bxl Hôpital Erasme, Brussels

1431

Military Medical Academy; Hematology And Oncology, Sofia

UMHAT Alexandrovska EAD; Hematology, Sofia

1600

Hospital de Santa Maria; Servico de Hematologia e Transplantacao de Medula, Lisbon

2020

ZNA Middelheim, Antwerp

2122

Banco Municipal de Sangre; Hematología, Caracas

2300

AZ Turnhout Sint Elisabeth, Turnhout

3010

Hospital General Univ. de Alicante; Servicio de Oncologia, Alicante

3500

Jessa Zkh (Campus Virga Jesse), Hasselt

4002

University Hospital Sv.Georgi Clnic of Hematology; Hematology, Plovdiv

4800

CHR de Verviers - East Belgium, Verviers

6000

CHU Charleroi-ISPPC-Espace Santé, Charleroi

CHU de Charleroi, Charleroi

GHdC Site Notre Dame, Charleroi

7505

Tygerberg Hospital; Haematology Department, Cape Town

7600

Hospital Privado de Comunidad; Oncology, Mar del Plata

9000

UZ Gent, Ghent

9300

Onze Lieve Vrouwziekenhuis Aalst, Aalst

9301

National Hospital; Oncotherapy Dept, Bloemfontein

10128

Ospedale Mauriziano Umberto I, Turin

10330

King Chulalongkorn Memorial Hospital; Division of Hematology, Department of Medicine, Bangkok

10400

Ramathibodi Hospital; Division of Hematology, Department of Medicine, Bangkok

10700

Siriraj Hospital; Division of Hematology, Department of Medicine, Bangkok

11159

Riyadh Military Hospital, Riyadh

11207

Hospital Punta Europa; Servicio de Hematologia, Algeciras

15000

Centre hospitalo-univerisitaire de Tizi Ouzou - Nedir Mohamed;Service d'hématologie, Tizi Ouzou

17007

Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Hematologia, Girona

18000

Clinic of Haematology Cc Nis, Niš

18101

Haemek Medical Center; Hematology Department, Afula

18547

Metropolitan Hospital; Hematology Dept, Athens

20014

Hospital de Donostia; Servicio de Hematologia, Donostia / San Sebastian

20520

Turku Uni Central Hospital; Oncology Clinics, Turku

21100

Ospedale Di Circolo E Fondazione Macchi; Ematologia, Varese

22027

Hopital Yves Le Foll; Hematologie Oncologie, Saint-Brieuc

24127

ASST PAPA GIOVANNI XXIII; Ematologia, Bergamo

26100

ASST DI CREMONA; U.O.S. di Ematologia, Cremona

27003

Hospital Lucus Augusti; Servicio de Hematologia, Lugo

27310

Gaziantep Uni Medical School; Hematology, Gaziantep

28007

Hospital General Universitario Gregorio Marañon; Servicio de Hematología, Madrid

28041

Hospital Univ. 12 de Octubre; Servicio de Hematologia, Madrid

28046

Hospital Universitario la Paz; Servicio de Hematologia, Madrid

28222

Hospital Universitario Puerta de Hierro; Servicio de Oncologia, Madrid

29600

Hospital Costa del Sol; Servicio de Hematologia, Málaga

29609

Hopital Augustin Morvan; Hematologie, Brest

30029

Centre ONCOGARD - Institut de Cancerologie du Gard, Nîmes

33081

Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica, Aviano

33203

Hospital de Cabueñes; Servicio de Hematología y Hemoterapia, Gijón

33520

Tampere University Hospital; Dept of Oncology, Tampere

34000

Clinical Center Kragujevac;Center for Hematology, Kragujevac

34098

Istanbul University Cerrahpasa Medical Faculty; Hematology Department, Istanbul

34125

AOU Ospedali Riuniti; Ematologia, Trieste

35016

Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Hematologia, Las Palmas de Gran Canarias

35020

Hospital de Gran Canaria Dr. Negrin; Servicio de Oncologia, Las Palmas de Gran Canaria

35100

Dokuz Eylul Uni ; Hematology, Izmir

Ege Uni Medical School; Hematology, Izmir

35128

Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia, Padua

38039

Erciyes Uni ; Hematology, Kayseri

39008

Hospital Universitario Marques de Valdecilla; Servicio de Hematologia, Santander

40002

Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine, Khon Kaen

40620

Middle Finland Central Hospital, Jyväskylä

46010

Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia, Valencia

46017

Hospital Universitario Dr. Peset; Servicio de Hematologia, Valencia

47014

IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica, Meldola

47900

Ospedale Infermi Di Rimini; Unità Operativa di Oncologia e Oncoematologia, Rimini

48100

Az. Osp. S. Maria Delle Croci; U.O. Di Ematologia, Ravenna

48903

Hospital de Cruces; Servicio de Hematologia, Barakaldo

49100

Beilinson Medical Center; Haematology, Petah Tikva

49102

Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU; Chair of Oncology and Medical Radiology, Dnipropetrovsk

50009

Hospital Clinico Universitario Lozano Blesa; Servicio de Hematologia, Zaragoza

Hospital Universitario Miguel Servet; Servicio Hematologia, Zaragoza

52662

Chaim Sheba Medical Center; Hematology BMT & CBB, Ramat Gan

54007

Theagenio Anticancer Hospital; Dept. of Haematology, Thessaloniki

55139

Ondokuzmayis University Medical Faculty Heamatology Department, Samsun

58140

Cumhuriyet Uni. Med. Fac.; Hematology, Sivas

60020

A.O. Univ.Ospedali Riuniti Umerto I -G.M.Lancisi G.Salesi; U.O. Clinica Di Ematologia, Torrette Di Ancona

61100

Ospedale Civile; S.C. Ematologia, Pesaro

61800

Karadeniz Technical Uni School of Medicine; Hematology, Trabzon

65100

Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia, Pescara

67000

Clinique Ste Anne, Strasbourg

67098

Hopital Hautepierre; Hematologie Oncologie, Strasbourg

68100

University General Hospital of Alexandroupolis; Haemotology, Alexandroupoli

72037

Ch Du Mans; Medecine Hematologie Oncologie, Le Mans

74100

Az. Osp. G. Moscati; U.O. Do Ematologia, Taranto

79031

State Oncology Regional Treatment-Diagnostic Center; Chemotherapy Department, Lviv

80480

Hopital Sud; Hematologie Clinique, Salouël

83041

Hia Sainte Anne; Medecine Interne Oncologie, Toulon

90029

Oulu University Hospital; Oncology, Oulu

90146

Casa Di Cura La Maddalena; Oncoematologia E Trapianto Del Midollo Osseo, Palermo

95107

Ch Victor Dupouy; Hematologie, Argenteuil

98123

Azienda Ospedaliero Uni Ria Policlinico G. Martino; U.O. Di Oncologia Medica, Messina

115478

N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis, Moscow

123995

Rus Med Academy for Postgraduate Education; Oncology Department, Moscow

129110

Vladimirskiy Regional Scientific Research Inst. ; Hematology, Moscow

197110

Saint-Petersburg SHI City Clinical Hospital #31, Saint Petersburg

198205

City Clinical Hospital #15; Hematology department, Saint Petersburg

420029

Republican Clinical Oncologic Dispensary of Republic Of Tatarstan, Kazan'

454087

Regional Oncology Center, Chelyabinsk

603126

Regional Clinical Hospital N.A. Semashko; Hematology, Nizhny Novgorod

614077

Clinical MSCh No1, Perm

620137

Central City Hospital #7; Hematology, Yekaterinburg

3109601

Rambam Medical Center; Heamatology & Bone Marrow Transplantation, Haifa

4428164

Meir Medical Center; Heamatology Dept, Kfar Saba

5810001

Wolfson Mc; Haematology, Holon

6423906

Ichilov Sourasky Medical Center; Heamatology, Tel Aviv

7661041

Kaplan Medical Center, Rehovot

9103102

Shaare Zedek Medical Center; Hematology Dept., Jerusalem

90470340

Hospital Giovanni Battista - Mae de Deus Center; Instituto do Cancer, Porto Alegre

09000

EHS CAC Hospital FRANTZ FANON ZABANA BLIDA; Hematology ward, Blida

C1431FWO

Cemic; Haematology, Buenos Aires

60336-550

Crio - Centro Regional Integrado de Oncologia, Fortaleza

20560-120

Instituto Nacional de Cancer - INCa; Oncologia, Rio de Janeiro

22290-160

Clinicas Oncologicas Integradas - COI, Rio de Janeiro

17210-080

Hospital Amaral Carvalho, Jaú

05403-000

Hospital das Clinicas - FMUSP; Hematologia, São Paulo

V7L 2L7

Lion'S Gate Hospital, North Vancouver

R3E 0V9

Cancer Care Manitoba, Winnipeg

E1C 8X3

Regional health authority A vitalite health network, Moncton

L4M 6M2

Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials, Barrie

L6R 3J7

William Osler Health System Brampton Civic Hospital, Brampton

N2G 1G3

Grand River Regional Cancer Centre, Kitchener

L3Y 2P9

Southlake Regional Health Center; Community Care Clinic / Oncology, Newmarket

M4C 3E7

Toronto East General Hospital; Haematology/Oncology, Toronto

M5G 2M9

University Health Network; Princess Margaret Hospital; Medical Oncology Dept, Toronto

N8W 2X3

Windsor Regional Cancer Centre, Windsor

Unknown

Hospital Pablo Tobon Uribe, Medellin-Antioquia

Clínica Imbanaco; Oncology, Santiago de Cali

Cork Uni Hospital; Oncology Dept, Cork

St James' Hospital; Cancer Clinical Trials Office, Dublin

Galway Uni Hospital; Oncology Dept, Galway

University Hospital Limerick - Oncology, Limerick

00029

Helsinki University Central Hospital; Dept of Oncology, Helsinki

02321

Ch De Saint Quentin; Medecine B10, Saint-Quentin

106 76

General Hospital of Athens Evangelismos; Hematology, Athens

115 27

Laiko General Hospital; Hematology Clinic, Athens

711 10

Periph. University General Hospital of Heraklion; Hematology, Heraklion

455 00

University Hospital of Ioannina; Hematology, Ioannina

265 00

University Hospital Of Patras; Dept. Of Internal Medicine-Hematology Division, Pátrai

570 10

Georgios Papanikolaou Hospital; Hematology Department, Thessaloniki

00168

Uni Cattolica; Divisione Di Ematologia, Rome

00189

Az. Osp. Sant'Andrea; U.O. C. Ematologia, Rome

09121

Ospedale Oncologico A Businco-Cagliari; Ematologia Sez., Cagliari

06156

Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica, Perugia

1815 JD

Medisch Centrum Alkmaar, Alkmaar

3818 ES

Meander Medisch Centrum; Locatie Lichtenberg, Amersfoort

7416 SE

Deventer Ziekenhuis; Interne Geneeskunde, Deventer

3371 NM

Albert Schweitzer Ziekenhuis, Dordrecht

5631 BM

Maxima Medisch Centrum; Inwendige Geneeskunde, Eindhoven

2803 HH

Groene Hart Ziekenhuis Bleulandlocatie; Inwendige Geneeskunde, Gouda

9700 RB

Universitair Medisch Centrum Groningen, Groningen

6419 PC

Atrium Medisch Centrum, Heerlen

2134 TM

Spaarne Ziekenhuis; Inwendige Geneeskunde, Hoofddorp

8934 AD

Medisch Centrum Leeuwarden; Interne, Leeuwarden

3430 EM

St. Antonius Ziekenhuis Nieuwegein, Nieuwegein

3015 CE

Erasmus Mc - Locatie Centrum; Dept of Hematology, Rotterdam

3075EA

Erasmus Medisch Centrum Rotterdam; Lokatie Daniel den Hoed, Rotterdam

3078 HT

Maasstad ziekenhuis, Rotterdam

6162 BG

Zuyderland ziekenhuis locatie Geleen, Sittard-Geleen

8025 AB

Isala Klinieken, Locatie Sophia; Inwendige Geneeskunde, Zwolle

CIX

Hospital Nacional Almanzor Aguinaga Asenjo; Unidad De Investigacion Del Servicio De Oncologia Medica, Chiclayo

40-032

Katedra i Klinika Hematologii i Transplantacji Szpiku SUM, Katowice

25-734

Swietokrzyskie Centrum Onkologii; Onkologia Ogolna, Kielce

30-510

Malopolskie Centrum Medyczne, Krakow

45-061

Szpital Wojewodzki w Opolu, Oddzial Hematologii i Onkologii Hematologicznej, Opole

76-200

Wojewodzki Szpital Specjalistyczny im. J. Korczaka; Oddział Chorób Wewnetrznych/Hematologiczny, Słupsk

02-781

Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego, Warsaw

3000-075

HUC; Servico de Hematologia, Coimbra

1150-314

Hospital Santo Antonio dos Capuchos; Servico de Hemato-Oncologia, Lisbon

4200-072

IPO do Porto; Servico de Onco-Hematologia, Porto

4200-319

Hospital de Sao Joao; Servico de Hematologia Clinica, Porto

0002

Steve Biko Academic Hospital; Oncology, Pretoria

08208

Corporacio Sanitaria Parc Tauli; Servicio de Hematologia, Sabadell

01330

Cukurova Uni ; Hematology, Adana

06000

Diskapi Research And Training Hospital; hematology, Ankara

06100

Hacettepe Uni Medical Faculty; Hematology, Ankara

06620

Ankara University; Hematology, Ankara

03115

Kyiv City Clinical Oncological Center; Chemotherapy Department, Kiev

BS10 5NB

SOUTHMEAD HOSPITAL; Richard Bright Dialysis Centre, Bristol

IP4 5PD

Ipswich Hospital; Oncology Pharmacy, Ipswich

SK10 3BL

Macclesfield District General Hospital, Macclesfield

NG17 4JL

Kings Mill Hospital, Sutton in Ashfield

SA2 8QA

Singleton Hospital: Pharmacy Department, Swansea

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT01649856 - A Study of Subcutaneous Versus Intravenous MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in Patients With Previously Untreated CD20-Positive Diffuse Large B-Cell Lymphoma | Biotech Hunter | Biotech Hunter