AzTrials
AzTrials

B-cell LymphomaPhase 3NCT00486759

A Study of Bevacizumab (Avastin) in Combination With Rituximab (MabThera) and CHOP (Cyclophosphamide, Hydroxydaunorubicin [Doxorubicin], Oncovin [Vincristine], Prednisone) Chemotherapy in Patients With Diffuse Large B-cell Lymphoma

A Phase 3 study testing Bevacizumab, Rituximab and CHOP in people with B-cell Lymphoma, run by Hoffmann-La Roche at 266 sites in 34 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This 2-arm study was designed to compare the efficacy and safety of bevacizumab (Avastin) in combination with rituximab (MabThera) and CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) chemotherapy (R-CHOP) versus rituximab plus CHOP chemotherapy (R-CHOP) in previously… Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
B-cell Lymphoma
What is being tested?
Bevacizumab, Rituximab and CHOP
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
787 participants
Where
266 sitesin 34 countries
Study dates
26 Jul 2007to 30 Nov 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients, ≥ 18 and < 80 years of age.
  • CD20-positive diffuse large B-cell lymphoma.
  • Low-intermediate, high-intermediate, or high risk disease and/or bulky tumor (largest diameter ≥ 7.5 cm).
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

Who cannot join

  • Prior treatment for diffuse large B-cell lymphoma.
  • Types of non-Hodgkin's lymphoma other than diffuse large B-cell lymphoma (DLBCL).
  • Central nervous system (CNS) involvement of lymphoma.

Trial locations and contacts

266 sites in 34 countries.

266 sites in 34 countries

Germany43 sites

  • Gesundheitszentrum St. Marien GmbH; Med. II, Hämatologie/Onkologie

    Amberg, 92224

  • Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.

    Berlin, 10117

  • Charité; Onkologie & Hämatologie

    Berlin, 10117

  • DIAKO Ev. Diakonie-Krankenhaus Bremen GmbH; Med. Klinik II; Hämatologie und internistische Onkologie

    Bremen, 28239

  • Carl-Thiem-Klinik Cottbus; Medizinische Klinik

    Cottbus, 03048

  • Klinikzentrum Mitte; Medizinische Klinik Gastroenterologie Haematologie / Onkologie

    Dortmund, 44137

  • St. Johannes Hospital; Abt. Innere Medizin

    Dortmund, 44137

  • St Antonius Hospital; Haematologie/Onkologie

    Eschweiler, 52249

  • Krankenhaus Nordwest Medizinische Klinik

    Frankfurt, 60488

  • Klinik Fulda; Abt. Itz

    Fulda, 36043

  • Georg-August-Uniklinik ; Zentrum Innere Medizin Abt. Hämatologie & Onkologie

    Göttingen, 37075

  • Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik

    Greifswald, 17475

  • Kath.Krankenhaus Hagen gem.GmbH St.-Marien-Hospital

    Hagen, 58095

  • Asklepios Klinik St. Georg; Allgemeine Innere Medizin

    Hamburg, 20099

  • Facharztzentrum Eppendorf, Studien GbR

    Hamburg, 20249

  • Evang.Krankenhaus Abt. Hämatologie und Onkologie

    Hamm, 59063

  • St.-Marien-Hospital Klinik Knappenstraße; Klinik für Hämatologie und Onkologie

    Hamm, 59071

  • KRH Klinikum Siloah Medizinische Klinik III

    Hanover, 30449

  • St. Bernward-Krankenhaus

    Hildesheim, 31134

  • Universitaetsklinikum des Saarlandes; medizinische Klinik und Poliklinik; Innere Medizin I

    Homburg/Saar, 66421

  • Städtisches Klinikum Karlsruhe gGmbH, II. Medizinische Klinik

    Karlsruhe, 76133

  • St. Vincentius Kliniken Ag; Medizinische Klinik Abt. 2

    Karlsruhe, 76137

  • Tagesklinik Landshut; Hämatologie/Onkologie

    Landshut, 84028

  • Universitätsklinikum Leipzig Medizinische Klinik II Gastroenterolog. u. Hepatolog.

    Leipzig, 04103

  • Klinikum St.Georg gGmbH Klinik für Internistische Onkologie und Hämotologie

    Leipzig, 04129

  • Universitätsklinikum Schleswig-Holstein / Campus Lübeck, Med. Klinik I, Hämatologie/Onkologie

    Lübeck, 23562

  • Märkische Kliniken GmbH, Klinikum Lüdenscheid; Hämatologie / Onkologie

    Lüdenscheid, 58515

  • Klinikum der Stadt Ludwigshafen; Medizinische Klinik A

    Ludwigshafen, 67063

  • Otto von Guericke Uni Magdeburg Uniklinik; Hämatologie/Onkologie

    Magdeburg, 39120

  • Klinikum Magdeburg gemeinnützige GmbH; Klinik Haematologie und Onkologie

    Magdeburg, 39130

  • Klinikum Mannheim III. Medizinische Klinik

    Mannheim, 68167

  • Klinikum der Universitaet Muenchen; Campus Großhadern; Medizinische Klinik III und Poliklinik

    München, 81377

  • Westfälische Wilhelms-Universität Münster, Medizinische Klinik und Poliklinik A

    Münster, 48149

  • Klinikum Oldenburg gGmbH; Klinik für Onkologie und Hämatologie

    Oldenburg, 26133

  • Prosper-Hospital, Medizinische Klinik I

    Recklinghausen, 45659

  • St Marien Krankenhaus; Medizinische Klinik Iii

    Siegen, 57072

  • Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

    Trier, 54290

  • Krankenhaus der Barmherzigen Brüder Trier; Innere Medizin I, Hämatologie / Internistische Onkologie

    Trier, 54292

  • Eberhard-Karls-Universität Tübingen; Medizinische Klinik I

    Tübingen, 72076

  • Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.

    Ulm, 89081

  • HSK Dr.-Horst-Schmidt-Kliniken; Innere Medizin I Kardiologie; Angiologie und Intensivmedizin

    Wiesbaden, 65199

  • Helios Klinik Wuppertal; Medizinische Klinik I

    Wuppertal, 42283

  • Kliniken St. Antonius; Zentrum Für Innere Medizin, Haematologie/Onkologie

    Wuppertal, 42283

Other trials in Germany

France33 sites

  • Clinique Claude Bernard; Onco Hematologie

    Albi, 81030

  • Centre Hospitalier Uni Ire; Service de Medecine D

    Angers, 49033

  • Institut Bergonie; Hematologie Oncologie

    Bordeaux, 33076

  • Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

    Bordeaux, 33077

  • Centre Francois Baclesse; Comite 2

    Caen, 14076

  • Chu Estaing; Cons Hemato Medecine Interne

    Clermont-Ferrand, 63003

  • Chu Site Du Bocage;Hematologie Clinique

    Dijon, 21079

  • CH Dptal Les Oudairies; Hematologie Oncologie

    La Roche-sur-Yon, 85925

  • Hopital Albert Michallon; Oncologie

    La Tronche, 38700

  • Clinique Victor Hugo; Chimiotherapie

    Le Mans, 72015

  • Hopital Claude Huriez; Hematologie

    Lille, 59037

  • Hopital Uni Ire Dupuytren; Hematologie

    Limoges, 87042

  • Centre Leon Berard; Departement Oncologie Medicale

    Lyon, 69373

  • Institut J Paolii Calmettes; Onco Hematologie 1

    Marseille, 13273

  • Clinique Pont de Chaume; Oncologie Et Radiotherapie

    Montauban, 82017

  • Hopital Saint Eloi; Hematologie Oncologie Medicale

    Montpellier, 34295

  • Hopital de L'Archet; Hematologie Clinique

    Nice, 06202

  • Polyclinique Kenval ; Radiotherapie Oncologie

    Nîmes, 30900

  • Institut Curie; Oncologie Medicale

    Paris, 75231

  • Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)

    Paris, 75475

  • Hopital Pitie Salpetriere; Hematologie Clinique

    Paris, 75651

  • Hopital Saint Jean; Hematologie

    Perpignan, 66046

  • Hopital De Haut Leveque; Hematologie Clinique

    Pessac, 33604

  • Ch Lyon Sud; Hemato Secteur Jules Courmont

    Pierre-Bénite, 69495

  • Hopital De La Miletrie; Hematologie Et Oncologie Medicale

    Poitiers, 86021

  • Ch Jacques Puel;Oncologie Medicale

    Rodez, 12027

  • ICL; Hematologie

    Saint-Priest-en-Jarez, 42271

  • Hopital Sud; Hematologie Clinique

    Salouël, 80480

  • Hopital Purpan; Hematologie Clinique

    Toulouse, 31059

  • Clinique Pasteur; Oncologie Medicale

    Toulouse, 31076

  • Hopital Bretonneau; Hematologie Therapie Cellulaire

    Tours, 37044

  • Hopitaux De Brabois; Hematologie Medecine Interne

    Vandœuvre-lès-Nancy, 54511

  • Institut Gustave Roussy; Unite D'Hematologie

    Villejuif, 94805

Other trials in France

Spain19 sites

  • Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Hematologia

    A Coruña, La Coruña, 15006

  • Hospital de la Santa Creu i Sant Pau; Servicio de Hematologia

    Barcelona, 08025

  • Hospital Universitari Vall d'Hebron; Servicio de Hematologia

    Barcelona, 08035

  • Hospital Clínic i Provincial; Servicio de Hematología y Oncología

    Barcelona, 08036

  • Hospital Duran i Reynals; Servicio de Hematologia

    Barcelona, 08907

  • Hospital de Basurto; Servicio de Hematologia

    Bilbao, Vizcaya, 48013

  • Hospital de Galdakano

    Galdakano, Vizcaya, 48960

  • Complejo Hospitalario de Jaen- Hospital Universitario Medico Quirurgico; Servicio de Hematologia

    Jaén, 23007

  • Hospital Universitario Clínico San Carlos; Servicio de Hematología

    Madrid, 28040

  • Hospital Universitario la Paz; Servicio de Hematologia

    Madrid, 28046

  • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

    Málaga, 29010

  • Hospital Clinico Universitario de Salamanca;Servicio de Hematologia

    Salamanca, 37007

  • Hospital Universitario de Canarias;servicio de Oncologia

    San Cristóbal de La Laguna, Tenerife, 38320

  • Hospital Universitario Marques de Valdecilla; Servicio de Hematologia

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen del Rocio; Servicio de Hematologia

    Seville, 41013

  • Hospital Mutua de Terrassa; Servicio de Hematologia

    Terrassa, Barcelona, 08221

  • Hospital Universitario la Fe; Servicio de Medicina Intena

    Valencia, 46009

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

    Valencia, 46010

  • Hospital Universitario Miguel Servet; Servicio Hematologia

    Zaragoza, 50009

Other trials in Spain

Canada18 sites

  • Tom Baker Cancer Centre; Dept of Medicine

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute ; Dept of Medical Oncology

    Edmonton, Alberta, T6G 1Z2

  • Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie

    Greenfield Park, Quebec, J4V 2H1

  • QEII HSC; Oncology

    Halifax, Nova Scotia, B3H 2Y9

  • Cancer Centre of Southeastern Ontario; Kingston General Hospital

    Kingston, Ontario, K7L 5P9

  • Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre

    Mississauga, Ontario, L5M 2N1

  • Moncton Hospital

    Moncton, New Brunswick, E1C 6Z8

  • Mcgill University - Royal Victoria Hospital; Oncology

    Montreal, Quebec, H3A 1A1

  • McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

    Montreal, Quebec, H3T 1E2

  • Hopital de L'Enfant-Jesus; Hematology

    Québec, Quebec, G1J 1Z4

  • Chuq - Hopital Hotel Dieu de Quebec; Oncology

    Québec, Quebec, G1R 2J6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Saskatoon Cancer Centre; Uni of Saskatoon Campus

    Saskatoon, Saskatchewan, S7N 4H4

  • Health Science Centre

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Toronto Sunnybrook Regional Cancer Centre

    Toronto, Ontario, M4N 3M5

  • University Health Network; Princess Margaret Hospital; Medical Oncology Dept

    Toronto, Ontario, M5G 2M9

  • Windsor Regional Cancer Centre

    Windsor, Ontario, N8W 2X3

  • Cancer Care Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

United States17 sites

  • St. Joseph Mercy Hospital; Department of Oncology

    Ann Arbor, Michigan, 48106

  • University of Colorado Cancer Center Department of Hematology

    Aurora, Colorado, 80045

  • Charleston Cancer Center

    Charleston, South Carolina, 29406

  • Northeast Oncology Associates

    Concord, North Carolina, 28025

  • Uni of Texas Southwestern Medical Center

    Dallas, Texas, 75390-9063

  • Northwest Medical Specialties B

    Federal Way, Washington, 98003

  • Uni Medical Center; Division Of Hemotology/Oncology

    Jacksonville, Florida, 32207

  • University of Kansas Medical Center; Department of Hematology

    Kansas City, Kansas, 66160

  • Uni of California - San Diego; Cancer Center & Dept of Medicine

    La Jolla, California, 92093

  • Northwest Georgia Oncology Centers

    Marietta, Georgia, 30060

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Rainier Physicians

    Puyallup, Washington, 98372

  • Cancer Therapy & Research Center

    San Antonio, Texas, 78229

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

  • Florida Cancer Specialists

    West Palm Beach, Florida, 33401

  • Kenmar Research Inst.

    Whittier, California, 90603

  • Forsyth Regional Cancer Center; Piedmont Hematology/Oncology Associates

    Winston-Salem, North Carolina, 27103

Other trials in United States

Italy15 sites

  • Ospedale Gen.Le Prov.Le 'C.G.Mazzoni'; Ematologia

    Ascoli Piceno, The Marches, 63100

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

    Aviano, Friuli Venezia Giulia, 33081

  • Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica

    Bari, Apulia, 70124

  • A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna

    Bologna, Emilia-Romagna, 40138

  • Università Cattolica Del Sacro Cuore S.S. Giovanni Paolo Ii; Uoc Di Onco-Ematologia

    Campobasso, Molise, 86100

  • ASST DI MONZA; Ematologia

    Monza, Lombardy, 20052

  • Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico

    Orbassano, Piedmont, 10043

  • Ospedale Regionale Di Parma; Divisione Di Oncologia Medica

    Parma, Emilia-Romagna, 43100

  • Irccs Policlinico San Matteo; Divisione Di Ematologia

    Pavia, Lombardy, 27100

  • Ospedale Santa Chiara; Unita Operativa Di Ematologia

    Pisa, Tuscany, 56100

  • Az. Osp. Arcispedale S. Maria Nuova; U.O. Di Ematologia

    Reggio Emilia, Emilia-Romagna, 42100

  • Univ. Cattolica La Sapienza; Cattedra Di Ematologia

    Rome, Lazio, 00161

  • A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1

    Turin, Piedmont, 10126

  • A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica

    Udine, Friuli Venezia Giulia, 33100

  • Ospedale Ferrarotto; Divisione Di Ematologia

    Via S. Sofia 78, Sicily, 95123

Other trials in Italy

China12 sites

  • Cancer Hospital Chinese Academy of Medical Sciences.

    Beijing, 100021

  • Beijing Cancer Hospital

    Beijing, 100142

  • Beijing Union Hospital

    Beijing, 100730

  • General Hospital of Chinese PLA; Department of Hematology

    Beijing, 100853

  • Fujian Cancer Hospital

    Fuzhou, 350014

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032

  • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, 200127

  • Changhai Hospital of Shanghai

    Shanghai, 200433

  • The Second Affiliated Hospital of Soochow University

    Suzhou, 215004

  • First Affiliated Hospital of Soochow University

    Suzhou, 215006

  • Tianjin Institute of Hematology & Blood Diseases Hospital

    Tianjin, 300020

  • The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)

    Xi'an, 710032

Other trials in China

United Kingdom12 sites

  • Birmingham Heartlands Hospital; Department of Haematology

    Birmingham, B9 5SS

  • Bradford Royal Infirmary; Haematology Department

    Bradford, BD9 6RJ

  • North Hampshire Hospital; Dept. of Haematology

    Hampshire, RG24 9NA

  • Princess Alexandra Hospital; Department of Haematology

    Harlow, CM20 1QX

  • Leicester Royal Infirmary; Dept. of Medical Oncology

    Leicester, LE1 5WW

  • Royal Liverpool Uni Hospital; Haematology

    Liverpool, L7 8XP

  • St. George'S Hospital; Haematology

    London, SW17 0QT

  • Hillingdon Hospital

    Middx, UB8 3NN

  • Churchill Hospital; Oxford Cancer and Haematology Centre

    Oxford, OX3 7LJ

  • Royal Hallamshire Hospital; Haematology Dept

    Sheffield, S10 2JF

  • Weston Park Hospital; Cancer Clinical Trials Centre

    Sheffield, S10 2SJ

  • The Royal Wolverhampton Hospitals NHS Trust; Department of Haematology

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Australia9 sites

  • Royal Adelaide Hospital; Haematology, Institute of Medical Veterinary Science

    Adelaide, South Australia, 5000

  • Frankston Hospital; Oncology/Haematology

    Frankston, Victoria, 3199

  • Fremantle Hospital; Haematology

    Fremantle, Western Australia, 6160

  • Greenslopes Private Hospital; Gallipoli Research Centre

    Greenslopes, Queensland, 4120

  • Ashford Cancer Center Research

    Kurralta Park, South Australia, 5037

  • Peter Maccallum Cancer Institute; Medical Oncology

    Melbourne, Victoria, 3000

  • Alfred Hospital; Bone Marrow Transplant Unit

    Melbourne, Victoria, 3181

  • Border Medical Oncology; Murray Valley Private Hospital

    Wodonga, Victoria, 3690

  • Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology

    Woolloongabba, Queensland, 4102

Other trials in Australia

Brazil8 sites

  • Hospital das Clinicas - UNICAMP

    Campinas, São Paulo, 13083-888

  • Centro Goiano de Oncologia - CGO

    Goiânia, Goiás, 74140-050

  • Hospital de Caridade de Ijui; Oncologia

    Ijuí, Rio Grande do Sul, 98700-000

  • Hospital das Clinicas - UFRGS; Hematologia

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia

    Santo André, São Paulo, 09060-650

  • Santa Casa de Misericordia de Sao Paulo; Hematologia e Hemoterapia

    São Paulo, São Paulo, 01221-020

  • Hospital das Clinicas - FMUSP; Hematologia

    São Paulo, São Paulo, 05403-000

Other trials in Brazil

Poland8 sites

  • Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny

    Brzozów, 36-200

  • Szpital Uniwersytecki W Krakowie; Klinika Hematologii

    Krakow, 31-501

  • Medical University School; Dept. of Haematology

    Lodz, 93-510

  • Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie

    Lublin, 20-081

  • Zaklad Opieki Zdrowotnej Mswia; Oddzial Chemioterapii

    Olsztyn, 10-228

  • Samodzielny Publiczny Centralny Szpital Kliniczny; Haematology Dept.

    Warsaw, 02-097

  • Centralny Szpital Kliniczny Mswia; Klinika onkologii, hematologii i chorob wewnetrznych

    Warsaw, 02-507

  • Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Lymphoma Dept.

    Warsaw, 02-781

Other trials in Poland

Czechia6 sites

  • Fakultni nemocnice Brno; Interni hematoonkologicka klinika

    Brno, 625 00

  • Fn Hr. Kralove; IV. Interni Hematologicka Klinika

    Hradec Králové, 500 05

  • Fakultni nemocnice Olomouc; Hemato-onkologicka klinika

    Olomouc, 775 20

  • Fakultni Nemocnice Plzen, Hematologicko-Onkologicke Oddeleni

    Plzen - Lochotin, 304 60

  • Fakultní Nemocnice Královské Vinohrady; Hematologická Klinika

    Prague, 100 34

  • VshEOBECNÁ FAKULTNÍ NEMOCNICE; I. INTERNI KLINIKA

    Prague, 128 08

Other trials in Czechia

Thailand6 sites

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

    Bangkok, 10330

  • National Cancer Inst.

    Bangkok, 10400

  • Rajavithi Hospital; Medicine

    Bangkok, 10400

  • Siriraj Hospital; Division of Hematology, Department of Medicine

    Bangkok, 10700

  • Chiang Mai Uni Hospital; Division of Hematology,Dept of Medicine,Faculty of Medicine

    Chiang Mai, 50200

  • Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine

    Khon Kaen, 40002

Other trials in Thailand

Peru5 sites

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

    Chiclayo, CIX

  • Hospital Nacional Edgardo Rebagliati Martins; Oncologia

    Lima, 11

  • Hospital Nacional Guillermo Almenara Irigoyen; Oncology

    Lima, 13

  • Instituto Nacional de Enfermedades Neoplasicas

    Lima, 34

  • Hospital Nacional LNS dela Policia Nacional del Perú. Unidad Onco; Deapartamento de Oncología

    Lima, Lima11

Other trials in Peru

Russia5 sites

  • Republican Clinical Oncologic Dispensary of Republic Of Tatarstan

    Kazan', 420029

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

    Moscow, 115478

  • Haematology Research Center; Haematology

    Moscow, 125167

  • Semashko Central Clinical Hospital Moscow; Hematology

    Moscow, 129128

  • Research Inst. of Hematology & Blood Transfusion ; Hematology

    Saint Petersburg, 191024

Other trials in Russia

Argentina4 sites

  • Hospital Italiano; Haemathology

    Buenos Aires, 1425

  • Fundaleu; Haematology

    Buenos Aires, C1114AAN

  • Hospital Britanico; Haematology

    Buenos Aires, C1280AEB

  • HOSPITAL PRIVADO - CENTRO MEDICO DE CÓRDOBA; Dpto Oncología

    Córdoba, 5016

Other trials in Argentina

Colombia4 sites

  • Organizacion Sanitas Internacional

    Bogotá

  • Instituto Cancerologia Medellin; Clinica Las Americas

    Medellín, 2A-80

  • Hospital Pablo Tobon Uribe

    Medellin-Antioquia

  • Oncólogos de Occidente

    Pereira, 600004

Other trials in Colombia

Mexico4 sites

  • Instituto Biomedico De Investigacion A.C.

    Aguascalientes, 20127

  • Hospital Español; Hematología Sala 19

    Mexico City, 11520

  • Col Instituto Tecnologico Y Estudios Superiores de Monterrey

    Monterrey, 00000

  • Hospital Universitario Dr. Jose E. Gonzalez; Haematology

    Monterrey, 64460

Other trials in Mexico

South Korea4 sites

  • Samsung Medical Centre; Oncology

    Seoul, 135-170

  • Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology

    Seoul, 138-736

  • Korean Cancer Center Hospital; Oncology

    Seoul, 139-709

  • Severance Hospital - Yonsei University; Medicine Dept.

    Seoul

Other trials in South Korea

Sweden4 sites

  • Skånes University Hospital, Skånes Department of Onclology

    Lund, 22185

  • Skånes Universitetssjukhus; Kliniska Forskningsenheten Onkologimottagning medicinsk behandling

    Malmö, 205 02

  • Länssjukhuset; Medicinkliniken

    Sundsvall, 85186

  • Akademiska sjukhuset, Onkologkliniken

    Uppsala, 75185

Other trials in Sweden

Austria3 sites

  • Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I

    Graz, 8036

  • Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

    Salzburg, 5020

  • Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Hämatologie & Hämostaseologie

    Vienna, 1090

Other trials in Austria

Ecuador3 sites

  • Teodoro Maldonado Carbo Hospital; Oncology Service

    Guayaquil, EC090150

  • Hospital Carlos Andrade Marin; Servicio de Oncología

    Quito, 2569

  • Hospital Solca Quito; Oncologia

    Quito, EC170124

Other trials in Ecuador

Hungary3 sites

  • Fov. Onk. Egyesitett Szent Istvan es Szent Laszlo Korhaz; Dept Of Bone Marrow Transplant

    Budapest, 1097

  • National Institute of Oncology, A Dept of Internal Medicine

    Budapest, 1122

  • University of Debrecen Medical and Health Science Center, Institute of Internal Medicine, Hematology

    Debrecen, 4032

Other trials in Hungary

New Zealand3 sites

  • North Shore Hospital; Haematolgy

    Auckland, 1309

  • Uni of Auckland; Dept of Molecular Medicine & Haematology

    Auckland

  • Christchurch Hospital; Canterbury Health Laboratories

    Christchurch

Other trials in New Zealand

Philippines3 sites

  • Cebu Cancer Institute; Perpetual Succour Hospital

    Cebu, 6000

  • National Kidney and Transplant Institute; Chemotherapy Unit

    Diliman, Quezon City, 1100

  • St Luke'S Medical Centre; Oncology

    Quezon City, 1114

Other trials in Philippines

Portugal3 sites

  • HUC; Servico de Hematologia

    Coimbra, 3000-075

  • IPO de Lisboa; Servico de Hematologia

    Lisbon, 1099-166

  • Hospital de Sao Joao; Servico de Hematologia Clinica

    Porto, 4200-319

Other trials in Portugal

Taiwan3 sites

  • Veterans General Hospital; Division of Oncology

    Taipei, 00112

  • Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology

    Taipei, 112

  • Chang Gung Medical Foundation-Taipei

    Taoyuan, 333

Other trials in Taiwan

Hong Kong2 sites

  • Queen Elizabeth Hospital; Clinical Oncology

    Hong Kong

  • Queen Mary Hospital; Dept of Medicine

    Hong Kong

Other trials in Hong Kong

Lithuania2 sites

  • Seamen' Hospital' Dept. of haematology

    Klaipėda, 92288

  • Uni Hospital Santariskiu Clinic; Haematology

    Vilnius, 08661

Other trials in Lithuania

Greece1 site

  • Georgios Papanikolaou Hospital; Hematology Department

    Thessaloniki, 570 10

Other trials in Greece

Malaysia1 site

  • Hospital Pulau Pinang

    George Town, Pulau Pinang, 10990

Other trials in Malaysia

Panama1 site

  • Centro Hemato Oncologico Paitilla

    Panama City, 083200752

Other trials in Panama

Slovakia1 site

  • National Cancer Inst. ; Dept. of Chemotherapy

    Bratislava, 833 10

Other trials in Slovakia

Switzerland1 site

  • Universitätsspital Zürich; Klinik für Onkologie

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial Comparing the Efficacy of Bevacizumab in Combination With Rituximab and CHOP (R-CHOP + Bevacizumab) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With CD20-positive Diffuse Large B-cell Lymphoma (DLBCL)

This 2-arm study was designed to compare the efficacy and safety of bevacizumab (Avastin) in combination with rituximab (MabThera) and CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone) chemotherapy (R-CHOP) versus rituximab plus CHOP chemotherapy (R-CHOP) in previously untreated patients with CD20-positive diffuse large B-cell lymphoma (DLBCL). Patients were randomized to receive 8 cycles of treatment with R-CHOP plus bevacizumab or R-CHOP plus placebo. Treatment with bevacizumab/placebo and R-CHOP was given either on a 2-week or 3-week schedule and bevacizumab was given at a weekly average dose of 5 mg/kg (10 mg/kg for 2-week cycles and 15 mg/kg for 3-week cycles).

Read the detailed description

An independent Data and Safety Monitoring Board (DSMB) was established to review safety data collected during the study on an ongoing basis. At its meeting in December 2009, the DSMB noted a trend for increased cardiac toxicity in the experimental arm (R-CHOP + bevacizumab) compared with the control arm (R-CHOP + placebo). Additional efficacy analyses of data from 720 randomized patients were presented at a DSMB meeting on May 22, 2010; they indicated no improvement in efficacy with the addition of bevacizumab to R-CHOP. It was noted, however, that there was an apparent increase in the risk of cardiotoxicity, premature treatment withdrawal, serious adverse events (SAEs), fatal adverse events (AEs), and perforation/ulcer in the experimental arm. Based on its assessment of an increased risk with unlikely benefit for patients randomized to the experimental arm, the DSMB recommended that further enrollment in the study be permanently halted and that bevacizumab be discontinued for any patients randomized to the experimental arm. On May 31, 2010, the sponsor took the decision to stop enrollment into the study and the bevacizumab treatment was terminated with immediate effect as recommended by the DSMB.

The study protocol was amended. The primary objective of the study was changed from evaluation of efficacy to evaluation of safety and the study was extended to include an 18-month safety follow-up period. Because enrollment was terminated prematurely resulting in fewer enrolled patients than planned, the outcome measure data are premature due to fewer than expected events.

The time frame for the reporting of serious adverse events was modified. Serious adverse events (SAE) unrelated to study treatment were reported until 1 year post-treatment or until new anti-lymphoma treatment was initiated. SAEs judged to be related to study treatment and congestive heart failure events were reported at any time during the study.

Conditions
B-cell Lymphoma
Being tested
Bevacizumab, Rituximab, CHOP, Placebo
Medical subject headings
Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BevacizumabDrug

    Also called Avastin

    Bevacizumab was administered at a dose of 15 mg/kg IV on Day 1 of each 21-day cycle for 8 cycles or at a dose 10 mg/kg IV on Day 1 of each 14-day cycle for 8 cycles. The cycle duration (14- or 21-day) was chosen by each center prior to initiation of the study and was the same for all patients enrolled at that center.

  • RituximabDrug

    Also called MabThera

    Rituximab was administered at a dose of 375 mg/m^2 IV on Day 1 of each 14- or 21-day cycle for 8 cycles. The cycle duration (14- or 21-day) was chosen by each center prior to initiation of the study and was the same for all patients enrolled at that center.

  • CHOPDrug

    Cyclophosphamide was administered at a dose of 750 mg/m^2 IV on Day 1 of each cycle. Doxorubicin was administered at a dose of 50 mg/m^2 IV on Day 1 of each cycle. Vincristine was administered at a dose of 1.4 mg/m^2 IV (maximum of 2 mg) on Day 1 of each cycle. Prednisone was administered at a dose of 100 mg orally on Days 1-5 of each cycle. All 4 drugs were administered either every 21 days for 8 cycles or every 14 days for 6 cycles. The cycle duration (14- or 21-day) was chosen by each center prior to initiation of the study and was the same for all patients enrolled at that center.

  • PlaceboDrug

    Placebo to bevacizumab was administered on Day 1 of each 14- or 21-day cycle for 8 cycles. The cycle duration (14- or 21-day) was chosen by each center prior to initiation of the study and was the same for all patients enrolled at that center.

Study groups in NCT00486759
Study groupRoleWhat they receive
Bevacizumab + rituximab + CHOPExperimentalPatients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
Receives: Drug: Bevacizumab; Drug: Rituximab; Drug: CHOP
Placebo + rituximab + CHOPActive comparatorPatients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
Receives: Drug: Rituximab; Drug: CHOP; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS)

    PFS was defined as the time from the date of randomization to the date of disease progression (PD)/relapse, as determined by the investigator, or death from any cause, whichever occurred earlier. A patient with PD/relapse must meet at least 1 of the following criteria: (1) Appearance of any new lesion > 1.0 cm in the short axis during or at the end of therapy. (2) ≥ 50 % increase from nadir in the sum of the products of diameters (SPD, maximum diameter of a tumor x largest diameter perpendicular to the maximum diameter) of any previously involved nodes, in a single involved node, or the size of other lesions (eg, splenic or hepatic nodules). To be considered progressive disease, a lymph node with a diameter of the short axis < 1.0 cm must increase by ≥ 50% to a size of 1.5 x 1.5 cm or > 1.5 cm in the long axis. (3) ≥ 50 % increase in the greatest diameter of any previously identified node > 1.0 cm in its short axis or in the SPD of more than 1 node.

    Measured: Baseline to end of the study (up to 4 years, 4 months)

Secondary outcomes (2)

  1. Overall Survival

    Overall survival was defined as the time from the date of randomization to the date of death due to any cause.

    Measured: Baseline to end of the study (up to 4 years, 4 months)

  2. Overall Response (OR) Assessed According to the Revised Response Criteria for Malignant Lymphoma

    OR = a complete response (CR), an unconfirmed CR, or a partial response (PR). CR = Complete disappearance of disease and disease-related symptoms. All lymph nodes and nodal masses regressed on computed tomography (CT) to normal size (≤ 1.5 cm in their greatest transverse diameter for nodes > 1.5 cm prior to therapy and ≤ 1.0 cm in their short axis for nodes 1.1-1.5 cm in their long axis and > 1.0 cm in their short axis prior to therapy). Spleen and/or liver not palpable on physical examination, normal size by imaging, and disappearance of nodules related to lymphoma. If bone marrow was involved prior to therapy, infiltrate must have cleared on repeat biopsy. PR = ≥ 50% decrease in sum of the product of the diameters (SPD) of up to 6 of the largest dominant nodes or nodal masses. No increase in the size of the other nodes, liver, or spleen. Splenic and hepatic nodules regressed by ≥ 50% in their SPD or, for single nodules, in the greatest transverse diameter. No new sites of disease.

    Measured: At the end of treatment (Cycle 8, up to 12 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2007 (estimated)
  2. Study start26 Jul 2007
  3. Primary completion30 Nov 2011
  4. Study completion30 Nov 2011

Why it stopped: Due to an unfavorable benefit/risk ratio.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
787 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00486759
Sponsor's protocol ID
BO20603
Status last verified
Jun 2017
First submitted
14 Jun 2007
Last updated
25 Jul 2017

Publications

  • Morschhauser F, Lenz G, Herrera AF, Flowers CR, Trneny M, Burke JM, Hou JZ, Staber PB, Hawkes EA, Izutsu K, Le Gouill S, Belada D, Tucci A, Yan M, Harris W, Lu K, Bolen CR, Hirata J, Lee C, Jiang Y, Jardin F, Hatzi K. Low lymphoma macrophage infiltration predicts poor outcomes for R-CHOP- but not Pola-R-CHP-treated patients with DLBCL. Blood Neoplasia. 2026 Jul 2;3(4):100264. doi: 10.1016/j.bneo.2026.100264. eCollection 2026 Nov.

    PubMed 42699559

  • McCord R, Bolen CR, Koeppen H, Kadel EE 3rd, Oestergaard MZ, Nielsen T, Sehn LH, Venstrom JM. PD-L1 and tumor-associated macrophages in de novo DLBCL. Blood Adv. 2019 Feb 26;3(4):531-540. doi: 10.1182/bloodadvances.2018020602.

    PubMed 30770362

  • Seymour JF, Pfreundschuh M, Trneny M, Sehn LH, Catalano J, Csinady E, Moore N, Coiffier B; MAIN Study Investigators. R-CHOP with or without bevacizumab in patients with previously untreated diffuse large B-cell lymphoma: final MAIN study outcomes. Haematologica. 2014 Aug;99(8):1343-9. doi: 10.3324/haematol.2013.100818. Epub 2014 Jun 3.

    PubMed 24895339

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bevacizumab, Rituximab and CHOP in people with B-cell Lymphoma, run by Hoffmann-La Roche at 266 sites in 34 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 266 sites in Germany, France, Spain, Canada, United States and 29 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: Baseline to end of the study (up to 4 years, 4 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00486759, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2017; AzTrials last refreshed its copy on 8 Nov 2026.

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