Study Stopped
Due to an unfavorable benefit/risk ratio.
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 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)
1 other identifier
interventional
787
33 countries
263
Brief 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 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2007
Typical duration for phase_3
263 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2007
CompletedFirst Posted
Study publicly available on registry
June 15, 2007
CompletedStudy Start
First participant enrolled
July 26, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2011
CompletedResults Posted
Study results publicly available
December 31, 2012
CompletedJuly 25, 2017
June 1, 2017
4.4 years
June 14, 2007
November 28, 2012
June 26, 2017
Conditions
Outcome Measures
Primary Outcomes (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.
Baseline to end of the study (up to 4 years, 4 months)
Secondary Outcomes (2)
Overall Survival
Baseline to end of the study (up to 4 years, 4 months)
Overall Response (OR) Assessed According to the Revised Response Criteria for Malignant Lymphoma
At the end of treatment (Cycle 8, up to 12 months)
Study Arms (2)
Bevacizumab + rituximab + CHOP
EXPERIMENTALPatients 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).
Placebo + rituximab + CHOP
ACTIVE 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).
Interventions
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoffmann-La Rochelead
- Genentech, Inc.collaborator
Study Sites (266)
Uni of California - San Diego; Cancer Center & Dept of Medicine
La Jolla, California, 92093, United States
Kenmar Research Inst.
Whittier, California, 90603, United States
University of Colorado Cancer Center Department of Hematology
Aurora, Colorado, 80045, United States
Uni Medical Center; Division Of Hemotology/Oncology
Jacksonville, Florida, 32207, United States
Florida Cancer Specialists
West Palm Beach, Florida, 33401, United States
Northwest Georgia Oncology Centers
Marietta, Georgia, 30060, United States
University of Kansas Medical Center; Department of Hematology
Kansas City, Kansas, 66160, United States
St. Joseph Mercy Hospital; Department of Oncology
Ann Arbor, Michigan, 48106, United States
Northeast Oncology Associates
Concord, North Carolina, 28025, United States
Forsyth Regional Cancer Center; Piedmont Hematology/Oncology Associates
Winston-Salem, North Carolina, 27103, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Charleston Cancer Center
Charleston, South Carolina, 29406, United States
Uni of Texas Southwestern Medical Center
Dallas, Texas, 75390-9063, United States
Cancer Therapy & Research Center
San Antonio, Texas, 78229, United States
Northwest Medical Specialties B
Federal Way, Washington, 98003, United States
Rainier Physicians
Puyallup, Washington, 98372, United States
Northwest Medical Specialties
Tacoma, Washington, 98405, United States
Hospital Italiano; Haemathology
Buenos Aires, 1425, Argentina
Fundaleu; Haematology
Buenos Aires, C1114AAN, Argentina
Hospital Britanico; Haematology
Buenos Aires, C1280AEB, Argentina
HOSPITAL PRIVADO - CENTRO MEDICO DE CÓRDOBA; Dpto Oncología
Córdoba, 5016, Argentina
Greenslopes Private Hospital; Gallipoli Research Centre
Greenslopes, Queensland, 4120, Australia
Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology
Woolloongabba, Queensland, 4102, Australia
Royal Adelaide Hospital; Haematology, Institute of Medical Veterinary Science
Adelaide, South Australia, 5000, Australia
Ashford Cancer Center Research
Kurralta Park, South Australia, 5037, Australia
Frankston Hospital; Oncology/Haematology
Frankston, Victoria, 3199, Australia
Peter Maccallum Cancer Institute; Medical Oncology
Melbourne, Victoria, 3000, Australia
Alfred Hospital; Bone Marrow Transplant Unit
Melbourne, Victoria, 3181, Australia
Border Medical Oncology; Murray Valley Private Hospital
Wodonga, Victoria, 3690, Australia
Fremantle Hospital; Haematology
Fremantle, Western Australia, 6160, Australia
Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I
Graz, 8036, Austria
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
Salzburg, 5020, Austria
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Hämatologie & Hämostaseologie
Vienna, 1090, Austria
Centro Goiano de Oncologia - CGO
Goiânia, Goiás, 74140-050, Brazil
Hospital de Caridade de Ijui; Oncologia
Ijuí, Rio Grande do Sul, 98700-000, Brazil
Hospital das Clinicas - UFRGS; Hematologia
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, 91350-200, Brazil
Hospital das Clinicas - UNICAMP
Campinas, São Paulo, 13083-888, Brazil
Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia
Santo André, São Paulo, 09060-650, Brazil
Santa Casa de Misericordia de Sao Paulo; Hematologia e Hemoterapia
São Paulo, São Paulo, 01221-020, Brazil
Hospital das Clinicas - FMUSP; Hematologia
São Paulo, São Paulo, 05403-000, Brazil
Tom Baker Cancer Centre; Dept of Medicine
Calgary, Alberta, T2N 4N2, Canada
Cross Cancer Institute ; Dept of Medical Oncology
Edmonton, Alberta, T6G 1Z2, Canada
Cancer Care Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
Moncton Hospital
Moncton, New Brunswick, E1C 6Z8, Canada
Health Science Centre
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
QEII HSC; Oncology
Halifax, Nova Scotia, B3H 2Y9, Canada
Cancer Centre of Southeastern Ontario; Kingston General Hospital
Kingston, Ontario, K7L 5P9, Canada
Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre
Mississauga, Ontario, L5M 2N1, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
Toronto, Ontario, M5G 2M9, Canada
Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3, Canada
Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie
Greenfield Park, Quebec, J4V 2H1, Canada
Mcgill University - Royal Victoria Hospital; Oncology
Montreal, Quebec, H3A 1A1, Canada
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Montreal, Quebec, H3T 1E2, Canada
Hopital de L'Enfant-Jesus; Hematology
Québec, Quebec, G1J 1Z4, Canada
Chuq - Hopital Hotel Dieu de Quebec; Oncology
Québec, Quebec, G1R 2J6, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
Saskatoon Cancer Centre; Uni of Saskatoon Campus
Saskatoon, Saskatchewan, S7N 4H4, Canada
Cancer Hospital Chinese Academy of Medical Sciences.
Beijing, 100021, China
Beijing Cancer Hospital
Beijing, 100142, China
Beijing Union Hospital
Beijing, 100730, China
General Hospital of Chinese PLA; Department of Hematology
Beijing, 100853, China
Fujian Cancer Hospital
Fuzhou, 350014, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200127, China
Changhai Hospital of Shanghai
Shanghai, 200433, China
The Second Affiliated Hospital of Soochow University
Suzhou, 215004, China
First Affiliated Hospital of Soochow University
Suzhou, 215006, China
Tianjin Institute of Hematology & Blood Diseases Hospital
Tianjin, 300020, China
The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)
Xi'an, 710032, China
Organizacion Sanitas Internacional
Bogotá, Colombia
Hospital Pablo Tobon Uribe
Medellin-Antioquia, Colombia
Instituto Cancerologia Medellin; Clinica Las Americas
Medellín, 2A-80, Colombia
Oncólogos de Occidente
Pereira, 600004, Colombia
Fakultni nemocnice Brno; Interni hematoonkologicka klinika
Brno, 625 00, Czechia
Fn Hr. Kralove; IV. Interni Hematologicka Klinika
Hradec Králové, 500 05, Czechia
Fakultni nemocnice Olomouc; Hemato-onkologicka klinika
Olomouc, 775 20, Czechia
Fakultni Nemocnice Plzen, Hematologicko-Onkologicke Oddeleni
Plzen - Lochotin, 304 60, Czechia
Fakultní Nemocnice Královské Vinohrady; Hematologická Klinika
Prague, 100 34, Czechia
VshEOBECNÁ FAKULTNÍ NEMOCNICE; I. INTERNI KLINIKA
Prague, 128 08, Czechia
Teodoro Maldonado Carbo Hospital; Oncology Service
Guayaquil, EC090150, Ecuador
Hospital Carlos Andrade Marin; Servicio de Oncología
Quito, 2569, Ecuador
Hospital Solca Quito; Oncologia
Quito, EC170124, Ecuador
Clinique Claude Bernard; Onco Hematologie
Albi, 81030, France
Centre Hospitalier Uni Ire; Service de Medecine D
Angers, 49033, France
Institut Bergonie; Hematologie Oncologie
Bordeaux, 33076, France
Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
Bordeaux, 33077, France
Centre Francois Baclesse; Comite 2
Caen, 14076, France
Chu Estaing; Cons Hemato Medecine Interne
Clermont-Ferrand, 63003, France
Chu Site Du Bocage;Hematologie Clinique
Dijon, 21079, France
CH Dptal Les Oudairies; Hematologie Oncologie
La Roche-sur-Yon, 85925, France
Hopital Albert Michallon; Oncologie
La Tronche, 38700, France
Clinique Victor Hugo; Chimiotherapie
Le Mans, 72015, France
Hopital Claude Huriez; Hematologie
Lille, 59037, France
Hopital Uni Ire Dupuytren; Hematologie
Limoges, 87042, France
Centre Leon Berard; Departement Oncologie Medicale
Lyon, 69373, France
Institut J Paolii Calmettes; Onco Hematologie 1
Marseille, 13273, France
Clinique Pont de Chaume; Oncologie Et Radiotherapie
Montauban, 82017, France
Hopital Saint Eloi; Hematologie Oncologie Medicale
Montpellier, 34295, France
Hopital de L'Archet; Hematologie Clinique
Nice, 06202, France
Polyclinique Kenval ; Radiotherapie Oncologie
Nîmes, 30900, France
Institut Curie; Oncologie Medicale
Paris, 75231, France
Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)
Paris, 75475, France
Hopital Pitie Salpetriere; Hematologie Clinique
Paris, 75651, France
Hopital Saint Jean; Hematologie
Perpignan, 66046, France
Hopital De Haut Leveque; Hematologie Clinique
Pessac, 33604, France
Ch Lyon Sud; Hemato Secteur Jules Courmont
Pierre-Bénite, 69495, France
Hopital De La Miletrie; Hematologie Et Oncologie Medicale
Poitiers, 86021, France
Ch Jacques Puel;Oncologie Medicale
Rodez, 12027, France
ICL; Hematologie
Saint-Priest-en-Jarez, 42271, France
Hopital Sud; Hematologie Clinique
Salouël, 80480, France
Hopital Purpan; Hematologie Clinique
Toulouse, 31059, France
Clinique Pasteur; Oncologie Medicale
Toulouse, 31076, France
Hopital Bretonneau; Hematologie Therapie Cellulaire
Tours, 37044, France
Hopitaux De Brabois; Hematologie Medecine Interne
Vandœuvre-lès-Nancy, 54511, France
Institut Gustave Roussy; Unite D'Hematologie
Villejuif, 94805, France
Gesundheitszentrum St. Marien GmbH; Med. II, Hämatologie/Onkologie
Amberg, 92224, Germany
Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.
Berlin, 10117, Germany
Charité; Onkologie & Hämatologie
Berlin, 10117, Germany
DIAKO Ev. Diakonie-Krankenhaus Bremen GmbH; Med. Klinik II; Hämatologie und internistische Onkologie
Bremen, 28239, Germany
Carl-Thiem-Klinik Cottbus; Medizinische Klinik
Cottbus, 03048, Germany
Klinikzentrum Mitte; Medizinische Klinik Gastroenterologie Haematologie / Onkologie
Dortmund, 44137, Germany
St. Johannes Hospital; Abt. Innere Medizin
Dortmund, 44137, Germany
St Antonius Hospital; Haematologie/Onkologie
Eschweiler, 52249, Germany
Krankenhaus Nordwest Medizinische Klinik
Frankfurt, 60488, Germany
Klinik Fulda; Abt. Itz
Fulda, 36043, Germany
Georg-August-Uniklinik ; Zentrum Innere Medizin Abt. Hämatologie & Onkologie
Göttingen, 37075, Germany
Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik
Greifswald, 17475, Germany
Kath.Krankenhaus Hagen gem.GmbH St.-Marien-Hospital
Hagen, 58095, Germany
Asklepios Klinik St. Georg; Allgemeine Innere Medizin
Hamburg, 20099, Germany
Facharztzentrum Eppendorf, Studien GbR
Hamburg, 20249, Germany
Evang.Krankenhaus Abt. Hämatologie und Onkologie
Hamm, 59063, Germany
St.-Marien-Hospital Klinik Knappenstraße; Klinik für Hämatologie und Onkologie
Hamm, 59071, Germany
KRH Klinikum Siloah Medizinische Klinik III
Hanover, 30449, Germany
St. Bernward-Krankenhaus
Hildesheim, 31134, Germany
Universitaetsklinikum des Saarlandes; medizinische Klinik und Poliklinik; Innere Medizin I
Homburg/Saar, 66421, Germany
Städtisches Klinikum Karlsruhe gGmbH, II. Medizinische Klinik
Karlsruhe, 76133, Germany
St. Vincentius Kliniken Ag; Medizinische Klinik Abt. 2
Karlsruhe, 76137, Germany
Tagesklinik Landshut; Hämatologie/Onkologie
Landshut, 84028, Germany
Universitätsklinikum Leipzig Medizinische Klinik II Gastroenterolog. u. Hepatolog.
Leipzig, 04103, Germany
Klinikum St.Georg gGmbH Klinik für Internistische Onkologie und Hämotologie
Leipzig, 04129, Germany
Klinikum der Stadt Ludwigshafen; Medizinische Klinik A
Ludwigshafen, 67063, Germany
Universitätsklinikum Schleswig-Holstein / Campus Lübeck, Med. Klinik I, Hämatologie/Onkologie
Lübeck, 23562, Germany
Märkische Kliniken GmbH, Klinikum Lüdenscheid; Hämatologie / Onkologie
Lüdenscheid, 58515, Germany
Otto von Guericke Uni Magdeburg Uniklinik; Hämatologie/Onkologie
Magdeburg, 39120, Germany
Klinikum Magdeburg gemeinnützige GmbH; Klinik Haematologie und Onkologie
Magdeburg, 39130, Germany
Klinikum Mannheim III. Medizinische Klinik
Mannheim, 68167, Germany
Klinikum der Universitaet Muenchen; Campus Großhadern; Medizinische Klinik III und Poliklinik
München, 81377, Germany
Westfälische Wilhelms-Universität Münster, Medizinische Klinik und Poliklinik A
Münster, 48149, Germany
Klinikum Oldenburg gGmbH; Klinik für Onkologie und Hämatologie
Oldenburg, 26133, Germany
Prosper-Hospital, Medizinische Klinik I
Recklinghausen, 45659, Germany
St Marien Krankenhaus; Medizinische Klinik Iii
Siegen, 57072, Germany
Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie
Trier, 54290, Germany
Krankenhaus der Barmherzigen Brüder Trier; Innere Medizin I, Hämatologie / Internistische Onkologie
Trier, 54292, Germany
Eberhard-Karls-Universität Tübingen; Medizinische Klinik I
Tübingen, 72076, Germany
Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.
Ulm, 89081, Germany
HSK Dr.-Horst-Schmidt-Kliniken; Innere Medizin I Kardiologie; Angiologie und Intensivmedizin
Wiesbaden, 65199, Germany
Helios Klinik Wuppertal; Medizinische Klinik I
Wuppertal, 42283, Germany
Kliniken St. Antonius; Zentrum Für Innere Medizin, Haematologie/Onkologie
Wuppertal, 42283, Germany
Georgios Papanikolaou Hospital; Hematology Department
Thessaloniki, 570 10, Greece
Queen Elizabeth Hospital; Clinical Oncology
Hong Kong, Hong Kong
Queen Mary Hospital; Dept of Medicine
Hong Kong, Hong Kong
Fov. Onk. Egyesitett Szent Istvan es Szent Laszlo Korhaz; Dept Of Bone Marrow Transplant
Budapest, 1097, Hungary
National Institute of Oncology, A Dept of Internal Medicine
Budapest, 1122, Hungary
University of Debrecen Medical and Health Science Center, Institute of Internal Medicine, Hematology
Debrecen, 4032, Hungary
Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
Bari, Apulia, 70124, Italy
A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
Bologna, Emilia-Romagna, 40138, Italy
Ospedale Regionale Di Parma; Divisione Di Oncologia Medica
Parma, Emilia-Romagna, 43100, Italy
Az. Osp. Arcispedale S. Maria Nuova; U.O. Di Ematologia
Reggio Emilia, Emilia-Romagna, 42100, Italy
Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
Aviano, Friuli Venezia Giulia, 33081, Italy
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica
Udine, Friuli Venezia Giulia, 33100, Italy
Univ. Cattolica La Sapienza; Cattedra Di Ematologia
Rome, Lazio, 00161, Italy
ASST DI MONZA; Ematologia
Monza, Lombardy, 20052, Italy
Irccs Policlinico San Matteo; Divisione Di Ematologia
Pavia, Lombardy, 27100, Italy
Università Cattolica Del Sacro Cuore S.S. Giovanni Paolo Ii; Uoc Di Onco-Ematologia
Campobasso, Molise, 86100, Italy
Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico
Orbassano, Piedmont, 10043, Italy
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1
Turin, Piedmont, 10126, Italy
Ospedale Ferrarotto; Divisione Di Ematologia
Via S. Sofia 78, Sicily, 95123, Italy
Ospedale Gen.Le Prov.Le 'C.G.Mazzoni'; Ematologia
Ascoli Piceno, The Marches, 63100, Italy
Ospedale Santa Chiara; Unita Operativa Di Ematologia
Pisa, Tuscany, 56100, Italy
Seamen' Hospital' Dept. of haematology
Klaipėda, 92288, Lithuania
Uni Hospital Santariskiu Clinic; Haematology
Vilnius, 08661, Lithuania
Hospital Pulau Pinang
George Town, Pulau Pinang, 10990, Malaysia
Instituto Biomedico De Investigacion A.C.
Aguascalientes, 20127, Mexico
Hospital Español; Hematología Sala 19
Mexico City, 11520, Mexico
Col Instituto Tecnologico Y Estudios Superiores de Monterrey
Monterrey, 00000, Mexico
Hospital Universitario Dr. Jose E. Gonzalez; Haematology
Monterrey, 64460, Mexico
North Shore Hospital; Haematolgy
Auckland, 1309, New Zealand
Uni of Auckland; Dept of Molecular Medicine & Haematology
Auckland, New Zealand
Christchurch Hospital; Canterbury Health Laboratories
Christchurch, New Zealand
Centro Hemato Oncologico Paitilla
Panama City, 083200752, Panama
Hospital Nacional Almanzor Aguinaga Asenjo; Unidad De Investigacion Del Servicio De Oncologia Medica
Chiclayo, CIX, Peru
Hospital Nacional Edgardo Rebagliati Martins; Oncologia
Lima, 11, Peru
Hospital Nacional Guillermo Almenara Irigoyen; Oncology
Lima, 13, Peru
Instituto Nacional de Enfermedades Neoplasicas
Lima, 34, Peru
Hospital Nacional LNS dela Policia Nacional del Perú. Unidad Onco; Deapartamento de Oncología
Lima, Lima11, Peru
Cebu Cancer Institute; Perpetual Succour Hospital
Cebu, 6000, Philippines
National Kidney and Transplant Institute; Chemotherapy Unit
Diliman, Quezon City, 1100, Philippines
St Luke'S Medical Centre; Oncology
Quezon City, 1114, Philippines
Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny
Brzozów, 36-200, Poland
Szpital Uniwersytecki W Krakowie; Klinika Hematologii
Krakow, 31-501, Poland
Medical University School; Dept. of Haematology
Lodz, 93-510, Poland
Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie
Lublin, 20-081, Poland
Zaklad Opieki Zdrowotnej Mswia; Oddzial Chemioterapii
Olsztyn, 10-228, Poland
Samodzielny Publiczny Centralny Szpital Kliniczny; Haematology Dept.
Warsaw, 02-097, Poland
Centralny Szpital Kliniczny Mswia; Klinika onkologii, hematologii i chorob wewnetrznych
Warsaw, 02-507, Poland
Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Lymphoma Dept.
Warsaw, 02-781, Poland
HUC; Servico de Hematologia
Coimbra, 3000-075, Portugal
IPO de Lisboa; Servico de Hematologia
Lisbon, 1099-166, Portugal
Hospital de Sao Joao; Servico de Hematologia Clinica
Porto, 4200-319, Portugal
Republican Clinical Oncologic Dispensary of Republic Of Tatarstan
Kazan', 420029, Russia
N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis
Moscow, 115478, Russia
Haematology Research Center; Haematology
Moscow, 125167, Russia
Semashko Central Clinical Hospital Moscow; Hematology
Moscow, 129128, Russia
Research Inst. of Hematology & Blood Transfusion ; Hematology
Saint Petersburg, 191024, Russia
National Cancer Inst. ; Dept. of Chemotherapy
Bratislava, 833 10, Slovakia
Samsung Medical Centre; Oncology
Seoul, 135-170, South Korea
Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology
Seoul, 138-736, South Korea
Korean Cancer Center Hospital; Oncology
Seoul, 139-709, South Korea
Severance Hospital - Yonsei University; Medicine Dept.
Seoul, South Korea
Hospital Mutua de Terrassa; Servicio de Hematologia
Terrassa, Barcelona, 08221, Spain
Hospital Universitario Marques de Valdecilla; Servicio de Hematologia
Santander, Cantabria, 39008, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Hematologia
A Coruña, La Coruña, 15006, Spain
Hospital Universitario de Canarias;servicio de Oncologia
San Cristóbal de La Laguna, Tenerife, 38320, Spain
Hospital de Basurto; Servicio de Hematologia
Bilbao, Vizcaya, 48013, Spain
Hospital de Galdakano
Galdakano, Vizcaya, 48960, Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Hematologia
Barcelona, 08025, Spain
Hospital Universitari Vall d'Hebron; Servicio de Hematologia
Barcelona, 08035, Spain
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
Barcelona, 08036, Spain
Hospital Duran i Reynals; Servicio de Hematologia
Barcelona, 08907, Spain
Complejo Hospitalario de Jaen- Hospital Universitario Medico Quirurgico; Servicio de Hematologia
Jaén, 23007, Spain
Hospital Universitario Clínico San Carlos; Servicio de Hematología
Madrid, 28040, Spain
Hospital Universitario la Paz; Servicio de Hematologia
Madrid, 28046, Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Málaga, 29010, Spain
Hospital Clinico Universitario de Salamanca;Servicio de Hematologia
Salamanca, 37007, Spain
Hospital Universitario Virgen del Rocio; Servicio de Hematologia
Seville, 41013, Spain
Hospital Universitario la Fe; Servicio de Medicina Intena
Valencia, 46009, Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, 46010, Spain
Hospital Universitario Miguel Servet; Servicio Hematologia
Zaragoza, 50009, Spain
Skånes University Hospital, Skånes Department of Onclology
Lund, 22185, Sweden
Skånes Universitetssjukhus; Kliniska Forskningsenheten Onkologimottagning medicinsk behandling
Malmo, 205 02, Sweden
Länssjukhuset; Medicinkliniken
Sundsvall, 85186, Sweden
Akademiska sjukhuset, Onkologkliniken
Uppsala, 75185, Sweden
Universitätsspital Zürich; Klinik für Onkologie
Zurich, 8091, Switzerland
Veterans General Hospital; Division of Oncology
Taipei, 00112, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
Taipei, 112, Taiwan
Chang Gung Medical Foundation-Taipei
Taoyuan District, 333, Taiwan
King Chulalongkorn Memorial Hospital; Division of Hematology, Department of Medicine
Bangkok, 10330, Thailand
National Cancer Inst.
Bangkok, 10400, Thailand
Rajavithi Hospital; Medicine
Bangkok, 10400, Thailand
Siriraj Hospital; Division of Hematology, Department of Medicine
Bangkok, 10700, Thailand
Chiang Mai Uni Hospital; Division of Hematology,Dept of Medicine,Faculty of Medicine
Chiang Mai, 50200, Thailand
Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine
Khon Kaen, 40002, Thailand
Birmingham Heartlands Hospital; Department of Haematology
Birmingham, B9 5SS, United Kingdom
Bradford Royal Infirmary; Haematology Department
Bradford, BD9 6RJ, United Kingdom
North Hampshire Hospital; Dept. of Haematology
Hampshire, RG24 9NA, United Kingdom
Princess Alexandra Hospital; Department of Haematology
Harlow, CM20 1QX, United Kingdom
Leicester Royal Infirmary; Dept. of Medical Oncology
Leicester, LE1 5WW, United Kingdom
Royal Liverpool Uni Hospital; Haematology
Liverpool, L7 8XP, United Kingdom
St. George'S Hospital; Haematology
London, SW17 0QT, United Kingdom
Hillingdon Hospital
Middx, UB8 3NN, United Kingdom
Churchill Hospital; Oxford Cancer and Haematology Centre
Oxford, OX3 7LJ, United Kingdom
Royal Hallamshire Hospital; Haematology Dept
Sheffield, S10 2JF, United Kingdom
Weston Park Hospital; Cancer Clinical Trials Centre
Sheffield, S10 2SJ, United Kingdom
The Royal Wolverhampton Hospitals NHS Trust; Department of Haematology
Wolverhampton, WV10 0QP, United Kingdom
Related Publications (2)
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.
PMID: 30770362DERIVEDSeymour 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.
PMID: 24895339DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to premature termination of the study, the efficacy results should be interpreted with caution.
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 14, 2007
First Posted
June 15, 2007
Study Start
July 26, 2007
Primary Completion
November 30, 2011
Study Completion
November 30, 2011
Last Updated
July 25, 2017
Results First Posted
December 31, 2012
Record last verified: 2017-06