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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

Primary Purpose

B-cell Lymphoma

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Bevacizumab

Rituximab

CHOP

Placebo

About this trial

This is an interventional treatment trial for B-cell Lymphoma

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Uni of California - San Diego; Cancer Center & Dept of Medicine
Kenmar Research Inst.
University of Colorado Cancer Center Department of Hematology
Uni Medical Center; Division Of Hemotology/Oncology
Florida Cancer Specialists
Northwest Georgia Oncology Centers
University of Kansas Medical Center; Department of Hematology
St. Joseph Mercy Hospital; Department of Oncology
Northeast Oncology Associates
Forsyth Regional Cancer Center; Piedmont Hematology/Oncology Associates
Providence Portland Medical Center
Charleston Cancer Center
Uni of Texas Southwestern Medical Center
Cancer Therapy & Research Center
Northwest Medical Specialties B
Rainier Physicians
Northwest Medical Specialties
Hospital Italiano; Haemathology
Fundaleu; Haematology
Hospital Britanico; Haematology
HOSPITAL PRIVADO - CENTRO MEDICO DE CÓRDOBA; Dpto Oncología
Greenslopes Private Hospital; Gallipoli Research Centre
Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology
Royal Adelaide Hospital; Haematology, Institute of Medical Veterinary Science
Ashford Cancer Center Research
Frankston Hospital; Oncology/Haematology
Peter Maccallum Cancer Institute; Medical Oncology
Alfred Hospital; Bone Marrow Transplant Unit
Border Medical Oncology; Murray Valley Private Hospital
Fremantle Hospital; Haematology
Lkh-Univ. Klinikum Graz; Klinik Für Innere Medizin I
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Hämatologie & Hämostaseologie
Centro Goiano de Oncologia - CGO
Hospital de Caridade de Ijui; Oncologia
Hospital das Clinicas - UFRGS; Hematologia
Hospital Nossa Senhora da Conceicao
Hospital das Clinicas - UNICAMP
Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia
Santa Casa de Misericordia de Sao Paulo; Hematologia e Hemoterapia
Hospital das Clinicas - FMUSP; Hematologia
Tom Baker Cancer Centre; Dept of Medicine
Cross Cancer Institute ; Dept of Medical Oncology
Cancer Care Manitoba
Moncton Hospital
Health Science Centre
QEII HSC; Oncology
Cancer Centre of Southeastern Ontario; Kingston General Hospital
Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre
Toronto Sunnybrook Regional Cancer Centre
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
Windsor Regional Cancer Centre
Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie
Mcgill University - Royal Victoria Hospital; Oncology
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Hopital de L'Enfant-Jesus; Hematology
Chuq - Hopital Hotel Dieu de Quebec; Oncology
Allan Blair Cancer Centre
Saskatoon Cancer Centre; Uni of Saskatoon Campus
Cancer Hospital Chinese Academy of Medical Sciences.
Beijing Cancer Hospital
Beijing Union Hospital
General Hospital of Chinese PLA; Department of Hematology
Fujian Cancer Hospital
Fudan University Shanghai Cancer Center
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Changhai Hospital of Shanghai
The Second Affiliated Hospital of Soochow University
First Affiliated Hospital of Soochow University
Tianjin Institute of Hematology & Blood Diseases Hospital
The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)
Organizacion Sanitas Internacional
Hospital Pablo Tobon Uribe
Instituto Cancerologia Medellin; Clinica Las Americas
Oncólogos de Occidente
Fakultni nemocnice Brno; Interni hematoonkologicka klinika
Fn Hr. Kralove; IV. Interni Hematologicka Klinika
Fakultni nemocnice Olomouc; Hemato-onkologicka klinika
Fakultni Nemocnice Plzen, Hematologicko-Onkologicke Oddeleni
VshEOBECNÁ FAKULTNÍ NEMOCNICE; I. INTERNI KLINIKA
Fakultní Nemocnice Královské Vinohrady; Hematologická Klinika
Teodoro Maldonado Carbo Hospital; Oncology Service
Hospital Carlos Andrade Marin; Servicio de Oncología
Hospital Solca Quito; Oncologia
Clinique Claude Bernard; Onco Hematologie
Centre Hospitalier Uni Ire; Service de Medecine D
Institut Bergonie; Hematologie Oncologie
Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
Centre Francois Baclesse; Comite 2
Chu Estaing; Cons Hemato Medecine Interne
Chu Site Du Bocage;Hematologie Clinique
CH Dptal Les Oudairies; Hematologie Oncologie
Hopital Albert Michallon; Oncologie
Clinique Victor Hugo; Chimiotherapie
Hopital Claude Huriez; Hematologie
Hopital Uni Ire Dupuytren; Hematologie
Centre Leon Berard; Departement Oncologie Medicale
Institut J Paolii Calmettes; Onco Hematologie 1
Clinique Pont de Chaume; Oncologie Et Radiotherapie
Hopital Saint Eloi; Hematologie Oncologie Medicale
Hopital de L'Archet; Hematologie Clinique
Polyclinique Kenval ; Radiotherapie Oncologie
Institut Curie; Oncologie Medicale
Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)
Hopital Pitie Salpetriere; Hematologie Clinique
Hopital Saint Jean; Hematologie
Hopital De Haut Leveque; Hematologie Clinique
Ch Lyon Sud; Hemato Secteur Jules Courmont
Hopital De La Miletrie; Hematologie Et Oncologie Medicale
Ch Jacques Puel;Oncologie Medicale
ICL; Hematologie
Hopital Sud; Hematologie Clinique
Hopital Purpan; Hematologie Clinique
Clinique Pasteur; Oncologie Medicale
Hopital Bretonneau; Hematologie Therapie Cellulaire
Hopitaux De Brabois; Hematologie Medecine Interne
Institut Gustave Roussy; Unite D'Hematologie
Gesundheitszentrum St. Marien GmbH; Med. II, Hämatologie/Onkologie
Charité-Universitätsm. Berlin; Med. Klinik mit Schwerpunkt Hämatologie, Onkologie und Tumorimmunolo.
Charité; Onkologie & Hämatologie
DIAKO Ev. Diakonie-Krankenhaus Bremen GmbH; Med. Klinik II; Hämatologie und internistische Onkologie
Carl-Thiem-Klinik Cottbus; Medizinische Klinik
Klinikzentrum Mitte; Medizinische Klinik Gastroenterologie Haematologie / Onkologie
St. Johannes Hospital; Abt. Innere Medizin
St Antonius Hospital; Haematologie/Onkologie
Krankenhaus Nordwest Medizinische Klinik
Klinik Fulda; Abt. Itz
Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik
Georg-August-Uniklinik ; Zentrum Innere Medizin Abt. Hämatologie & Onkologie
Kath.Krankenhaus Hagen gem.GmbH St.-Marien-Hospital
Asklepios Klinik St. Georg; Allgemeine Innere Medizin
Facharztzentrum Eppendorf, Studien GbR
Evang.Krankenhaus Abt. Hämatologie und Onkologie
St.-Marien-Hospital Klinik Knappenstraße; Klinik für Hämatologie und Onkologie
KRH Klinikum Siloah Medizinische Klinik III
St. Bernward-Krankenhaus
Universitaetsklinikum des Saarlandes; medizinische Klinik und Poliklinik; Innere Medizin I
Städtisches Klinikum Karlsruhe gGmbH, II. Medizinische Klinik
St. Vincentius Kliniken Ag; Medizinische Klinik Abt. 2
Tagesklinik Landshut; Hämatologie/Onkologie
Universitätsklinikum Leipzig Medizinische Klinik II Gastroenterolog. u. Hepatolog.
Klinikum St.Georg gGmbH Klinik für Internistische Onkologie und Hämotologie
Klinikum der Stadt Ludwigshafen; Medizinische Klinik A
Universitätsklinikum Schleswig-Holstein / Campus Lübeck, Med. Klinik I, Hämatologie/Onkologie
Märkische Kliniken GmbH, Klinikum Lüdenscheid; Hämatologie / Onkologie
Otto von Guericke Uni Magdeburg Uniklinik; Hämatologie/Onkologie
Klinikum Magdeburg gemeinnützige GmbH; Klinik Haematologie und Onkologie
Klinikum Mannheim III. Medizinische Klinik
Klinikum der Universitaet Muenchen; Campus Großhadern; Medizinische Klinik III und Poliklinik
Westfälische Wilhelms-Universität Münster, Medizinische Klinik und Poliklinik A
Klinikum Oldenburg gGmbH; Klinik für Onkologie und Hämatologie
Prosper-Hospital, Medizinische Klinik I
St Marien Krankenhaus; Medizinische Klinik Iii
Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie
Krankenhaus der Barmherzigen Brüder Trier; Innere Medizin I, Hämatologie / Internistische Onkologie
Eberhard-Karls-Universität Tübingen; Medizinische Klinik I
Universitätsklinikum Ulm; Medizinische Uni-Klinik III Abt. Innere Medizin III Hämatologie u. Onkolo.
HSK Dr.-Horst-Schmidt-Kliniken; Innere Medizin I Kardiologie; Angiologie und Intensivmedizin
Helios Klinik Wuppertal; Medizinische Klinik I
Kliniken St. Antonius; Zentrum Für Innere Medizin, Haematologie/Onkologie
Georgios Papanikolaou Hospital; Hematology Department
Queen Elizabeth Hospital; Clinical Oncology
Queen Mary Hospital; Dept of Medicine
Fov. Onk. Egyesitett Szent Istvan es Szent Laszlo Korhaz; Dept Of Bone Marrow Transplant
National Institute of Oncology, A Dept of Internal Medicine
University of Debrecen Medical and Health Science Center, Institute of Internal Medicine, Hematology
A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
Ospedale Regionale Di Parma; Divisione Di Oncologia Medica
Az. Osp. Arcispedale S. Maria Nuova; U.O. Di Ematologia
Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica
Univ. Cattolica La Sapienza; Cattedra Di Ematologia
ASST DI MONZA; Ematologia
Irccs Policlinico San Matteo; Divisione Di Ematologia
Ospedale Gen.Le Prov.Le 'C.G.Mazzoni'; Ematologia
Università Cattolica Del Sacro Cuore S.S. Giovanni Paolo Ii; Uoc Di Onco-Ematologia
Az. Osp. S. Luigi Gonzaga; Malattie Apparato Respiratorio 5 Ad Indirizzo Oncologico
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1
Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
Ospedale Ferrarotto; Divisione Di Ematologia
Ospedale Santa Chiara; Unita Operativa Di Ematologia
Samsung Medical Centre; Oncology
Asan Medical Center, Uni Ulsan Collegemedicine; Dept.Internal Medicine / Divisionhematology/Oncology
Korean Cancer Center Hospital; Oncology
Severance Hospital - Yonsei University; Medicine Dept.
Seamen' Hospital' Dept. of haematology
Uni Hospital Santariskiu Clinic; Haematology
Hospital Pulau Pinang
Instituto Biomedico De Investigacion A.C.
Hospital Español; Hematología Sala 19
Col Instituto Tecnologico Y Estudios Superiores de Monterrey
Hospital Universitario Dr. Jose E. Gonzalez; Haematology
North Shore Hospital; Haematolgy
Uni of Auckland; Dept of Molecular Medicine & Haematology
Christchurch Hospital; Canterbury Health Laboratories
Centro Hemato Oncologico Paitilla
Hospital Nacional Almanzor Aguinaga Asenjo; Unidad De Investigacion Del Servicio De Oncologia Medica
Hospital Nacional Edgardo Rebagliati Martins; Oncologia
Hospital Nacional Guillermo Almenara Irigoyen; Oncology
Instituto Nacional de Enfermedades Neoplasicas
Hospital Nacional LNS dela Policia Nacional del Perú. Unidad Onco; Deapartamento de Oncología
Cebu Cancer Institute; Perpetual Succour Hospital
National Kidney and Transplant Institute; Chemotherapy Unit
St Luke'S Medical Centre; Oncology
Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny
Szpital Uniwersytecki W Krakowie; Klinika Hematologii
Medical University School; Dept. of Haematology
Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie
Zaklad Opieki Zdrowotnej Mswia; Oddzial Chemioterapii
Samodzielny Publiczny Centralny Szpital Kliniczny; Haematology Dept.
Centralny Szpital Kliniczny Mswia; Klinika onkologii, hematologii i chorob wewnetrznych
Centrum Onkologii - Inst.Im. Marii Sklodowskiej-Curie; Lymphoma Dept.
HUC; Servico de Hematologia
IPO de Lisboa; Servico de Hematologia
Hospital de Sao Joao; Servico de Hematologia Clinica
Republican Clinical Oncologic Dispensary of Republic Of Tatarstan
N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis
Haematology Research Center; Haematology
Semashko Central Clinical Hospital Moscow; Hematology
Research Inst. of Hematology & Blood Transfusion ; Hematology
National Cancer Inst. ; Dept. of Chemotherapy
Hospital Mutua de Terrassa; Servicio de Hematologia
Hospital Universitario Marques de Valdecilla; Servicio de Hematologia
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Hematologia
Hospital Universitario de Canarias;servicio de Oncologia
Hospital de Basurto; Servicio de Hematologia
Hospital de Galdakano
Hospital de la Santa Creu i Sant Pau; Servicio de Hematologia
Hospital Universitari Vall d'Hebron; Servicio de Hematologia
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
Hospital Duran i Reynals; Servicio de Hematologia
Complejo Hospitalario de Jaen- Hospital Universitario Medico Quirurgico; Servicio de Hematologia
Hospital Universitario Clínico San Carlos; Servicio de Hematología
Hospital Universitario la Paz; Servicio de Hematologia
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
Hospital Clinico Universitario de Salamanca;Servicio de Hematologia
Hospital Universitario Virgen del Rocio; Servicio de Hematologia
Hospital Universitario la Fe; Servicio de Medicina Intena
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Hospital Universitario Miguel Servet; Servicio Hematologia
Skånes University Hospital, Skånes Department of Onclology
Skånes Universitetssjukhus; Kliniska Forskningsenheten Onkologimottagning medicinsk behandling
Länssjukhuset; Medicinkliniken
Akademiska sjukhuset, Onkologkliniken
Universitätsspital Zürich; Klinik für Onkologie
Veterans General Hospital; Division of Oncology
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
Chang Gung Medical Foundation-Taipei
King Chulalongkorn Memorial Hospital; Division of Hematology, Department of Medicine
National Cancer Inst.
Rajavithi Hospital; Medicine
Siriraj Hospital; Division of Hematology, Department of Medicine
Chiang Mai Uni Hospital; Division of Hematology,Dept of Medicine,Faculty of Medicine
Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine
Birmingham Heartlands Hospital; Department of Haematology
Bradford Royal Infirmary; Haematology Department
North Hampshire Hospital; Dept. of Haematology
Princess Alexandra Hospital; Department of Haematology
Leicester Royal Infirmary; Dept. of Medical Oncology
Royal Liverpool Uni Hospital; Haematology
St. George'S Hospital; Haematology
Hillingdon Hospital
Churchill Hospital; Oxford Cancer and Haematology Centre
Royal Hallamshire Hospital; Haematology Dept
Weston Park Hospital; Cancer Clinical Trials Centre
The Royal Wolverhampton Hospitals NHS Trust; Department of Haematology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bevacizumab + rituximab + CHOP

Placebo + rituximab + CHOP

Arm Description

Patients 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).

Patients 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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall Survival

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

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.

Full Information

NCT ID

NCT00486759

First Posted

June 14, 2007

Last Updated

June 26, 2017

Sponsor

Hoffmann-La Roche

Collaborators

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00486759

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Terminated

Why Stopped

Due to an unfavorable benefit/risk ratio.

Study Start Date

July 26, 2007 (Actual)

Primary Completion Date

November 30, 2011 (Actual)

Study Completion Date

November 30, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

Collaborators

Genentech, Inc.

4. Oversight

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

B-cell Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

787 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Bevacizumab + rituximab + CHOP

Arm Type

Experimental

Arm Description

Arm Title

Placebo + rituximab + CHOP

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Bevacizumab

Other Intervention Name(s)

Avastin

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Rituximab

Other Intervention Name(s)

MabThera

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

CHOP

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Progression-free Survival (PFS)

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Overall Survival

Description

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

Time Frame

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

Title

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

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

Facility Name

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

City

La Jolla

State/Province

California

ZIP/Postal Code

92093

Country

United States

Facility Name

Kenmar Research Inst.

City

Whittier

State/Province

California

ZIP/Postal Code

90603

Country

United States

Facility Name

University of Colorado Cancer Center Department of Hematology

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Uni Medical Center; Division Of Hemotology/Oncology

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32207

Country

United States

Facility Name

Florida Cancer Specialists

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33401

Country

United States

Facility Name

Northwest Georgia Oncology Centers

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

University of Kansas Medical Center; Department of Hematology

City

Kansas City

State/Province

Kansas

ZIP/Postal Code

66160

Country

United States

Facility Name

St. Joseph Mercy Hospital; Department of Oncology

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48106

Country

United States

Facility Name

Northeast Oncology Associates

City

Concord

State/Province

North Carolina

ZIP/Postal Code

28025

Country

United States

Facility Name

Forsyth Regional Cancer Center; Piedmont Hematology/Oncology Associates

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Providence Portland Medical Center

City

Portland

State/Province

Oregon

ZIP/Postal Code

97213

Country

United States

Facility Name

Charleston Cancer Center

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

Uni of Texas Southwestern Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390-9063

Country

United States

Facility Name

Cancer Therapy & Research Center

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Northwest Medical Specialties B

City

Federal Way

State/Province

Washington

ZIP/Postal Code

98003

Country

United States

Facility Name

Rainier Physicians

City

Puyallup

State/Province

Washington

ZIP/Postal Code

98372

Country

United States

Facility Name

Northwest Medical Specialties

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

Hospital Italiano; Haemathology

City

Buenos Aires

ZIP/Postal Code

1425

Country

Argentina

Facility Name

Fundaleu; Haematology

City

Buenos Aires

ZIP/Postal Code

C1114AAN

Country

Argentina

Facility Name

Hospital Britanico; Haematology

City

Buenos Aires

ZIP/Postal Code

C1280AEB

Country

Argentina

Facility Name

HOSPITAL PRIVADO - CENTRO MEDICO DE CÓRDOBA; Dpto Oncología

City

Córdoba

ZIP/Postal Code

5016

Country

Argentina

Facility Name

Greenslopes Private Hospital; Gallipoli Research Centre

City

Greenslopes

State/Province

Queensland

ZIP/Postal Code

4120

Country

Australia

Facility Name

Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology

City

Woolloongabba

State/Province

Queensland

ZIP/Postal Code

4102

Country

Australia

Facility Name

Royal Adelaide Hospital; Haematology, Institute of Medical Veterinary Science

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

Ashford Cancer Center Research

City

Kurralta Park

State/Province

South Australia

ZIP/Postal Code

5037

Country

Australia

Facility Name

Frankston Hospital; Oncology/Haematology

City

Frankston

State/Province

Victoria

ZIP/Postal Code

3199

Country

Australia

Facility Name

Peter Maccallum Cancer Institute; Medical Oncology

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3000

Country

Australia

Facility Name

Alfred Hospital; Bone Marrow Transplant Unit

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3181

Country

Australia

Facility Name

Border Medical Oncology; Murray Valley Private Hospital

City

Wodonga

State/Province

Victoria

ZIP/Postal Code

3690

Country

Australia

Facility Name

Fremantle Hospital; Haematology

City

Fremantle

State/Province

Western Australia

ZIP/Postal Code

6160

Country

Australia

Facility Name

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

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

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

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

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

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Centro Goiano de Oncologia - CGO

City

Goiania

State/Province

ZIP/Postal Code

74140-050

Country

Brazil

Facility Name

Hospital de Caridade de Ijui; Oncologia

City

Ijui

State/Province

ZIP/Postal Code

98700-000

Country

Brazil

Facility Name

Hospital das Clinicas - UFRGS; Hematologia

City

Porto Alegre

State/Province

ZIP/Postal Code

90035-903

Country

Brazil

Facility Name

Hospital Nossa Senhora da Conceicao

City

Porto Alegre

State/Province

ZIP/Postal Code

91350-200

Country

Brazil

Facility Name

Hospital das Clinicas - UNICAMP

City

Campinas

State/Province

ZIP/Postal Code

13083-888

Country

Brazil

Facility Name

Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia

City

Santo Andre

State/Province

ZIP/Postal Code

09060-650

Country

Brazil

Facility Name

Santa Casa de Misericordia de Sao Paulo; Hematologia e Hemoterapia

City

Sao Paulo

State/Province

ZIP/Postal Code

01221-020

Country

Brazil

Facility Name

Hospital das Clinicas - FMUSP; Hematologia

City

Sao Paulo

State/Province

ZIP/Postal Code

05403-000

Country

Brazil

Facility Name

Tom Baker Cancer Centre; Dept of Medicine

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 4N2

Country

Canada

Facility Name

Cross Cancer Institute ; Dept of Medical Oncology

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 1Z2

Country

Canada

Facility Name

Cancer Care Manitoba

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3E 0V9

Country

Canada

Facility Name

Moncton Hospital

City

Moncton

State/Province

New Brunswick

ZIP/Postal Code

E1C 6Z8

Country

Canada

Facility Name

Health Science Centre

City

St. John's

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1B 3V6

Country

Canada

Facility Name

QEII HSC; Oncology

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y9

Country

Canada

Facility Name

Cancer Centre of Southeastern Ontario; Kingston General Hospital

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 5P9

Country

Canada

Facility Name

Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre

City

Mississauga

State/Province

Ontario

ZIP/Postal Code

L5M 2N1

Country

Canada

Facility Name

Toronto Sunnybrook Regional Cancer Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

Facility Name

University Health Network; Princess Margaret Hospital; Medical Oncology Dept

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

Facility Name

Windsor Regional Cancer Centre

City

Windsor

State/Province

Ontario

ZIP/Postal Code

N8W 2X3

Country

Canada

Facility Name

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

City

Greenfield Park

State/Province

Quebec

ZIP/Postal Code

J4V 2H1

Country

Canada

Facility Name

Mcgill University - Royal Victoria Hospital; Oncology

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 1A1

Country

Canada

Facility Name

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

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1E2

Country

Canada

Facility Name

Hopital de L'Enfant-Jesus; Hematology

City

Quebec City

State/Province

Quebec

ZIP/Postal Code

G1J 1Z4

Country

Canada

Facility Name

Chuq - Hopital Hotel Dieu de Quebec; Oncology

City

Quebec City

State/Province

Quebec

ZIP/Postal Code

G1R 2J6

Country

Canada

Facility Name

Allan Blair Cancer Centre

City

Regina

State/Province

Saskatchewan

ZIP/Postal Code

S4T 7T1

Country

Canada

Facility Name

Saskatoon Cancer Centre; Uni of Saskatoon Campus

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7N 4H4

Country

Canada

Facility Name

Cancer Hospital Chinese Academy of Medical Sciences.

City

Beijing

ZIP/Postal Code

100021

Country

China

Facility Name

Beijing Cancer Hospital

City

Beijing

ZIP/Postal Code

100142

Country

China

Facility Name

Beijing Union Hospital

City

Beijing

ZIP/Postal Code

100730

Country

China

Facility Name

General Hospital of Chinese PLA; Department of Hematology

City

Beijing

ZIP/Postal Code

100853

Country

China

Facility Name

Fujian Cancer Hospital

City

Fuzhou

ZIP/Postal Code

350014

Country

China

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Name

Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

City

Shanghai

ZIP/Postal Code

200127

Country

China

Facility Name

Changhai Hospital of Shanghai

City

Shanghai

ZIP/Postal Code

200433

Country

China

Facility Name

The Second Affiliated Hospital of Soochow University

City

Suzhou

ZIP/Postal Code

215004

Country

China

Facility Name

First Affiliated Hospital of Soochow University

City

Suzhou

ZIP/Postal Code

215006

Country

China

Facility Name

Tianjin Institute of Hematology & Blood Diseases Hospital

City

Tianjin

ZIP/Postal Code

300020

Country

China

Facility Name

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

City

Xi'an

ZIP/Postal Code

710032

Country

China

Facility Name

Organizacion Sanitas Internacional

City

Bogota

Country

Colombia

Facility Name

Hospital Pablo Tobon Uribe

City

Medellin-Antioquia

Country

Colombia

Facility Name

Instituto Cancerologia Medellin; Clinica Las Americas

City

Medellin

ZIP/Postal Code

2A-80

Country

Colombia

Facility Name

Oncólogos de Occidente

City

Pereira

ZIP/Postal Code

600004

Country

Colombia

Facility Name

Fakultni nemocnice Brno; Interni hematoonkologicka klinika

City

Brno

ZIP/Postal Code

625 00

Country

Czechia

Facility Name

Fn Hr. Kralove; IV. Interni Hematologicka Klinika

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Fakultni nemocnice Olomouc; Hemato-onkologicka klinika

City

Olomouc

ZIP/Postal Code

775 20

Country

Czechia

Facility Name

Fakultni Nemocnice Plzen, Hematologicko-Onkologicke Oddeleni

City

Plzen - Lochotin

ZIP/Postal Code

304 60

Country

Czechia

Facility Name

VshEOBECNÁ FAKULTNÍ NEMOCNICE; I. INTERNI KLINIKA

City

Praha 2

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

Fakultní Nemocnice Královské Vinohrady; Hematologická Klinika

City

Praha

ZIP/Postal Code

100 34

Country

Czechia

Facility Name

Teodoro Maldonado Carbo Hospital; Oncology Service

City

Guayaquil

ZIP/Postal Code

EC090150

Country

Ecuador

Facility Name

Hospital Carlos Andrade Marin; Servicio de Oncología

City

Quito

ZIP/Postal Code

2569

Country

Ecuador

Facility Name

Hospital Solca Quito; Oncologia

City

Quito

ZIP/Postal Code

EC170124

Country

Ecuador

Facility Name

Clinique Claude Bernard; Onco Hematologie

City

Albi

ZIP/Postal Code

81030

Country

France

Facility Name

Centre Hospitalier Uni Ire; Service de Medecine D

City

Angers

ZIP/Postal Code

49033

Country

France

Facility Name

Institut Bergonie; Hematologie Oncologie

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Facility Name

Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

City

Bordeaux

ZIP/Postal Code

33077

Country

France

Facility Name

Centre Francois Baclesse; Comite 2

City

Caen

ZIP/Postal Code

14076

Country

France

Facility Name

Chu Estaing; Cons Hemato Medecine Interne

City

Clermont Ferrand

ZIP/Postal Code

63003

Country

France

Facility Name

Chu Site Du Bocage;Hematologie Clinique

City

Dijon

ZIP/Postal Code

21079

Country

France

Facility Name

CH Dptal Les Oudairies; Hematologie Oncologie

City

La Roche Sur Yon

ZIP/Postal Code

85925

Country

France

Facility Name

Hopital Albert Michallon; Oncologie

City

La Tronche

ZIP/Postal Code

38700

Country

France

Facility Name

Clinique Victor Hugo; Chimiotherapie

City

Le Mans

ZIP/Postal Code

72015

Country

France

Facility Name

Hopital Claude Huriez; Hematologie

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

Hopital Uni Ire Dupuytren; Hematologie

City

Limoges

ZIP/Postal Code

87042

Country

France

Facility Name

Centre Leon Berard; Departement Oncologie Medicale

City

Lyon

ZIP/Postal Code

69373

Country

France

Facility Name

Institut J Paolii Calmettes; Onco Hematologie 1

City

Marseille

ZIP/Postal Code

13273

Country

France

Facility Name

Clinique Pont de Chaume; Oncologie Et Radiotherapie

City

Montauban

ZIP/Postal Code

82017

Country

France

Facility Name

Hopital Saint Eloi; Hematologie Oncologie Medicale

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

Hopital de L'Archet; Hematologie Clinique

City

Nice

ZIP/Postal Code

06202

Country

France

Facility Name

Polyclinique Kenval ; Radiotherapie Oncologie

City

Nimes

ZIP/Postal Code

30900

Country

France

Facility Name

Institut Curie; Oncologie Medicale

City

Paris

ZIP/Postal Code

75231

Country

France

Facility Name

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

City

Paris

ZIP/Postal Code

75475

Country

France

Facility Name

Hopital Pitie Salpetriere; Hematologie Clinique

City

Paris

ZIP/Postal Code

75651

Country

France

Facility Name

Hopital Saint Jean; Hematologie

City

Perpignan

ZIP/Postal Code

66046

Country

France

Facility Name

Hopital De Haut Leveque; Hematologie Clinique

City

Pessac

ZIP/Postal Code

33604

Country

France

Facility Name

Ch Lyon Sud; Hemato Secteur Jules Courmont

City

Pierre Benite

ZIP/Postal Code

69495

Country

France

Facility Name

Hopital De La Miletrie; Hematologie Et Oncologie Medicale

City

Poitiers

ZIP/Postal Code

86021

Country

France

Facility Name

Ch Jacques Puel;Oncologie Medicale

City

Rodez

ZIP/Postal Code

12027

Country

France

Facility Name

ICL; Hematologie

City

Saint-Priest en Jarez

ZIP/Postal Code

42271

Country

France

Facility Name

Hopital Sud; Hematologie Clinique

City

Salouel

ZIP/Postal Code

80480

Country

France

Facility Name

Hopital Purpan; Hematologie Clinique

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Clinique Pasteur; Oncologie Medicale

City

Toulouse

ZIP/Postal Code

31076

Country

France

Facility Name

Hopital Bretonneau; Hematologie Therapie Cellulaire

City

Tours

ZIP/Postal Code

37044

Country

France

Facility Name

Hopitaux De Brabois; Hematologie Medecine Interne

City

Vandoeuvre Les Nancy

ZIP/Postal Code

54511

Country

France

Facility Name

Institut Gustave Roussy; Unite D'Hematologie

City

Villejuif

ZIP/Postal Code

94805

Country

France

Facility Name

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

City

Amberg

ZIP/Postal Code

92224

Country

Germany

Facility Name

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

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

Charité; Onkologie & Hämatologie

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

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

City

Bremen

ZIP/Postal Code

28239

Country

Germany

Facility Name

Carl-Thiem-Klinik Cottbus; Medizinische Klinik

City

Cottbus

ZIP/Postal Code

03048

Country

Germany

Facility Name

Klinikzentrum Mitte; Medizinische Klinik Gastroenterologie Haematologie / Onkologie

City

Dortmund

ZIP/Postal Code

44137

Country

Germany

Facility Name

St. Johannes Hospital; Abt. Innere Medizin

City

Dortmund

ZIP/Postal Code

44137

Country

Germany

Facility Name

St Antonius Hospital; Haematologie/Onkologie

City

Eschweiler

ZIP/Postal Code

52249

Country

Germany

Facility Name

Krankenhaus Nordwest Medizinische Klinik

City

Frankfurt

ZIP/Postal Code

60488

Country

Germany

Facility Name

Klinik Fulda; Abt. Itz

City

Fulda

ZIP/Postal Code

36043

Country

Germany

Facility Name

Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik

City

Greifswald

ZIP/Postal Code

17475

Country

Germany

Facility Name

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

City

Göttingen

ZIP/Postal Code

37075

Country

Germany

Facility Name

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

City

Hagen

ZIP/Postal Code

58095

Country

Germany

Facility Name

Asklepios Klinik St. Georg; Allgemeine Innere Medizin

City

Hamburg

ZIP/Postal Code

20099

Country

Germany

Facility Name

Facharztzentrum Eppendorf, Studien GbR

City

Hamburg

ZIP/Postal Code

20249

Country

Germany

Facility Name

Evang.Krankenhaus Abt. Hämatologie und Onkologie

City

Hamm

ZIP/Postal Code

59063

Country

Germany

Facility Name

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

City

Hamm

ZIP/Postal Code

59071

Country

Germany

Facility Name

KRH Klinikum Siloah Medizinische Klinik III

City

Hannover

ZIP/Postal Code

30449

Country

Germany

Facility Name

St. Bernward-Krankenhaus

City

Hildesheim

ZIP/Postal Code

31134

Country

Germany

Facility Name

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

City

Homburg/Saar

ZIP/Postal Code

66421

Country

Germany

Facility Name

Städtisches Klinikum Karlsruhe gGmbH, II. Medizinische Klinik

City

Karlsruhe

ZIP/Postal Code

76133

Country

Germany

Facility Name

St. Vincentius Kliniken Ag; Medizinische Klinik Abt. 2

City

Karlsruhe

ZIP/Postal Code

76137

Country

Germany

Facility Name

Tagesklinik Landshut; Hämatologie/Onkologie

City

Landshut

ZIP/Postal Code

84028

Country

Germany

Facility Name

Universitätsklinikum Leipzig Medizinische Klinik II Gastroenterolog. u. Hepatolog.

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Klinikum St.Georg gGmbH Klinik für Internistische Onkologie und Hämotologie

City

Leipzig

ZIP/Postal Code

04129

Country

Germany

Facility Name

Klinikum der Stadt Ludwigshafen; Medizinische Klinik A

City

Ludwigshafen

ZIP/Postal Code

67063

Country

Germany

Facility Name

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

City

Lübeck

ZIP/Postal Code

23562

Country

Germany

Facility Name

Märkische Kliniken GmbH, Klinikum Lüdenscheid; Hämatologie / Onkologie

City

Lüdenscheid

ZIP/Postal Code

58515

Country

Germany

Facility Name

Otto von Guericke Uni Magdeburg Uniklinik; Hämatologie/Onkologie

City

Magdeburg

ZIP/Postal Code

39120

Country

Germany

Facility Name

Klinikum Magdeburg gemeinnützige GmbH; Klinik Haematologie und Onkologie

City

Magdeburg

ZIP/Postal Code

39130

Country

Germany

Facility Name

Klinikum Mannheim III. Medizinische Klinik

City

Mannheim

ZIP/Postal Code

68167

Country

Germany

Facility Name

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

City

Muenchen

ZIP/Postal Code

81377

Country

Germany

Facility Name

Westfälische Wilhelms-Universität Münster, Medizinische Klinik und Poliklinik A

City

Münster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Klinikum Oldenburg gGmbH; Klinik für Onkologie und Hämatologie

City

Oldenburg

ZIP/Postal Code

26133

Country

Germany

Facility Name

Prosper-Hospital, Medizinische Klinik I

City

Recklinghausen

ZIP/Postal Code

45659

Country

Germany

Facility Name

St Marien Krankenhaus; Medizinische Klinik Iii

City

Siegen

ZIP/Postal Code

57072

Country

Germany

Facility Name

Klinikum Mutterhaus der Borromaeerinnen gGmbH; Haematologie/Onkologie

City

Trier

ZIP/Postal Code

54290

Country

Germany

Facility Name

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

City

Trier

ZIP/Postal Code

54292

Country

Germany

Facility Name

Eberhard-Karls-Universität Tübingen; Medizinische Klinik I

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

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

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

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

City

Wiesbaden

ZIP/Postal Code

65199

Country

Germany

Facility Name

Helios Klinik Wuppertal; Medizinische Klinik I

City

Wuppertal

ZIP/Postal Code

42283

Country

Germany

Facility Name

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

City

Wuppertal

ZIP/Postal Code

42283

Country

Germany

Facility Name

Georgios Papanikolaou Hospital; Hematology Department

City

Thessaloniki

ZIP/Postal Code

570 10

Country

Greece

Facility Name

Queen Elizabeth Hospital; Clinical Oncology

City

Hong Kong

Country

Hong Kong

Facility Name

Queen Mary Hospital; Dept of Medicine

City

Hong Kong

Country

Hong Kong

Facility Name

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

City

Budapest

ZIP/Postal Code

1097

Country

Hungary

Facility Name

National Institute of Oncology, A Dept of Internal Medicine

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

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

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

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

City

Bologna

State/Province

Emilia-Romagna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Ospedale Regionale Di Parma; Divisione Di Oncologia Medica

City

Parma

State/Province

Emilia-Romagna

ZIP/Postal Code

43100

Country

Italy

Facility Name

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

City

Reggio Emilia

State/Province

Emilia-Romagna

ZIP/Postal Code

42100

Country

Italy

Facility Name

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

City

Aviano

State/Province

Friuli-Venezia Giulia

ZIP/Postal Code

33081

Country

Italy

Facility Name

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

City

Udine

State/Province

Friuli-Venezia Giulia

ZIP/Postal Code

33100

Country

Italy

Facility Name

Univ. Cattolica La Sapienza; Cattedra Di Ematologia

City

Roma

State/Province

Lazio

ZIP/Postal Code

00161

Country

Italy

Facility Name

ASST DI MONZA; Ematologia

City

Monza

State/Province

Lombardia

ZIP/Postal Code

20052

Country

Italy

Facility Name

Irccs Policlinico San Matteo; Divisione Di Ematologia

City

Pavia

State/Province

Lombardia

ZIP/Postal Code

27100

Country

Italy

Facility Name

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

City

Ascoli Piceno

State/Province

Marche

ZIP/Postal Code

63100

Country

Italy

Facility Name

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

City

Campobasso

State/Province

Molise

ZIP/Postal Code

86100

Country

Italy

Facility Name

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

City

Orbassano

State/Province

Piemonte

ZIP/Postal Code

10043

Country

Italy

Facility Name

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

City

Torino

State/Province

Piemonte

ZIP/Postal Code

10126

Country

Italy

Facility Name

Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica

City

Bari

State/Province

Puglia

ZIP/Postal Code

70124

Country

Italy

Facility Name

Ospedale Ferrarotto; Divisione Di Ematologia

City

Via S. Sofia 78

State/Province

Sicilia

ZIP/Postal Code

95123

Country

Italy

Facility Name

Ospedale Santa Chiara; Unita Operativa Di Ematologia

City

Pisa

State/Province

Toscana

ZIP/Postal Code

56100

Country

Italy

Facility Name

Samsung Medical Centre; Oncology

City

Seoul

ZIP/Postal Code

135-170

Country

Korea, Republic of

Facility Name

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

City

Seoul

ZIP/Postal Code

138-736

Country

Korea, Republic of

Facility Name

Korean Cancer Center Hospital; Oncology

City

Seoul

ZIP/Postal Code

139-709

Country

Korea, Republic of

Facility Name

Severance Hospital - Yonsei University; Medicine Dept.

City

Seoul

Country

Korea, Republic of

Facility Name

Seamen' Hospital' Dept. of haematology

City

Klaipeda

ZIP/Postal Code

92288

Country

Lithuania

Facility Name

Uni Hospital Santariskiu Clinic; Haematology

City

Vilnius

ZIP/Postal Code

08661

Country

Lithuania

Facility Name

Hospital Pulau Pinang

City

Penang

ZIP/Postal Code

10990

Country

Malaysia

Facility Name

Instituto Biomedico De Investigacion A.C.

City

Aguascalientes

ZIP/Postal Code

20127

Country

Mexico

Facility Name

Hospital Español; Hematología Sala 19

City

Mexico City

ZIP/Postal Code

11520

Country

Mexico

Facility Name

Col Instituto Tecnologico Y Estudios Superiores de Monterrey

City

Monterrey

ZIP/Postal Code

00000

Country

Mexico

Facility Name

Hospital Universitario Dr. Jose E. Gonzalez; Haematology

City

Monterrey

ZIP/Postal Code

64460

Country

Mexico

Facility Name

North Shore Hospital; Haematolgy

City

Auckland

ZIP/Postal Code

1309

Country

New Zealand

Facility Name

Uni of Auckland; Dept of Molecular Medicine & Haematology

City

Auckland

Country

New Zealand

Facility Name

Christchurch Hospital; Canterbury Health Laboratories

City

Christchurch

Country

New Zealand

Facility Name

Centro Hemato Oncologico Paitilla

City

Panama City

ZIP/Postal Code

083200752

Country

Panama

Facility Name

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

City

Chiclayo

ZIP/Postal Code

CIX

Country

Peru

Facility Name

Hospital Nacional Edgardo Rebagliati Martins; Oncologia

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Hospital Nacional Guillermo Almenara Irigoyen; Oncology

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

Instituto Nacional de Enfermedades Neoplasicas

City

Lima

ZIP/Postal Code

Country

Peru

Facility Name

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

City

Lima

ZIP/Postal Code

Lima11

Country

Peru

Facility Name

Cebu Cancer Institute; Perpetual Succour Hospital

City

Cebu

ZIP/Postal Code

6000

Country

Philippines

Facility Name

National Kidney and Transplant Institute; Chemotherapy Unit

City

Diliman, Quezon City

ZIP/Postal Code

1100

Country

Philippines

Facility Name

St Luke'S Medical Centre; Oncology

City

Quezon City

ZIP/Postal Code

1114

Country

Philippines

Facility Name

Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny

City

Brzozów

ZIP/Postal Code

36-200

Country

Poland

Facility Name

Szpital Uniwersytecki W Krakowie; Klinika Hematologii

City

Krakow

ZIP/Postal Code

31-501

Country

Poland

Facility Name

Medical University School; Dept. of Haematology

City

Lodz

ZIP/Postal Code

93-510

Country

Poland

Facility Name

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

City

Lublin

ZIP/Postal Code

20-081

Country

Poland

Facility Name

Zaklad Opieki Zdrowotnej Mswia; Oddzial Chemioterapii

City

Olsztyn

ZIP/Postal Code

10-228

Country

Poland

Facility Name

Samodzielny Publiczny Centralny Szpital Kliniczny; Haematology Dept.

City

Warszawa

ZIP/Postal Code

02-097

Country

Poland

Facility Name

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

City

Warszawa

ZIP/Postal Code

02-507

Country

Poland

Facility Name

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

City

Warszawa

ZIP/Postal Code

02-781

Country

Poland

Facility Name

HUC; Servico de Hematologia

City

Coimbra

ZIP/Postal Code

3000-075

Country

Portugal

Facility Name

IPO de Lisboa; Servico de Hematologia

City

Lisboa

ZIP/Postal Code

1099-166

Country

Portugal

Facility Name

Hospital de Sao Joao; Servico de Hematologia Clinica

City

Porto

ZIP/Postal Code

4200-319

Country

Portugal

Facility Name

Republican Clinical Oncologic Dispensary of Republic Of Tatarstan

City

Kazan

ZIP/Postal Code

420029

Country

Russian Federation

Facility Name

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

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Haematology Research Center; Haematology

City

Moscow

ZIP/Postal Code

125167

Country

Russian Federation

Facility Name

Semashko Central Clinical Hospital Moscow; Hematology

City

Moscow

ZIP/Postal Code

129128

Country

Russian Federation

Facility Name

Research Inst. of Hematology & Blood Transfusion ; Hematology

City

St Petersburg

ZIP/Postal Code

191024

Country

Russian Federation

Facility Name

National Cancer Inst. ; Dept. of Chemotherapy

City

Bratislava

ZIP/Postal Code

833 10

Country

Slovakia

Facility Name

Hospital Mutua de Terrassa; Servicio de Hematologia

City

Terrassa

State/Province

Barcelona

ZIP/Postal Code

08221

Country

Spain

Facility Name

Hospital Universitario Marques de Valdecilla; Servicio de Hematologia

City

Santander

State/Province

Cantabria

ZIP/Postal Code

39008

Country

Spain

Facility Name

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

City

La Coruna

State/Province

La Coruña

ZIP/Postal Code

15006

Country

Spain

Facility Name

Hospital Universitario de Canarias;servicio de Oncologia

City

La Laguna

State/Province

Tenerife

ZIP/Postal Code

38320

Country

Spain

Facility Name

Hospital de Basurto; Servicio de Hematologia

City

Bilbao

State/Province

Vizcaya

ZIP/Postal Code

48013

Country

Spain

Facility Name

Hospital de Galdakano

City

Galdakano

State/Province

Vizcaya

ZIP/Postal Code

48960

Country

Spain

Facility Name

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

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

Hospital Universitari Vall d'Hebron; Servicio de Hematologia

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Hospital Clínic i Provincial; Servicio de Hematología y Oncología

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Hospital Duran i Reynals; Servicio de Hematologia

City

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

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

City

Jaen

ZIP/Postal Code

23007

Country

Spain

Facility Name

Hospital Universitario Clínico San Carlos; Servicio de Hematología

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Hospital Universitario la Paz; Servicio de Hematologia

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia

City

Malaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Hospital Clinico Universitario de Salamanca;Servicio de Hematologia

City

Salamanca

ZIP/Postal Code

37007

Country

Spain

Facility Name

Hospital Universitario Virgen del Rocio; Servicio de Hematologia

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Hospital Universitario la Fe; Servicio de Medicina Intena

City

Valencia

ZIP/Postal Code

46009

Country

Spain

Facility Name

Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Name

Hospital Universitario Miguel Servet; Servicio Hematologia

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

Skånes University Hospital, Skånes Department of Onclology

City

Lund

ZIP/Postal Code

22185

Country

Sweden

Facility Name

Skånes Universitetssjukhus; Kliniska Forskningsenheten Onkologimottagning medicinsk behandling

City

Malmö

ZIP/Postal Code

205 02

Country

Sweden

Facility Name

Länssjukhuset; Medicinkliniken

City

Sundsvall

ZIP/Postal Code

85186

Country

Sweden

Facility Name

Akademiska sjukhuset, Onkologkliniken

City

Uppsala

ZIP/Postal Code

75185

Country

Sweden

Facility Name

Universitätsspital Zürich; Klinik für Onkologie

City

Zürich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

Veterans General Hospital; Division of Oncology

City

Taipei

ZIP/Postal Code

00112

Country

Taiwan

Facility Name

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

City

Taipei

ZIP/Postal Code

112

Country

Taiwan

Facility Name

Chang Gung Medical Foundation-Taipei

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

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

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

National Cancer Inst.

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Rajavithi Hospital; Medicine

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Siriraj Hospital; Division of Hematology, Department of Medicine

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

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

City

Chiang Mai

ZIP/Postal Code

50200

Country

Thailand

Facility Name

Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine

City

Khon Kaen

ZIP/Postal Code

40002

Country

Thailand

Facility Name

Birmingham Heartlands Hospital; Department of Haematology

City

Birmingham

ZIP/Postal Code

B9 5SS

Country

United Kingdom

Facility Name

Bradford Royal Infirmary; Haematology Department

City

Bradford

ZIP/Postal Code

BD9 6RJ

Country

United Kingdom

Facility Name

North Hampshire Hospital; Dept. of Haematology

City

Hampshire

ZIP/Postal Code

RG24 9NA

Country

United Kingdom

Facility Name

Princess Alexandra Hospital; Department of Haematology

City

Harlow

ZIP/Postal Code

CM20 1QX

Country

United Kingdom

Facility Name

Leicester Royal Infirmary; Dept. of Medical Oncology

City

Leicester

ZIP/Postal Code

LE1 5WW

Country

United Kingdom

Facility Name

Royal Liverpool Uni Hospital; Haematology

City

Liverpool

ZIP/Postal Code

L7 8XP

Country

United Kingdom

Facility Name

St. George'S Hospital; Haematology

City

London

ZIP/Postal Code

SW17 0QT

Country

United Kingdom

Facility Name

Hillingdon Hospital

City

Middx

ZIP/Postal Code

UB8 3NN

Country

United Kingdom

Facility Name

Churchill Hospital; Oxford Cancer and Haematology Centre

City

Oxford

ZIP/Postal Code

OX3 7LJ

Country

United Kingdom

Facility Name

Royal Hallamshire Hospital; Haematology Dept

City

Sheffield

ZIP/Postal Code

S10 2JF

Country

United Kingdom

Facility Name

Weston Park Hospital; Cancer Clinical Trials Centre

City

Sheffield

ZIP/Postal Code

S10 2SJ

Country

United Kingdom

Facility Name

The Royal Wolverhampton Hospitals NHS Trust; Department of Haematology

City

Wolverhampton

ZIP/Postal Code

WV10 0QP

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

30770362

Citation

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.

Results Reference

derived

PubMed Identifier

24895339

Citation

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.

Results Reference

derived

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