Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of Obinutuzumab in Combination With CHOP Chemotherapy Versus Rituximab With CHOP in Participants With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01287741
Recruitment Status : Terminated (The study was closed by the Sponsor according to the protocol-specified minimum post-treatment follow-up period of 3 years.)
First Posted : February 1, 2011
Results First Posted : August 17, 2017
Last Update Posted : April 12, 2019
Sponsor:
Collaborator:
Fondazione Italiana Linfomi ONLUS
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This open-label, randomized, parallel group study will evaluate the efficacy and safety of obinutuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone or prednisone (CHOP) chemotherapy versus rituximab (MabThera/Rituxan) with CHOP in previously untreated participants with cluster of differentiation 20 (CD20)-positive diffuse large B-cell lymphoma (DLBCL). Participants will be randomized to receive either obinutuzumab 1000 milligrams (mg) intravenously (IV) every 21 days or rituximab 375 milligrams per square meter (mg/m^2) IV every 21 days for 8 cycles, in addition to 6-8 cycles of CHOP chemotherapy IV every 21 days. Participants randomized to the obinutuzumab arm will receive an additional two doses on Days 8 and 15 of Cycle 1. Anticipated time on study treatment is 24 weeks.

Condition or disease Intervention/treatment Phase
Diffuse Large B-Cell Lymphoma Drug: Rituximab Drug: Obinutuzumab Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisone Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1418 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Open-Label Randomized Trial Comparing the Efficacy of GA101 (RO5072759) in Combination With CHOP (G-CHOP) Versus Rituximab and CHOP (R-CHOP) in Previously Untreated Patients With CD20-Positive Diffuse Large B-Cell Lymphoma (DLBCL)
Actual Study Start Date : July 26, 2011
Actual Primary Completion Date : April 29, 2016
Actual Study Completion Date : January 31, 2018


Arm Intervention/treatment
Active Comparator: Rituximab+Chemotherapy
Participants received eight 21-day cycles of rituximab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Drug: Rituximab
Rituximab at a dose of 375 mg/m^2, administered by intravenous (IV) infusion on Day 1 of each 21-day cycle for 8 cycles.
Other Name: MabThera, Rituxan

Drug: Cyclophosphamide
Cyclophosphamide 750 milligrams per square metre (mg/m^2), administered intravenously (IV) on Day 1 of each 21-day cycle.

Drug: Doxorubicin
Doxorubicin 50 mg/m^2 IV, administered on Day 1 of each 21-day cycle.

Drug: Vincristine
Vincristine 1.4 mg/m^2 (maximum 2 mg) IV, administered on Day 1 of each 21-day cycle.

Drug: Prednisone
Prednisone 100 mg (or equivalent prednisolone or methylprednisolone), administered orally on Days 1-5 of each 21-day cycle.

Experimental: Obinutuzumab+Chemotherapy
Participants received eight 21-day cycles of obinutuzumab, combined with six or eight cycles of standard cyclophosphamide, doxorubicin, vincristine, and prednisone/prednisolone (CHOP) chemotherapy (21-day cycles). Participants received an additional two doses of obinutuzumab on Days 8 and 15 of Cycle 1. Prior to study start, study centers chose whether they planned to administer 6 or 8 cycles of CHOP chemotherapy.
Drug: Obinutuzumab
Obinutuzumab 1000 mg IV infusion, administered on Day 1 of each 21-day cycle for 8 cycles. During Cycle 1, obinutuzumab was also infused on Days 8 and 15.
Other Name: GA101, RO5072759

Drug: Cyclophosphamide
Cyclophosphamide 750 milligrams per square metre (mg/m^2), administered intravenously (IV) on Day 1 of each 21-day cycle.

Drug: Doxorubicin
Doxorubicin 50 mg/m^2 IV, administered on Day 1 of each 21-day cycle.

Drug: Vincristine
Vincristine 1.4 mg/m^2 (maximum 2 mg) IV, administered on Day 1 of each 21-day cycle.

Drug: Prednisone
Prednisone 100 mg (or equivalent prednisolone or methylprednisolone), administered orally on Days 1-5 of each 21-day cycle.




Primary Outcome Measures :
  1. Median Time to Progression-Free Survival (PFS), Investigator-Assessed [ Time Frame: Baseline up to approximately 6.5 years (up to 31 January 2018) ]
    Kaplan Meier estimate of the median PFS was defined as the time at which half of the participants have progressed (progressive disease [PD]). Progression-free survival was defined as the time from randomization until the first documented day of disease progression or relapse, using a modified version of the Revised Response Criteria for Malignant Lymphoma, or death from any cause, whichever occurred first, on the basis of investigator assessments. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI).


Secondary Outcome Measures :
  1. Median Time to Progression-Free Survival (PFS), Independent Review Committee (IRC)-Assessed [ Time Frame: Baseline up to approximately 4 years and 9 months (up to 29 April 2016) ]
    Kaplan Meier estimate of median PFS was defined as time at which half of participants have progressed (progressive disease [PD]). Progression-free survival was defined as time from randomization until first documented day of disease progression or relapse, using a modified version of Revised Response Criteria for Malignant Lymphoma, or death from any cause, whichever occurred first, on basis of IRC assessments. Progression was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 cm or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT or MRI. This outcome measure used data from primary analysis which included all 1418 participants.

  2. Median Time to Overall Survival (OS) [ Time Frame: Baseline up to approximately 6.5 years (up to 31 January 2018) ]
    Kaplan Meier estimate of median OS was defined as the time at which half of the participants had died, regardless of the cause of death. Overall survival in the overall study population was defined as the time from the date of randomization to the date of death from any cause.

  3. Overall Response Rate (ORR), Investigator-Assessed [ Time Frame: Baseline up to approximately 6.5 years (up to 31 January 2018) ]
    Overall response was determined on the basis of investigator assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Overall response was defined as the disappearance of all evidence of disease, regression of measurable disease, and no new sites.

  4. Overall Response Rate (ORR), IRC-Assessed [ Time Frame: Baseline up to approximately 4 years and 9 months (up to 29 April 2016) ]
    Overall response was determined on the basis of IRC assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Overall response was defined as the disappearance of all evidence of disease, regression of measurable disease, and no new sites. This outcome measure used data from primary analysis which included all 1418 participants.

  5. Complete Response (CR) at the End of Treatment, Investigator-Assessed [ Time Frame: Baseline up to approximately 6.5 years (up to 31 January 2018) ]
    Percentage of participants with complete response was determined on the basis of investigator assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Complete response was defined as the disappearance of all evidence of disease.

  6. Complete Response (CR) at the End of Treatment, IRC-Assessed [ Time Frame: Baseline up to approximately 4 years and 9 months (up to 29 April 2016) ]
    Percentage of participants with complete response was determined on the basis of IRC assessments according to the International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma, 2007. Tumor assessments were performed with CT/MRI with or without PET. Complete response was defined as the disappearance of all evidence of disease. This outcome measure used data from primary analysis which included all 1418 participants.

  7. Median Time to Event-Free Survival (EFS), Investigator-Assessed [ Time Frame: Baseline up to death or disease progression, or initiation of new anti-lymphoma treatment (NALT), whichever occurred first, approximately 6.5 years (up to 31 January 2018) ]
    Kaplan Meier estimate of median EFS is the time at which half of the participants have progressed. Event-free survival was defined as the time from the date of randomization until the date of disease progression, relapse, initiation of a new non-protocol-specified anti-lymphoma treatment, or death from any cause on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Disease progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI.

  8. Median Time to Disease-Free Survival (DFS), Investigator-Assessed [ Time Frame: Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018) ]
    Kaplan Meier estimate of median DFS was defined as time at which half of participants have disease progression/relapse or death from any cause. Disease-free survival was defined as time from date of the first occurrence of a documented CR to date of disease progression/relapse or death from any cause on basis of investigator assessments with use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. Progression/relapse was defined as at least 50% increase in nodal lesions or >/=50% increase in any node > 1 centimeter (cm) or >/= 50% increase in other target measurable lesions (e.g., splenic or hepatic nodules) and/or appearance of any new bone marrow involvement and/or appearance of any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm.

  9. Duration of Response (DOR), Investigator-Assessed [ Time Frame: Baseline up to death or disease progression, whichever occurred first, approximately 6.5 years (up to 31 January 2018) ]
    DOR: time from first occurrence of documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR. Tumor assessments were performed with CT/MRI. CR: disappearance of all target lesions. PR: >/=50% decrease target lesions in up to six dominant lesions identified at baseline, no new lesions and no increase in the size of the liver, spleen, or other nodes. Splenic and hepatic nodule regression >/= 50%. Progression/relapse: at least 50% increase in nodal lesions or >/=50% increase in any node > 1 cm or >/= 50% increase in other target lesions (e.g., splenic or hepatic nodules) and/or any new bone marrow involvement and/or any new lesion > 1.5 cm or >/= 50% increase in any previously involved node with a diameter </= 1 cm such that it is now >1.5 cm. A participant in the Rituximab+CHOP arm with the longest follow-up, 53 months, had an event. The criterion for median was the minimum time when survival went below 50%.

  10. Time to Next Anti-Lymphoma Treatment (TTNALT) [ Time Frame: Baseline up to start of next anti-lymphoma treatment or death due to any cause, whichever occurred first, approximately 6.5 years (31 January 2018) ]
    Time to next anti-lymphoma treatment was defined as the time from the date of randomization to the start date of the next anti-lymphoma treatment or death from any cause.

  11. Percentage of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to approximately 6.5 years (up to 31 January 2018) ]
    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

  12. Percentage of Participants With Human Anti-Human Antibodies (HAHAs) to Obinutuzumab [ Time Frame: Pre-dose (Hour 0) on Cycle (C) 4 Day (D) 1, at end of treatment/early termination (up to Month 6), every 6 months thereafter for 30 months (cycle length = 21 days) ]
    The presence of HAHAs to obinutuzumab was assessed in the first 100 randomized participants.

  13. Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Subscale Score [ Time Frame: Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to approximately 6.5 years, (cycle length = 21 days) ]
    The FACT-Lym subscale was developed to assess health-related quality of life in participants with non-Hodgkin lymphoma. The score range is 0-60, with higher scores indicating better outcomes. A positive change from baseline indicates an improvement.

  14. Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Core 30 (EORTC QLQ-C30) Domain Scores [ Time Frame: Baseline (pre-dose [Hour 0] on C1D1), C3D1, end of treatment (up to Month 6), every 12 months thereafter up to data cut-off, up to approximately 6.5 years, (cycle length = 21 days) ]
    The EORTC QLQ-C30 is a health-related quality of life questionnaire. A higher score indicates better quality of life, with changes of 5 to 10 points considered to be a minimally important difference to participants.

  15. Serum Concentrations of Obinutuzumab in Japanese Participants With Diffuse Large B-Cell Lymphoma (DLBCL) [ Time Frame: C1: D1 post-infusion and 20-28 and 66-80 hours after end of infusion, D8 and D15 pre-and post-infusion; C2: D1 pre- and post-infusion; C4: D1 pre- and post-infusion; C6: D1 pre- and post-infusion; C8: D1 pre- and post-infusion (cycle length = 21 days) ]
    Serum samples for assessment of obinutuzumab serum concentrations were collected only from a subset of Japanese participants following administration of 1000 mg obinutuzumab.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previously untreated CD20-positive DLBCL
  • At least 1 bi-dimensionally measurable lesion (greater than [>]1.5 centimeters [cm] in its largest dimension on the computed tomography [CT] scan)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
  • Adequate hematological function
  • Low-intermediate, high-intermediate or high-risk International Prognostic Index (IPI) score (low-risk IPI score: IPI 1 irrespective of bulky disease or IPI 0 with bulky disease, defined as one lesion greater than equal to (>/=) 7.5 cm)
  • Left ventricular ejection fraction (LVEF) >/=50 percent (%) on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram

Exclusion Criteria:

  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products or to any component of CHOP or obinutuzumab
  • Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines
  • Participants with transformed lymphoma and participants with follicular lymphoma IIIB
  • Prior therapy for DLBCL, with the exception of nodal biopsy or local irradiation
  • Prior treatment with cytotoxic drugs or rituximab for another condition (for example, rheumatoid arthritis) or prior use of an anti-CD20 antibody
  • Prior use of any monoclonal antibody within 3 months of the start of Cycle 1
  • Corticosteroid use of >30 milligrams per day (mg/day) of prednisone or equivalent, for purposes other than lymphoma symptom control
  • Primary central nervous system (CNS) lymphoma and secondary CNS involvement by lymphoma, mantle-cell lymphoma (MCL), or histologic evidence of transformation to a Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, plasmablastic lymphoma, and primary cutaneous DLBCL

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01287741


Locations
Hide Hide 235 study locations
Layout table for location information
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300
United States, Arizona
Ironwood Cancer TX & Rsch Ctrs
Chandler, Arizona, United States, 85224
Arizona Oncology
Tucson, Arizona, United States, 85704
United States, California
California Cancer Associates for Research & Excellence, Inc.
Encinitas, California, United States, 92008
cCare
Encinitas, California, United States, 92024
UCLA - School of Medicine; Division of Hematology/Oncology
Los Angeles, California, United States, 90095-6984
United States, Colorado
Rocky Mountain Cancer Center - Aurora
Aurora, Colorado, United States, 80012
United States, Florida
Florida Cancer Specialists; Department of Oncology
Fort Myers, Florida, United States, 33901-8101
Florida Cancer Specialists; Saint Petersburg
Saint Petersburg, Florida, United States, 33719
United States, Georgia
Central Georgia Cancer Care PC
Macon, Georgia, United States, 31201
United States, Illinois
Illinois Cancer Care, P.C. - Galesburg
Galesburg, Illinois, United States, 61401
Joliet Oncology-Hematology; Associates, Ltd.
Joliet, Illinois, United States, 60435
Cancer Care & Hematology; Specialists of Chicagoland
Niles, Illinois, United States, 60714
Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Maine
Mercy Oncology / Hematology Center; Oncology
Portland, Maine, United States, 04102
United States, Minnesota
Park Nicollet Clin-Cancer Ctr
Saint Louis Park, Minnesota, United States, 55426
Minnesota Oncology Hematology Woodbury
Woodbury, Minnesota, United States, 55125
United States, New York
New York Oncology Hematology, P.C.
Albany, New York, United States, 12206
United States, North Carolina
Mecklenburg Medical Group Charlotte
Charlotte, North Carolina, United States, 28204
Forsyth Regional Cancer Center; Piedmont Hematology/Oncology Associates
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Signal Point Clinical; Research Center, LLC
Middletown, Ohio, United States, 45042
Cleveland CL N Coast Cancer Cr
Sandusky, Ohio, United States, 44870
United States, Oregon
Willamette Valley Cancer Insitute and Research Center
Springfield, Oregon, United States, 97477
United States, South Carolina
Medical University of SC (MUSC)
Charleston, South Carolina, United States, 29425
South Carolina Oncology Associates - SCRI
Columbia, South Carolina, United States, 29210
United States, Tennessee
Chattanooga Oncology and Hematology Associates, PC
Chattanooga, Tennessee, United States, 37404
Tennessee Onc., PLLC - SCRI
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Oncology, Pa - Amarillo
Amarillo, Texas, United States, 79106
Texas Oncology-Fort Worth 12th Ave
Fort Worth, Texas, United States, 76104
MD Anderson Cancer Center Department of Lymphoma & Myeloma
Houston, Texas, United States, 77030
Cancer Care Centers of South Texas-HOAST - San Antonio
New Braunfels, Texas, United States, 78130
United States, Virginia
Virginia Cancer Institute
Richmond, Virginia, United States, 23226
Blue Ridge Cancer Care
Roanoke, Virginia, United States, 24014
Virginia Cancer Specialists - Winchester
Winchester, Virginia, United States, 22601
United States, Washington
Northwest Medical Specialties
Tacoma, Washington, United States, 98405
Wenatchee Valley Hospital & Clinics
Wenatchee, Washington, United States, 98801
Argentina
Instituto Damic
Cordoba, Argentina, X5003DCE
Sanatorio Britanico: Hematologia
Rosario, Argentina, 2000
Sanatorio Parque de Rosario
Rosario, Argentina, S2000DSV
Australia, Queensland
Cairns Base Hospital; Cancer Care Centre
Cairns, Queensland, Australia, 4870
Australia, Victoria
Frankston Hospital; Oncology/Haematology
Frankston, Victoria, Australia, 3199
Monash Medical Centre; Haematology
Melbourne, Victoria, Australia, 3168
Australia, Western Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
Austria
Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
Innsbruck, Austria, 6020
Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.
Salzburg, Austria, 5020
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Hämatologie & Hämostaseologie
Wien, Austria, 1090
Brazil
Hospital Mae de Deus
Porto Alegre, RS, Brazil, 90470-340
Hospital Sao Lucas - PUCRS
Porto Alegre, RS, Brazil, 90610-000
Centro de Pesquisas Oncologicas - CEPON
Florianopolis, SC, Brazil, 88034-000
Instituto de Ensino e Pesquisa Sao Lucas - IEP
Sao Paulo, SP, Brazil, 01236-030
Hospital Santa Marcelina;Oncologia
Sao Paulo, SP, Brazil, 08270-070
Canada, Alberta
Tom Baker Cancer Centre; Dept of Medicine
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
BCCA-Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre; Oncology
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Ottawa General Hospital
Ottawa, Ontario, Canada, K1H 8L6
North York General Hospital
Toronto, Ontario, Canada, M2J 1V1
Humber River Hospital
Toronto, Ontario, Canada, M3M 0B2
University Health Network; Princess Margaret Hospital; Medical Oncology Dept
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Hopital Maisonneuve- Rosemont; Oncology
Montreal, Quebec, Canada, H1T 2M4
Chum Hopital Notre Dame; Centre D'Oncologie
Montreal, Quebec, Canada, H2L 4M1
Mcgill University - Royal Victoria Hospital; Oncology
Montreal, Quebec, Canada, H3A 1A1
McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
Montreal, Quebec, Canada, H3T 1E2
Hopital de L'Enfant-Jesus; Hematology
Quebec City, Quebec, Canada, G1J 1Z4
Centre de sante et de services sociaux Rimouski Neigette
Rimouski, Quebec, Canada, G5L 5T1
Canada, Saskatchewan
Saskatoon Cancer Centre; Uni of Saskatoon Campus
Saskatoon, Saskatchewan, Canada, S7N 4H4
China
Cancer Hospital Chinese Academy of Medical Sciences.
Beijing, China, 100021
Peking University First Hospital
Beijing, China, 100034
The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA)
Beijing, China, 100071
Beijing Cancer Hospital
Beijing, China, 100142
Beijing Hospital of Ministry of Health; Hematology
Beijing, China, 100730
General Hospital of Chinese PLA; Department of Hematology
Beijing, China, 100853
the First Hospital of Jilin University
Changchun, China, 130021
Hu Nan Provincial Cancer Hospital
Changsha, China, 410006
Fujian Medical University Union Hospital
Fujian, China, 350001
Fujian Cancer Hospital
Fuzhou, China, 350014
Sun Yet-sen University Cancer Center
Guangzhou, China, 510060
Guangdong General Hospital
Guangzhou, China, 510080
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, China, 310003
Harbin Medical University Cancer Hospital
Harbin, China, 150081
The Second Affiliated Hospital to Nanchang University
Nanchang, China, 330006
Jiangsu Cancer Hospital
Nanjing, China, 210009
Jiangsu Province Hospital
Nanjing, China, 210036
The First Affiliate Hospital of Guangxi Medical University
Nanning, China, 530021
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200025
Fudan University Shanghai Cancer Center
Shanghai, China, 200032
Changhai Hospital of Shanghai
Shanghai, China, 200433
First Hospital of China Medical University
Shenyang, China, 110001
The Second Affiliated Hospital of Soochow University
Suzhou, China, 215004
First Affiliated Hospital of Soochow University
Suzhou, China, 215006
Tianjin Cancer Hospital
Tianjin, China, 300060
Xiehe Hospital, Tongji Medical College Huazhong University of Science & Technology
Wuhan, China, 430022
Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center
Wuhan, China, 430023
The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
Xi'an, China, 710038
Colombia
Fundacion Cardioinfantil
Bogota, Colombia
Organizacion Sanitas Internacional
Bogota, Colombia
FOSCAL
Floridablanca, Colombia
Czechia
Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika
Brno, Czechia, 625 00
Fn Hr. Kralove; IV. Interni Hematologicka Klinika
Hradec Kralove, Czechia, 500 05
Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK
Praha 2, Czechia, 128 08
Denmark
Rigshospitalet; Hæmatologisk Klinik
København Ø, Denmark, 2100
Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium
Roskilde, Denmark, 4000
Aarhus Universitetshospital, Hæmatologisk Afdeling R
Århus, Denmark, 8000
Germany
Uniklinik RWTH Aachen; Klinik IV; Klinik Hämatologie, Onkologie, Hämostaseologie und Stammz
Aachen, Germany, 52074
Onkologische Schwerpunktpraxis Kurfürstendamm
Berlin, Germany, 10707
Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik und Poliklinik I
Dresden, Germany, 01307
Friedrich-Alexander-Universität Erlangen-Nürnberg; Medizinische Klinik V
Erlangen, Germany, 91054
Klinik der Justus-Liebig-Universität; Innere Medizin
Gießen, Germany, 35392
Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V
Heidelberg, Germany, 69120
Universitätsklinikum Würzburg; Medizinische Klinik und Poliklinik II; Hämatologie / Onkologie
Würzburg, Germany, 97080
Hong Kong
Pamela Youde Nethersole Eastern Hospital; Department of Medicine
Hong Kong, Hong Kong
Queen Mary Hospital; Dept of Medicine
Hong Kong, Hong Kong
Hungary
Semmelweis University, First Dept of Medicine
Budapest, Hungary, 1083
National Institute of Oncology, A Dept of Internal Medicine
Budapest, Hungary, 1122
University of Debrecen Medical and Health Science Center, Institute of Internal medicine Building B
Debrecen, Hungary, 4032
Petz Aladar Megyei Korhaz; Hematologia
Gyor, Hungary, 9024
Kaposi Mor Teaching Hospital, Dept of Internal Medicine/Hematology
Kaposvar, Hungary, 7400
University of Pecs, I st Dept of Internal Medicine
Pecs, Hungary, 7624
University of Szeged, II Dept of Internal Medicine
Szeged, Hungary, 6720
Italy
Ospedale Riuniti; Divisione Di Ematologia
Reggio Calabria, Calabria, Italy, 89100
Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica
Napoli, Campania, Italy, 80131
Nuovo Policlinico, Ii Facolta; Divisione Di Ematologia
Napoli, Campania, Italy, 80131
Ospedale "A.Tortora" - Ematologia; Dipartimento Di Ematologia
Pagani (Sa), Campania, Italy, 84016
A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
Bologna, Emilia-Romagna, Italy, 40138
AUSL - IRCCS Santa Maria Nuova; U.O. Day Hospital di Oncologia
Reggio Emilia, Emilia-Romagna, Italy, 42100
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica
Udine, Friuli-Venezia Giulia, Italy, 33100
Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol
Roma, Lazio, Italy, 00161
A.O. Universitaria S. Martino Di Genova; Ematologia 1
Genova, Liguria, Italy, 16132
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia
Brescia, Lombardia, Italy, 25123
Hospital San Raffaele
Milano, Lombardia, Italy, 20132
Ist. Nazionale Per Lo Studio E Cura Dei Tumori; Div. Ematologia Trapianto Midollo Osseo Allogenico
Milano, Lombardia, Italy, 20133
Irccs Istituto Europeo Di Oncologia (IEO); Emato-Oncologia
Milano, Lombardia, Italy, 20141
Irccs Policlinico San Matteo; Divisione Di Ematologia
Pavia, Lombardia, Italy, 27100
Ospedale Civile SS. Antonio E Biagio DI Alessandria; Ematologia
Alessandria, Piemonte, Italy, 15121
Ospedali Riuniti del Canavese
Ivrea, Piemonte, Italy, 10015
Univ. Piemonte Est Amedeo Avogadro; Div.Ematologia- Dip.Clinica Med.Sperim.& Ircad
Novara, Piemonte, Italy, 28100
Az. Osp. S. Luigi Gonzaga; S.C.D.U. Medicina Interna Ii
Orbassano, Piemonte, Italy, 10043
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1
Torino, Piemonte, Italy, 10126
A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia
Torino, Piemonte, Italy, 10126
Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica
Bari, Puglia, Italy, 70124
IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo
San Giovanni Rotondo, Puglia, Italy, 71013
Az. Osp. C. Panico; Rep. Ematologia E Trapianto
Tricase - LE, Puglia, Italy, 73039
Azienda Ospedaliero Univ
Catania, Sicilia, Italy, 95124
Az. Osp. Papardo; Struttura Complessa Di Ematologia
Messina, Sicilia, Italy, 98165
Azienda Ospedaliera Univ
Firenze, Toscana, Italy, 50141
Ospedale Santa Chiara; Unita Operativa Di Ematologia
Pisa, Toscana, Italy, 56100
Az. Osp. S. Maria; Dept. Di Oncologia Medica
Terni, Umbria, Italy, 05100
Ospedale Ca Foncello; Ematologia
Treviso, Veneto, Italy, 31100
Uni Di Verona Policlinico G.B. Rossi; Divisione E Cattedra Di Ematologia
Verona, Veneto, Italy, 37130
Ospedale Di Vicenza; Nefrologia, Ematologia
Vicenza, Veneto, Italy, 36100
Japan
Nagoya Daini Red Cross Hospital; Hematology & Oncology
Aichi, Japan, 466-8650
Chiba University Hospital; Hematology
Chiba, Japan, 260-8670
Kyushu University Hospital; Hematology, Oncology & Cardiovascular medicine
Fukuoka, Japan, 812-8582
Kurume University Hospital; Hematology and Oncology
Fukuoka, Japan, 830-0011
Gifu University Hospital; First Department of Internal Medicine
Gifu, Japan, 501-1194
Hokkaido University Hospital; Hematology
Hokkaido, Japan, 060-8648
Kobe City Medical Center General Hospital; Hematology
Hyogo, Japan, 650-0047
Iwate Medical University Hospital;Hematology and Oncology
Iwate, Japan, 020-8505
Yokohama City University Hospital; Hematology, Rheumatology, Infectious Disease
Kanagawa, Japan, 236-0004
Kyoto University Hospital; Department of Hematology/Oncology
Kyoto, Japan, 606-8507
Niigata Cancer Center Hospital; Internal Medicine
Niigata, Japan, 951-8566
Kurashiki Central Hospital; Hematology
Okayama, Japan, 710-8602
Osaka City University Hospital; Hematology
Osaka, Japan, 545-8586
Osaka University Hospital; Hematology and Oncology
Osaka, Japan, 565-0871
Kindai University Hospital; Hematology and Rheumatology
Osaka, Japan, 589-8511
Shimane University Hospital;Hematology
Shimane, Japan, 693-8501
Jichi Medical University Hospital; Hematology
Tochigi, Japan, 329-0498
National Cancer Center Hospital; Hematology
Tokyo, Japan, 104-0045
Toranomon Hospital; Hematology
Tokyo, Japan, 105-8470
Nippon Medical School Hospital; Hematology
Tokyo, Japan, 113-8603
The Cancer Institute Hospital of JFCR; Hematology Oncology
Tokyo, Japan, 135-8550
Korea, Republic of
National Cancer Center
Gyeonggi-do, Korea, Republic of, 10408
Chonnam National University Hwasun Hospital
Jeollanam-do, Korea, Republic of, 58128
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Asan Medical Center - Oncology
Seoul, Korea, Republic of, 05505
Yonsei University Severance Hospital; Medical Oncology
Seoul, Korea, Republic of, 120-752
St. Mary'S Hospital, the Catholic University School of Medicine; Internal Medicine
Seoul, Korea, Republic of, 137-701
Samsung Medical Center
Seoul, Korea, Republic of, 6351
Mexico
Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre
Chihuahua, Mexico, 31000
Hospital Universitario Dr. Jose E. Gonzalez; Haematology
Monterrey, Mexico, 64460
Oaxaca Site Management Organization
Oaxaca, Mexico, 68000
Centro de Estudios Clinicos de Queretaro, SC
Queretaro, Mexico, 76000
Panama
Centro Hemato Oncologico Panama
Panama, Panama, 0832
Peru
Instituto Nacional de Enfermedades Neoplasicas
Lima, Peru, 15038
Instituto;Oncologico Miraflores
Lima, Peru, 18
Clinica de Especialidades Medicas
Lima, Peru, Lima 41
Poland
Szpital Specjalistyczny Podkarpacki Ośrodek Onkologiczny
Brzozów, Poland, 36-200
Uniwersyteckie Centrum Kliniczne; Klinika Hematologii i Transplantologii
Gdansk, Poland, 80-952
Medical University of Lodz; Hematology
Lodz, Poland, 93-510
Katedra i Klinika Hematoonkologii i Transplantacji Szpiku; Uniwersytetu Medycznego w Lublinie
Lublin, Poland, 20-081
Centrum Onkologii Instytut im. M. Sklodowskiej-Curie, Klinika Nowotworow Ukladu Chlonnego
Warszawa, Poland, 02-781
Medical Uni of Wroclaw; Hematology
Wroclaw, Poland, 50-367
Russian Federation
Clinical Oncology Dispensary of Ministry of Health of Tatarstan
Kazan, Russian Federation, 420029
Blokhin Cancer Research Center; Clinical Oncology
Moscow, Russian Federation, 115478
Regional Clinical Hospital N.A. Semashko; Hematology
Nizhny Novgorod, Russian Federation, 603126
Penza Regional Oncology Dispensary
Penza, Russian Federation, 440071
Republican Clinical Hospital n.a. Baranov; Haematology
Petrozavodsk, Russian Federation, 185019
Research Inst. of Hematology & Blood Transfusion ; Hematology
St Petersburg, Russian Federation, 191024
Serbia
Institute of Hematology
Belgrade, Serbia, 11000
Clinical Center Vojvodine; Clinic for Hematology
Novi Sad, Serbia, 21000
Slovakia
National Oncology Inst. ; Dept. of Haematology
Bratislava, Slovakia, 833 10
South Africa
Constantiaberg Medical Clinic; Dept. of Haematology & Bone Marrow Translant
Cape Town, South Africa, 7800
Mary Potter Oncology Centre
Groenkloof, South Africa, 0181
Medical Oncology Centre of Rosebank; Oncology
Johannesburg, South Africa, 2196
Wits Donald Gordon Clinical Trial Centre; Medical Oncology
Parktown, Johannesburg, South Africa, 2193
Drs Thomson, Brittain an Partners Inc
Pretoria, South Africa, 0044
Spain
Hospital de Navarra, Servicio de Hematología
Pamplona, Navarra, Spain, 31008
Hospital Universitari Sant Joan de Reus; Servicio de Oncologia
Reus, Tarragona, Spain, 43204
Hospital del Mar; Servicio de Hematologia
Barcelona, Spain, 08003
Hospital Universitari Vall d'Hebron; Servicio de Hematologia
Barcelona, Spain, 08035
Hospital Clínic i Provincial; Servicio de Hematología y Oncología
Barcelona, Spain, 08036
Hospital Duran i Reynals; Servicio de Hematologia
Barcelona, Spain, 08907
Hospital Ramon y Cajal; Servicio de Hematologia
Madrid, Spain, 28034
Complejo Hospitalario de Pontevedra; Servicio de Oncologia
Pontevedra, Spain, 36002
Hospital Universitario Virgen Macarena; Servicio de Oncologia
Sevilla, Spain, 41009
Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia
Toledo, Spain, 45004
Switzerland
Kantonsspital Aarau; Zentrum Für Onkologie, Hämatologie & Transfusionsmedizin
Aarau, Switzerland, 5001
Ospedale San Giovanni; Oncologia
Bellinzona, Switzerland, 6500
Kantonsspital Graubünden;Onkologie und Hämatologie
Chur, Switzerland, 7000
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
Zürich, Switzerland, 8091
Taiwan
Veterans General Hospital; Division of Oncology
Taipei, Taiwan, 00112
National Taiwan Universtiy Hospital; Division of Hematology
Taipei, Taiwan, 100
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
Taipei, Taiwan, 112
Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology
Taoyuan, Taiwan, 333
Thailand
King Chulalongkorn Memorial Hospital; Division of Hematology, Department of Medicine
Bangkok, Thailand, 10330
National Cancer Inst.
Bangkok, Thailand, 10400
Rajavithi Hospital; Medicine
Bangkok, Thailand, 10400
Ramathibodi Hospital; Division of Hematology, Department of Medicine
Bangkok, Thailand, 10400
Siriraj Hospital; Division of Hematology, Department of Medicine
Bangkok, Thailand, 10700
Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine
Khon Kaen, Thailand, 40002
United Kingdom
Aberdeen Royal Infirmary; Haematology - Ward 16
Aberdeen, United Kingdom, AB25 2ZN
Birmingham Heartlands Hospital; Department of Haematology
Birmingham, United Kingdom, B9 5SS
Addenbrookes Hospital; Haematology
Cambridge, United Kingdom, CB2 0QQ
The HOPE Clinical Trials Unit
Leicester, United Kingdom, LE1 5WW
New Cross Hospital; Dept. Of Haematology
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Hoffmann-La Roche
Fondazione Italiana Linfomi ONLUS
Investigators
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01287741    
Other Study ID Numbers: BO21005
2010-024194-39
First Posted: February 1, 2011    Key Record Dates
Results First Posted: August 17, 2017
Last Update Posted: April 12, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Prednisone
Cyclophosphamide
Rituximab
Doxorubicin
Vincristine
Obinutuzumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors