Clinical trial NCT01332968: A Study of Obinutuzumab (RO5072759) Plus Chemotherapy in Comparison With Rituximab Plus Chemotherapy Followed by Obinutuzumab or Rituximab Maintenance in Patients With Untreated Advanced Indolent Non-Hodgkin's Lymphoma (GALLIUM)
Official title: A Multicenter, Phase III, Open-Label, Randomized Study in Previously Untreated Patients With Advanced Indolent Non-Hodgkin's Lymphoma Evaluating the Benefit of GA101 (RO5072759) Plus Chemotherapy Compared With Rituximab Plus Chemotherapy Followed by GA101 or Rituximab Maintenance Therapy in Responders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Hodgkin's Lymphoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: German Low Grade Lymphoma Study Group
name: Institute of Cancer Research, United Kingdom
First posted: 2011-04-11
Enrollment: 1401
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This open-label, randomized study will assess the efficacy and safety of obinutuzumab (RO5072759) in combination with chemotherapy compared to rituximab (MabThera/Rituxan) with chemotherapy followed by obinutuzumab or rituximab maintenance in participants with untreated advanced indolent non-Hodgkin's lymphoma. After the end of the induction period, participants achieving response (Complete response \[CR\] or partial response \[PR\]) will undergo a maintenance period continuing on the randomized antibody treatment alone every 2 months until disease progression for a total of 2 years. Anticipated time on study treatment is up to approximately 2.5 years. After maintenance or observation, participants will be followed for 5 years until progression. After progression, participants will be followed for new anti-lymphoma therapy and overall survival until the end of the study.


Eligibility criteria: Inclusion Criteria:

* Cluster of differentiation 20 (CD20)-positive indolent B-cell non-Hodgkin's lymphoma (follicular lymphoma or splenic, nodal or extranodal marginal zone lymphoma)
* Stage III or IV disease, or Stage II bulky disease (defined as tumor diameter greater than or equal to \[\>/=\] 7 centimeters \[cm\])
* For participants with follicular lymphoma: requirement for treatment according to Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria
* For participants with symptomatic splenic, nodal, or non-gastric extranodal marginal zone lymphoma: disease that is de novo or has relapsed following local therapy (i.e. surgery or radiotherapy) and requires therapy as assessed by the investigator
* At least one bi-dimensionally measurable lesion (greater than \[\>\] 2 cm in its largest dimension by computed tomography \[CT\] scan or magnetic resonance imaging \[MRI\])
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
* Adequate hematologic function

Exclusion Criteria:

* Central nervous system lymphoma, leptomeningeal lymphoma, or histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
* Grade 3b follicular lymphoma, small lymphocytic lymphoma or Waldenström's macroglobulinaemia
* Ann Arbor Stage I disease
* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
* Known hypersensitivity to any of the study drugs or sensitivity to murine products, or history of sensitivity to mannitol
* For participants with follicular lymphoma: prior treatment for non-Hodgkin's lymphoma with chemotherapy, immunotherapy, or radiotherapy
* For participants with non-follicular lymphoma: prior treatment with chemotherapy or immunotherapy
* Regular treatment with corticosteroids during the 4 weeks prior to the start of Cycle 1
* Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
* For participants who will be receiving cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP): left ventricular ejection fraction (LVEF) less than (\<) 50% by multiple-gated acquisition (MUGA) scan or echocardiogram
* History of prior other malignancy with the exception of curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix at any time prior to study
* Known active infection, or major episode of infection within 4 week prior to the start of Cycle 1
* Vaccination with a live vaccine within 28 days prior to randomization
* Recent major surgery (within 4 weeks prior to start of Cycle 1), other than for diagnosis
* Abnormal laboratory values as defined by protocol for creatinine, creatinine clearance, aspartate transaminase (AST) or alanine transaminase (ALT), total bilirubin, international normalized ration (INR), partial thromboplastin time (PTT) or activated partial thromboplastin time (aPPT), unless these abnormalities are due to underlying lymphoma
* Positive test results for human immunodeficiency virus (HIV), human T-lymphotropic virus 1 (HTLV1), hepatitis C or chronic hepatitis B
* Pregnant or lactating women
* Life expectancy \<12 months
* Participation in another clinical trial with drug intervention within 28 days prior to start of Cycle 1 and during study

Primary outcomes:
measure: Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed
timeFrame: Baseline up to data cut-off (up to approximately 4 years and 7 months)
Secondary outcomes:
measure: Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed
timeFrame: Baseline up to final analysis (up to 10 years)
measure: Progression-Free Survival in the Overall Study Population, Investigator-Assessed
timeFrame: Baseline up to data cut-off (up to approximately 5 years and 2 months)
measure: Progression-Free Survival (Follicular Lymphoma Population), IRC-Assessed
timeFrame: Baseline up to data cut-off (up to approximately 5 years and 2 months)
measure: Progression-Free Survival (Overall Study Population), Assessed by Independent Review Committee (IRC)
timeFrame: Baseline up to data cut-off (up to approximately 5 years and 2 months)
measure: Overall Response (Follicular Lymphoma Population), Investigator-Assessed
timeFrame: Baseline up to end of induction period (up to approximately 7 months)
measure: Overall Response (Overall Study Population), Investigator-Assessed
timeFrame: Baseline up to end of induction period (up to approximately 7 months)
measure: Complete Response (Follicular Lymphoma Population), Investigator-Assessed
timeFrame: Baseline up to end of induction period (up to approximately 7 months)
measure: Complete Response (Overall Study Population), Investigator-Assessed
timeFrame: Baseline up to end of induction period (up to approximately 7 months)
measure: Overall Response (Follicular Lymphoma Population), IRC-Assessed
timeFrame: Baseline up to end of induction period (up to approximately 7 months)
measure: Overall Response (Overall Study Population), IRC-Assessed
timeFrame: Baseline up to end of induction period (up to approximately 7 months)
measure: Complete Response (Follicular Lymphoma Population), IRC-Assessed
timeFrame: Baseline up to end of induction period (up to approximately 7 months)
measure: Complete Response (Overall Study Population), IRC-Assessed
timeFrame: Baseline up to end of induction period (up to approximately 7 months)]
measure: Overall Survival (Follicular Lymphoma Population)
timeFrame: Baseline up to 10 years
measure: Overall Survival (Overall Study Population)
timeFrame: Baseline up to data cut-off (up to approximately 5 years and 2 months)
measure: Event-Free Survival (Follicular Lymphoma Population)
timeFrame: Baseline up to 10 years
measure: Event-Free Survival (Overall Study Population)
timeFrame: Baseline up to data cut-off (up to approximately 5 years and 2 months)
measure: Disease-Free Survival (Follicular Lymphoma Population)
timeFrame: From first occurrence of documented CR to data cut-off (up to approximately 5 years and 2 months)
measure: Disease-Free Survival (Overall Study Population)
timeFrame: From first occurrence of documented CR to data cut-off (up to approximately 5 years and 2 months)
measure: Duration of Response (DOR) (Follicular Lymphoma Population), Investigator-Assessed
timeFrame: From first occurrence of documented CR or PR to data cut-off (up to approximately 5 years and 2 months)
measure: Duration of Response (DOR) (Overall Study Population), Investigator-Assessed
timeFrame: From first occurrence of documented CR or PR to data cut-off (up to approximately 4 years and 7 months)
measure: Time to Next Anti-Lymphoma Treatment (Follicular Lymphoma Population)
timeFrame: Baseline up to 10 years
measure: Time to Next Anti-Lymphoma Treatment (Overall Study Population)
timeFrame: Baseline up to data cut-off (up to approximately 5 years and 2 months)
measure: Percentage of Participants With Adverse Events
timeFrame: Baseline up to 10 years
measure: Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population)
timeFrame: Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)
measure: Change From Baseline in FACT-Lym Total Outcome Index (TOI) Score (Follicular Lymphoma Population)
timeFrame: Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)
measure: Change From Baseline in FACT-Lym Individual Subscale Lymphoma Score (Follicular Population)
timeFrame: Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)
measure: Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score (Follicular Population)
timeFrame: Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)
measure: Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase
timeFrame: Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 5 years and 2 months)
measure: Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Maintenance/Observation Phase
timeFrame: Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 months after Day 1 of last induction cycle, Follow-up: every year up to data cut-off (up to 5 years and 2 months)
measure: Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Follow Up Phase
timeFrame: Induction: Cycle 1 Day 1 (Baseline), Cycle 3 Day 1, End of Induction (up to 7 months); Maintenance: 2, 12 after Day 1 of last induction cycle, Follow-up: every year for up to data cut-off (up to 5 years and 2 months)
Other outcomes:
Locations:
city: Springdale
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Irvine
country: United States
facility: The Regents of the University of California; Office of Research
state: California
city: Post Falls
country: United States
facility: Kootenai Cancer Center
state: Idaho
city: Galesburg
country: United States
facility: Illinois Cancer Care, P.C. - Galesburg
state: Illinois
city: Sioux City
country: United States
facility: Siouxland Hematology/Oncology
state: Iowa
city: Westwood
country: United States
facility: University of Kansas; Medical Center & Medical pavilion
state: Kansas
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Springfield
country: United States
facility: Mercy Medical Research Institute
state: Missouri
city: Missoula
country: United States
facility: MT Cancer Inst Fndtn; MT Can Spec
state: Montana
city: Farmington
country: United States
facility: San Juan Oncology Associates
state: New Mexico
city: Portland
country: United States
facility: Providence St. Vincent Medical Center
state: Oregon
city: Tacoma
country: United States
facility: Northwest Medical Specialties
state: Washington
city: Sydney
country: Australia
facility: Concord Repatriation General Hospital; Haematology
state: New South Wales
city: Sydney
country: Australia
facility: Westmead Hospital; Haematology
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology
state: Queensland
city: Fitzroy
country: Australia
facility: St Vincent'S Hospital; Haematology
state: Victoria
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre; Department of Haematology
state: Victoria
city: Melbourne
country: Australia
facility: Austin and Repatriation Medical Centre; Cancer Services
state: Victoria
city: Melbourne
country: Australia
facility: Monash Medical Centre; Haematology
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Gent
country: Belgium
facility: UZ Gent
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Calgary
country: Canada
facility: Tom Baker Cancer Centre-Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Moncton
country: Canada
facility: Dr. Georges L. Dumont University Hospital Centre
state: New Brunswick
city: Ottawa
country: Canada
facility: Ottawa General Hospital
state: Ontario
city: Toronto
country: Canada
facility: North York General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Humber River Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto East General Hospital; Haematology/Oncology
state: Ontario
city: Greenfield Park
country: Canada
facility: Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie
state: Quebec
city: Beijing City
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences.
city: Beijing
country: China
facility: Beijing Cancer Hospital
city: Beijing
country: China
facility: General Hospital of Chinese PLA; Department of Hematology
city: Changchun
country: China
facility: the First Hospital of Jilin University
city: Fuzhou City
country: China
facility: Fujian Medical University Union Hospital
city: Guangzhou
country: China
facility: Sun Yet-sen University Cancer Center
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
city: Nanjing City
country: China
facility: Jiangsu Cancer Hospital
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Shanghai City
country: China
facility: Fudan University Shanghai Cancer Center
city: Shanghai
country: China
facility: Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
city: Wuhan
country: China
facility: Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center
city: Brno
country: Czechia
facility: Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika
city: Hradec Kralove
country: Czechia
facility: Fn Hr. Kralove; IV. Interni Hematologicka Klinika
city: Praha 2
country: Czechia
facility: Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital; Dept of Oncology
city: Angers
country: France
facility: Hotel Dieu; Medecine D
city: Brest
country: France
facility: Hopital Augustin Morvan; Hematologie
city: Clermont Ferrand
country: France
facility: Chu Estaing; Hematologie Clinique Adultes
city: LeMans
country: France
facility: Clinique Victor Hugo
city: Marseille
country: France
facility: Hopital De La Conception; Hematologie Clinique
city: Montpellier
country: France
facility: Hopital Saint Eloi; Hematologie Oncologie Medicale
city: Perpignan
country: France
facility: Hopital Saint Jean; Hematologie
city: Berlin
country: Germany
facility: Onkologischer Schwerpunkt am Oskar-Helene-Heim; Dres. Herrenberger, Keitel-Wittig u. Kirsch
city: Chemnitz
country: Germany
facility: Klinikum Chemnitz gGmbH Krankenhaus Küchwald Klinik f.Innere Medizin III
city: Dessau-Roßlau
country: Germany
facility: Städtisches Klinikum Dessau
city: Dresden
country: Germany
facility: BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie
city: Dresden
country: Germany
facility: Gemeinschaftspraxis Dr. med. J. Mohm und Dr. med. G. Prange-Krex; Fachaerzte fuer Innere Medizin
city: Erfurt
country: Germany
facility: HELIOS Klinikum Erfurt I.Medizinische Klinik
city: Eschweiler
country: Germany
facility: St.-Antonius-Hospital gGmbH; Klinik für Hämatologie und Onkologie
city: Essen
country: Germany
facility: Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung
city: Frankfurt
country: Germany
facility: Klinik Johann Wolfgang von Goethe Uni; Medizinische Klinik II
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg; Klinik für Innere Medizin I; Hämatologie/Onkologie
city: Greifswald
country: Germany
facility: Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik
city: Göttingen
country: Germany
facility: Uni Göttingen, Georg-August-Universität; Klinik für Hämatologie und Medizinische Onkologie
city: Hagen
country: Germany
facility: Kath. Krankenhaus Hagen gem. GmbH, St.-Josefs-Hospital; Klinik für Hämatologie und Onkologie
city: Hannover
country: Germany
facility: Onkologische Schwerpunktpraxis Dres. Bernd Gaede, Hans-Ulrich Ehlers, Ulrike Rodewig u.w.
city: Heidelberg
country: Germany
facility: Dres.Andreas Karcher und Stefan Fuxius
city: Heidelberg
country: Germany
facility: Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V
city: Homburg/Saar
country: Germany
facility: Universitaetsklinikum des Saarlandes; medizinische Klinik und Poliklinik; Innere Medizin I
city: Jena
country: Germany
facility: Universitätsklinikum Jena; Klinik für Innere Medizin II
city: Kiel
country: Germany
facility: UKSH, Campus Kiel; Klinik für Innere Medizin II, Hämatologie und Internistische Onkologie
city: Koblenz
country: Germany
facility: Institut für Versorgungsforschung in der Onkologie GbR Koblenz
city: Köln
country: Germany
facility: Klinik der Uni zu Köln; Klinik für Innere Medizin
city: Landshut
country: Germany
facility: Tagesklinik Landshut; Hämatologie/Onkologie
city: Lebach
country: Germany
facility: Gemeinschaftspraxis für Hämatologie und Onkologie
city: Leipzig
country: Germany
facility: Klinikum St.Georg gGmbH Klinik für Internistische Onkologie und Hämotologie
city: Ludwigshafen
country: Germany
facility: Klinikum der Stadt Ludwigshafen; Medizinische Klinik A
city: Magdeburg
country: Germany
facility: Onkologische Gemeinschaftspraxis
city: Magdeburg
country: Germany
facility: Otto von Guericke Uni Magdeburg Uniklinik; Hämatologie/Onkologie
city: Mainz
country: Germany
facility: Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik
city: Mannheim
country: Germany
facility: Mannheimer Onkologie Praxis Dres. Jürgen Brust Dieter Schuster
city: Mannheim
country: Germany
facility: Klinikum Mannheim III. Medizinische Klinik
city: Mutlangen
country: Germany
facility: Kliniken Ostalb, Stauferklinikum Schwäbisch-Gmünd; Zentrum für Innere Medizin
city: Mönchengladbach
country: Germany
facility: St. Frankziskus Krankenhaus, Med. Klinik I; Klinik für Hämatologie,Onkologie u. Gastroenterologie
city: München
country: Germany
facility: Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III
city: München
country: Germany
facility: Klinikum rechts der Isar der TU München; III. Medizinischen Klinik (Hämatologie/Onkologie)
city: Neunkirchen/Saar
country: Germany
facility: Gemeinschaftspraxis Dr. med. Holger Klaproth
city: Oldenburg
country: Germany
facility: Pius-Hospital; Klinik fuer Haematologie und Onkologie
city: Paderborn
country: Germany
facility: Brüderkrankenhaus St. Josef
city: Recklinghausen
country: Germany
facility: Prosper-Hospital, Medizinische Klinik I
city: Regensburg
country: Germany
facility: Krankenhaus Barmherziger Brüder; Klinik für Internistische Onkologie / Hämatologie
city: Saarbruecken
country: Germany
facility: Praxis für Hämatologie & Onkologie
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder Trier; Innere Medizin I, Hämatologie / Internistische Onkologie
city: Tübingen
country: Germany
facility: Universität Tübingen; Med. Klinik; Innere Medizin I
city: Ulm
country: Germany
facility: Universtitätsklinikum Ulm; Klinik für Innere Medizin III
city: Wiesbaden
country: Germany
facility: Helios Dr. Horst Schmidt Kliniken; Klinik Innere MED III: Hämatologie, Onkologie, Palliativmedizin
city: Würzburg
country: Germany
facility: Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker
city: Budapest
country: Hungary
facility: Semmelweis University, First Dept of Medicine
city: Budapest
country: Hungary
facility: National Institute of Oncology, A Dept of Internal Medicine
city: Debrecen
country: Hungary
facility: University of Debrecen Medical and Health Science Center, Institute of Internal Medicine, Hematology
city: Gyor
country: Hungary
facility: Petz Aladar Megyei Korhaz; Hematologia
city: Szeged
country: Hungary
facility: University of Szeged, II Dept of Internal Medicine
city: Haifa
country: Israel
facility: Rambam Medical Center; Heamatology & Bone Marrow Transplantation
city: Petach Tikva
country: Israel
facility: Beilinson Medical Center; Haematology
city: Ramat-Gan
country: Israel
facility: Chaim Sheba Medical Center; Hematology BMT & CBB
city: Modena
country: Italy
facility: Azienda Ospedaliera Universitaria di Modena
state: Emilia-Romagna
city: Roma
country: Italy
facility: Az. Osp. S. Camillo Forlanini; Uo Ematologia E Trapianti Di Midollo Osseo
state: Lazio
city: Bergamo
country: Italy
facility: ASST PAPA GIOVANNI XXIII; Ematologia
state: Lombardia
city: Milano
country: Italy
facility: Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora
state: Lombardia
city: Milano
country: Italy
facility: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
state: Lombardia
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
state: Lombardia
city: Torrette DI Ancona
country: Italy
facility: A.O. Univ.Ospedali Riuniti Umerto I -G.M.Lancisi G.Salesi; U.O. Clinica Di Ematologia
state: Marche
city: Palermo
country: Italy
facility: Ospedale V. Cervello; U.O. Ematologia E Trapianti
state: Sicilia
city: Padova
country: Italy
facility: Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia
state: Veneto
city: Aichi
country: Japan
facility: Aichi Cancer Center Hospital; Hematology and Cell Therapy
city: Aichi
country: Japan
facility: Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital; Hematology & Oncology
city: Aichi
country: Japan
facility: Nagoya City University Hospital; Hematology and Oncology
city: Aomori
country: Japan
facility: Aomori Prefectural Central Hospital; Hematology
city: Chiba
country: Japan
facility: Chiba Cancer Center;Hematology and Oncology
city: Chiba
country: Japan
facility: National Cancer Center Hospital East;Hematology
city: Ehime
country: Japan
facility: Shikoku Cancer Center; Hematology and Oncology
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center; Hematology
city: Gunma
country: Japan
facility: Gunma University Hospital;Hematology
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital; Hematology
city: Hyogo
country: Japan
facility: Kobe City Medical Center General Hospital; Hematology
city: Hyogo
country: Japan
facility: Hyogo Cancer Center; Department of hematology
city: Kanagawa
country: Japan
facility: Tokai University Hospital; Hematology
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital; Hematology Rheumatology and Clinical Immunology
city: Kyoto
country: Japan
facility: University Hospital, Kyoto Prefectural University of Medicine; Hematology
city: Miyagi
country: Japan
facility: Tohoku University Hospital; Hematology and Immunology
city: Nagano
country: Japan
facility: Shinshu University Hospital; Hematology
city: Niigata
country: Japan
facility: Niigata Cancer Center Hospital; Internal Medicine
city: Osaka
country: Japan
facility: Matsushita Memorial Hospital; hematology
city: Tochigi
country: Japan
facility: Jichi Medical University Hospital; Hematology
city: Tokyo
country: Japan
facility: National Cancer Center Hospital; Hematology
city: Tokyo
country: Japan
facility: Toranomon Hospital; Hematology
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR; Hematology Oncology
city: Tokyo
country: Japan
facility: The Jikei University Daisan Hospital; Department of Clinical Oncology and Hematology
city: Moscow
country: Russian Federation
facility: FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF
city: Nizhny Novgorod
country: Russian Federation
facility: Regional Clinical Hospital N.A. Semashko; Hematology
city: Petrozavodsk
country: Russian Federation
facility: Republican Clinical Hospital n.a. Baranov; Haematology
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia
state: Barcelona
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli; Servicio de Hematologia
state: Barcelona
city: Alcorcon
country: Spain
facility: Fundacion Hospital de Alcorcon; Servicio de Hematologia
state: Madrid
city: Bilbao
country: Spain
facility: Hospital de Basurto; Servicio de Hematologia
state: Vizcaya
city: Madrid
country: Spain
facility: Hospital Univ. 12 de Octubre; Servicio de Hematologia
city: Madrid
country: Spain
facility: Hospital Universitario la Paz; Servicio de Hematologia
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset; Sektionen för hematologi och koagulation
city: Taipei City
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
city: Taipei
country: Taiwan
facility: National Taiwan Universtiy Hospital; Division of Hematology
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary; Haematology - Ward 16
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital; Centre for Clinical Haematology
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth General Hospital; Haematology
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital; Haematology
city: Canterbury
country: United Kingdom
facility: Kent & Canterbury Hospital; Clinical Haematology
city: Cardiff
country: United Kingdom
facility: Velindre NHS Trust; Haematology Department
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital; The Queens Centre for Oncology and Haematology
city: Edinburgh
country: United Kingdom
facility: Western General Hospital; Department of Haematology
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre
city: Great Yarmouth
country: United Kingdom
facility: James Paget Hospital; Haematology Department
city: Harlow
country: United Kingdom
facility: Princess Alexandra Hospital; Department of Haematology
city: Leeds
country: United Kingdom
facility: St James Uni Hospital; Icrf Cancer Medicine Research Unit
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary; Dept of Haematology
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
city: London
country: United Kingdom
facility: King'S College Hospital; Haematology
city: London
country: United Kingdom
facility: St. George'S Hospital; Haematology
city: London
country: United Kingdom
facility: Hammersmith Hospital; Haematology
city: London
country: United Kingdom
facility: University College Hospital; Macmillan Cancer Centre
city: Manchester
country: United Kingdom
facility: Christie Hospital; Breast Cancer Research Office
city: Norwich
country: United Kingdom
facility: Norfolk & Norwich Hospital; Dept of Haematology
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital; Dept of Haematology
city: Oxford
country: United Kingdom
facility: Churchill Hospital; Oxford Cancer and Haematology Centre
city: Portsmouth
country: United Kingdom
facility: Queen Alexandra Hospital; Haematology and Oncology Centre
city: Southampton
country: United Kingdom
facility: Southampton General Hospital; Medical Oncology
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital; Dept of Medical Oncology
city: Swansea
country: United Kingdom
facility: Singleton Hospital; Pharmacy
city: Swindon
country: United Kingdom
facility: Great Western;Department of Haematology
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital; Haematology Clinic
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Casulo C, Herold M, Hiddemann W, Iyengar S, Marcus RE, Seymour JF, Launonen A, Knapp A, Nielsen TG, Mir F. Risk Factors for and Outcomes of Follicular Lymphoma Histological Transformation at First Progression in the GALLIUM Study. Clin Lymphoma Myeloma Leuk. 2023 Jan;23(1):40-48. doi: 10.1016/j.clml.2022.09.003. Epub 2022 Oct 4.
citation: Hong X, Song Y, Shi Y, Zhang Q, Guo W, Wu G, Li J, Feng J, Kinkolykh A, Knapp A, Lin T. Efficacy and safety of obinutuzumab for the first-line treatment of follicular lymphoma: a subgroup analysis of Chinese patients enrolled in the phase III GALLIUM study. Chin Med J (Engl). 2021 Sep 16;135(4):433-440. doi: 10.1097/CM9.0000000000001737.
citation: Strefford JC, Nowicka M, Hargreaves CE, Burton C, Davies A, Ganderton R, Hiddemann W, Iriyama C, Klapper W, Latham KV, Martelli M, Mir F, Parker H, Potter KN, Rose-Zerilli MJJ, Sehn LH, Trneny M, Vitolo U, Bolen CR, Klein C, Knapp A, Oestergaard MZ, Cragg MS. Single-nucleotide Fcgamma receptor polymorphisms do not impact obinutuzumab/rituximab outcome in patients with lymphoma. Blood Adv. 2021 Aug 10;5(15):2935-2944. doi: 10.1182/bloodadvances.2020003985.
citation: Davies A, Trask P, Demeter J, Florschutz A, Hanel M, Kinoshita T, Pettengell R, Quach H, Robinson S, Sadullah S, Sancho JM, Udvardy M, Witzens-Harig M, Knapp A, Liu W. Health-related quality of life in the phase III GALLIUM study of obinutuzumab- or rituximab-based chemotherapy in patients with previously untreated advanced follicular lymphoma. Ann Hematol. 2020 Dec;99(12):2837-2846. doi: 10.1007/s00277-020-04021-6. Epub 2020 Apr 20.
citation: Klanova M, Oestergaard MZ, Trneny M, Hiddemann W, Marcus R, Sehn LH, Vitolo U, Bazeos A, Goede V, Zeuner H, Knapp A, Sahin D, Spielewoy N, Bolen CR, Cardona A, Klein C, Venstrom JM, Nielsen T, Fingerle-Rowson G. Prognostic Impact of Natural Killer Cell Count in Follicular Lymphoma and Diffuse Large B-cell Lymphoma Patients Treated with Immunochemotherapy. Clin Cancer Res. 2019 Aug 1;25(15):4634-4643. doi: 10.1158/1078-0432.CCR-18-3270. Epub 2019 May 3.
citation: Kusumoto S, Arcaini L, Hong X, Jin J, Kim WS, Kwong YL, Peters MG, Tanaka Y, Zelenetz AD, Kuriki H, Fingerle-Rowson G, Nielsen T, Ueda E, Piper-Lepoutre H, Sellam G, Tobinai K. Risk of HBV reactivation in patients with B-cell lymphomas receiving obinutuzumab or rituximab immunochemotherapy. Blood. 2019 Jan 10;133(2):137-146. doi: 10.1182/blood-2018-04-848044. Epub 2018 Oct 19.
citation: Trotman J, Barrington SF, Belada D, Meignan M, MacEwan R, Owen C, Ptacnik V, Rosta A, Fingerle-Rowson GR, Zhu J, Nielsen T, Sahin D, Hiddemann W, Marcus RE, Davies A; PET investigators from the GALLIUM study. Prognostic value of end-of-induction PET response after first-line immunochemotherapy for follicular lymphoma (GALLIUM): secondary analysis of a randomised, phase 3 trial. Lancet Oncol. 2018 Nov;19(11):1530-1542. doi: 10.1016/S1470-2045(18)30618-1. Epub 2018 Oct 8.
citation: Hiddemann W, Barbui AM, Canales MA, Cannell PK, Collins GP, Durig J, Forstpointner R, Herold M, Hertzberg M, Klanova M, Radford J, Seymour JF, Tobinai K, Trotman J, Burciu A, Fingerle-Rowson G, Wolbers M, Nielsen T, Marcus RE. Immunochemotherapy With Obinutuzumab or Rituximab for Previously Untreated Follicular Lymphoma in the GALLIUM Study: Influence of Chemotherapy on Efficacy and Safety. J Clin Oncol. 2018 Aug 10;36(23):2395-2404. doi: 10.1200/JCO.2017.76.8960. Epub 2018 Jun 1.
citation: Marcus R, Davies A, Ando K, Klapper W, Opat S, Owen C, Phillips E, Sangha R, Schlag R, Seymour JF, Townsend W, Trneny M, Wenger M, Fingerle-Rowson G, Rufibach K, Moore T, Herold M, Hiddemann W. Obinutuzumab for the First-Line Treatment of Follicular Lymphoma. N Engl J Med. 2017 Oct 5;377(14):1331-1344. doi: 10.1056/NEJMoa1614598.