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)
NCT ID: NCT01332968
Last Updated: 2022-08-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1401 participants
INTERVENTIONAL
2011-07-06
2021-07-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Rituximab+Chemotherapy
Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
Cyclophosphamide
Cyclophosphamide 750 mg/m\^2 IV will be administered on Day 1 of each cycle during induction period.
Doxorubicin
Doxorubicin 50 mg/m\^2 IV will be administered on Day 1 of each cycle during induction period.
Vincristine
Vincristine 1.4 mg/m\^2 (maximum 2 mg) IV will be administered on Day 1 of each cycle during induction period.
Prednisone
Prednisone 100 mg (or equivalent prednisolone or methylprednisolone) will be administered orally on Days 1-5 of each cycle during induction period.
Bendamustine
Bendamustine 90 mg/m\^2 IV infusion will be administered on Days 1 and 2 of each cycle during induction period.
Rituximab
Rituximab 375 milligrams per square meter (mg/m\^2) IV infusion will be administered on Day 1 of each cycle during induction period and rituximab 375 mg/m\^2 every 2 months during maintenance period.
Obinutuzumab+Chemotherapy
Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
Obinutuzumab
Obinutuzumab 1000 milligrams (mg) intravenous (IV) infusion will be administered on Day 1, 8, and 15 of Cycle 1 and then on Day 1 of each subsequent cycle during induction period and obinutuzumab 1000 mg IV infusion every 2 months during maintenance period.
Cyclophosphamide
Cyclophosphamide 750 mg/m\^2 IV will be administered on Day 1 of each cycle during induction period.
Doxorubicin
Doxorubicin 50 mg/m\^2 IV will be administered on Day 1 of each cycle during induction period.
Vincristine
Vincristine 1.4 mg/m\^2 (maximum 2 mg) IV will be administered on Day 1 of each cycle during induction period.
Prednisone
Prednisone 100 mg (or equivalent prednisolone or methylprednisolone) will be administered orally on Days 1-5 of each cycle during induction period.
Bendamustine
Bendamustine 90 mg/m\^2 IV infusion will be administered on Days 1 and 2 of each cycle during induction period.
Interventions
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Obinutuzumab
Obinutuzumab 1000 milligrams (mg) intravenous (IV) infusion will be administered on Day 1, 8, and 15 of Cycle 1 and then on Day 1 of each subsequent cycle during induction period and obinutuzumab 1000 mg IV infusion every 2 months during maintenance period.
Cyclophosphamide
Cyclophosphamide 750 mg/m\^2 IV will be administered on Day 1 of each cycle during induction period.
Doxorubicin
Doxorubicin 50 mg/m\^2 IV will be administered on Day 1 of each cycle during induction period.
Vincristine
Vincristine 1.4 mg/m\^2 (maximum 2 mg) IV will be administered on Day 1 of each cycle during induction period.
Prednisone
Prednisone 100 mg (or equivalent prednisolone or methylprednisolone) will be administered orally on Days 1-5 of each cycle during induction period.
Bendamustine
Bendamustine 90 mg/m\^2 IV infusion will be administered on Days 1 and 2 of each cycle during induction period.
Rituximab
Rituximab 375 milligrams per square meter (mg/m\^2) IV infusion will be administered on Day 1 of each cycle during induction period and rituximab 375 mg/m\^2 every 2 months during maintenance period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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German Low Grade Lymphoma Study Group
OTHER
Institute of Cancer Research, United Kingdom
OTHER
Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Highlands Oncology Group
Springdale, Arkansas, United States
The Regents of the University of California; Office of Research
Irvine, California, United States
Kootenai Cancer Center
Post Falls, Idaho, United States
Illinois Cancer Care, P.C. - Galesburg
Galesburg, Illinois, United States
Siouxland Hematology/Oncology
Sioux City, Iowa, United States
University of Kansas; Medical Center & Medical pavilion
Westwood, Kansas, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Mercy Medical Research Institute
Springfield, Missouri, United States
MT Cancer Inst Fndtn; MT Can Spec
Missoula, Montana, United States
San Juan Oncology Associates
Farmington, New Mexico, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Northwest Medical Specialties
Tacoma, Washington, United States
Concord Repatriation General Hospital; Haematology
Sydney, New South Wales, Australia
Westmead Hospital; Haematology
Sydney, New South Wales, Australia
Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology
Woolloongabba, Queensland, Australia
St Vincent'S Hospital; Haematology
Fitzroy, Victoria, Australia
Peter MacCallum Cancer Centre; Department of Haematology
Melbourne, Victoria, Australia
Austin and Repatriation Medical Centre; Cancer Services
Melbourne, Victoria, Australia
Monash Medical Centre; Haematology
Melbourne, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
UZ Gent
Ghent, , Belgium
AZ Groeninge
Kortrijk, , Belgium
UZ Leuven Gasthuisberg
Leuven, , Belgium
Tom Baker Cancer Centre-Calgary
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
Dr. Georges L. Dumont University Hospital Centre
Moncton, New Brunswick, Canada
Ottawa General Hospital
Ottawa, Ontario, Canada
North York General Hospital
Toronto, Ontario, Canada
Humber River Hospital
Toronto, Ontario, Canada
Toronto East General Hospital; Haematology/Oncology
Toronto, Ontario, Canada
Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie
Greenfield Park, Quebec, Canada
Cancer Hospital Chinese Academy of Medical Sciences.
Beijing, , China
Peking University First Hospital
Beijing, , China
Beijing Cancer Hospital
Beijing, , China
General Hospital of Chinese PLA; Department of Hematology
Beijing, , China
the First Hospital of Jilin University
Changchun, , China
Fujian Medical University Union Hospital
Fuzhou, , China
Sun Yet-sen University Cancer Center
Guangzhou, , China
Harbin Medical University Cancer Hospital
Harbin, , China
Jiangsu Province Hospital
Nanjing, , China
Jiangsu Cancer Hospital
Nanjing, , China
Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
Shanghai, , China
Fudan University Shanghai Cancer Center
Shanghai, , China
Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center
Wuhan, , China
Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika
Brno, , Czechia
Fn Hr. Kralove; IV. Interni Hematologicka Klinika
Hradec Králové, , Czechia
Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK
Prague, , Czechia
Helsinki University Central Hospital; Dept of Oncology
Helsinki, , Finland
Hotel Dieu; Medecine D
Angers, , France
Hopital Augustin Morvan; Hematologie
Brest, , France
Chu Estaing; Hematologie Clinique Adultes
Clermont-Ferrand, , France
Clinique Victor Hugo
LeMans, , France
Hopital De La Conception; Hematologie Clinique
Marseille, , France
Hopital Saint Eloi; Hematologie Oncologie Medicale
Montpellier, , France
Hopital Saint Jean; Hematologie
Perpignan, , France
Onkologischer Schwerpunkt am Oskar-Helene-Heim; Dres. Herrenberger, Keitel-Wittig u. Kirsch
Berlin, , Germany
Klinikum Chemnitz gGmbH Krankenhaus Küchwald Klinik f.Innere Medizin III
Chemnitz, , Germany
Klinik der Uni zu Köln; Klinik für Innere Medizin
Cologne, , Germany
Städtisches Klinikum Dessau
Dessau, , Germany
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie
Dresden, , Germany
Gemeinschaftspraxis Dr. med. J. Mohm und Dr. med. G. Prange-Krex; Fachaerzte fuer Innere Medizin
Dresden, , Germany
HELIOS Klinikum Erfurt I.Medizinische Klinik
Erfurt, , Germany
St.-Antonius-Hospital gGmbH; Klinik für Hämatologie und Onkologie
Eschweiler, , Germany
Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung
Essen, , Germany
Klinik Johann Wolfgang von Goethe Uni; Medizinische Klinik II
Frankfurt, , Germany
Universitätsklinikum Freiburg; Klinik für Innere Medizin I; Hämatologie/Onkologie
Freiburg im Breisgau, , Germany
Uni Göttingen, Georg-August-Universität; Klinik für Hämatologie und Medizinische Onkologie
Göttingen, , Germany
Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik
Greifswald, , Germany
Kath. Krankenhaus Hagen gem. GmbH, St.-Josefs-Hospital; Klinik für Hämatologie und Onkologie
Hagen, , Germany
Onkologische Schwerpunktpraxis Dres. Bernd Gaede, Hans-Ulrich Ehlers, Ulrike Rodewig u.w.
Hanover, , Germany
Dres.Andreas Karcher und Stefan Fuxius
Heidelberg, , Germany
Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V
Heidelberg, , Germany
Universitaetsklinikum des Saarlandes; medizinische Klinik und Poliklinik; Innere Medizin I
Homburg/Saar, , Germany
Universitätsklinikum Jena; Klinik für Innere Medizin II
Jena, , Germany
UKSH, Campus Kiel; Klinik für Innere Medizin II, Hämatologie und Internistische Onkologie
Kiel, , Germany
Institut für Versorgungsforschung in der Onkologie GbR Koblenz
Koblenz, , Germany
Tagesklinik Landshut; Hämatologie/Onkologie
Landshut, , Germany
Gemeinschaftspraxis für Hämatologie und Onkologie
Lebach, , Germany
Klinikum St.Georg gGmbH Klinik für Internistische Onkologie und Hämotologie
Leipzig, , Germany
Klinikum der Stadt Ludwigshafen; Medizinische Klinik A
Ludwigshafen, , Germany
Onkologische Gemeinschaftspraxis
Magdeburg, , Germany
Otto von Guericke Uni Magdeburg Uniklinik; Hämatologie/Onkologie
Magdeburg, , Germany
Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik
Mainz, , Germany
Mannheimer Onkologie Praxis Dres. Jürgen Brust Dieter Schuster
Mannheim, , Germany
Klinikum Mannheim III. Medizinische Klinik
Mannheim, , Germany
St. Frankziskus Krankenhaus, Med. Klinik I; Klinik für Hämatologie,Onkologie u. Gastroenterologie
Mönchengladbach, , Germany
Kliniken Ostalb, Stauferklinikum Schwäbisch-Gmünd; Zentrum für Innere Medizin
Mutlangen, , Germany
Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III
München, , Germany
Klinikum rechts der Isar der TU München; III. Medizinischen Klinik (Hämatologie/Onkologie)
München, , Germany
Gemeinschaftspraxis Dr. med. Holger Klaproth
Neunkirchen/Saar, , Germany
Pius-Hospital; Klinik fuer Haematologie und Onkologie
Oldenburg, , Germany
Brüderkrankenhaus St. Josef
Paderborn, , Germany
Prosper-Hospital, Medizinische Klinik I
Recklinghausen, , Germany
Krankenhaus Barmherziger Brüder; Klinik für Internistische Onkologie / Hämatologie
Regensburg, , Germany
Praxis für Hämatologie & Onkologie
Saarbrücken, , Germany
Krankenhaus der Barmherzigen Brüder Trier; Innere Medizin I, Hämatologie / Internistische Onkologie
Trier, , Germany
Universität Tübingen; Med. Klinik; Innere Medizin I
Tübingen, , Germany
Universtitätsklinikum Ulm; Klinik für Innere Medizin III
Ulm, , Germany
Helios Dr. Horst Schmidt Kliniken; Klinik Innere MED III: Hämatologie, Onkologie, Palliativmedizin
Wiesbaden, , Germany
Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker
Würzburg, , Germany
Semmelweis University, First Dept of Medicine
Budapest, , Hungary
National Institute of Oncology, A Dept of Internal Medicine
Budapest, , Hungary
University of Debrecen Medical and Health Science Center, Institute of Internal Medicine, Hematology
Debrecen, , Hungary
Petz Aladar Megyei Korhaz; Hematologia
Győr, , Hungary
University of Szeged, II Dept of Internal Medicine
Szeged, , Hungary
Rambam Medical Center; Heamatology & Bone Marrow Transplantation
Haifa, , Israel
Beilinson Medical Center; Haematology
Petah Tikva, , Israel
Chaim Sheba Medical Center; Hematology BMT & CBB
Ramat Gan, , Israel
Azienda Ospedaliera Universitaria di Modena
Modena, Emilia-Romagna, Italy
Az. Osp. S. Camillo Forlanini; Uo Ematologia E Trapianti Di Midollo Osseo
Rome, Lazio, Italy
ASST PAPA GIOVANNI XXIII; Ematologia
Bergamo, Lombardy, Italy
Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora
Milan, Lombardy, Italy
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
Milan, Lombardy, Italy
Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
Rozzano, Lombardy, Italy
Ospedale V. Cervello; U.O. Ematologia E Trapianti
Palermo, Sicily, Italy
A.O. Univ.Ospedali Riuniti Umerto I -G.M.Lancisi G.Salesi; U.O. Clinica Di Ematologia
Torrette DI Ancona, The Marches, Italy
Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia
Padua, Veneto, Italy
Aichi Cancer Center Hospital; Hematology and Cell Therapy
Aichi, , Japan
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital; Hematology & Oncology
Aichi, , Japan
Nagoya City University Hospital; Hematology and Oncology
Aichi, , Japan
Aomori Prefectural Central Hospital; Hematology
Aomori, , Japan
Chiba Cancer Center;Hematology and Oncology
Chiba, , Japan
National Cancer Center Hospital East;Hematology
Chiba, , Japan
Shikoku Cancer Center; Hematology and Oncology
Ehime, , Japan
National Hospital Organization Kyushu Cancer Center; Hematology
Fukuoka, , Japan
Gunma University Hospital;Hematology
Gunma, , Japan
Hiroshima University Hospital; Hematology
Hiroshima, , Japan
Kobe City Medical Center General Hospital; Hematology
Hyōgo, , Japan
Hyogo Cancer Center; Department of hematology
Hyōgo, , Japan
Tokai University Hospital; Hematology
Kanagawa, , Japan
Kumamoto University Hospital; Hematology Rheumatology and Clinical Immunology
Kumamoto, , Japan
University Hospital, Kyoto Prefectural University of Medicine; Hematology
Kyoto, , Japan
Tohoku University Hospital; Hematology and Immunology
Miyagi, , Japan
Shinshu University Hospital; Hematology
Nagano, , Japan
Niigata Cancer Center Hospital; Internal Medicine
Niigata, , Japan
Matsushita Memorial Hospital; hematology
Osaka, , Japan
Jichi Medical University Hospital; Hematology
Tochigi, , Japan
National Cancer Center Hospital; Hematology
Tokyo, , Japan
Toranomon Hospital; Hematology
Tokyo, , Japan
The Cancer Institute Hospital of JFCR; Hematology Oncology
Tokyo, , Japan
The Jikei University Daisan Hospital; Department of Clinical Oncology and Hematology
Tokyo, , Japan
FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF
Moscow, , Russia
Regional Clinical Hospital N.A. Semashko; Hematology
Nizhny Novgorod, , Russia
Republican Clinical Hospital n.a. Baranov; Haematology
Petrozavodsk, , Russia
Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia
Badalona, Barcelona, Spain
Corporacio Sanitaria Parc Tauli; Servicio de Hematologia
Sabadell, Barcelona, Spain
Fundacion Hospital de Alcorcon; Servicio de Hematologia
Alcorcón, Madrid, Spain
Hospital de Basurto; Servicio de Hematologia
Bilbao, Vizcaya, Spain
Hospital Univ. 12 de Octubre; Servicio de Hematologia
Madrid, , Spain
Hospital Universitario la Paz; Servicio de Hematologia
Madrid, , Spain
Sahlgrenska Universitetssjukhuset; Sektionen för hematologi och koagulation
Gothenburg, , Sweden
National Taiwan Universtiy Hospital; Division of Hematology
Taipei, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
Taipei, , Taiwan
Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology
Taoyuan District, , Taiwan
Aberdeen Royal Infirmary; Haematology - Ward 16
Aberdeen, , United Kingdom
Queen Elizabeth Hospital; Centre for Clinical Haematology
Birmingham, , United Kingdom
Royal Bournemouth General Hospital; Haematology
Bournemouth, , United Kingdom
Bristol Haematology and Oncology Centre
Bristol, , United Kingdom
Addenbrookes Hospital; Haematology
Cambridge, , United Kingdom
Kent & Canterbury Hospital; Clinical Haematology
Canterbury, , United Kingdom
Velindre NHS Trust; Haematology Department
Cardiff, , United Kingdom
Castle Hill Hospital; The Queens Centre for Oncology and Haematology
Cottingham, , United Kingdom
Western General Hospital; Department of Haematology
Edinburgh, , United Kingdom
Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
James Paget Hospital; Haematology Department
Great Yarmouth, , United Kingdom
Princess Alexandra Hospital; Department of Haematology
Harlow, , United Kingdom
St James Uni Hospital; Icrf Cancer Medicine Research Unit
Leeds, , United Kingdom
Leicester Royal Infirmary; Dept of Haematology
Leicester, , United Kingdom
St Bartholomew's Hospital
London, , United Kingdom
King'S College Hospital; Haematology
London, , United Kingdom
St. George'S Hospital; Haematology
London, , United Kingdom
Hammersmith Hospital; Haematology
London, , United Kingdom
University College Hospital; Macmillan Cancer Centre
London, , United Kingdom
Christie Hospital; Breast Cancer Research Office
Manchester, , United Kingdom
Norfolk & Norwich Hospital; Dept of Haematology
Norwich, , United Kingdom
Nottingham City Hospital; Dept of Haematology
Nottingham, , United Kingdom
Churchill Hospital; Oxford Cancer and Haematology Centre
Oxford, , United Kingdom
Queen Alexandra Hospital; Haematology and Oncology Centre
Portsmouth, , United Kingdom
Southampton General Hospital; Medical Oncology
Southampton, , United Kingdom
Royal Marsden Hospital; Dept of Medical Oncology
Sutton, , United Kingdom
Singleton Hospital; Pharmacy
Swansea, , United Kingdom
Great Western;Department of Haematology
Swindon, , United Kingdom
Royal Cornwall Hospital; Haematology Clinic
Truro, , United Kingdom
Countries
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References
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Pott C, Jurinovic V, Trotman J, Kehden B, Unterhalt M, Herold M, Jagt RV, Janssens A, Kneba M, Mayer J, Young M, Schmidt C, Knapp A, Nielsen T, Brown H, Spielewoy N, Harbron C, Bottos A, Mundt K, Marcus R, Hiddemann W, Hoster E. Minimal Residual Disease Status Predicts Outcome in Patients With Previously Untreated Follicular Lymphoma: A Prospective Analysis of the Phase III GALLIUM Study. J Clin Oncol. 2024 Feb 10;42(5):550-561. doi: 10.1200/JCO.23.00838. Epub 2023 Dec 14.
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.
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.
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.
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.
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2010-024132-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BO21223
Identifier Type: -
Identifier Source: org_study_id
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