Breast Cancer Clinical Trial
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)
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
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There are 182 Locations for this study
Springdale Arkansas, 72762, United States
Irvine California, 92697, United States
Post Falls Idaho, 83854, United States
Galesburg Illinois, 61401, United States
Sioux City Iowa, 51101, United States
Westwood Kansas, 66205, United States
Wichita Kansas, 67214, United States
Springfield Missouri, 65807, United States
Missoula Montana, 59802, United States
Farmington New Mexico, 87401, United States
Portland Oregon, 97225, United States
Tacoma Washington, 98405, United States
Sydney New South Wales, 2139, Australia
Sydney New South Wales, 2145, Australia
Woolloongabba Queensland, 4102, Australia
Fitzroy Victoria, 3065, Australia
Melbourne Victoria, 3002, Australia
Melbourne Victoria, 3084, Australia
Melbourne Victoria, 3168, Australia
Murdoch Western Australia, 6150, Australia
Gent , 9000, Belgium
Kortrijk , 8500, Belgium
Leuven , 3000, Belgium
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 1, Canada
Moncton New Brunswick, E1C 8, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M2K 1, Canada
Toronto Ontario, M3M 0, Canada
Toronto Ontario, M4C 3, Canada
Greenfield Park Quebec, J4V 2, Canada
Beijing City , 10003, China
Beijing , 10002, China
Beijing , 10014, China
Beijing , 10085, China
Changchun , 13002, China
Fuzhou City , 35000, China
Guangzhou , 51006, China
Harbin , 15008, China
Nanjing City , 21110, China
Nanjing , 21003, China
Shanghai City , 20012, China
Shanghai , 20002, China
Wuhan , 43002, China
Brno , 625 0, Czechia
Hradec Kralove , 500 0, Czechia
Praha 2 , 128 0, Czechia
Helsinki , 00250, Finland
Angers , 49933, France
Brest , 29609, France
Clermont Ferrand , 63003, France
LeMans , 72000, France
Marseille , 13005, France
Montpellier , 34295, France
Perpignan , 66046, France
Berlin , 14195, Germany
Chemnitz , 09113, Germany
Dessau-Roßlau , 06847, Germany
Dresden , 01307, Germany
Dresden , 01307, Germany
Erfurt , 99089, Germany
Eschweiler , 52249, Germany
Essen , 45122, Germany
Frankfurt , 60596, Germany
Freiburg , 79106, Germany
Greifswald , 17475, Germany
Göttingen , 37075, Germany
Hagen , 58097, Germany
Hannover , 30171, Germany
Heidelberg , 69115, Germany
Heidelberg , 69120, Germany
Homburg/Saar , 64421, Germany
Jena , 07747, Germany
Kiel , 24105, Germany
Koblenz , 56068, Germany
Köln , 50924, Germany
Landshut , 84028, Germany
Lebach , 66822, Germany
Leipzig , 04129, Germany
Ludwigshafen , 67063, Germany
Magdeburg , 39104, Germany
Magdeburg , 39120, Germany
Mainz , 55131, Germany
Mannheim , 68161, Germany
Mannheim , 68167, Germany
Mutlangen , 73557, Germany
Mönchengladbach , 41063, Germany
München , 81377, Germany
München , 81675, Germany
Neunkirchen/Saar , 66538, Germany
Oldenburg , 26121, Germany
Paderborn , 33098, Germany
Recklinghausen , 45659, Germany
Regensburg , 93049, Germany
Saarbruecken , 66113, Germany
Trier , 54292, Germany
Tübingen , 72076, Germany
Ulm , 89081, Germany
Wiesbaden , 65199, Germany
Würzburg , 97080, Germany
Budapest , 1083, Hungary
Budapest , 1122, Hungary
Debrecen , 4032, Hungary
Gyor , 9024, Hungary
Szeged , 6720, Hungary
Haifa , 31096, Israel
Petach Tikva , 49100, Israel
Ramat-Gan , 52621, Israel
Modena Emilia-Romagna, 41100, Italy
Roma Lazio, 00152, Italy
Bergamo Lombardia, 24127, Italy
Milano Lombardia, 20122, Italy
Milano Lombardia, 20162, Italy
Rozzano Lombardia, 20089, Italy
Torrette DI Ancona Marche, 60020, Italy
Palermo Sicilia, 90146, Italy
Padova Veneto, 35128, Italy
Aichi , 464-8, Japan
Aichi , 466-8, Japan
Aichi , 467-8, Japan
Aomori , 030-8, Japan
Chiba , 260-8, Japan
Chiba , 277-8, Japan
Ehime , 791-0, Japan
Fukuoka , 811-1, Japan
Gunma , 371-8, Japan
Hiroshima , 734-8, Japan
Hyogo , 650-0, Japan
Hyogo , 673-8, Japan
Kanagawa , 259-1, Japan
Kumamoto , 860-8, Japan
Kyoto , 602-8, Japan
Miyagi , 980-8, Japan
Nagano , 390-8, Japan
Niigata , 951-8, Japan
Osaka , 570-8, Japan
Tochigi , 329-0, Japan
Tokyo , 104-0, Japan
Tokyo , 105-8, Japan
Tokyo , 135-8, Japan
Tokyo , 201-8, Japan
Moscow , 11547, Russian Federation
Nizhny Novgorod , 60312, Russian Federation
Petrozavodsk , 18501, Russian Federation
Badalona Barcelona, 08915, Spain
Sabadell Barcelona, 08208, Spain
Alcorcon Madrid, 28922, Spain
Bilbao Vizcaya, 48013, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Göteborg , S-413, Sweden
Taipei City , 11259, Taiwan
Taipei , 100, Taiwan
Taoyuan , 333, Taiwan
Aberdeen , AB25 , United Kingdom
Birmingham , B15 2, United Kingdom
Bournemouth , BH7 7, United Kingdom
Bristol , BS2 8, United Kingdom
Cambridge , CB2 0, United Kingdom
Canterbury , CT1 3, United Kingdom
Cardiff , CF14 , United Kingdom
Cottingham , HU16 , United Kingdom
Edinburgh , EH4 2, United Kingdom
Glasgow , G12 0, United Kingdom
Great Yarmouth , NR31 , United Kingdom
Harlow , CM20 , United Kingdom
Leeds , LS9 7, United Kingdom
Leicester , LE1 5, United Kingdom
London , EC1M , United Kingdom
London , SE5 9, United Kingdom
London , SW17 , United Kingdom
London , W12 O, United Kingdom
London , WC1E , United Kingdom
Manchester , M20 4, United Kingdom
Norwich , NR4 7, United Kingdom
Nottingham , NG5 1, United Kingdom
Oxford , OX3 7, United Kingdom
Portsmouth , PO6 3, United Kingdom
Southampton , SO16 , United Kingdom
Sutton , SM2 5, United Kingdom
Swansea , SA2 8, United Kingdom
Swindon , SN3 6, United Kingdom
Truro , TR1 3, United Kingdom
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