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)

Non-Hodgkin's Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01332968
• Other study ID #: BO21223
• Secondary ID: 2010-024132-41
• Status: Completed
• Phase: Phase 3
• Start date: July 6, 2011
• Est. completion date: July 30, 2021

Study information

• Verified date: August 2022
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1401
• Est. completion date: July 30, 2021
• Est. primary completion date: February 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Australia	St Vincent'S Hospital; Haematology	Fitzroy	Victoria
Australia	Austin and Repatriation Medical Centre; Cancer Services	Melbourne	Victoria
Australia	Monash Medical Centre; Haematology	Melbourne	Victoria
Australia	Peter MacCallum Cancer Centre; Department of Haematology	Melbourne	Victoria
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	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
Belgium	UZ Gent	Gent
Belgium	AZ Groeninge	Kortrijk
Belgium	UZ Leuven Gasthuisberg	Leuven
Canada	Tom Baker Cancer Centre-Calgary	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie	Greenfield Park	Quebec
Canada	Dr. Georges L. Dumont University Hospital Centre	Moncton	New Brunswick
Canada	Ottawa General Hospital	Ottawa	Ontario
Canada	Humber River Hospital	Toronto	Ontario
Canada	North York General Hospital	Toronto	Ontario
Canada	Toronto East General Hospital; Haematology/Oncology	Toronto	Ontario
China	Beijing Cancer Hospital	Beijing
China	Cancer Hospital Chinese Academy of Medical Sciences.	Beijing
China	General Hospital of Chinese PLA; Department of Hematology	Beijing
China	Peking University First Hospital	Beijing City
China	the First Hospital of Jilin University	Changchun
China	Fujian Medical University Union Hospital	Fuzhou City
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 City
China	Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)	Shanghai
China	Fudan University Shanghai Cancer Center	Shanghai City
China	Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center	Wuhan
Czechia	Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika	Brno
Czechia	Fn Hr. Kralove; IV. Interni Hematologicka Klinika	Hradec Kralove
Czechia	Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK	Praha 2
Finland	Helsinki University Central Hospital; Dept of Oncology	Helsinki
France	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
Germany	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	Städtisches Klinikum Dessau	Dessau-Roßlau
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
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.	Hannover
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	Klinik der Uni zu Köln; Klinik für Innere Medizin	Köln
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	Klinikum Mannheim III. Medizinische Klinik	Mannheim
Germany	Mannheimer Onkologie Praxis Dres. Jürgen Brust Dieter Schuster	Mannheim
Germany	St. Frankziskus Krankenhaus, Med. Klinik I; Klinik für Hämatologie,Onkologie u. Gastroenterologie	Mönchengladbach
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	Kliniken Ostalb, Stauferklinikum Schwäbisch-Gmünd; Zentrum für Innere Medizin	Mutlangen
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	Saarbruecken
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
Hungary	National Institute of Oncology, A Dept of Internal Medicine	Budapest
Hungary	Semmelweis University, First Dept of Medicine	Budapest
Hungary	University of Debrecen Medical and Health Science Center, Institute of Internal Medicine, Hematology	Debrecen
Hungary	Petz Aladar Megyei Korhaz; Hematologia	Gyor
Hungary	University of Szeged, II Dept of Internal Medicine	Szeged
Israel	Rambam Medical Center; Heamatology & Bone Marrow Transplantation	Haifa
Israel	Beilinson Medical Center; Haematology	Petach Tikva
Israel	Chaim Sheba Medical Center; Hematology BMT & CBB	Ramat-Gan
Italy	ASST PAPA GIOVANNI XXIII; Ematologia	Bergamo	Lombardia
Italy	Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia	Milano	Lombardia
Italy	Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora	Milano	Lombardia
Italy	Azienda Ospedaliera Universitaria di Modena	Modena	Emilia-Romagna
Italy	Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia	Padova	Veneto
Italy	Ospedale V. Cervello; U.O. Ematologia E Trapianti	Palermo	Sicilia
Italy	Az. Osp. S. Camillo Forlanini; Uo Ematologia E Trapianti Di Midollo Osseo	Roma	Lazio
Italy	Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia	Rozzano	Lombardia
Italy	A.O. Univ.Ospedali Riuniti Umerto I -G.M.Lancisi G.Salesi; U.O. Clinica Di Ematologia	Torrette DI Ancona	Marche
Japan	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	Hyogo Cancer Center; Department of hematology	Hyogo
Japan	Kobe City Medical Center General Hospital; Hematology	Hyogo
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	The Cancer Institute Hospital of JFCR; Hematology Oncology	Tokyo
Japan	The Jikei University Daisan Hospital; Department of Clinical Oncology and Hematology	Tokyo
Japan	Toranomon Hospital; Hematology	Tokyo
Russian Federation	FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF	Moscow
Russian Federation	Regional Clinical Hospital N.A. Semashko; Hematology	Nizhny Novgorod
Russian Federation	Republican Clinical Hospital n.a. Baranov; Haematology	Petrozavodsk
Spain	Fundacion Hospital de Alcorcon; Servicio de Hematologia	Alcorcon	Madrid
Spain	Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia	Badalona	Barcelona
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	Corporacio Sanitaria Parc Tauli; Servicio de Hematologia	Sabadell	Barcelona
Sweden	Sahlgrenska Universitetssjukhuset; Sektionen för hematologi och koagulation	Göteborg
Taiwan	National Taiwan Universtiy Hospital; Division of Hematology	Taipei
Taiwan	Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology	Taipei City
Taiwan	Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology	Taoyuan
United Kingdom	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	Hammersmith Hospital; Haematology	London
United Kingdom	King'S College Hospital; Haematology	London
United Kingdom	St Bartholomew's Hospital	London
United Kingdom	St. George'S 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 States	San Juan Oncology Associates	Farmington	New Mexico
United States	Illinois Cancer Care, P.C. - Galesburg	Galesburg	Illinois
United States	The Regents of the University of California; Office of Research	Irvine	California
United States	MT Cancer Inst Fndtn; MT Can Spec	Missoula	Montana
United States	Providence St. Vincent Medical Center	Portland	Oregon
United States	Kootenai Cancer Center	Post Falls	Idaho
United States	Siouxland Hematology/Oncology	Sioux City	Iowa
United States	Highlands Oncology Group	Springdale	Arkansas
United States	Mercy Medical Research Institute	Springfield	Missouri
United States	Northwest Medical Specialties	Tacoma	Washington
United States	University of Kansas; Medical Center & Medical pavilion	Westwood	Kansas
United States	Cancer Center of Kansas	Wichita	Kansas

Sponsors (3)

Lead Sponsor	Collaborator
Hoffmann-La Roche	German Low Grade Lymphoma Study Group, Institute of Cancer Research, United Kingdom

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  China,  Czechia,  Finland,  France,  Germany,  Hungary,  Israel,  Italy,  Japan,  Russian Federation,  Spain,  Sweden,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed	Progression-free survival in participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. 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	Baseline up to data cut-off (up to approximately 4 years and 7 months)
Secondary	Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed	Progression-free survival in participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. 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	Baseline up to final analysis (up to 10 years)
Secondary	Progression-Free Survival in the Overall Study Population, Investigator-Assessed	Progression-free survival in the overall study population was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments according to the Revised Response Criteria for Malignant Lymphoma. 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	Baseline up to data cut-off (up to approximately 5 years and 2 months)
Secondary	Progression-Free Survival (Follicular Lymphoma Population), IRC-Assessed	Progression-free survival in the participants with follicular lymphoma was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of IRC assessments according to the Revised Response Criteria for Malignant Lymphoma. 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	Baseline up to data cut-off (up to approximately 5 years and 2 months)
Secondary	Progression-Free Survival (Overall Study Population), Assessed by Independent Review Committee (IRC)	Progression-free survival in the overall study population was defined as the time from randomization until the first documented day of disease progression or death from any cause, whichever occurred first, on the basis of IRC assessments according to the Revised Response Criteria for Malignant Lymphoma. 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	Baseline up to data cut-off (up to approximately 5 years and 2 months)
Secondary	Overall Response (Follicular Lymphoma Population), Investigator-Assessed	Overall response in the follicular lymphoma population was defined as percentage of participants with PR or complete response CR determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with and without PET. CR was defined as disappearance of all target lesions; PR was defined as >=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 nodules must have regressed by >/= 50%. Overall Response (OR) = CR + PR.	Baseline up to end of induction period (up to approximately 7 months)
Secondary	Overall Response (Overall Study Population), Investigator-Assessed	Overall response in the overall study population was defined as percentage of participants with partial response (PR) or complete response (CR) determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without positron emission tomography (PET). CR was defined as disappearance of all target lesions; PR was defined as >=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 nodules must have regressed by >/= 50%; Overall Response (OR) = CR + PR.	Baseline up to end of induction period (up to approximately 7 months)
Secondary	Complete Response (Follicular Lymphoma Population), Investigator-Assessed	Percentage of participants with complete response in the follicular lymphoma population was determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.	Baseline up to end of induction period (up to approximately 7 months)
Secondary	Complete Response (Overall Study Population), Investigator-Assessed	Percentage of participants with complete response in the overall study population was determined on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.	Baseline up to end of induction period (up to approximately 7 months)
Secondary	Overall Response (Follicular Lymphoma Population), IRC-Assessed	Overall response in the follicular lymphoma population was defined as percentage of participants with PR or complete response CR determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions; PR was defined as >=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 nodules must have regressed by >/= 50%. Overall Response (OR) = CR + PR.	Baseline up to end of induction period (up to approximately 7 months)
Secondary	Overall Response (Overall Study Population), IRC-Assessed	Overall response in the overall study population was defined as percentage of participants with PR or CR determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions; PR was defined as >=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 nodules must have regressed by >/= 50%; Overall Response (OR) = CR + PR.	Baseline up to end of induction period (up to approximately 7 months)
Secondary	Complete Response (Follicular Lymphoma Population), IRC-Assessed	Percentage of participants with complete response in the follicular lymphoma population was determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.	Baseline up to end of induction period (up to approximately 7 months)
Secondary	Complete Response (Overall Study Population), IRC-Assessed	Percentage of participants with complete response in the overall study population was determined on the basis of IRC assessments with the use of Revised Response Criteria for Malignant Lymphoma. Tumor assessments were performed with CT/MRI with or without PET. CR was defined as disappearance of all target lesions.	Baseline up to end of induction period (up to approximately 7 months)]
Secondary	Overall Survival (Follicular Lymphoma Population)	Overall survival in the follicular lymphoma population was defined as the time from the date of randomization to the date of death from any cause. Reported is the percentage of participants with event.	Baseline up to 10 years
Secondary	Overall Survival (Overall Study Population)	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. Reported is the percentage of participants with event.	Baseline up to data cut-off (up to approximately 5 years and 2 months)
Secondary	Event-Free Survival (Follicular Lymphoma Population)	Event-free survival in the follicular lymphoma population was defined as the time from the date of randomization to the date to disease progression/relapse, death from any cause, or initiation of a new anti-lymphoma treatment (NALT) on the basis of investigator assessment 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	Baseline up to 10 years
Secondary	Event-Free Survival (Overall Study Population)	Event-free survival in the overall study population was defined as the time from the date of randomization to the date to disease progression/relapse, death from any cause, or initiation of a new anti-lymphoma treatment (NALT) on the basis of investigator assessment 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	Baseline up to data cut-off (up to approximately 5 years and 2 months)
Secondary	Disease-Free Survival (Follicular Lymphoma Population)	Disease-free survival in the follicular lymphoma population was defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/ relapse, or death from any cause for the subgroup of participants with a response of CR at any time prior to NALT on the basis of investigator assessments with the use of Revised Response Criteria for Malignant Lymphoma (RRCML). 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	From first occurrence of documented CR to data cut-off (up to approximately 5 years and 2 months)
Secondary	Disease-Free Survival (Overall Study Population)	Disease-free survival in the overall study population was defined as the time from the date of the first occurrence of a documented CR to the date of disease progression/ relapse, or death from any cause for the subgroup of participants with a response of CR at any time prior to NALT on the basis of investigator assessments with the 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	From first occurrence of documented CR to data cut-off (up to approximately 5 years and 2 months)
Secondary	Duration of Response (DOR) (Follicular Lymphoma Population), Investigator-Assessed	DOR was defined as the time from first occurrence of a documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR any time prior to NALT based on RRCML. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. PR was defined as >/=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 nodules must have regressed by >/= 50%. 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	From first occurrence of documented CR or PR to data cut-off (up to approximately 5 years and 2 months)
Secondary	Duration of Response (DOR) (Overall Study Population), Investigator-Assessed	DOR was defined as the time from first occurrence of a documented CR or PR to disease progression/relapse, or death from any cause for participants with a response of CR or PR any time prior to NALT based on RRCML. Tumor assessments were performed with CT/MRI. CR was defined as disappearance of all target lesions. PR was defined as >/=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 nodules must have regressed by >/= 50%. 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	From first occurrence of documented CR or PR to data cut-off (up to approximately 4 years and 7 months)
Secondary	Time to Next Anti-Lymphoma Treatment (Follicular Lymphoma Population)	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. Reported is the percentage of participants with event.	Baseline up to 10 years
Secondary	Time to Next Anti-Lymphoma Treatment (Overall Study Population)	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. Reported is the percentage of participants with event.	Baseline up to data cut-off (up to approximately 5 years and 2 months)
Secondary	Percentage of Participants With Adverse Events	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.	Baseline up to 10 years
Secondary	Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population)	FACT-G consists of the following 4 FACT-Lym sub-questionnaires: Physical Well-being (range: 0-28), Social/Family Well-being (range: 0-28), Emotional Well-being (range: 0-24) and Functional Well-being (range: 0-28). Higher scores indicate better outcomes. A positive change from baseline indicates improvement. Maint = Maintenance period.	Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)
Secondary	Change From Baseline in FACT-Lym Total Outcome Index (TOI) Score (Follicular Lymphoma Population)	The FACT-Lym TOI Score for the follicular lymphoma population was derived from the following 3 individual FACT-Lym questionnaire subscale scores: Physical Well-being (range: 0-28), Functional Well-being (range: 0-28) and Lymphoma (range: 0-60). The FACT-Lym TOI Score is the sum of the 3 individual subscales (range 0-116). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement.	Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)
Secondary	Change From Baseline in FACT-Lym Individual Subscale Lymphoma Score (Follicular Population)	The FACT-Lym Individual Subscale Lymphoma Score for the follicular lymphoma population was derived from the Lymphoma subscale questionnaire (range: 0-60). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement.	Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)
Secondary	Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score (Follicular Population)	The FACT-Lym Total Score for the follicular lymphoma population was derived from the following 5 individual FACT-Lym questionnaire subscale scores: Physical Well-being (range: 0-28), Social/Family Well-being (range: 0-28), Emotional Well-being (range: 0-24),Functional Well-being (range: 0-28) and Lymphoma (range: 0-60). The FACT-Lym Total Score is the sum of all 5 individual subscales (range 0-168). Higher scores indicate better outcomes. A positive change from baseline indicates an improvement.	Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)
Secondary	Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase	The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1. Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Completion (Compl) includes completion visit and early termination visit. Maintenance/Observation is indicated as Maint/Obs.	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)
Secondary	Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Maintenance/Observation Phase	The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1 Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Maintenance/Observation is indicated as Maint/Obs. Completion includes completion visit and early termination visit.	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)
Secondary	Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Follow Up Phase	The EQ-5D is a quality of life questionnaire with five questions, each with three categories (no problem, moderate problem, severe problems) and a visual analogue scale (VAS) from 0 (worst possible health state) to 100 (best possible health state. Summary score ranges from 0 to 1. Higher scores indicate better outcomes. A positive change from baseline indicates an improvement. Maintenance/Observation is indicated as Maint/Obs in data categories. Completion includes completion visit and early termination visit.	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)