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)

August 9, 2022 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1401

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2139
        • Concord Repatriation General Hospital; Haematology
      • Sydney, New South Wales, Australia, 2145
        • Westmead Hospital; Haematology
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital Woolloongabba; Clinical Hematology and Medical Oncology
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • St Vincent'S Hospital; Haematology
      • Melbourne, Victoria, Australia, 3168
        • Monash Medical Centre; Haematology
      • Melbourne, Victoria, Australia, 3002
        • Peter MacCallum Cancer Centre; Department of Haematology
      • Melbourne, Victoria, Australia, 3084
        • Austin and Repatriation Medical Centre; Cancer Services
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Fiona Stanley Hospital
  • Belgium
      • Gent, Belgium, 9000
        • UZ Gent
      • Kortrijk, Belgium, 8500
        • Az Groeninge
      • Leuven, Belgium, 3000
        • UZ Leuven Gasthuisberg
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Centre-Calgary
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 8X3
        • Dr. Georges L. Dumont University Hospital Centre
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa General Hospital
      • Toronto, Ontario, Canada, M3M 0B2
        • Humber River Hospital
      • Toronto, Ontario, Canada, M4C 3E7
        • Toronto East General Hospital; Haematology/Oncology
      • Toronto, Ontario, Canada, M2K 1E1
        • North York General Hospital
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie
  • China
      • Beijing, China, 100021
        • Cancer Hospital Chinese Academy of Medical Sciences.
      • Beijing, China, 100142
        • Beijing Cancer Hospital
      • Beijing, China, 100853
        • General Hospital of Chinese PLA; Department of Hematology
      • Beijing City, China, 100034
        • Peking University First Hospital
      • Changchun, China, 130021
        • The First Hospital of Jilin University
      • Fuzhou City, China, 350001
        • Fujian Medical University Union Hospital
      • Guangzhou, China, 510060
        • Sun Yet-sen University Cancer Center
      • Harbin, China, 150081
        • Harbin Medical University Cancer Hospital
      • Nanjing, China, 210036
        • Jiangsu Province Hospital
      • Nanjing City, China, 211100
        • Jiangsu Cancer Hospital
      • Shanghai, China, 200025
        • Shanghai Jiao Tong University School of Medicine (SJTUSM) - Ruijin Hospital (GuangCi Hospital)
      • Shanghai City, China, 200120
        • Fudan University Shanghai Cancer Center
      • Wuhan, China, 430023
        • Union Hospital of Tongji Medical College, Dept. of Cancer Center; Cancer Center
  • Czechia
      • Brno, Czechia, 625 00
        • Fakultni nemocnice Brno; Interni hematologicka a onkologicka klinika
      • Hradec Kralove, Czechia, 500 05
        • Fn Hr. Kralove; IV. Interni Hematologicka Klinika
      • Praha 2, Czechia, 128 08
        • Vseobecna Fakultni Nemocnice v Praze, I. Interni Klinika - Klinika Hematoonkologie VFN a 1. LF UK
  • Finland
      • Helsinki, Finland, 00250
        • Helsinki University Central Hospital; Dept of Oncology
  • France
      • Angers, France, 49933
        • Hotel Dieu; Medecine D
      • Brest, France, 29609
        • Hopital Augustin Morvan; Hematologie
      • Clermont Ferrand, France, 63003
        • Chu Estaing; Hematologie Clinique Adultes
      • LeMans, France, 72000
        • Clinique Victor Hugo
      • Marseille, France, 13005
        • Hopital De La Conception; Hematologie Clinique
      • Montpellier, France, 34295
        • Hopital Saint Eloi; Hematologie Oncologie Medicale
      • Perpignan, France, 66046
        • Hopital Saint Jean; Hematologie
  • Germany
      • Berlin, Germany, 14195
        • Onkologischer Schwerpunkt am Oskar-Helene-Heim; Dres. Herrenberger, Keitel-Wittig u. Kirsch
      • Chemnitz, Germany, 09113
        • Klinikum Chemnitz gGmbH Krankenhaus Küchwald Klinik f.Innere Medizin III
      • Dessau-Roßlau, Germany, 06847
        • Städtisches Klinikum Dessau
      • Dresden, Germany, 01307
        • BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie
      • Dresden, Germany, 01307
        • Gemeinschaftspraxis Dr. med. J. Mohm und Dr. med. G. Prange-Krex; Fachaerzte fuer Innere Medizin
      • Erfurt, Germany, 99089
        • HELIOS Klinikum Erfurt I.Medizinische Klinik
      • Eschweiler, Germany, 52249
        • St.-Antonius-Hospital gGmbH; Klinik für Hämatologie und Onkologie
      • Essen, Germany, 45122
        • Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung
      • Frankfurt, Germany, 60596
        • Klinik Johann Wolfgang von Goethe Uni; Medizinische Klinik II
      • Freiburg, Germany, 79106
        • Universitätsklinikum Freiburg; Klinik für Innere Medizin I; Hämatologie/Onkologie
      • Greifswald, Germany, 17475
        • Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik
      • Göttingen, Germany, 37075
        • Uni Göttingen, Georg-August-Universität; Klinik für Hämatologie und Medizinische Onkologie
      • Hagen, Germany, 58097
        • Kath. Krankenhaus Hagen gem. GmbH, St.-Josefs-Hospital; Klinik für Hämatologie und Onkologie
      • Hannover, Germany, 30171
        • Onkologische Schwerpunktpraxis Dres. Bernd Gaede, Hans-Ulrich Ehlers, Ulrike Rodewig u.w.
      • Heidelberg, Germany, 69115
        • Dres.Andreas Karcher und Stefan Fuxius
      • Heidelberg, Germany, 69120
        • Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V
      • Homburg/Saar, Germany, 64421
        • Universitaetsklinikum des Saarlandes; medizinische Klinik und Poliklinik; Innere Medizin I
      • Jena, Germany, 07747
        • Universitätsklinikum Jena; Klinik für Innere Medizin II
      • Kiel, Germany, 24105
        • UKSH, Campus Kiel; Klinik für Innere Medizin II, Hämatologie und Internistische Onkologie
      • Koblenz, Germany, 56068
        • Institut für Versorgungsforschung in der Onkologie GbR Koblenz
      • Köln, Germany, 50924
        • Klinik der Uni zu Köln; Klinik für Innere Medizin
      • Landshut, Germany, 84028
        • Tagesklinik Landshut; Hämatologie/Onkologie
      • Lebach, Germany, 66822
        • Gemeinschaftspraxis für Hämatologie und Onkologie
      • Leipzig, Germany, 04129
        • Klinikum St.Georg gGmbH Klinik für Internistische Onkologie und Hämotologie
      • Ludwigshafen, Germany, 67063
        • Klinikum der Stadt Ludwigshafen; Medizinische Klinik A
      • Magdeburg, Germany, 39104
        • Onkologische Gemeinschaftspraxis
      • Magdeburg, Germany, 39120
        • Otto von Guericke Uni Magdeburg Uniklinik; Hämatologie/Onkologie
      • Mainz, Germany, 55131
        • Uni. der Johannes Gutenberg-Universitaet Mainz; III. Medizinische Klinik und Poliklinik
      • Mannheim, Germany, 68167
        • Klinikum Mannheim III. Medizinische Klinik
      • Mannheim, Germany, 68161
        • Mannheimer Onkologie Praxis Dres. Jürgen Brust Dieter Schuster
      • Mutlangen, Germany, 73557
        • Kliniken Ostalb, Stauferklinikum Schwäbisch-Gmünd; Zentrum für Innere Medizin
      • Mönchengladbach, Germany, 41063
        • St. Frankziskus Krankenhaus, Med. Klinik I; Klinik für Hämatologie,Onkologie u. Gastroenterologie
      • München, Germany, 81377
        • Klinikum der Universität München, Campus Großhadern; Medizinische Klinik und Poliklinik III
      • München, Germany, 81675
        • Klinikum rechts der Isar der TU München; III. Medizinischen Klinik (Hämatologie/Onkologie)
      • Neunkirchen/Saar, Germany, 66538
        • Gemeinschaftspraxis Dr. med. Holger Klaproth
      • Oldenburg, Germany, 26121
        • Pius-Hospital; Klinik fuer Haematologie und Onkologie
      • Paderborn, Germany, 33098
        • Brüderkrankenhaus St. Josef
      • Recklinghausen, Germany, 45659
        • Prosper-Hospital, Medizinische Klinik I
      • Regensburg, Germany, 93049
        • Krankenhaus Barmherziger Brüder; Klinik für Internistische Onkologie / Hämatologie
      • Saarbruecken, Germany, 66113
        • Praxis für Hämatologie & Onkologie
      • Trier, Germany, 54292
        • Krankenhaus der Barmherzigen Brüder Trier; Innere Medizin I, Hämatologie / Internistische Onkologie
      • Tübingen, Germany, 72076
        • Universität Tübingen; Med. Klinik; Innere Medizin I
      • Ulm, Germany, 89081
        • Universtitätsklinikum Ulm; Klinik für Innere Medizin III
      • Wiesbaden, Germany, 65199
        • Helios Dr. Horst Schmidt Kliniken; Klinik Innere MED III: Hämatologie, Onkologie, Palliativmedizin
      • Würzburg, Germany, 97080
        • Hämatologisch-Onkologische Schwerpunktpraxis Dres. Schlag & Schöttker
  • Hungary
      • Budapest, Hungary, 1122
        • National Institute of Oncology, A Dept of Internal Medicine
      • Budapest, Hungary, 1083
        • Semmelweis University, First Dept of Medicine
      • Debrecen, Hungary, 4032
        • University of Debrecen Medical and Health Science Center, Institute of Internal Medicine, Hematology
      • Gyor, Hungary, 9024
        • Petz Aladar Megyei Korhaz; Hematologia
      • Szeged, Hungary, 6720
        • University of Szeged, II Dept of Internal Medicine
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Medical Center; Heamatology & Bone Marrow Transplantation
      • Petach Tikva, Israel, 4910000
        • Beilinson Medical Center; Haematology
      • Ramat-Gan, Israel, 5262100
        • Chaim Sheba Medical Center; Hematology BMT & CBB
  • Italy
    • Emilia-Romagna
      • Modena, Emilia-Romagna, Italy, 41100
        • Azienda ospedaliera universitaria di Modena
    • Lazio
      • Roma, Lazio, Italy, 00152
        • Az. Osp. S. Camillo Forlanini; Uo Ematologia E Trapianti Di Midollo Osseo
    • Lombardia
      • Bergamo, Lombardia, Italy, 24127
        • ASST PAPA GIOVANNI XXIII; Ematologia
      • Milano, Lombardia, Italy, 20122
        • Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora
      • Milano, Lombardia, Italy, 20162
        • Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
      • Rozzano, Lombardia, Italy, 20089
        • Istituto Clinico Humanitas;U.O. Oncologia Medica Ed Ematologia
    • Marche
      • Torrette DI Ancona, Marche, Italy, 60020
        • A.O. Univ.Ospedali Riuniti Umerto I -G.M.Lancisi G.Salesi; U.O. Clinica Di Ematologia
    • Sicilia
      • Palermo, Sicilia, Italy, 90146
        • Ospedale V. Cervello; U.O. Ematologia E Trapianti
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia
  • Japan
      • Aichi, Japan, 464-8681
        • Aichi Cancer Center Hospital; Hematology and Cell Therapy
      • Aichi, Japan, 466-8650
        • Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital; Hematology & Oncology
      • Aichi, Japan, 467-8602
        • Nagoya City University Hospital; Hematology and Oncology
      • Aomori, Japan, 030-8553
        • Aomori Prefectural Central Hospital; Hematology
      • Chiba, Japan, 260-8717
        • Chiba Cancer Center;Hematology and Oncology
      • Chiba, Japan, 277-8577
        • National Cancer Center Hospital East;Hematology
      • Ehime, Japan, 791-0280
        • Shikoku Cancer Center; Hematology and Oncology
      • Fukuoka, Japan, 811-1395
        • National Hospital Organization Kyushu Cancer Center; Hematology
      • Gunma, Japan, 371-8511
        • Gunma University Hospital;Hematology
      • Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital; Hematology
      • Hyogo, Japan, 650-0047
        • Kobe City Medical Center General Hospital; Hematology
      • Hyogo, Japan, 673-8558
        • Hyogo Cancer Center; Department of hematology
      • Kanagawa, Japan, 259-1193
        • Tokai University Hospital; Hematology
      • Kumamoto, Japan, 860-8556
        • Kumamoto University Hospital; Hematology Rheumatology and Clinical Immunology
      • Kyoto, Japan, 602-8566
        • University Hospital, Kyoto Prefectural University of Medicine; Hematology
      • Miyagi, Japan, 980-8574
        • Tohoku University Hospital; Hematology and Immunology
      • Nagano, Japan, 390-8621
        • Shinshu University Hospital; Hematology
      • Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital; Internal Medicine
      • Osaka, Japan, 570-8540
        • Matsushita Memorial Hospital; hematology
      • Tochigi, Japan, 329-0498
        • Jichi Medical University Hospital; Hematology
      • Tokyo, Japan, 104-0045
        • National Cancer Center Hospital; Hematology
      • Tokyo, Japan, 105-8470
        • Toranomon Hospital; Hematology
      • Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital of JFCR; Hematology Oncology
      • Tokyo, Japan, 201-8601
        • The Jikei University Daisan Hospital; Department of Clinical Oncology and Hematology
  • Russian Federation
      • Moscow, Russian Federation, 115478
        • FSBI Russian Oncology Research Center n.a. Blokhin of MOH RF
      • Nizhny Novgorod, Russian Federation, 603126
        • Regional Clinical Hospital N.A. Semashko; Hematology
      • Petrozavodsk, Russian Federation, 185019
        • Republican Clinical Hospital n.a. Baranov; Haematology
  • Spain
      • Madrid, Spain, 28046
        • Hospital Universitario la Paz; Servicio de Hematologia
      • Madrid, Spain, 28041
        • Hospital Univ. 12 de Octubre; Servicio de Hematologia
    • Barcelona
      • Badalona, Barcelona, Spain, 08915
        • Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia
      • Sabadell, Barcelona, Spain, 08208
        • Corporacio Sanitaria Parc Tauli; Servicio de Hematologia
    • Madrid
      • Alcorcon, Madrid, Spain, 28922
        • Fundacion Hospital de Alcorcon; Servicio de Hematologia
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48013
        • Hospital de Basurto; Servicio de Hematologia
  • Sweden
      • Göteborg, Sweden, S-413 45
        • Sahlgrenska Universitetssjukhuset; Sektionen för hematologi och koagulation
  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan Universtiy Hospital; Division of Hematology
      • Taipei City, Taiwan, 11259
        • Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology
      • Taoyuan, Taiwan, 333
        • Chang Gung Medical Foundation - Linkou; Division of Hematology- Oncology
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary; Haematology - Ward 16
      • Birmingham, United Kingdom, B15 2TH
        • Queen Elizabeth Hospital; Centre for Clinical Haematology
      • Bournemouth, United Kingdom, BH7 7DW
        • Royal Bournemouth General Hospital; Haematology
      • Bristol, United Kingdom, BS2 8ED
        • Bristol Haematology and Oncology centre
      • Cambridge, United Kingdom, CB2 0QQ
        • Addenbrookes Hospital; Haematology
      • Canterbury, United Kingdom, CT1 3NG
        • Kent & Canterbury Hospital; Clinical Haematology
      • Cardiff, United Kingdom, CF14 2TL
        • Velindre NHS Trust; Haematology Department
      • Cottingham, United Kingdom, HU16 5JG
        • Castle Hill Hospital; The Queens Centre for Oncology and Haematology
      • Edinburgh, United Kingdom, EH4 2XU
        • Western General Hospital; Department of Haematology
      • Glasgow, United Kingdom, G12 0YN
        • Beatson West of Scotland Cancer Centre
      • Great Yarmouth, United Kingdom, NR31 6LA
        • James Paget Hospital; Haematology Department
      • Harlow, United Kingdom, CM20 1QX
        • Princess Alexandra Hospital; Department of Haematology
      • Leeds, United Kingdom, LS9 7TF
        • St James Uni Hospital; Icrf Cancer Medicine Research Unit
      • Leicester, United Kingdom, LE1 5WW
        • Leicester Royal Infirmary; Dept of Haematology
      • London, United Kingdom, EC1M 6BQ
        • St Bartholomew's Hospital
      • London, United Kingdom, SE5 9RS
        • King'S College Hospital; Haematology
      • London, United Kingdom, SW17 0QT
        • St. George'S Hospital; Haematology
      • London, United Kingdom, W12 OHS
        • Hammersmith Hospital; Haematology
      • London, United Kingdom, WC1E 6AG
        • University College Hospital; Macmillan Cancer Centre
      • Manchester, United Kingdom, M20 4QL
        • Christie Hospital; Breast Cancer Research Office
      • Norwich, United Kingdom, NR4 7UY
        • Norfolk & Norwich Hospital; Dept of Haematology
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham City Hospital; Dept of Haematology
      • Oxford, United Kingdom, OX3 7LJ
        • Churchill Hospital; Oxford Cancer and Haematology Centre
      • Portsmouth, United Kingdom, PO6 3LY
        • Queen Alexandra Hospital; Haematology and Oncology Centre
      • Southampton, United Kingdom, SO16 6YD
        • Southampton General Hospital; Medical Oncology
      • Sutton, United Kingdom, SM2 5PT
        • Royal Marsden Hospital; Dept of Medical Oncology
      • Swansea, United Kingdom, SA2 8QA
        • Singleton Hospital; Pharmacy
      • Swindon, United Kingdom, SN3 6BB
        • Great Western;Department of Haematology
      • Truro, United Kingdom, TR1 3LJ
        • Royal Cornwall Hospital; Haematology Clinic
  • United States
    • Arkansas
      • Springdale, Arkansas, United States, 72762
        • Highlands Oncology Group
    • California
      • Irvine, California, United States, 92697
        • The Regents of the University of California; Office of Research
    • Idaho
      • Post Falls, Idaho, United States, 83854
        • Kootenai Cancer Center
    • Illinois
      • Galesburg, Illinois, United States, 61401
        • Illinois Cancer Care, P.C. - Galesburg
    • Iowa
      • Sioux City, Iowa, United States, 51101
        • Siouxland Hematology/Oncology
    • Kansas
      • Westwood, Kansas, United States, 66205
        • University of Kansas; Medical Center & Medical pavilion
      • Wichita, Kansas, United States, 67214-3728
        • Cancer Center of Kansas
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Mercy Medical Research Institute
    • Montana
      • Missoula, Montana, United States, 59802
        • MT Cancer Inst Fndtn; MT Can Spec
    • New Mexico
      • Farmington, New Mexico, United States, 87401
        • San Juan Oncology Associates
    • Oregon
      • Portland, Oregon, United States, 97225
        • Providence St. Vincent Medical Center
    • Washington
      • Tacoma, Washington, United States, 98405
        • Northwest Medical Specialties

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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.
Drug: Cyclophosphamide
Cyclophosphamide 750 mg/m^2 IV will be administered on Day 1 of each cycle during induction period.
Drug: Doxorubicin
Doxorubicin 50 mg/m^2 IV will be administered on Day 1 of each cycle during induction period.
Drug: Vincristine
Vincristine 1.4 mg/m^2 (maximum 2 mg) IV will be administered on Day 1 of each cycle during induction period.
Drug: Prednisone
Prednisone 100 mg (or equivalent prednisolone or methylprednisolone) will be administered orally on Days 1-5 of each cycle during induction period.
Drug: Bendamustine
Bendamustine 90 mg/m^2 IV infusion will be administered on Days 1 and 2 of each cycle during induction period.
Drug: 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 Names:
  • MabThera/Rituxan
EXPERIMENTAL: 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.
Drug: Cyclophosphamide
Cyclophosphamide 750 mg/m^2 IV will be administered on Day 1 of each cycle during induction period.
Drug: Doxorubicin
Doxorubicin 50 mg/m^2 IV will be administered on Day 1 of each cycle during induction period.
Drug: Vincristine
Vincristine 1.4 mg/m^2 (maximum 2 mg) IV will be administered on Day 1 of each cycle during induction period.
Drug: Prednisone
Prednisone 100 mg (or equivalent prednisolone or methylprednisolone) will be administered orally on Days 1-5 of each cycle during induction period.
Drug: Bendamustine
Bendamustine 90 mg/m^2 IV infusion will be administered on Days 1 and 2 of each cycle during induction period.
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.
Other Names:
  • GA101; RO5072759

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed
Time Frame: Baseline up to data cut-off (up to approximately 4 years and 7 months)
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 </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI).
Baseline up to data cut-off (up to approximately 4 years and 7 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival in the Follicular Lymphoma Population, Investigator-Assessed
Time Frame: Baseline up to final analysis (up to 10 years)
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 </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by computed tomography (CT) or magnetic resonance imaging (MRI).
Baseline up to final analysis (up to 10 years)
Progression-Free Survival in the Overall Study Population, Investigator-Assessed
Time Frame: Baseline up to data cut-off (up to approximately 5 years and 2 months)
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 </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI.
Baseline up to data cut-off (up to approximately 5 years and 2 months)
Progression-Free Survival (Follicular Lymphoma Population), IRC-Assessed
Time Frame: Baseline up to data cut-off (up to approximately 5 years and 2 months)
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 </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI. In the first 170 patients with follicular lymphoma, an FDG-PET was mandatory where a PET scanner was available.
Baseline up to data cut-off (up to approximately 5 years and 2 months)
Progression-Free Survival (Overall Study Population), Assessed by Independent Review Committee (IRC)
Time Frame: Baseline up to data cut-off (up to approximately 5 years and 2 months)
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 </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI.
Baseline up to data cut-off (up to approximately 5 years and 2 months)
Overall Response (Follicular Lymphoma Population), Investigator-Assessed
Time Frame: Baseline up to end of induction period (up to approximately 7 months)
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)
Overall Response (Overall Study Population), Investigator-Assessed
Time Frame: Baseline up to end of induction period (up to approximately 7 months)
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)
Complete Response (Follicular Lymphoma Population), Investigator-Assessed
Time Frame: Baseline up to end of induction period (up to approximately 7 months)
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)
Complete Response (Overall Study Population), Investigator-Assessed
Time Frame: Baseline up to end of induction period (up to approximately 7 months)
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)
Overall Response (Follicular Lymphoma Population), IRC-Assessed
Time Frame: Baseline up to end of induction period (up to approximately 7 months)
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)
Overall Response (Overall Study Population), IRC-Assessed
Time Frame: Baseline up to end of induction period (up to approximately 7 months)
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)
Complete Response (Follicular Lymphoma Population), IRC-Assessed
Time Frame: Baseline up to end of induction period (up to approximately 7 months)
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)
Complete Response (Overall Study Population), IRC-Assessed
Time Frame: Baseline up to end of induction period (up to approximately 7 months)]
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)]
Overall Survival (Follicular Lymphoma Population)
Time Frame: Baseline up to 10 years
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
Overall Survival (Overall Study Population)
Time Frame: Baseline up to data cut-off (up to approximately 5 years and 2 months)
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)
Event-Free Survival (Follicular Lymphoma Population)
Time Frame: Baseline up to 10 years
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 </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI. Reported is the percentage of participants with an event.
Baseline up to 10 years
Event-Free Survival (Overall Study Population)
Time Frame: Baseline up to data cut-off (up to approximately 5 years and 2 months)
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 </= 1 cm such that it is now >1.5 cm. Tumor measurements were obtained by CT/MRI. Reported is the percentage of participants with event.
Baseline up to data cut-off (up to approximately 5 years and 2 months)
Disease-Free Survival (Follicular Lymphoma Population)
Time Frame: From first occurrence of documented CR to data cut-off (up to approximately 5 years and 2 months)
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 </= 1 cm such that it is now >1.5 cm. Reported is the percentage of participants with event.
From first occurrence of documented CR to data cut-off (up to approximately 5 years and 2 months)
Disease-Free Survival (Overall Study Population)
Time Frame: From first occurrence of documented CR to data cut-off (up to approximately 5 years and 2 months)
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 </= 1 cm such that it is now >1.5 cm. Reported is the percentage of participants with event.
From first occurrence of documented CR to data cut-off (up to approximately 5 years and 2 months)
Duration of Response (DOR) (Follicular Lymphoma Population), Investigator-Assessed
Time Frame: From first occurrence of documented CR or PR to data cut-off (up to approximately 5 years and 2 months)
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 </= 1 cm such that it is now >1.5 cm.
From first occurrence of documented CR or PR to data cut-off (up to approximately 5 years and 2 months)
Duration of Response (DOR) (Overall Study Population), Investigator-Assessed
Time Frame: From first occurrence of documented CR or PR to data cut-off (up to approximately 4 years and 7 months)
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 </= 1 cm such that it is now >1.5 cm.
From first occurrence of documented CR or PR to data cut-off (up to approximately 4 years and 7 months)
Time to Next Anti-Lymphoma Treatment (Follicular Lymphoma Population)
Time Frame: Baseline up to 10 years
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
Time to Next Anti-Lymphoma Treatment (Overall Study Population)
Time Frame: Baseline up to data cut-off (up to approximately 5 years and 2 months)
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)
Percentage of Participants With Adverse Events
Time Frame: Baseline up to 10 years
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
Change From Baseline in All Domains of FACT-G (Follicular Lymphoma Population)
Time Frame: Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)
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)
Change From Baseline in FACT-Lym Total Outcome Index (TOI) Score (Follicular Lymphoma Population)
Time Frame: Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)
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)
Change From Baseline in FACT-Lym Individual Subscale Lymphoma Score (Follicular Population)
Time Frame: Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)
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)
Change From Baseline in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Total Score (Follicular Population)
Time Frame: Baseline (Induction Cycle 1, Day 1), data cut-off (up to approximately 5 years and 2 months)
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)
Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Induction Phase
Time Frame: 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)
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)
Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Maintenance/Observation Phase
Time Frame: 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)
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)
Change From Baseline in Euro-Quality of Life-5 Dimensions (EQ-5D) Questionnaire Summary Score (Follicular Lymphoma Population) During Follow Up Phase
Time Frame: 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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Collaborators

Institute of Cancer Research, United Kingdom
German Low Grade Lymphoma Study Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 6, 2011

Primary Completion (ACTUAL)

February 1, 2016

Study Completion (ACTUAL)

July 30, 2021

Study Registration Dates

First Submitted

April 8, 2011

First Submitted That Met QC Criteria

April 8, 2011

First Posted (ESTIMATE)

April 11, 2011

Study Record Updates

Last Update Posted (ACTUAL)

August 11, 2022

Last Update Submitted That Met QC Criteria

August 9, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BO21223
  • 2010-024132-41 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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