A Study of Rituximab (MabThera) Subcutaneous (SC) Versus Rituximab (MabThera) Intravenous in Participannts With Follicular Non-Hodgkin's Lymphoma

Last updated: October 29, 2018
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

Lymphoma

Cancer/tumors

Non-hodgkin's Lymphoma

Treatment

N/A

Clinical Study ID

NCT01200758
BO22334
2010-021377-36
  • Ages > 18
  • All Genders

Study Summary

This two-stage, multi-center, randomized, controlled, open-label study will investigate the pharmacokinetics, efficacy and safety of rituximab SC versus rituximab IV in participants with previously untreated follicular non-Hodgkin's lymphoma. Participants will be randomized to receive 375 milligrams per meter square (mg/m^2) rituximab as IV infusion or 1400 milligrams (mg) rituximab SC. In addition, participants will receive standard chemotherapy. Participants who achieved a complete or partial response (PR) after 8 treatment cycles, will receive maintenance treatment for a further maximum number of 12 cycles. Maintenance treatment cycles will be repeated every 8 weeks. This is a two-stage study. Stage 1 was designed to confirm the chosen rituximab SC dose resulting in comparable rituximab serum Ctrough levels compared with rituximab IV, when given as part of induction treatment every 3 weeks. Enrollment for Stage 2 started after the rituximab SC dose was established in Stage 1. Stage 2 aimed to further investigate the efficacy and safety of rituximab SC compared with rituximab IV. The anticipated time on study treatment is 96 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Cluster of differentiation 20 (CD20)-positive, follicular Non-Hodgkin's lymphoma grade 1, 2, 3a. A tumor biopsy must have been performed within 6 months before study entrywith material available for central review

  • No prior treatment

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Exclusion

Exclusion Criteria:

  • Grade 3b follicular lymphoma

  • Transformation to high-grade lymphoma secondary to follicular lymphoma

  • Types of Non-Hodgkin's lymphoma other than follicular lymphoma

  • Presence or history of central nervous system (CNS) disease

  • Corticoid therapy during the last 4 weeks, except prednisone treatment less than (<) 20 milligrams per day (mg per day)

  • Known active bacterial, viral, fungal, or mycobacterial, or any major episode ofinfections requiring hospitalization or treatment with IV antibiotics within 4 weeksof start of study medication, or oral antibiotics within 2 weeks prior to start ofstudy medication

Study Design

Total Participants: 410
Study Start date:
February 15, 2011
Estimated Completion Date:
October 31, 2017

Connect with a study center

  • Gosford Hospital; Cancer Care Services

    Gosford, New South Wales 2250
    Australia

    Site Not Available

  • Wollongong Hospital; Cancer Services

    Wollongong, New South Wales 2500
    Australia

    Site Not Available

  • Royal Brisbane and Women's Hospital

    Herston, Queensland 4029
    Australia

    Site Not Available

  • Gold Coast Hospital; Haematology Department

    Southport, Queensland 4215
    Australia

    Site Not Available

  • Queen Elizabeth Hospital; Haematology

    Woodville South, South Australia 5011
    Australia

    Site Not Available

  • empty

    Adelaide, 5011
    Australia

    Site Not Available

  • UZ Antwerpen

    Edegem, 2650
    Belgium

    Site Not Available

  • empty

    Liège, 4000
    Belgium

    Site Not Available

  • CHU Sart-Tilman

    Liège, 4000
    Belgium

    Site Not Available

  • Sint Augustinus Wilrijk

    Wilrijk, 2610
    Belgium

    Site Not Available

  • University Clinical Center of the Republic of Srpska, Clinic for Internal Disease, Hematology Dept

    Banja Luka, 88000
    Bosnia and Herzegovina

    Site Not Available

  • University Clinical Center Sarajevo, Clinic for Hematology

    Sarajevo, 71000
    Bosnia and Herzegovina

    Site Not Available

  • University Clinical Centre Tuzla, Clinic for Oncology, Hematology and Radiotherapy

    Tuzla, 75000
    Bosnia and Herzegovina

    Site Not Available

  • Nucleo de Hematologia e Transplante de Medula Ossea de Minas Gerais

    Belo Horizonte, MG 30140-001
    Brazil

    Site Not Available

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, RS 90610-000
    Brazil

    Site Not Available

  • Hospital das Clinicas - UFRGS

    Porto Alegre, RS 90035-003
    Brazil

    Site Not Available

  • Hospital das Clinicas - FMUSP

    Sao Paulo, SP 05403-000
    Brazil

    Site Not Available

  • Santa Casa de Misericordia de Sao Paulo; Hematologia e Hemoterapia

    Sao Paulo, SP 01221-020
    Brazil

    Site Not Available

  • empty

    Sao Paulo - Sp, 01246-903
    Brazil

    Site Not Available

  • empty

    São Paulo, 05403-000
    Brazil

    Site Not Available

  • empty

    São Paulo, 01223-001
    Brazil

    Site Not Available

  • UMHAT Dr Georgi Stranski; Hematology

    Pleven, 5800
    Bulgaria

    Site Not Available

  • Umhat S. George; Hematology

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • Specialised Hospital For Treatment Of Hematological Diseases; Hematology

    Sofia, 1756
    Bulgaria

    Site Not Available

  • Mhat Sveta Marina; Dept. of Haematology

    Varna, 9010
    Bulgaria

    Site Not Available

  • Queen Elizabeth II Health Sciences Centre; Oncology

    Halifax, Nova Scotia B3H 2Y9
    Canada

    Site Not Available

  • Cite de La Sante de Laval; Hemato-Oncologie

    Laval, Quebec H7M 3L9
    Canada

    Site Not Available

  • Centre de sante et de services sociaux Rimouski Neigette

    Rimouski, Quebec G5L 5T1
    Canada

    Site Not Available

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec J1H 5N4
    Canada

    Site Not Available

  • Centre hospitalier regional de Trois-Rivieres

    Trois-Rivieres, Quebec G8Z 3R9
    Canada

    Site Not Available

  • CHU de Quebec - Hopital de l'Enfant-Jesus; Unite de Recherche en Hematologie et Oncologie

    Quebec, G1J 1Z4
    Canada

    Site Not Available

  • Fundacion Cardioinfantil

    Bogota,
    Colombia

    Site Not Available

  • Centro Medico Imbanaco

    Cali,
    Colombia

    Site Not Available

  • empty

    Medellin,
    Colombia

    Site Not Available

  • Hospital Pablo Tobon Uribe

    Medellin-Antioquia,
    Colombia

    Site Not Available

  • Oncólogos de Occidente

    Pereira, 600004
    Colombia

    Site Not Available

  • UHC Rijeka

    Rijeka, 51000
    Croatia

    Site Not Available

  • University Hospital Center Zagreb; Haematology Department

    Zagreb, 10000
    Croatia

    Site Not Available

  • Herlev Uni Hospital; Hæmatologisk Afdeling L 121

    Herlev, 2730
    Denmark

    Site Not Available

  • empty

    Hillerød, 3400
    Denmark

    Site Not Available

  • empty

    København, 2100
    Denmark

    Site Not Available

  • empty

    København, 2100
    Denmark

    Site Not Available

  • Rigshospitalet; Hæmatologisk Klinik

    København Ø, 2100
    Denmark

    Site Not Available

  • Odense Universitetshospital; Hæmatologisk Afdeling

    Odense, 5000
    Denmark

    Site Not Available

  • Odense Universitetshospital; Hæmatologisk Afdeling

    Odense C, 5000
    Denmark

    Site Not Available

  • Sygehus Syd Roskilde; Onkologisk/haematologisk ambulatorium

    Roskilde, 4000
    Denmark

    Site Not Available

  • Vejle Hospital; Dept of Medicine, Division of Hematology

    Vejle, 7100
    Denmark

    Site Not Available

  • empty

    Ã…rhus, 8000
    Denmark

    Site Not Available

  • Aarhus Universitetshospital, Hæmatologisk Afdeling R

    Århus, 8000
    Denmark

    Site Not Available

  • Helsinki University Central Hospital; Dept of Oncology

    Helsinki, 00029
    Finland

    Site Not Available

  • Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie

    Bordeaux, 33077
    France

    Site Not Available

  • Hopital Henri Mondor; Hematologie Clinique

    Creteil, 94010
    France

    Site Not Available

  • Chu Site Du Bocage;Hematologie Clinique

    Dijon, 21079
    France

    Site Not Available

  • Clinique Victor Hugo; Chimiotherapie

    Le Mans, 72015
    France

    Site Not Available

  • Institut J Paolii Calmettes; Onco Hematologie 1

    Marseille, 13273
    France

    Site Not Available

  • Hopital Saint Eloi; Hematologie Oncologie Medicale

    Montpellier, 34295
    France

    Site Not Available

  • Hopital Hotel Dieu Et Hme;Hopital De Jour

    Nantes, 44093
    France

    Site Not Available

  • Hopital Saint Louis ; Service d Oncologie Medicale Fougere 6 (Pr Misset)

    Paris, 75475
    France

    Site Not Available

  • Hopital De Haut Leveque; Hematologie Clinique

    Pessac, 33604
    France

    Site Not Available

  • Ch Lyon Sud; Hemato Secteur Jules Courmont

    Pierre Benite, 69495
    France

    Site Not Available

  • Hopital De La Miletrie; Hematologie Et Oncologie Medicale

    Poitiers, 86021
    France

    Site Not Available

  • Hopital Bretonneau; Hematologie Therapie Cellulaire

    Tours, 37044
    France

    Site Not Available

  • Chemotherapy and Immunotherapy Clinic Medulla

    Tbilisi, 0186
    Georgia

    Site Not Available

  • Institute of Hematology and Transfusiology

    Tbilisi, 0177
    Georgia

    Site Not Available

  • M.Zodelava's Hematology Center

    Tbilisi, 0112
    Georgia

    Site Not Available

  • Mediclub

    Tbilisi, 0160
    Georgia

    Site Not Available

  • Onkologische Schwerpunktpraxis Kurfürstendamm

    Berlin, 10707
    Germany

    Site Not Available

  • Klinikum Darmstadt GmbH; Med. Klinik V; Onkologie & Hämatologie

    Darmstadt, 64283
    Germany

    Site Not Available

  • Gemeinschaftspraxis Dr. med. J. Mohm und Dr. med. G. Prange-Krex; Fachaerzte fuer Innere Medizin

    Dresden, 01307
    Germany

    Site Not Available

  • PIOH PD Dr. R. Schnell - Dr. H. Schulz - Dr. M. Hellmann

    Frechen, 50226
    Germany

    Site Not Available

  • empty

    GIEßEN, 35390
    Germany

    Site Not Available

  • empty

    GIEßEN, 35390
    Germany

    Site Not Available

  • Universitätsklinikum Gießen und Marburg GmbH Standort Gießen Medizinische Klinik I

    Giessen, 35392
    Germany

    Site Not Available

  • Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik

    Greifswald, 17475
    Germany

    Site Not Available

  • Internistisch-Onkologische Gemeinschaftspraxis; Dres. Rohrberg, Hurtz, Schma usw.

    Halle, 06110
    Germany

    Site Not Available

  • Medizinische Hochschule; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie

    Hannover, 30625
    Germany

    Site Not Available

  • St. Vincentius Kliniken Ag; Medizinische Klinik Abt. 2

    Karlsruhe, 76137
    Germany

    Site Not Available

  • UKSH Klinik für Innere Medizin II, Hämatologie und Internistische Onkologie

    Kiel, 24105
    Germany

    Site Not Available

  • Gemeinschaftspraxis PD Dr. med. Marcel Reiser und Dr. med. Ildiko Kátay

    Koeln, 50674
    Germany

    Site Not Available

  • empty

    Köln, 50674
    Germany

    Site Not Available

  • empty

    Köln, 50674
    Germany

    Site Not Available

  • Onkologische Gemeinschaftspraxis

    Magdeburg, 39104
    Germany

    Site Not Available

  • empty

    Magedburg, 39104
    Germany

    Site Not Available

  • Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach

    Marburg, 35037
    Germany

    Site Not Available

  • empty

    Muenster, 48149
    Germany

    Site Not Available

  • empty

    München, 80335
    Germany

    Site Not Available

  • empty

    Münster, 48149
    Germany

    Site Not Available

  • Medizinisches Versorgungszentrum MOP

    München, 80335
    Germany

    Site Not Available

  • empty

    Münster, 48149
    Germany

    Site Not Available

  • Praxis Dr.med. Jens Uhlig

    Naunhof, 04683
    Germany

    Site Not Available

  • Praxis Dr. Clemens Müller-Naendrup (Onkologische Schwerpunktpraxis im MVZ 2 GmbH)

    Olpe, 57462
    Germany

    Site Not Available

  • Prosper-Hospital, Medizinische Klinik I

    Recklinghausen, 45659
    Germany

    Site Not Available

  • Praxis Dr. Fenchel

    Saalfeld, 07318
    Germany

    Site Not Available

  • Caritas Kilinik St. Theresia; Abt. Innere Medizin

    Saarbruecken, 66113
    Germany

    Site Not Available

  • Praxis für Hämatologie & Onkologie

    Saarbruecken, 66113
    Germany

    Site Not Available

  • empty

    Saarbrücken, 66113
    Germany

    Site Not Available

  • empty

    Saarbrücken, 66113
    Germany

    Site Not Available

  • Attiko Hospital; Haematology Clinic

    Athens, 124 62
    Greece

    Site Not Available

  • Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine

    Athens, 115 27
    Greece

    Site Not Available

  • Azienda Ospedaliera Ospedale S.Carlo; Ematologia

    Potenza, Basilicata 85100
    Italy

    Site Not Available

  • A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica

    Napoli, Campania 80131
    Italy

    Site Not Available

  • AUSL - IRCCS Santa Maria Nuova; U.O. Day Hospital di Oncologia

    Reggio Emilia, Emilia-Romagna 42100
    Italy

    Site Not Available

  • Ospedale S. Eugenio; Divisione Di Ematologia

    Roma, Lazio 00144
    Italy

    Site Not Available

  • Uni Degli Studi Di Genova; 1A Divisione Di Ematologia

    Genova, Liguria 16132
    Italy

    Site Not Available

  • A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia

    Brescia, Lombardia 25123
    Italy

    Site Not Available

  • Irccs Istituto Europeo Di Oncologia (IEO); Emato-Oncologia

    Milano, Lombardia 20141
    Italy

    Site Not Available

  • IRCCS Ospedale Casa Sollievo Della Sofferenza; Ematologia E Trapianto Di Midollo Osseo

    San Giovanni Rotondo, Puglia 71013
    Italy

    Site Not Available

  • Ospedale Ca Foncello; Ematologia

    Treviso, Veneto 31100
    Italy

    Site Not Available

  • Ospedale Di Vicenza; Nefrologia, Ematologia

    Vicenza, Veneto 36100
    Italy

    Site Not Available

  • University Clinic for Hematology; HSCT Department

    Skopje, 1000
    Macedonia, The Former Yugoslav Republic of

    Site Not Available

  • University Clinic of Hematology Skopje, Hospital Care Department

    Skopje, 1000
    Macedonia, The Former Yugoslav Republic of

    Site Not Available

  • University Malaya Medical Center; Hematology Unit of Department of Internal Medicine

    Kuala Lumpur, FED. Territory OF Kuala Lumpur 59100
    Malaysia

    Site Not Available

  • Ampang Hospital; Department of Haematology

    Ampang, 68000
    Malaysia

    Site Not Available

  • empty

    Kuching, 93586
    Malaysia

    Site Not Available

  • Sarawak General Hospital; Department of Radiotherapy, Oncology and Palliative care

    Sarawak, 93586
    Malaysia

    Site Not Available

  • Centro Estatal De Cancerologia De Chihuahua; Servicio De Hematologia Banco De Sangre

    Chihuahua, 31000
    Mexico

    Site Not Available

  • Hospital General De Culiacan; Servicio De Hematologia

    Culiacan, 80230
    Mexico

    Site Not Available

  • Hospital Universitario Dr. Jose E. Gonzalez; Haematology

    Monterrey, 64460
    Mexico

    Site Not Available

  • Centro de Estudios Clinicos de Queretaro (CECLIQ)

    Queretaro, 76000
    Mexico

    Site Not Available

  • Canterbury Health Laboratories; Haematology

    Christchurch, 8011
    New Zealand

    Site Not Available

  • Palmerston North Hospital; Regional Cancer Treatment Service

    Palmerston North, 4442
    New Zealand

    Site Not Available

  • Hospital Maria Auxiliadora

    Lima, Lima 29
    Peru

    Site Not Available

  • Instituto;Oncologico Miraflores

    Lima, 18
    Peru

    Site Not Available

  • Oncosalud Sac; Oncología

    Lima, 41
    Peru

    Site Not Available

  • empty

    San Juan de Miraflores, Lima 29
    Peru

    Site Not Available

  • Spitalul Clinic Judetean de Urgenta Brasov,Clinica de Hematologie

    Brasov, 500326
    Romania

    Site Not Available

  • Fundeni Clinical Inst. ; Hematology Dept

    Bucharest, 022328
    Romania

    Site Not Available

  • Institutul Regional de Oncologie Iasi; Clinica de Hematologie

    Iasi, 700483
    Romania

    Site Not Available

  • Spitalul Clinic Judetean de Urgenta Sf. Spiridon Iasi, Clinica de Hematologie

    Iasi, 700111
    Romania

    Site Not Available

  • Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie

    Targu-mures, 540136
    Romania

    Site Not Available

  • Spitalul Clinic municipal de Urgenta Timisoara; Clinica de Hematologie

    Timisoara, 300079
    Romania

    Site Not Available

  • Clinical Oncology Dispensary of Ministry of Health of Tatarstan

    Kazan, 420029
    Russian Federation

    Site Not Available

  • Haematology Research Center; Haematology

    Moscow, 125167
    Russian Federation

    Site Not Available

  • N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis

    Moscow, 115478
    Russian Federation

    Site Not Available

  • Penza Regional Oncology Dispensary

    Penza, 440071
    Russian Federation

    Site Not Available

  • St. Petersburg State Medical University n.a. I.P. Pavlov; Hematology, transfusiology and transplanta

    Saint-Petersburg, 197022
    Russian Federation

    Site Not Available

  • Research Inst. of Hematology & Blood Transfusion ; Hematology

    St Petersburg, 191024
    Russian Federation

    Site Not Available

  • Russian Scientific Center of Radiology and Surgical Technologies; Dept of Radiology

    St.Petersburg, Pesochny, 197758
    Russian Federation

    Site Not Available

  • Institute of Hematology

    Belgrade, 11000
    Serbia

    Site Not Available

  • Clinical Center Vojvodine; Clinic for Hematology

    Novi Sad, 21000
    Serbia

    Site Not Available

  • National Cancer Centre; Medical Oncology

    Singapore, 169610
    Singapore

    Site Not Available

  • National University Hospital; National University Cancer Institute, Singapore (NCIS)

    Singapore, 119228
    Singapore

    Site Not Available

  • Singapore General Hospital; Department of Haematology

    Singapore, 169608
    Singapore

    Site Not Available

  • National Cancer Inst. ; Dept. of Chemotherapy

    Bratislava, 833 10
    Slovakia

    Site Not Available

  • St. Elisabeths Cancer Center

    Bratislava, 812 50
    Slovakia

    Site Not Available

  • National Hospital; Oncotherapy Dept

    Bloemfontein, 9301
    South Africa

    Site Not Available

  • empty

    Cape Town, 7506
    South Africa

    Site Not Available

  • King Edward VIII; Department of Haematology

    Congella, 4013
    South Africa

    Site Not Available

  • Durban Oncology Center

    Durban, 4091
    South Africa

    Site Not Available

  • University of Witwatersrand/Johannesburg Hospital; Dept. of ocnology

    Johannesburg, 2193
    South Africa

    Site Not Available

  • Cancercare

    Kraaifontein, 7570
    South Africa

    Site Not Available

  • Hospital Universitario Puerta del Mar; Servicio de Hematologia

    Cádiz, Cadiz 11009
    Spain

    Site Not Available

  • Hospital Clínic i Provincial; Servicio de Hematología y Oncología

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Duran i Reynals; Servicio de Hematologia

    Barcelona, 08907
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron; Servicio de Hematologia

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital del Mar; Servicio de Hematologia

    Barcelona, 08003
    Spain

    Site Not Available

  • empty

    Cádiz, 11009
    Spain

    Site Not Available

  • empty

    Hospitalet de Llobregat, 08907
    Spain

    Site Not Available

  • Hospital Ramon y Cajal; Servicio de Hematologia

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Universitario de la Princesa; Servicio de Hematologia

    Madrid, 28006
    Spain

    Site Not Available

  • Hospital Universitario Virgen de Arrixaca; Servicio de Hematologia

    Murcia, 30120
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Salamanca;Servicio de Hematologia

    Salamanca, 37007
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio; Servicio de Hematologia

    Sevilla, 41013
    Spain

    Site Not Available

  • Hospital Universitario la Fe; Servicio de Oncologia

    Valencia, 46026
    Spain

    Site Not Available

  • National Cancer Inst.

    Bangkok, 10400
    Thailand

    Site Not Available

  • Siriraj Hospital; Division of Hematology, Department of Medicine

    Bangkok, 10700
    Thailand

    Site Not Available

  • Srinagarind Hospital, Khon Kaen Uni ; Dept of Medicine

    Khon Kaen, 40002
    Thailand

    Site Not Available

  • Adana Baskent University Hospital; Medical Oncology

    Adana, 01120
    Turkey

    Site Not Available

  • Bilim University School of Medicine; Hematology

    Istanbul, 34394
    Turkey

    Site Not Available

  • Istanbul University Cerrahpasa Medical Faculty; Hematology Department

    Istanbul, 34098
    Turkey

    Site Not Available

  • Dokuz Eylul Uni ; Hematology

    Izmir, 35100
    Turkey

    Site Not Available

  • Ege Uni Medical School; Hematology

    Izmir, 35100
    Turkey

    Site Not Available

  • Ninewells Hospital & Medical School; Ward 34

    Dundee, DD1 9SY
    United Kingdom

    Site Not Available

  • empty

    London, NW3 2QS
    United Kingdom

    Site Not Available

  • Maidstone & Tonbridge Wells Hospital; Kent Oncology Center

    Maidstone, ME16 9QQ
    United Kingdom

    Site Not Available

  • Derriford Hospital; Department of Haematology

    Plymouth, PL6 8DH
    United Kingdom

    Site Not Available

  • Queen's Hospital; Oncology

    Romford, RM7 0AG
    United Kingdom

    Site Not Available

  • Southampton General Hospital

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • Pinderfields General Hospital; Dept of Haematology

    Wakefield, WF1 4DG
    United Kingdom

    Site Not Available

  • New Cross Hospital; Dept. Of Haematology

    Wolverhampton, WV10 0QP
    United Kingdom

    Site Not Available

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