A Study Comparing Maintenance Subcutaneous Rituximab With Observation Only in Participants With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma Who Had Responded to Rituximab-based Immunochemotherapy Induction and 2-year Maintenance With Subcutaneous Rituximab

PHASE3CompletedINTERVENTIONAL
Enrollment

692

Participants

Timeline

Start Date

December 20, 2011

Primary Completion Date

June 2, 2018

Study Completion Date

June 2, 2018

Conditions
Non-Hodgkin's Lymphoma
Interventions
DRUG

Chemotherapy (Induction Period)

Participants will receive standard combination chemotherapy every 3-4 weeks for 6 to 8 months. The chemotherapy regimen will be selected at Investigator's discretion, for individual participant. Study protocol does not enforce any particular chemotherapy regimen.

DRUG

Rituximab

Participants will receive rituximab according to the regimen specified in individual arm.

Trial Locations (180)

1000

"University Mother Theresa Hospital Center; Oncology Department", Tirana

Institute of Oncology Ljubljana, Ljubljana

1083

Semmelweis University, First Dept of Medicine, Budapest

1090

Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Hämatologie & Hämostaseologie, Vienna

1097

St Laszlo Hospital, Pharmacy, Budapest

1122

National Institute of Oncology, A Dept of Internal Medicine, Budapest

1407

Tokuda Hospital Sofia; Hematology department, Sofia

1431

CEMIC Saavedra, Buenos Aires

UMHAT Alexandrovska EAD; Hematology, Sofia

4004

Uni of Debrecen; 2Nd Clinic of Internal Medicine, Debrecen

4011

Helse Stavanger HF, Stavanger Universitetssjukehus; Klinikk for Blod og kreftsykdommer, Stavanger

4020

Kepler Universitätskliniken GmbH - Med Campus III; III. Medizinische Abteilung, Linz

5021

Haukeland Universitetssykehus, Bergen

5800

UMHAT Dr Georgi Stranski; Hematology, Pleven

6020

Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie, Innsbruck

6500

Ospedale San Giovanni; Oncologia, Bellinzona

6830

Landeskrankenhaus Rankweil; Interne E, Rankweil

7030

St. Olavs Hospital HF, Kreftavdelingen, Gastrosentret, Trondheim

7600

Hospital Privado de Comunidad; Oncology, Mar del Plata

7624

University of Pecs, I st Dept of Internal Medicine, Pécs

8036

Lkh-Univ. Klinikum Graz; Klin. Abt. Für Hämatologie, Graz

8091

UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie, Zurich

10003

Hospital San Pedro De Alcantara; Servicio de Hematologia, Cáceres

10126

A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1, Turin

11407

Hospital de Jerez de la Frontera; Servicio de Hematologia, Jerez de la Frontera

11562

Kasr Eieny Uni Hospital; Oncology (Nemrock), Cairo

13015

Hopital Nord; Laboratoire D'Hematologie, Marseille

14000

Institut d'Hématologie de Basse Normandie, Caen

15000

CH Henri Mondor; Med Interne Neuro Endocrinologie, Aurillac

16132

A.O. Universitaria S. Martino Di Genova; Ematologia 1, Genoa

17475

Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik, Greifswald

18003

Hospital Universitario San Cecilio; Servicio de Oncologia, Granada

18107

Dres. Andreas Hübner, Andreas Lück und Petra Bruhn, Rostock

20122

Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora, Milan

20162

Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia, Milan

21079

Chu Site Du Bocage;Hematologie Clinique, Dijon

22081

OncoResearch Lerchenfeld GmbH, Hamburg

23007

Complejo Hospitalario de Jaen- Hospital Universitario Medico Quirurgico; Servicio de Hematologia, Jaén

23562

Onkologische Schwerpunktpraxis Lübeck, Lübeck

25030

Hopital Jean Minjoz; Hematologie, Besançon

28050

HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio Hematologia, Madrid

28223

Hospital Quiron de Madrid; Servicio de Hematologia, Pozuelo de Alarcón

29010

Hospital Clinico Universitario Virgen de la Victoria; Servicio de Hematologia, Málaga

29609

Hopital Augustin Morvan; Hematologie, Brest

30185

Laenssjukhuset; Medicinkliniken/Hematologsektionen, Halmstad

31059

Hopital Purpan; Hematologie Clinique, Toulouse

31100

Ospedale Ca Foncello; Ematologia, Treviso

31275

Dres. Barbara Tschechne Stefanie Luft und Wolf-Oliver Jordan, Lehrte

32005

Complejo Hospitalario Universitario de Ourense, Servicio de Hematologia, Ourense

33011

Hospital Univ. Central de Asturias; servicio de Hematologia, Oviedo

33100

A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica, Udine

33604

Hopital De Haut Leveque; Hematologie Clinique, Pessac

34093

Istanbul Uni Capa Medical Faculty; Inst. of Oncology, Istanbul

34295

Hôpital Lapeyronie; Hématologie Oncologie Médicale, Montpellier

34300

Marmara University Pendik Training and Research Hospital, Hematology Department, Istanbul

35037

Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach, Marburg

35128

Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia, Padua

37130

Uni Di Verona Policlinico G.B. Rossi; Divisione E Cattedra Di Ematologia, Verona

38039

Erciyes Uni ; Hematology, Kayseri

38320

Hospital Universitario de Canarias;servicio de Hematologia, San Cristóbal de La Laguna

Hospital Universitario de Canarias;servicio de Oncologia, San Cristóbal de La Laguna

38700

Hôpital Albert Michallon; Hematologie Clinique, La Tronche

39100

Azienda Sanitaria Di Bolzano; Ematologia E Centro Trapianto Mid.Osseo, Bolzano

39104

Onkologische Gemeinschaftspraxis, Magdeburg

40138

A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna, Bologna

41100

A.O.U. Policlinico di Modena-Dipartimento di Medicina Diagnostica, Clinica e di Sanità pubblica, Modena

44093

Hopital Hotel Dieu Et Hme; Clinique Dermatologique, Nantes

44137

St. Johannes Hospital; Abt. für Hämatologie und Onkologie, Dortmund

44787

Gemeinschaftspraxis Dr. Bueckner und Dr. Nueckel, Bochum

45180

Uddevalla Sjukhus; Medicinkliniken, Uddevalla

45659

Oncologianova GmbH, Recklinghausen

46015

Hospital Arnau de Vilanova (Valencia) Servicio de Hematologia, Valencia

49002

Complejo Hospitalario Zamora- H. Virgen de la Concha; Servicio de Hematología, Zamora

49933

Centre Hospitalier Uni Ire; Service Des Maladies Du Sang, Angers

50015

Hospital Royo Villanova; Servicio de Hematologia, Zaragoza

50135

Az. Osp. Di Careggi; Divisione Di Ematologia, Florence

53100

A.O. Universitaria Senese; Ematologia, Siena

56100

Ospedale Santa Chiara; Unita Operativa Di Ematologia, Pisa

56727

Dres. Michael Maasberg Marion Schmitz und Maria Theresia Keller, Mayen

59037

Hopital Claude Huriez; Hematologie, Lille

63003

Chu Estaing; Hematologie Clinique Adultes, Clermont-Ferrand

64109

Centre Hospitalier de La Cote Basque; Hematologie, Bayonne

64283

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

67655

Dres. Richard Hansen Susanne Pfitzner-Dempfle und Manfred Reeb, Kaiserslautern

68070

Hopital Emile Muller; Hematologie, Mulhouse

70124

Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica, Bari

70190

Dres. Emil Höring Matthias Respondek und Ulrike Schwinger, Stuttgart

72037

Ch Du Mans; Medecine Hematologie Oncologie, Le Mans

72189

Västmanlands sjukhus Västerås, Onkologmottagningen, Västerås

73011

CH Metropole de Savoie, Chambéry

75651

Hopital Pitie Salpetriere; Hematologie Clinique, Paris

76038

Centre Henri Becquerel; Hematologie, Rouen

78157

Hopital Andre Mignot; Hematologie - Oncologie, Le Chesnay

78224

Dres. Ulrich Banhardt und Thomas Fietz, Singen

80131

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

Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica, Napoli

Ospedale Cardarelli; Divisione Di Ematologia, Napoli

80804

Staedtisches Krankenhaus Muenchen-Schwabing, Haematologie & Onkolgie, München

81241

Hamatol Onkol Praxisgemeinschaft Dres H H-D Schick/D Schick, München

81377

Klinikum Grosshadern der LMU, München

81675

Klinikum rechts der Isar der TU München; III. Medizinischen Klinik (Hämatologie/Onkologie), München

85925

Centre Hospitalier Departemental Les Oudairies, La Roche-sur-Yon

87042

Hopital Uni Ire Dupuytren; Hematologie, Limoges

91000

Ch Sud Francilien; Hematologie Oncologie, Corbeil-Essonnes

92288

Seamen' Hospital' Dept. of haematology, Klaipėda

93053

Klinik der Uni Regensburg; Hämatologie/Onkologie, Studienzentrale, Regensburg

94010

Hopital Henri Mondor, Créteil

95123

Ospedale Ferrarotto; Divisione Di Ematologia, Via S. Sofia 78

115478

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

123995

Rus Med Academy for Postgraduate Education; Oncology Department, Moscow

125101

City Clin Hosp n.a. S.P.Botkin, Moscow

191024

SRI of Hematology and Transfusiology, Saint Petersburg

194291

Leningrad Regional Clinical Hospital, Saint Petersburg

197758

Petrov Research Inst. of Oncology, Saint Petersburg

300079

Spitalul Clinic municipal de Urgenta Timisoara; Clinica de Hematologie, Timișoara

411100

University Hospital of Larissa; Hematology Dept., Larissa

454087

Regional Oncology Center, Chelyabinsk

500152

Policlinica de Diagnostic Rapid, Brasov

500360

County Clinical Emergency Hospital Brasov, Brasov

540136

Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie, Târgu Mureş

603126

Regional Clinical Hospital N.A. Semashko; Hematology, Nizhny Novgorod

X5003DCE

Instituto Damic, Córdoba

22250-906

Centro de Tratamento Oncologico - CETRON, Rio de Janeiro

99010-260

Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia, Passo Fundo

90035-003

Hospital das Clinicas - UFRGS, Porto Alegre

88034-000

Centro de Pesquisas Oncologicas - CEPON, Florianópolis

14784-400

Hospital de Cancer de Barretos, Barretos

01236-030

Instituto de Ensino e Pesquisa Sao Lucas - IEP, São Paulo

05403-000

Hospital das Clinicas - FMUSP; Hematologia, São Paulo

08270-070

Hospital Santa Marcelina;Oncologia, São Paulo

Unknown

Centro Javeriano de Oncología, Bogotá

Fundacion Santa Fe de Bogotá, Bogotá

Instituto Nacional de Cancerologia; Hematology, Bogotá

EC090104

Hospital Abel Gilbert Ponton; Oncology, Guayaquil

EC090150

Teodoro Maldonado Carbo Hospital; Oncology Service, Guayaquil

EC130104

Hospital Solca Portoviejo; Oncologia, Portoviejo

EC170124

Hospital Solca Quito; Oncologia, Quito

06189

Centre Antoine Lacassagne;B4 Hematologie Cancerologie, Nice

01307

BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie, Dresden

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

06110

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

07743

Onkologische Schwerpunktpraxis (Eps-Gmbh), Jena

04683

Praxis Dr.med. Jens Uhlig, Naunhof

106 76

General Hospital of Athens Evangelismos; Hematology, Athens

115 27

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

455 00

University Hospital of Ioannina; Hematology, Ioannina

265 00

University Hospital Of Patras; Dept. Of Internal Medicine-Hematology Division, Pátrai

00161

Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol, Rome

0310

Oslo Universitetssykehus HF; Radiumhospitalet, Oslo

022338

Institutul Clinic Fundeni; Hematologie, Bucharest

030171

Spitalul Clinic Coltea; Clinica de Hematologie, Bucharest

833 10

National Oncology Inst. ; Dept. of Haematology, Bratislava

036 59

Uni Hospital ; Dept. of Haematol. & Transfusion Medicine, Martin

03203

Hospital General Universitario de Elche; Servicio de Oncologia, Elche

07014

Hospital Universitario Son Espases, Palma de Mallorca

08915

Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia, Badalona

08025

Hospital de la Santa Creu i Sant Pau; Servicio de Hematologia, Barcelona

08035

Hospital Universitari Vall d'Hebron; Servicio de Hematologia, Barcelona

08907

Hospital Duran i Reynals; Servicio de Hematologia, Barcelona

S-971 80

Sunderby Sjukhus; Medicinkliniken, Luleå

112 81

Capio, S:T Gorans Hospital; Dept of Medicine, Stockholm

118 83

Södersjukhuset, Medicinkliniken/Sektionen för Hematologi, Stockholm

06010

GATA (Gulhane Military Medical School), Ankara

06100

Hacettepe Uni Medical Faculty; Hematology, Ankara

06500

Gazi Uni Medical School; Hematology, Ankara

B9 5SS

Birmingham Heartlands Hospital; Department of Haematology, Birmingham

BH7 7DW

Royal Bournemouth General Hospital; Haematology, Bournemouth

CB2 0QQ

Addenbrookes Hospital; Haematology, Cambridge

CT1 3NG

Kent & Canterbury Hospital; Clinical Haematology, Canterbury

CF14 4XW

Uni Hospital of Wales; Dept of Haematology, Cardiff

LE1 5WW

Leicester Royal Infirmary; Dept of Haematology, Leicester

L7 8XP

Royal Liverpool Uni Hospital; Haematology, Liverpool

NW1 2PG

University College London, Department of Haematology, London

SW3 5PT

The Royal Marsden Hospital; Dept of Medicine, London

NE7 7DN

Freeman Hospital, Newcastle upon Tyne

NR4 7UY

Norfolk & Norwich Hospital; Dept of Haematology, Norwich

NG5 1PB

Nottingham City Hospital; Dept of Haematology, Nottingham

OX3 7LJ

Churchill Hospital; Oxford Cancer and Haematology Centre, Oxford

PL6 8DH

Derriford Hospital; Haematology, Plymouth

SM2 5PT

Royal Marsden Hospital; Dept. of Medicine, Sutton

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT01461928 - A Study Comparing Maintenance Subcutaneous Rituximab With Observation Only in Participants With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma Who Had Responded to Rituximab-based Immunochemotherapy Induction and 2-year Maintenance With Subcutaneous Rituximab | Biotech Hunter | Biotech Hunter