Clinical trial 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
Official title: A Randomized Study Comparing Maintenance Therapy With Subcutaneous Rituximab Continued Until Progression With Observation Only in Patients With Relapsed or Refractory, Indolent Non-Hodgkin's Lymphoma Who Completed and Responded to Rituximab-based Immunochemotherapy Induction and Initial 2-year Rituximab Maintenance Therapy Administered Subcutaneously
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Hodgkin's Lymphoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-10-28
Enrollment: 692
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This multicenter, randomized, open-label, parallel-group study will evaluate the efficacy and safety of subcutaneously administered rituximab in comparison with observation only as maintenance therapy in participants with relapsed or refractory indolent Non-Hodgkin's lymphoma (NHL). All participants will receive induction therapy with rituximab (375 milligrams per square meter \[mg/m\^2\] intravenously \[IV\] in Cycle 1, then 1400 mg subcutaneous \[SC\] every 3-4 weeks) plus standard chemotherapy for 6-8 months; followed by 24 months of maintenance I period with rituximab (1400 mg SC every 8 weeks). Participants completing therapy and showing partial or complete response will be randomized to receive either rituximab (1400 mg SC every 8 weeks) or observation with no treatment during maintenance II period and will be followed for at least 15 months. Anticipated time on study treatment is until disease progression, unacceptable toxicity or end of study, whichever occurs first.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed Cluster of Differentiation 20-positive (CD20+) follicular NHL Grade 1, 2 or 3a, or other CD20+ indolent NHL (Waldenström's macroglobulinemia or lymphoplasmacytic lymphoma, marginal zone lymphoma) according to World Health Organization (WHO) classification system
* Participants must have received and must have relapsed or been refractory to, one or more lines of adequate therapy prior to enrollment, including at least one line consisting of immunotherapy and/or chemotherapy and/or radiotherapy
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to (\<=) 2

Exclusion Criteria:

* Transformation to high-grade lymphoma
* Aggressive lymphoma (for example, mantle cell lymphoma \[MCL\])
* Presence or history of central nervous system (CNS) lymphomatous disease
* Other malignancy within 5 years prior to enrollment, except for curatively treated carcinoma in situ of the cervix, squamous cell carcinoma of the skin or basal cell skin cancer, or cervical carcinoma Stage 1B or less, breast cancer in situ or localized prostate cancer Stage T1c if treated with curative intent and relapse- and metastasis-free for at least 2 years prior to enrollment
* Inadequate hematological, hepatic or renal function
* Known human immunodeficiency virus (HIV) infection
* Active and/or severe infection (e.g. tuberculosis, sepsis and opportunistic infections, active hepatitis B or C)
* Pregnant or breastfeeding women

Primary outcomes:
measure: Maintenance II: Progression-free Survival (PFS) Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia
timeFrame: From randomization (Maintenance II) up to disease progression or death, whichever occurs first (up to approximately 24 months)
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs), Serious AEs, and Infusion/Administration-related Reactions (IRRs/ARRs)
timeFrame: From day of first rituximab induction dose up to day of disease progression, or discontinuation of treatment for any reason (up to approximately 87 months)
measure: Event-free Survival (Time to Treatment Failure) Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia
timeFrame: From day of first rituximab induction dose up to day of any treatment failure, including disease progression, or discontinuation of treatment for any reason (up to approximately 87 months)
measure: Time to Next Lymphoma Treatment (TNLT)
timeFrame: From day of first rituximab induction dose up to any new lymphoma treatment (up to approximately 87 months)
measure: Overall Survival
timeFrame: From day of first rituximab induction dose up to death (up to approximately 87 months)
measure: Maintenance II: Overall Survival
timeFrame: From randomization (Maintenance II) up to death (up to approximately 24 months)
measure: Percentage of Participants With Partial or Complete Tumor Response (PR/CR) Assessment at End of Induction Using 1999 International Working Group Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia
timeFrame: From day of first rituximab induction dose up to end of induction period (up to approximately 8 months)
measure: Maintenance I: Percentage of Participants With Conversion of PR to CR Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia
timeFrame: From day of first rituximab induction dose up to end of Maintenance I period (up to approximately 32 months)
measure: Progression-free Survival (PFS) Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia
timeFrame: From day of first rituximab induction dose up to disease progression or death, whichever occurs first (up to approximately 87 months)
Other outcomes:
Locations:
city: Tirana
country: Albania
facility: University "Mother Theresa" Hospital Center; Oncology Department
city: Buenos Aires
country: Argentina
facility: CEMIC Saavedra
city: Cordoba
country: Argentina
facility: Instituto Damic
city: Mar Del Plata
country: Argentina
facility: Hospital Privado de Comunidad; Oncology
city: Graz
country: Austria
facility: Lkh-Univ. Klinikum Graz; Klin. Abt. Für Hämatologie
city: Innsbruck
country: Austria
facility: Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
city: Linz
country: Austria
facility: Kepler Universitätskliniken GmbH - Med Campus III; III. Medizinische Abteilung
city: Rankweil
country: Austria
facility: Landeskrankenhaus Rankweil; Interne E
city: Wien
country: Austria
facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Hämatologie & Hämostaseologie
city: Rio de janeiro
country: Brazil
facility: Centro de Tratamento Oncologico - CETRON
state: RJ
city: Passo Fundo
country: Brazil
facility: Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas - UFRGS
state: RS
city: Florianopolis
country: Brazil
facility: Centro de Pesquisas Oncologicas - CEPON
state: SC
city: Barretos
country: Brazil
facility: Hospital de Cancer de Barretos
state: SP
city: Sao Paulo
country: Brazil
facility: Instituto de Ensino e Pesquisa Sao Lucas - IEP
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas - FMUSP; Hematologia
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Santa Marcelina;Oncologia
state: SP
city: Pleven
country: Bulgaria
facility: UMHAT Dr Georgi Stranski; Hematology
city: Sofia
country: Bulgaria
facility: Tokuda Hospital Sofia; Hematology department
city: Sofia
country: Bulgaria
facility: UMHAT Alexandrovska EAD; Hematology
city: Bogota
country: Colombia
facility: Centro Javeriano de Oncología
city: Bogota
country: Colombia
facility: Fundacion Santa Fe de Bogotá
city: Bogota
country: Colombia
facility: Instituto Nacional de Cancerologia; Hematology
city: Guayaquil
country: Ecuador
facility: Hospital Abel Gilbert Ponton; Oncology
city: Guayaquil
country: Ecuador
facility: Teodoro Maldonado Carbo Hospital; Oncology Service
city: Portoviejo
country: Ecuador
facility: Hospital Solca Portoviejo; Oncologia
city: Quito
country: Ecuador
facility: Hospital Solca Quito; Oncologia
city: Cairo
country: Egypt
facility: Kasr Eieny Uni Hospital; Oncology (Nemrock)
city: Angers Cedex 9
country: France
facility: Centre Hospitalier Uni Ire; Service Des Maladies Du Sang
city: Aurillac
country: France
facility: CH Henri Mondor; Med Interne Neuro Endocrinologie
city: Bayonne
country: France
facility: Centre Hospitalier de La Cote Basque; Hematologie
city: Besancon
country: France
facility: Hopital Jean Minjoz; Hematologie
city: Brest
country: France
facility: Hopital Augustin Morvan; Hematologie
city: Caen
country: France
facility: Institut d'Hématologie de Basse Normandie
city: CHAMBERY Cedex
country: France
facility: CH Metropole de Savoie
city: Clermont Ferrand
country: France
facility: Chu Estaing; Hematologie Clinique Adultes
city: Corbeil Essonnes
country: France
facility: Ch Sud Francilien; Hematologie Oncologie
city: Creteil
country: France
facility: Hopital Henri Mondor
city: Dijon
country: France
facility: Chu Site Du Bocage;Hematologie Clinique
city: La Roche Sur Yon
country: France
facility: Centre Hospitalier Departemental Les Oudairies
city: La Tronche
country: France
facility: Hôpital Albert Michallon; Hematologie Clinique
city: Le Chesnay
country: France
facility: Hopital Andre Mignot; Hematologie - Oncologie
city: Le Mans
country: France
facility: Ch Du Mans; Medecine Hematologie Oncologie
city: Lille
country: France
facility: Hopital Claude Huriez; Hematologie
city: Limoges
country: France
facility: Hopital Uni Ire Dupuytren; Hematologie
city: Marseille
country: France
facility: Hopital Nord; Laboratoire D'Hematologie
city: Montpellier
country: France
facility: Hôpital Lapeyronie; Hématologie Oncologie Médicale
city: Mulhouse
country: France
facility: Hopital Emile Muller; Hematologie
city: Nantes
country: France
facility: Hopital Hotel Dieu Et Hme; Clinique Dermatologique
city: Nice
country: France
facility: Centre Antoine Lacassagne;B4 Hematologie Cancerologie
city: Paris
country: France
facility: Hopital Pitie Salpetriere; Hematologie Clinique
city: Pessac
country: France
facility: Hopital De Haut Leveque; Hematologie Clinique
city: Rouen
country: France
facility: Centre Henri Becquerel; Hematologie
city: Toulouse
country: France
facility: Hopital Purpan; Hematologie Clinique
city: Bochum
country: Germany
facility: Gemeinschaftspraxis Dr. Bueckner und Dr. Nueckel
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt GmbH; Med. Klinik V; Onkologie & Hämatologie
city: Dortmund
country: Germany
facility: St. Johannes Hospital; Abt. für Hämatologie und Onkologie
city: Dresden
country: Germany
facility: BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie
city: Dresden
country: Germany
facility: Gemeinschaftspraxis Dr. med. J. Mohm und Dr. med. G. Prange-Krex; Fachaerzte fuer Innere Medizin
city: Greifswald
country: Germany
facility: Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik
city: Halle
country: Germany
facility: Internistisch-Onkologische Gemeinschaftspraxis; Dres. Rohrberg, Hurtz, Schma usw.
city: Hamburg
country: Germany
facility: OncoResearch Lerchenfeld GmbH
city: Jena
country: Germany
facility: Onkologische Schwerpunktpraxis (Eps-Gmbh)
city: Kaiserslautern
country: Germany
facility: Dres. Richard Hansen Susanne Pfitzner-Dempfle und Manfred Reeb
city: Lehrte
country: Germany
facility: Dres. Barbara Tschechne Stefanie Luft und Wolf-Oliver Jordan
city: Lübeck
country: Germany
facility: Onkologische Schwerpunktpraxis Lübeck
city: Magdeburg
country: Germany
facility: Onkologische Gemeinschaftspraxis
city: Marburg
country: Germany
facility: Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach
city: Mayen
country: Germany
facility: Dres. Michael Maasberg Marion Schmitz und Maria Theresia Keller
city: Muenchen
country: Germany
facility: Klinikum Grosshadern der LMU
city: München
country: Germany
facility: Staedtisches Krankenhaus Muenchen-Schwabing, Haematologie & Onkolgie
city: München
country: Germany
facility: Hamatol Onkol Praxisgemeinschaft Dres H H-D Schick/D Schick
city: München
country: Germany
facility: Klinikum rechts der Isar der TU München; III. Medizinischen Klinik (Hämatologie/Onkologie)
city: Naunhof
country: Germany
facility: Praxis Dr.med. Jens Uhlig
city: Recklinghausen
country: Germany
facility: Oncologianova GmbH
city: Regensburg
country: Germany
facility: Klinik der Uni Regensburg; Hämatologie/Onkologie, Studienzentrale
city: Rostock
country: Germany
facility: Dres. Andreas Hübner, Andreas Lück und Petra Bruhn
city: Singen
country: Germany
facility: Dres. Ulrich Banhardt und Thomas Fietz
city: Stuttgart
country: Germany
facility: Dres. Emil Höring Matthias Respondek und Ulrike Schwinger
city: Athens
country: Greece
facility: General Hospital of Athens Evangelismos; Hematology
city: Athens
country: Greece
facility: Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine
city: Ioannina
country: Greece
facility: University Hospital of Ioannina; Hematology
city: Larissa
country: Greece
facility: University Hospital of Larissa; Hematology Dept.
city: Patras
country: Greece
facility: University Hospital Of Patras; Dept. Of Internal Medicine-Hematology Division
city: Budapest
country: Hungary
facility: Semmelweis University, First Dept of Medicine
city: Budapest
country: Hungary
facility: St Laszlo Hospital, Pharmacy
city: Budapest
country: Hungary
facility: National Institute of Oncology, A Dept of Internal Medicine
city: Debrecen
country: Hungary
facility: Uni of Debrecen; 2Nd Clinic of Internal Medicine
city: Pecs
country: Hungary
facility: University of Pecs, I st Dept of Internal Medicine
city: Napoli
country: Italy
facility: A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica
state: Campania
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica
state: Campania
city: Napoli
country: Italy
facility: Ospedale Cardarelli; Divisione Di Ematologia
state: Campania
city: Bologna
country: Italy
facility: A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
state: Emilia-Romagna
city: Modena
country: Italy
facility: A.O.U. Policlinico di Modena-Dipartimento di Medicina Diagnostica, Clinica e di Sanità pubblica
state: Emilia-Romagna
city: Udine
country: Italy
facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol
state: Lazio
city: Genova
country: Italy
facility: A.O. Universitaria S. Martino Di Genova; Ematologia 1
state: Liguria
city: Milano
country: Italy
facility: Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora
state: Lombardia
city: Milano
country: Italy
facility: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
state: Lombardia
city: Torino
country: Italy
facility: A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1
state: Piemonte
city: Bari
country: Italy
facility: Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica
state: Puglia
city: Via S. Sofia 78
country: Italy
facility: Ospedale Ferrarotto; Divisione Di Ematologia
state: Sicilia
city: Firenze
country: Italy
facility: Az. Osp. Di Careggi; Divisione Di Ematologia
state: Toscana
city: Pisa
country: Italy
facility: Ospedale Santa Chiara; Unita Operativa Di Ematologia
state: Toscana
city: Siena
country: Italy
facility: A.O. Universitaria Senese; Ematologia
state: Toscana
city: Bolzano
country: Italy
facility: Azienda Sanitaria Di Bolzano; Ematologia E Centro Trapianto Mid.Osseo
state: Trentino-Alto Adige
city: Padova
country: Italy
facility: Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia
state: Veneto
city: Treviso
country: Italy
facility: Ospedale Ca Foncello; Ematologia
state: Veneto
city: Verona
country: Italy
facility: Uni Di Verona Policlinico G.B. Rossi; Divisione E Cattedra Di Ematologia
state: Veneto
city: Klaipeda
country: Lithuania
facility: Seamen' Hospital' Dept. of haematology
city: Bergen
country: Norway
facility: Haukeland Universitetssykehus
city: Oslo
country: Norway
facility: Oslo Universitetssykehus HF; Radiumhospitalet
city: Stavanger
country: Norway
facility: Helse Stavanger HF, Stavanger Universitetssjukehus; Klinikk for Blod og kreftsykdommer
city: Trondheim
country: Norway
facility: St. Olavs Hospital HF, Kreftavdelingen, Gastrosentret
city: Brasov
country: Romania
facility: Policlinica de Diagnostic Rapid
city: Brasov
country: Romania
facility: County Clinical Emergency Hospital Brasov
city: Bucharest
country: Romania
facility: Institutul Clinic Fundeni; Hematologie
city: Bucuresti
country: Romania
facility: Spitalul Clinic Coltea; Clinica de Hematologie
city: Targu-mures
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie
city: Timisoara
country: Romania
facility: Spitalul Clinic municipal de Urgenta Timisoara; Clinica de Hematologie
city: Chelyabinsk
country: Russian Federation
facility: Regional Oncology Center
city: Moscow
country: Russian Federation
facility: N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis
city: Moscow
country: Russian Federation
facility: Rus Med Academy for Postgraduate Education; Oncology Department
city: Moscow
country: Russian Federation
facility: City Clin Hosp n.a. S.P.Botkin
city: Nizhny Novgorod
country: Russian Federation
facility: Regional Clinical Hospital N.A. Semashko; Hematology
city: St Petersburg
country: Russian Federation
facility: Leningrad Regional Clinical Hospital
city: St Petersburg
country: Russian Federation
facility: Petrov Research Inst. of Oncology
city: St. Petersburg
country: Russian Federation
facility: SRI of Hematology and Transfusiology
city: Bratislava
country: Slovakia
facility: National Oncology Inst. ; Dept. of Haematology
city: Martin
country: Slovakia
facility: Uni Hospital ; Dept. of Haematol. & Transfusion Medicine
city: Ljubljana
country: Slovenia
facility: Institute of Oncology Ljubljana
city: Elche
country: Spain
facility: Hospital General Universitario de Elche; Servicio de Oncologia
state: Alicante
city: Oviedo
country: Spain
facility: Hospital Univ. Central de Asturias; servicio de Hematologia
state: Asturias
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia
state: Barcelona
city: Jerez de La Frontera
country: Spain
facility: Hospital de Jerez de la Frontera; Servicio de Hematologia
state: Cadiz
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Islas Baleares
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Quiron de Madrid; Servicio de Hematologia
state: Madrid
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias;servicio de Hematologia
state: Tenerife
city: La Laguna
country: Spain
facility: Hospital Universitario de Canarias;servicio de Oncologia
state: Tenerife
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau; Servicio de Hematologia
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron; Servicio de Hematologia
city: Barcelona
country: Spain
facility: Hospital Duran i Reynals; Servicio de Hematologia
city: Caceres
country: Spain
facility: Hospital San Pedro De Alcantara; Servicio de Hematologia
city: Granada
country: Spain
facility: Hospital Universitario San Cecilio; Servicio de Oncologia
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaen- Hospital Universitario Medico Quirurgico; Servicio de Hematologia
city: Madrid
country: Spain
facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio Hematologia
city: Malaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria; Servicio de Hematologia
city: Orense
country: Spain
facility: Complejo Hospitalario Universitario de Ourense, Servicio de Hematologia
city: Valencia
country: Spain
facility: Hospital Arnau de Vilanova (Valencia) Servicio de Hematologia
city: Zamora
country: Spain
facility: Complejo Hospitalario Zamora- H. Virgen de la Concha; Servicio de Hematología
city: Zaragoza
country: Spain
facility: Hospital Royo Villanova; Servicio de Hematologia
city: Halmstad
country: Sweden
facility: Laenssjukhuset; Medicinkliniken/Hematologsektionen
city: Luleå
country: Sweden
facility: Sunderby Sjukhus; Medicinkliniken
city: Stockholm
country: Sweden
facility: Capio, S:T Gorans Hospital; Dept of Medicine
city: Stockholm
country: Sweden
facility: Södersjukhuset, Medicinkliniken/Sektionen för Hematologi
city: Uddevalla
country: Sweden
facility: Uddevalla Sjukhus; Medicinkliniken
city: Västerås
country: Sweden
facility: Västmanlands sjukhus Västerås, Onkologmottagningen
city: Bellinzona
country: Switzerland
facility: Ospedale San Giovanni; Oncologia
city: Zürich
country: Switzerland
facility: UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
city: Ankara
country: Turkey
facility: GATA (Gulhane Military Medical School)
city: Ankara
country: Turkey
facility: Hacettepe Uni Medical Faculty; Hematology
city: Ankara
country: Turkey
facility: Gazi Uni Medical School; Hematology
city: Istanbul
country: Turkey
facility: Istanbul Uni Capa Medical Faculty; Inst. of Oncology
city: Istanbul
country: Turkey
facility: Marmara University Pendik Training and Research Hospital, Hematology Department
city: Kayseri
country: Turkey
facility: Erciyes Uni ; Hematology
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital; Department of Haematology
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth General Hospital; Haematology
city: Cambridge
country: United Kingdom
facility: Addenbrookes Hospital; Haematology
city: Canterbury
country: United Kingdom
facility: Kent & Canterbury Hospital; Clinical Haematology
city: Cardiff
country: United Kingdom
facility: Uni Hospital of Wales; Dept of Haematology
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary; Dept of Haematology
city: Liverpool
country: United Kingdom
facility: Royal Liverpool Uni Hospital; Haematology
city: London
country: United Kingdom
facility: University College London, Department of Haematology
city: London
country: United Kingdom
facility: The Royal Marsden Hospital; Dept of Medicine
city: Newcastle upon Tyne
country: United Kingdom
facility: Freeman Hospital
city: Norwich
country: United Kingdom
facility: Norfolk & Norwich Hospital; Dept of Haematology
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital; Dept of Haematology
city: Oxford
country: United Kingdom
facility: Churchill Hospital; Oxford Cancer and Haematology Centre
city: Plymouth
country: United Kingdom
facility: Derriford Hospital; Haematology
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital; Dept. of Medicine
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Rule S, Barreto WG, Briones J, Carella AM, Casasnovas O, Pocock C, Wendtner CM, Zaja F, Robson S, MacGregor L, Tschopp RR, Nick S, Dreyling M. Efficacy and safety assessment of prolonged maintenance with subcutaneous rituximab in patients with relapsed or refractory indolent non-Hodgkin lymphoma: results of the phase III MabCute study. Haematologica. 2022 Feb 1;107(2):500-509. doi: 10.3324/haematol.2020.274803.
citation: Theodore-Oklota C, Humphrey L, Wiesner C, Schnetzler G, Hudgens S, Campbell A. Validation of a treatment satisfaction questionnaire in non-Hodgkin lymphoma: assessing the change from intravenous to subcutaneous administration of rituximab. Patient Prefer Adherence. 2016 Sep 13;10:1767-1776. doi: 10.2147/PPA.S108489. eCollection 2016.
citation: Rule S, Collins GP, Samanta K. Subcutaneous vs intravenous rituximab in patients with non-Hodgkin lymphoma: a time and motion study in the United Kingdom. J Med Econ. 2014 Jul;17(7):459-68. doi: 10.3111/13696998.2014.914033. Epub 2014 May 7.