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
MabCute
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
2 other identifiers
interventional
692
23 countries
178
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2011
Longer than P75 for phase_3
178 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2011
CompletedFirst Posted
Study publicly available on registry
October 28, 2011
CompletedStudy Start
First participant enrolled
December 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 2, 2018
CompletedResults Posted
Study results publicly available
August 6, 2019
CompletedAugust 6, 2019
July 1, 2019
6.5 years
October 19, 2011
May 31, 2019
July 16, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Maintenance II: Progression-free Survival (PFS) Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia
Progression free survival from randomization (PFSrand) is defined as the time from date of randomization to the date of first documented disease progression or death, whichever occurs first. One participant died in Induction before randomization and one participant died in Maintenance II Observation arm due to an SAE and were not considered in the analysis as no death page was completed. The Observation arm did not include one participant with AE outcome of death reported retrospectively 2 months after discontinuation from study (censored as having no event on Day 456 post-randomization).
From randomization (Maintenance II) up to disease progression or death, whichever occurs first (up to approximately 24 months)
Secondary Outcomes (8)
Number of Participants With Adverse Events (AEs), Serious AEs, and Infusion/Administration-related Reactions (IRRs/ARRs)
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)
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
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)
Time to Next Lymphoma Treatment (TNLT)
From day of first rituximab induction dose up to any new lymphoma treatment (up to approximately 87 months)
Overall Survival
From day of first rituximab induction dose up to death (up to approximately 87 months)
Maintenance II: Overall Survival
From randomization (Maintenance II) up to death (up to approximately 24 months)
- +3 more secondary outcomes
Study Arms (2)
Maintenance II Period Observation Only
OTHERParticipants will receive standard chemotherapy regimen in combination with 375 mg/m\^2 rituximab IV in Cycle 1 (3-4 week-cycles), followed by 1400 mg rituximab SC every 3-4 weeks for 8 cycles (induction period); 1400 mg rituximab SC every 8 weeks for 24 months (Maintenance I period); no treatment in Maintenance II period until disease progression or end of study, whichever occurs first.
Maintenance II Period Rituximab
EXPERIMENTALParticipants will receive standard chemotherapy regimen in combination with 375 mg/m\^2 rituximab IV in Cycle 1 (3-4 week-cycles), followed by 1400 mg rituximab SC every 3-4 weeks for 8 cycles (induction period); 1400 mg rituximab SC every 8 weeks for 24 months (Maintenance I period); 1400 mg rituximab SC every 8 weeks until disease progression or end of study, whichever occurs first (Maintenance II period).
Interventions
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.
Participants will receive rituximab according to the regimen specified in individual arm.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (180)
University "Mother Theresa" Hospital Center; Oncology Department
Tirana, 1000, Albania
CEMIC Saavedra
Buenos Aires, 1431, Argentina
Instituto Damic
Córdoba, X5003DCE, Argentina
Hospital Privado de Comunidad; Oncology
Mar del Plata, 7600, Argentina
Lkh-Univ. Klinikum Graz; Klin. Abt. Für Hämatologie
Graz, 8036, Austria
Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
Innsbruck, 6020, Austria
Kepler Universitätskliniken GmbH - Med Campus III; III. Medizinische Abteilung
Linz, 4020, Austria
Landeskrankenhaus Rankweil; Interne E
Rankweil, 6830, Austria
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Hämatologie & Hämostaseologie
Vienna, 1090, Austria
Centro de Tratamento Oncologico - CETRON
Rio de Janeiro, Rio de Janeiro, 22250-906, Brazil
Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia
Passo Fundo, Rio Grande do Sul, 99010-260, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
Centro de Pesquisas Oncologicas - CEPON
Florianópolis, Santa Catarina, 88034-000, Brazil
Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400, Brazil
Instituto de Ensino e Pesquisa Sao Lucas - IEP
São Paulo, São Paulo, 01236-030, Brazil
Hospital das Clinicas - FMUSP; Hematologia
São Paulo, São Paulo, 05403-000, Brazil
Hospital Santa Marcelina;Oncologia
São Paulo, São Paulo, 08270-070, Brazil
UMHAT Dr Georgi Stranski; Hematology
Pleven, 5800, Bulgaria
Tokuda Hospital Sofia; Hematology department
Sofia, 1407, Bulgaria
UMHAT Alexandrovska EAD; Hematology
Sofia, 1431, Bulgaria
Centro Javeriano de Oncología
Bogotá, Colombia
Fundacion Santa Fe de Bogotá
Bogotá, Colombia
Instituto Nacional de Cancerologia; Hematology
Bogotá, Colombia
Hospital Abel Gilbert Ponton; Oncology
Guayaquil, EC090104, Ecuador
Teodoro Maldonado Carbo Hospital; Oncology Service
Guayaquil, EC090150, Ecuador
Hospital Solca Portoviejo; Oncologia
Portoviejo, EC130104, Ecuador
Hospital Solca Quito; Oncologia
Quito, EC170124, Ecuador
Kasr Eieny Uni Hospital; Oncology (Nemrock)
Cairo, 11562, Egypt
Centre Hospitalier Uni Ire; Service Des Maladies Du Sang
Angers, 49933, France
CH Henri Mondor; Med Interne Neuro Endocrinologie
Aurillac, 15000, France
Centre Hospitalier de La Cote Basque; Hematologie
Bayonne, 64109, France
Hopital Jean Minjoz; Hematologie
Besançon, 25030, France
Hopital Augustin Morvan; Hematologie
Brest, 29609, France
Institut d'Hématologie de Basse Normandie
Caen, 14000, France
CH Metropole de Savoie
Chambéry, 73011, France
Chu Estaing; Hematologie Clinique Adultes
Clermont-Ferrand, 63003, France
Ch Sud Francilien; Hematologie Oncologie
Corbeil-Essonnes, 91000, France
Hopital Henri Mondor
Créteil, 94010, France
Chu Site Du Bocage;Hematologie Clinique
Dijon, 21079, France
Centre Hospitalier Departemental Les Oudairies
La Roche-sur-Yon, 85925, France
Hôpital Albert Michallon; Hematologie Clinique
La Tronche, 38700, France
Hopital Andre Mignot; Hematologie - Oncologie
Le Chesnay, 78157, France
Ch Du Mans; Medecine Hematologie Oncologie
Le Mans, 72037, France
Hopital Claude Huriez; Hematologie
Lille, 59037, France
Hopital Uni Ire Dupuytren; Hematologie
Limoges, 87042, France
Hopital Nord; Laboratoire D'Hematologie
Marseille, 13015, France
Hôpital Lapeyronie; Hématologie Oncologie Médicale
Montpellier, 34295, France
Hopital Emile Muller; Hematologie
Mulhouse, 68070, France
Hopital Hotel Dieu Et Hme; Clinique Dermatologique
Nantes, 44093, France
Centre Antoine Lacassagne;B4 Hematologie Cancerologie
Nice, 06189, France
Hopital Pitie Salpetriere; Hematologie Clinique
Paris, 75651, France
Hopital De Haut Leveque; Hematologie Clinique
Pessac, 33604, France
Centre Henri Becquerel; Hematologie
Rouen, 76038, France
Hopital Purpan; Hematologie Clinique
Toulouse, 31059, France
Gemeinschaftspraxis Dr. Bueckner und Dr. Nueckel
Bochum, 44787, Germany
Klinikum Darmstadt GmbH; Med. Klinik V; Onkologie & Hämatologie
Darmstadt, 64283, Germany
St. Johannes Hospital; Abt. für Hämatologie und Onkologie
Dortmund, 44137, Germany
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie
Dresden, 01307, Germany
Gemeinschaftspraxis Dr. med. J. Mohm und Dr. med. G. Prange-Krex; Fachaerzte fuer Innere Medizin
Dresden, 01307, Germany
Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik
Greifswald, 17475, Germany
Internistisch-Onkologische Gemeinschaftspraxis; Dres. Rohrberg, Hurtz, Schma usw.
Halle, 06110, Germany
OncoResearch Lerchenfeld GmbH
Hamburg, 22081, Germany
Onkologische Schwerpunktpraxis (Eps-Gmbh)
Jena, 07743, Germany
Dres. Richard Hansen Susanne Pfitzner-Dempfle und Manfred Reeb
Kaiserslautern, 67655, Germany
Dres. Barbara Tschechne Stefanie Luft und Wolf-Oliver Jordan
Lehrte, 31275, Germany
Onkologische Schwerpunktpraxis Lübeck
Lübeck, 23562, Germany
Onkologische Gemeinschaftspraxis
Magdeburg, 39104, Germany
Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach
Marburg, 35037, Germany
Dres. Michael Maasberg Marion Schmitz und Maria Theresia Keller
Mayen, 56727, Germany
Staedtisches Krankenhaus Muenchen-Schwabing, Haematologie & Onkolgie
München, 80804, Germany
Hamatol Onkol Praxisgemeinschaft Dres H H-D Schick/D Schick
München, 81241, Germany
Klinikum Grosshadern der LMU
München, 81377, Germany
Klinikum rechts der Isar der TU München; III. Medizinischen Klinik (Hämatologie/Onkologie)
München, 81675, Germany
Praxis Dr.med. Jens Uhlig
Naunhof, 04683, Germany
Oncologianova GmbH
Recklinghausen, 45659, Germany
Klinik der Uni Regensburg; Hämatologie/Onkologie, Studienzentrale
Regensburg, 93053, Germany
Dres. Andreas Hübner, Andreas Lück und Petra Bruhn
Rostock, 18107, Germany
Dres. Ulrich Banhardt und Thomas Fietz
Singen, 78224, Germany
Dres. Emil Höring Matthias Respondek und Ulrike Schwinger
Stuttgart, 70190, Germany
General Hospital of Athens Evangelismos; Hematology
Athens, 106 76, Greece
Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine
Athens, 115 27, Greece
University Hospital of Ioannina; Hematology
Ioannina, 455 00, Greece
University Hospital of Larissa; Hematology Dept.
Larissa, 411100, Greece
University Hospital Of Patras; Dept. Of Internal Medicine-Hematology Division
Pátrai, 265 00, Greece
Semmelweis University, First Dept of Medicine
Budapest, 1083, Hungary
St Laszlo Hospital, Pharmacy
Budapest, 1097, Hungary
National Institute of Oncology, A Dept of Internal Medicine
Budapest, 1122, Hungary
Uni of Debrecen; 2Nd Clinic of Internal Medicine
Debrecen, 4004, Hungary
University of Pecs, I st Dept of Internal Medicine
Pécs, 7624, Hungary
Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica
Bari, Apulia, 70124, Italy
A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica
Napoli, Campania, 80131, Italy
Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica
Napoli, Campania, 80131, Italy
Ospedale Cardarelli; Divisione Di Ematologia
Napoli, Campania, 80131, Italy
A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
Bologna, Emilia-Romagna, 40138, Italy
A.O.U. Policlinico di Modena-Dipartimento di Medicina Diagnostica, Clinica e di Sanità pubblica
Modena, Emilia-Romagna, 41100, Italy
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica
Udine, Friuli Venezia Giulia, 33100, Italy
Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol
Rome, Lazio, 00161, Italy
A.O. Universitaria S. Martino Di Genova; Ematologia 1
Genoa, Liguria, 16132, Italy
Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora
Milan, Lombardy, 20122, Italy
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
Milan, Lombardy, 20162, Italy
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1
Turin, Piedmont, 10126, Italy
Ospedale Ferrarotto; Divisione Di Ematologia
Via S. Sofia 78, Sicily, 95123, Italy
Azienda Sanitaria Di Bolzano; Ematologia E Centro Trapianto Mid.Osseo
Bolzano, Trentino-Alto Adige, 39100, Italy
Az. Osp. Di Careggi; Divisione Di Ematologia
Florence, Tuscany, 50135, Italy
Ospedale Santa Chiara; Unita Operativa Di Ematologia
Pisa, Tuscany, 56100, Italy
A.O. Universitaria Senese; Ematologia
Siena, Tuscany, 53100, Italy
Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia
Padua, Veneto, 35128, Italy
Ospedale Ca Foncello; Ematologia
Treviso, Veneto, 31100, Italy
Uni Di Verona Policlinico G.B. Rossi; Divisione E Cattedra Di Ematologia
Verona, Veneto, 37130, Italy
Seamen' Hospital' Dept. of haematology
Klaipėda, 92288, Lithuania
Haukeland Universitetssykehus
Bergen, 5021, Norway
Oslo Universitetssykehus HF; Radiumhospitalet
Oslo, 0310, Norway
Helse Stavanger HF, Stavanger Universitetssjukehus; Klinikk for Blod og kreftsykdommer
Stavanger, 4011, Norway
St. Olavs Hospital HF, Kreftavdelingen, Gastrosentret
Trondheim, 7030, Norway
Policlinica de Diagnostic Rapid
Brasov, 500152, Romania
County Clinical Emergency Hospital Brasov
Brasov, 500360, Romania
Institutul Clinic Fundeni; Hematologie
Bucharest, 022338, Romania
Spitalul Clinic Coltea; Clinica de Hematologie
Bucharest, 030171, Romania
Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie
Târgu Mureş, 540136, Romania
Spitalul Clinic municipal de Urgenta Timisoara; Clinica de Hematologie
Timișoara, 300079, Romania
Regional Oncology Center
Chelyabinsk, 454087, Russia
N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis
Moscow, 115478, Russia
Rus Med Academy for Postgraduate Education; Oncology Department
Moscow, 123995, Russia
City Clin Hosp n.a. S.P.Botkin
Moscow, 125101, Russia
Regional Clinical Hospital N.A. Semashko; Hematology
Nizhny Novgorod, 603126, Russia
SRI of Hematology and Transfusiology
Saint Petersburg, 191024, Russia
Leningrad Regional Clinical Hospital
Saint Petersburg, 194291, Russia
Petrov Research Inst. of Oncology
Saint Petersburg, 197758, Russia
National Oncology Inst. ; Dept. of Haematology
Bratislava, 833 10, Slovakia
Uni Hospital ; Dept. of Haematol. & Transfusion Medicine
Martin, 036 59, Slovakia
Institute of Oncology Ljubljana
Ljubljana, 1000, Slovenia
Hospital General Universitario de Elche; Servicio de Oncologia
Elche, Alicante, 03203, Spain
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07014, Spain
Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia
Badalona, Barcelona, 08915, Spain
Hospital de Jerez de la Frontera; Servicio de Hematologia
Jerez de la Frontera, Cadiz, 11407, Spain
Hospital Quiron de Madrid; Servicio de Hematologia
Pozuelo de Alarcón, Madrid, 28223, Spain
Hospital Univ. Central de Asturias; servicio de Hematologia
Oviedo, Principality of Asturias, 33011, Spain
Hospital Universitario de Canarias;servicio de Hematologia
San Cristóbal de La Laguna, Tenerife, 38320, Spain
Hospital Universitario de Canarias;servicio de Oncologia
San Cristóbal de La Laguna, Tenerife, 38320, Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Hematologia
Barcelona, 08025, Spain
Hospital Universitari Vall d'Hebron; Servicio de Hematologia
Barcelona, 08035, Spain
Hospital Duran i Reynals; Servicio de Hematologia
Barcelona, 08907, Spain
Hospital San Pedro De Alcantara; Servicio de Hematologia
Cáceres, 10003, Spain
Hospital Universitario San Cecilio; Servicio de Oncologia
Granada, 18003, Spain
Complejo Hospitalario de Jaen- Hospital Universitario Medico Quirurgico; Servicio de Hematologia
Jaén, 23007, Spain
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio Hematologia
Madrid, 28050, Spain
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Hematologia
Málaga, 29010, Spain
Complejo Hospitalario Universitario de Ourense, Servicio de Hematologia
Ourense, 32005, Spain
Hospital Arnau de Vilanova (Valencia) Servicio de Hematologia
Valencia, 46015, Spain
Complejo Hospitalario Zamora- H. Virgen de la Concha; Servicio de Hematología
Zamora, 49002, Spain
Hospital Royo Villanova; Servicio de Hematologia
Zaragoza, 50015, Spain
Laenssjukhuset; Medicinkliniken/Hematologsektionen
Halmstad, 30185, Sweden
Sunderby Sjukhus; Medicinkliniken
Luleå, S-971 80, Sweden
Capio, S:T Gorans Hospital; Dept of Medicine
Stockholm, 112 81, Sweden
Södersjukhuset, Medicinkliniken/Sektionen för Hematologi
Stockholm, 118 83, Sweden
Uddevalla Sjukhus; Medicinkliniken
Uddevalla, 45180, Sweden
Västmanlands sjukhus Västerås, Onkologmottagningen
Västerås, 72189, Sweden
Ospedale San Giovanni; Oncologia
Bellinzona, 6500, Switzerland
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
Zurich, 8091, Switzerland
GATA (Gulhane Military Medical School)
Ankara, 06010, Turkey (Türkiye)
Hacettepe Uni Medical Faculty; Hematology
Ankara, 06100, Turkey (Türkiye)
Gazi Uni Medical School; Hematology
Ankara, 06500, Turkey (Türkiye)
Istanbul Uni Capa Medical Faculty; Inst. of Oncology
Istanbul, 34093, Turkey (Türkiye)
Marmara University Pendik Training and Research Hospital, Hematology Department
Istanbul, 34300, Turkey (Türkiye)
Erciyes Uni ; Hematology
Kayseri, 38039, Turkey (Türkiye)
Birmingham Heartlands Hospital; Department of Haematology
Birmingham, B9 5SS, United Kingdom
Royal Bournemouth General Hospital; Haematology
Bournemouth, BH7 7DW, United Kingdom
Addenbrookes Hospital; Haematology
Cambridge, CB2 0QQ, United Kingdom
Kent & Canterbury Hospital; Clinical Haematology
Canterbury, CT1 3NG, United Kingdom
Uni Hospital of Wales; Dept of Haematology
Cardiff, CF14 4XW, United Kingdom
Leicester Royal Infirmary; Dept of Haematology
Leicester, LE1 5WW, United Kingdom
Royal Liverpool Uni Hospital; Haematology
Liverpool, L7 8XP, United Kingdom
University College London, Department of Haematology
London, NW1 2PG, United Kingdom
The Royal Marsden Hospital; Dept of Medicine
London, SW3 5PT, United Kingdom
Freeman Hospital
Newcastle upon Tyne, NE7 7DN, United Kingdom
Norfolk & Norwich Hospital; Dept of Haematology
Norwich, NR4 7UY, United Kingdom
Nottingham City Hospital; Dept of Haematology
Nottingham, NG5 1PB, United Kingdom
Churchill Hospital; Oxford Cancer and Haematology Centre
Oxford, OX3 7LJ, United Kingdom
Derriford Hospital; Haematology
Plymouth, PL6 8DH, United Kingdom
Royal Marsden Hospital; Dept. of Medicine
Sutton, SM2 5PT, United Kingdom
Related Publications (3)
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.
PMID: 34134469DERIVEDTheodore-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.
PMID: 27695295DERIVEDRule 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.
PMID: 24720836DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2011
First Posted
October 28, 2011
Study Start
December 20, 2011
Primary Completion
June 2, 2018
Study Completion
June 2, 2018
Last Updated
August 6, 2019
Results First Posted
August 6, 2019
Record last verified: 2019-07