Non-Hodgkin's LymphomaPhase 3MabCuteNCT01461928
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
A Phase 3 study testing Chemotherapy (Induction Period) and Rituximab in people with Non-Hodgkin's Lymphoma, run by Hoffmann-La Roche at 180 sites in 24 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma
- What is being tested?
- Chemotherapy (Induction Period) and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 692 participants
- Where
- 180 sitesin 24 countries
- Study dates
- 20 Dec 2011to 2 Jun 2018
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
180 sites in 24 countries.
180 sites in 24 countries
France26 sites
Centre Hospitalier Uni Ire; Service Des Maladies Du Sang
Angers, 49933
CH Henri Mondor; Med Interne Neuro Endocrinologie
Aurillac, 15000
Centre Hospitalier de La Cote Basque; Hematologie
Bayonne, 64109
Hopital Jean Minjoz; Hematologie
Besançon, 25030
Hopital Augustin Morvan; Hematologie
Brest, 29609
Institut d'Hématologie de Basse Normandie
Caen, 14000
CH Metropole de Savoie
Chambéry, 73011
Chu Estaing; Hematologie Clinique Adultes
Clermont-Ferrand, 63003
Ch Sud Francilien; Hematologie Oncologie
Corbeil-Essonnes, 91000
Hopital Henri Mondor
Créteil, 94010
Chu Site Du Bocage;Hematologie Clinique
Dijon, 21079
Centre Hospitalier Departemental Les Oudairies
La Roche-sur-Yon, 85925
Hôpital Albert Michallon; Hematologie Clinique
La Tronche, 38700
Hopital Andre Mignot; Hematologie - Oncologie
Le Chesnay, 78157
Ch Du Mans; Medecine Hematologie Oncologie
Le Mans, 72037
Hopital Claude Huriez; Hematologie
Lille, 59037
Hopital Uni Ire Dupuytren; Hematologie
Limoges, 87042
Hopital Nord; Laboratoire D'Hematologie
Marseille, 13015
Hôpital Lapeyronie; Hématologie Oncologie Médicale
Montpellier, 34295
Hopital Emile Muller; Hematologie
Mulhouse, 68070
Hopital Hotel Dieu Et Hme; Clinique Dermatologique
Nantes, 44093
Centre Antoine Lacassagne;B4 Hematologie Cancerologie
Nice, 06189
Hopital Pitie Salpetriere; Hematologie Clinique
Paris, 75651
Hopital De Haut Leveque; Hematologie Clinique
Pessac, 33604
Centre Henri Becquerel; Hematologie
Rouen, 76038
Hopital Purpan; Hematologie Clinique
Toulouse, 31059
Germany25 sites
Gemeinschaftspraxis Dr. Bueckner und Dr. Nueckel
Bochum, 44787
Klinikum Darmstadt GmbH; Med. Klinik V; Onkologie & Hämatologie
Darmstadt, 64283
St. Johannes Hospital; Abt. für Hämatologie und Onkologie
Dortmund, 44137
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie
Dresden, 01307
Gemeinschaftspraxis Dr. med. J. Mohm und Dr. med. G. Prange-Krex; Fachaerzte fuer Innere Medizin
Dresden, 01307
Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik
Greifswald, 17475
Internistisch-Onkologische Gemeinschaftspraxis; Dres. Rohrberg, Hurtz, Schma usw.
Halle, 06110
OncoResearch Lerchenfeld GmbH
Hamburg, 22081
Onkologische Schwerpunktpraxis (Eps-Gmbh)
Jena, 07743
Dres. Richard Hansen Susanne Pfitzner-Dempfle und Manfred Reeb
Kaiserslautern, 67655
Dres. Barbara Tschechne Stefanie Luft und Wolf-Oliver Jordan
Lehrte, 31275
Onkologische Schwerpunktpraxis Lübeck
Lübeck, 23562
Onkologische Gemeinschaftspraxis
Magdeburg, 39104
Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach
Marburg, 35037
Dres. Michael Maasberg Marion Schmitz und Maria Theresia Keller
Mayen, 56727
Staedtisches Krankenhaus Muenchen-Schwabing, Haematologie & Onkolgie
München, 80804
Hamatol Onkol Praxisgemeinschaft Dres H H-D Schick/D Schick
München, 81241
Klinikum Grosshadern der LMU
München, 81377
Klinikum rechts der Isar der TU München; III. Medizinischen Klinik (Hämatologie/Onkologie)
München, 81675
Praxis Dr.med. Jens Uhlig
Naunhof, 04683
Oncologianova GmbH
Recklinghausen, 45659
Klinik der Uni Regensburg; Hämatologie/Onkologie, Studienzentrale
Regensburg, 93053
Dres. Andreas Hübner, Andreas Lück und Petra Bruhn
Rostock, 18107
Dres. Ulrich Banhardt und Thomas Fietz
Singen, 78224
Dres. Emil Höring Matthias Respondek und Ulrike Schwinger
Stuttgart, 70190
Italy20 sites
Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica
Bari, Apulia, 70124
A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
Bologna, Emilia-Romagna, 40138
Azienda Sanitaria Di Bolzano; Ematologia E Centro Trapianto Mid.Osseo
Bolzano, Trentino-Alto Adige, 39100
Az. Osp. Di Careggi; Divisione Di Ematologia
Florence, Tuscany, 50135
A.O. Universitaria S. Martino Di Genova; Ematologia 1
Genoa, Liguria, 16132
Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora
Milan, Lombardy, 20122
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
Milan, Lombardy, 20162
A.O.U. Policlinico di Modena-Dipartimento di Medicina Diagnostica, Clinica e di Sanità pubblica
Modena, Emilia-Romagna, 41100
A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica
Naples, Campania, 80131
Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica
Naples, Campania, 80131
Ospedale Cardarelli; Divisione Di Ematologia
Naples, Campania, 80131
Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia
Padova, Veneto, 35128
Ospedale Santa Chiara; Unita Operativa Di Ematologia
Pisa, Tuscany, 56100
Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol
Rome, Lazio, 00161
A.O. Universitaria Senese; Ematologia
Siena, Tuscany, 53100
Ospedale Ca Foncello; Ematologia
Treviso, Veneto, 31100
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1
Turin, Piedmont, 10126
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica
Udine, Friuli Venezia Giulia, 33100
Uni Di Verona Policlinico G.B. Rossi; Divisione E Cattedra Di Ematologia
Verona, Veneto, 37130
Ospedale Ferrarotto; Divisione Di Ematologia
Via S. Sofia 78, Sicily, 95123
Spain20 sites
Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia
Badalona, Barcelona, 08915
Hospital de la Santa Creu i Sant Pau; Servicio de Hematologia
Barcelona, 08025
Hospital Universitari Vall d'Hebron; Servicio de Hematologia
Barcelona, 08035
Hospital Duran i Reynals; Servicio de Hematologia
Barcelona, 08907
Hospital San Pedro De Alcantara; Servicio de Hematologia
Cáceres, 10003
Hospital General Universitario de Elche; Servicio de Oncologia
Elche, Alicante, 03203
Hospital Universitario San Cecilio; Servicio de Oncologia
Granada, 18003
Complejo Hospitalario de Jaen- Hospital Universitario Medico Quirurgico; Servicio de Hematologia
Jaén, 23007
Hospital de Jerez de la Frontera; Servicio de Hematologia
Jerez de la Frontera, Cadiz, 11407
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio Hematologia
Madrid, 28050
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Hematologia
Málaga, 29010
Complejo Hospitalario Universitario de Ourense, Servicio de Hematologia
Ourense, 32005
Hospital Univ. Central de Asturias; servicio de Hematologia
Oviedo, Principality of Asturias, 33011
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07014
Hospital Quiron de Madrid; Servicio de Hematologia
Pozuelo de Alarcón, Madrid, 28223
Hospital Universitario de Canarias;servicio de Hematologia
San Cristóbal de La Laguna, Tenerife, 38320
Hospital Universitario de Canarias;servicio de Oncologia
San Cristóbal de La Laguna, Tenerife, 38320
Hospital Arnau de Vilanova (Valencia) Servicio de Hematologia
Valencia, 46015
Complejo Hospitalario Zamora- H. Virgen de la Concha; Servicio de Hematología
Zamora, 49002
Hospital Royo Villanova; Servicio de Hematologia
Zaragoza, 50015
United Kingdom15 sites
Birmingham Heartlands Hospital; Department of Haematology
Birmingham, B9 5SS
Royal Bournemouth General Hospital; Haematology
Bournemouth, BH7 7DW
Addenbrookes Hospital; Haematology
Cambridge, CB2 0QQ
Kent & Canterbury Hospital; Clinical Haematology
Canterbury, CT1 3NG
Uni Hospital of Wales; Dept of Haematology
Cardiff, CF14 4XW
Leicester Royal Infirmary; Dept of Haematology
Leicester, LE1 5WW
Royal Liverpool Uni Hospital; Haematology
Liverpool, L7 8XP
University College London, Department of Haematology
London, NW1 2PG
The Royal Marsden Hospital; Dept of Medicine
London, SW3 5PT
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
Norfolk & Norwich Hospital; Dept of Haematology
Norwich, NR4 7UY
Nottingham City Hospital; Dept of Haematology
Nottingham, NG5 1PB
Churchill Hospital; Oxford Cancer and Haematology Centre
Oxford, OX3 7LJ
Derriford Hospital; Haematology
Plymouth, PL6 8DH
Royal Marsden Hospital; Dept. of Medicine
Sutton, SM2 5PT
Brazil8 sites
Hospital de Cancer de Barretos
Barretos, São Paulo, 14784-400
Centro de Pesquisas Oncologicas - CEPON
Florianópolis, Santa Catarina, 88034-000
Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia
Passo Fundo, Rio Grande do Sul, 99010-260
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, 90035-003
Centro de Tratamento Oncologico - CETRON
Rio de Janeiro, Rio de Janeiro, 22250-906
Instituto de Ensino e Pesquisa Sao Lucas - IEP
São Paulo, São Paulo, 01236-030
Hospital das Clinicas - FMUSP; Hematologia
São Paulo, São Paulo, 05403-000
Hospital Santa Marcelina;Oncologia
São Paulo, São Paulo, 08270-070
Russia8 sites
Regional Oncology Center
Chelyabinsk, 454087
N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis
Moscow, 115478
Rus Med Academy for Postgraduate Education; Oncology Department
Moscow, 123995
City Clin Hosp n.a. S.P.Botkin
Moscow, 125101
Regional Clinical Hospital N.A. Semashko; Hematology
Nizhny Novgorod, 603126
SRI of Hematology and Transfusiology
Saint Petersburg, 191024
Leningrad Regional Clinical Hospital
Saint Petersburg, 194291
Petrov Research Inst. of Oncology
Saint Petersburg, 197758
Romania6 sites
Policlinica de Diagnostic Rapid
Brasov, 500152
County Clinical Emergency Hospital Brasov
Brasov, 500360
Institutul Clinic Fundeni; Hematologie
Bucharest, 022338
Spitalul Clinic Coltea; Clinica de Hematologie
Bucharest, 030171
Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie
Târgu Mureş, 540136
Spitalul Clinic municipal de Urgenta Timisoara; Clinica de Hematologie
Timișoara, 300079
Sweden6 sites
Laenssjukhuset; Medicinkliniken/Hematologsektionen
Halmstad, 30185
Sunderby Sjukhus; Medicinkliniken
Luleå, S-971 80
Capio, S:T Gorans Hospital; Dept of Medicine
Stockholm, 112 81
Södersjukhuset, Medicinkliniken/Sektionen för Hematologi
Stockholm, 118 83
Uddevalla Sjukhus; Medicinkliniken
Uddevalla, 45180
Västmanlands sjukhus Västerås, Onkologmottagningen
Västerås, 72189
Turkey (Türkiye)6 sites
GATA (Gulhane Military Medical School)
Ankara, 06010
Hacettepe Uni Medical Faculty; Hematology
Ankara, 06100
Gazi Uni Medical School; Hematology
Ankara, 06500
Istanbul Uni Capa Medical Faculty; Inst. of Oncology
Istanbul, 34093
Marmara University Pendik Training and Research Hospital, Hematology Department
Istanbul, 34300
Erciyes Uni ; Hematology
Kayseri, 38039
Austria5 sites
Lkh-Univ. Klinikum Graz; Klin. Abt. Für Hämatologie
Graz, 8036
Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
Innsbruck, 6020
Kepler Universitätskliniken GmbH - Med Campus III; III. Medizinische Abteilung
Linz, 4020
Landeskrankenhaus Rankweil; Interne E
Rankweil, 6830
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Hämatologie & Hämostaseologie
Vienna, 1090
Greece5 sites
General Hospital of Athens Evangelismos; Hematology
Athens, 106 76
Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine
Athens, 115 27
University Hospital of Ioannina; Hematology
Ioannina, 455 00
University Hospital of Larissa; Hematology Dept.
Larissa, 411100
University Hospital Of Patras; Dept. Of Internal Medicine-Hematology Division
Pátrai, 265 00
Hungary5 sites
Semmelweis University, First Dept of Medicine
Budapest, 1083
St Laszlo Hospital, Pharmacy
Budapest, 1097
National Institute of Oncology, A Dept of Internal Medicine
Budapest, 1122
Uni of Debrecen; 2Nd Clinic of Internal Medicine
Debrecen, 4004
University of Pecs, I st Dept of Internal Medicine
Pécs, 7624
Ecuador4 sites
Hospital Abel Gilbert Ponton; Oncology
Guayaquil, EC090104
Teodoro Maldonado Carbo Hospital; Oncology Service
Guayaquil, EC090150
Hospital Solca Portoviejo; Oncologia
Portoviejo, EC130104
Hospital Solca Quito; Oncologia
Quito, EC170124
Norway4 sites
Haukeland Universitetssykehus
Bergen, 5021
Oslo Universitetssykehus HF; Radiumhospitalet
Oslo, 0310
Helse Stavanger HF, Stavanger Universitetssjukehus; Klinikk for Blod og kreftsykdommer
Stavanger, 4011
St. Olavs Hospital HF, Kreftavdelingen, Gastrosentret
Trondheim, 7030
Argentina3 sites
CEMIC Saavedra
Buenos Aires, 1431
Instituto Damic
Córdoba, X5003DCE
Hospital Privado de Comunidad; Oncology
Mar del Plata, 7600
Bulgaria3 sites
UMHAT Dr Georgi Stranski; Hematology
Pleven, 5800
Tokuda Hospital Sofia; Hematology department
Sofia, 1407
UMHAT Alexandrovska EAD; Hematology
Sofia, 1431
Colombia3 sites
Centro Javeriano de Oncología
Bogotá
Fundacion Santa Fe de Bogotá
Bogotá
Instituto Nacional de Cancerologia; Hematology
Bogotá
Slovakia2 sites
National Oncology Inst. ; Dept. of Haematology
Bratislava, 833 10
Uni Hospital ; Dept. of Haematol. & Transfusion Medicine
Martin, 036 59
Switzerland2 sites
Ospedale San Giovanni; Oncologia
Bellinzona, 6500
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
Zurich, 8091
Albania1 site
University "Mother Theresa" Hospital Center; Oncology Department
Tirana, 1000
About this study
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
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.
- Conditions
- Non-Hodgkin's Lymphoma
- Being tested
- Chemotherapy (Induction Period), Rituximab
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemotherapy (Induction Period)Drug
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.
RituximabDrug
Also called Rituxan, MabThera, RO0452294
Participants will receive rituximab according to the regimen specified in individual arm.
| Study group | Role | What they receive |
|---|---|---|
| Maintenance II Period Observation Only | Other | Participants 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. Receives: Drug: Chemotherapy (Induction Period); Drug: Rituximab |
| Maintenance II Period Rituximab | Experimental | Participants 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). Receives: Drug: Chemotherapy (Induction Period); Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
An adverse event is any untoward medical occurrence in a subject 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. Not all AEs were followed up for the randomized Observation arm. Only Serious AEs and AE grade 3-5 (obtained retrospectively) were collected for this arm. Therefore arms are not comparable overall.
Measured: 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
Event-Free Survival was measured from the day of first rituximab Induction dose through Maintenance I and Maintenance II rituximab arm until the date of any treatment failure, including disease progression, or discontinuation of treatment for any reason (e.g. disease progression, toxicity, patient preference, initiation of new anti-lymphoma treatment, or death). Treatment discontinuation was considered as an event and was not applicable to the randomized observation arm.
Measured: 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)
Time to next lymphoma treatment (TNLT) is defined as the time from date of first rituximab induction dose to the date date of first documented intake of any new antilymphoma treatment (chemotherapy, radiotherapy, immunotherapy, etc.).
Measured: From day of first rituximab induction dose up to any new lymphoma treatment (up to approximately 87 months)
Overall Survival
Overall survival from first induction treatment (OSRegist) is defined as the time from date of first rituximab induction dose to the date of death, irrespective of cause. 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.
Measured: From day of first rituximab induction dose up to death (up to approximately 87 months)
Maintenance II: Overall Survival
Overall survival from randomization (OSrand) is defined as the time from date of randomization to the date of death, irrespective of cause.
Measured: From randomization (Maintenance II) up to death (up to approximately 24 months)
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
Overall response rate is defined as the proportion of responders at the end of the Induction period. A responder is defined as a participant experiencing either CR or PR tumor response according to the Cheson response criteria for indolent lymphoma or the recommendations for Waldenström's macroglobulinemia.
Measured: From day of first rituximab induction dose up to end of induction period (up to approximately 8 months)
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
Measured: From day of first rituximab induction dose up to end of Maintenance I period (up to approximately 32 months)
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 first induction treatment (PFSregist) is defined as the time from date of first rituximab induction dose to the date of first documented disease progression or death by any cause, whichever occurs first.
Measured: From day of first rituximab induction dose up to disease progression or death, whichever occurs first (up to approximately 87 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study start20 Dec 2011
- Primary completion2 Jun 2018
- Study completion2 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 692 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461928
- Sponsor's protocol ID
- MO25455
- Other IDs
- 2010-023407-95
- Acronym
- MabCute
- Status last verified
- Jul 2019
- First submitted
- 19 Oct 2011
- Last updated
- 6 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 34134469Theodore-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.
PubMed 27695295Rule 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.
PubMed 24720836