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

Non-Hodgkin's Lymphoma Clinical Trial

— MabCute  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01461928
• Other study ID #: MO25455
• Secondary ID: 2010-023407-95
• Status: Completed
• Phase: Phase 3
• Start date: December 20, 2011
• Est. completion date: June 2, 2018

Study information

• Verified date: July 2019
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 692
• Est. completion date: June 2, 2018
• Est. primary completion date: June 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Non-Hodgkin's Lymphoma

Intervention

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

Locations

Country	Name	City	State
Albania	University "Mother Theresa" Hospital Center; Oncology Department	Tirana
Argentina	CEMIC Saavedra	Buenos Aires
Argentina	Instituto Damic	Cordoba
Argentina	Hospital Privado de Comunidad; Oncology	Mar Del Plata
Austria	Lkh-Univ. Klinikum Graz; Klin. Abt. Für Hämatologie	Graz
Austria	Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie	Innsbruck
Austria	Kepler Universitätskliniken GmbH - Med Campus III; III. Medizinische Abteilung	Linz
Austria	Landeskrankenhaus Rankweil; Interne E	Rankweil
Austria	Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Hämatologie & Hämostaseologie	Wien
Brazil	Hospital de Cancer de Barretos	Barretos	SP
Brazil	Centro de Pesquisas Oncologicas - CEPON	Florianopolis	SC
Brazil	Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia	Passo Fundo	RS
Brazil	Hospital das Clinicas - UFRGS	Porto Alegre	RS
Brazil	Centro de Tratamento Oncologico - CETRON	Rio de janeiro	RJ
Brazil	Hospital das Clinicas - FMUSP; Hematologia	Sao Paulo	SP
Brazil	Hospital Santa Marcelina;Oncologia	Sao Paulo	SP
Brazil	Instituto de Ensino e Pesquisa Sao Lucas - IEP	Sao Paulo	SP
Bulgaria	UMHAT Dr Georgi Stranski; Hematology	Pleven
Bulgaria	Tokuda Hospital Sofia; Hematology department	Sofia
Bulgaria	UMHAT Alexandrovska EAD; Hematology	Sofia
Colombia	Centro Javeriano de Oncología	Bogota
Colombia	Fundacion Santa Fe de Bogotá	Bogota
Colombia	Instituto Nacional de Cancerologia; Hematology	Bogota
Ecuador	Hospital Abel Gilbert Ponton; Oncology	Guayaquil
Ecuador	Teodoro Maldonado Carbo Hospital; Oncology Service	Guayaquil
Ecuador	Hospital Solca Portoviejo; Oncologia	Portoviejo
Ecuador	Hospital Solca Quito; Oncologia	Quito
Egypt	Kasr Eieny Uni Hospital; Oncology (Nemrock)	Cairo
France	Centre Hospitalier Uni Ire; Service Des Maladies Du Sang	Angers Cedex 9
France	CH Henri Mondor; Med Interne Neuro Endocrinologie	Aurillac
France	Centre Hospitalier de La Cote Basque; Hematologie	Bayonne
France	Hopital Jean Minjoz; Hematologie	Besancon
France	Hopital Augustin Morvan; Hematologie	Brest
France	Institut d'Hématologie de Basse Normandie	Caen
France	CH Metropole de Savoie	CHAMBERY Cedex
France	Chu Estaing; Hematologie Clinique Adultes	Clermont Ferrand
France	Ch Sud Francilien; Hematologie Oncologie	Corbeil Essonnes
France	Hopital Henri Mondor	Creteil
France	Chu Site Du Bocage;Hematologie Clinique	Dijon
France	Centre Hospitalier Departemental Les Oudairies	La Roche Sur Yon
France	Hôpital Albert Michallon; Hematologie Clinique	La Tronche
France	Hopital Andre Mignot; Hematologie - Oncologie	Le Chesnay
France	Ch Du Mans; Medecine Hematologie Oncologie	Le Mans
France	Hopital Claude Huriez; Hematologie	Lille
France	Hopital Uni Ire Dupuytren; Hematologie	Limoges
France	Hopital Nord; Laboratoire D'Hematologie	Marseille
France	Hôpital Lapeyronie; Hématologie Oncologie Médicale	Montpellier
France	Hopital Emile Muller; Hematologie	Mulhouse
France	Hopital Hotel Dieu Et Hme; Clinique Dermatologique	Nantes
France	Centre Antoine Lacassagne;B4 Hematologie Cancerologie	Nice
France	Hopital Pitie Salpetriere; Hematologie Clinique	Paris
France	Hopital De Haut Leveque; Hematologie Clinique	Pessac
France	Centre Henri Becquerel; Hematologie	Rouen
France	Hopital Purpan; Hematologie Clinique	Toulouse
Germany	Gemeinschaftspraxis Dr. Bueckner und Dr. Nueckel	Bochum
Germany	Klinikum Darmstadt GmbH; Med. Klinik V; Onkologie & Hämatologie	Darmstadt
Germany	St. Johannes Hospital; Abt. für Hämatologie und Onkologie	Dortmund
Germany	BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie	Dresden
Germany	Gemeinschaftspraxis Dr. med. J. Mohm und Dr. med. G. Prange-Krex; Fachaerzte fuer Innere Medizin	Dresden
Germany	Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik	Greifswald
Germany	Internistisch-Onkologische Gemeinschaftspraxis; Dres. Rohrberg, Hurtz, Schma usw.	Halle
Germany	OncoResearch Lerchenfeld GmbH	Hamburg
Germany	Onkologische Schwerpunktpraxis (Eps-Gmbh)	Jena
Germany	Dres. Richard Hansen Susanne Pfitzner-Dempfle und Manfred Reeb	Kaiserslautern
Germany	Dres. Barbara Tschechne Stefanie Luft und Wolf-Oliver Jordan	Lehrte
Germany	Onkologische Schwerpunktpraxis Lübeck	Lübeck
Germany	Onkologische Gemeinschaftspraxis	Magdeburg
Germany	Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach	Marburg
Germany	Dres. Michael Maasberg Marion Schmitz und Maria Theresia Keller	Mayen
Germany	Klinikum Grosshadern der LMU	Muenchen
Germany	Hamatol Onkol Praxisgemeinschaft Dres H H-D Schick/D Schick	München
Germany	Klinikum rechts der Isar der TU München; III. Medizinischen Klinik (Hämatologie/Onkologie)	München
Germany	Staedtisches Krankenhaus Muenchen-Schwabing, Haematologie & Onkolgie	München
Germany	Praxis Dr.med. Jens Uhlig	Naunhof
Germany	Oncologianova GmbH	Recklinghausen
Germany	Klinik der Uni Regensburg; Hämatologie/Onkologie, Studienzentrale	Regensburg
Germany	Dres. Andreas Hübner, Andreas Lück und Petra Bruhn	Rostock
Germany	Dres. Ulrich Banhardt und Thomas Fietz	Singen
Germany	Dres. Emil Höring Matthias Respondek und Ulrike Schwinger	Stuttgart
Greece	General Hospital of Athens Evangelismos; Hematology	Athens
Greece	Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine	Athens
Greece	University Hospital of Ioannina; Hematology	Ioannina
Greece	University Hospital of Larissa; Hematology Dept.	Larissa
Greece	University Hospital Of Patras; Dept. Of Internal Medicine-Hematology Division	Patras
Hungary	National Institute of Oncology, A Dept of Internal Medicine	Budapest
Hungary	Semmelweis University, First Dept of Medicine	Budapest
Hungary	St Laszlo Hospital, Pharmacy	Budapest
Hungary	Uni of Debrecen; 2Nd Clinic of Internal Medicine	Debrecen
Hungary	University of Pecs, I st Dept of Internal Medicine	Pecs
Italy	Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica	Bari	Puglia
Italy	A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna	Bologna	Emilia-Romagna
Italy	Azienda Sanitaria Di Bolzano; Ematologia E Centro Trapianto Mid.Osseo	Bolzano	Trentino-Alto Adige
Italy	Az. Osp. Di Careggi; Divisione Di Ematologia	Firenze	Toscana
Italy	A.O. Universitaria S. Martino Di Genova; Ematologia 1	Genova	Liguria
Italy	Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia	Milano	Lombardia
Italy	Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora	Milano	Lombardia
Italy	A.O.U. Policlinico di Modena-Dipartimento di Medicina Diagnostica, Clinica e di Sanità pubblica	Modena	Emilia-Romagna
Italy	A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica	Napoli	Campania
Italy	Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica	Napoli	Campania
Italy	Ospedale Cardarelli; Divisione Di Ematologia	Napoli	Campania
Italy	Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia	Padova	Veneto
Italy	Ospedale Santa Chiara; Unita Operativa Di Ematologia	Pisa	Toscana
Italy	Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol	Roma	Lazio
Italy	A.O. Universitaria Senese; Ematologia	Siena	Toscana
Italy	A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1	Torino	Piemonte
Italy	Ospedale Ca Foncello; Ematologia	Treviso	Veneto
Italy	A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica	Udine	Friuli-Venezia Giulia
Italy	Uni Di Verona Policlinico G.B. Rossi; Divisione E Cattedra Di Ematologia	Verona	Veneto
Italy	Ospedale Ferrarotto; Divisione Di Ematologia	Via S. Sofia 78	Sicilia
Lithuania	Seamen' Hospital' Dept. of haematology	Klaipeda
Norway	Haukeland Universitetssykehus	Bergen
Norway	Oslo Universitetssykehus HF; Radiumhospitalet	Oslo
Norway	Helse Stavanger HF, Stavanger Universitetssjukehus; Klinikk for Blod og kreftsykdommer	Stavanger
Norway	St. Olavs Hospital HF, Kreftavdelingen, Gastrosentret	Trondheim
Romania	County Clinical Emergency Hospital Brasov	Brasov
Romania	Policlinica de Diagnostic Rapid	Brasov
Romania	Institutul Clinic Fundeni; Hematologie	Bucharest
Romania	Spitalul Clinic Coltea; Clinica de Hematologie	Bucuresti
Romania	Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie	Targu-mures
Romania	Spitalul Clinic municipal de Urgenta Timisoara; Clinica de Hematologie	Timisoara
Russian Federation	Regional Oncology Center	Chelyabinsk
Russian Federation	City Clin Hosp n.a. S.P.Botkin	Moscow
Russian Federation	N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis	Moscow
Russian Federation	Rus Med Academy for Postgraduate Education; Oncology Department	Moscow
Russian Federation	Regional Clinical Hospital N.A. Semashko; Hematology	Nizhny Novgorod
Russian Federation	Leningrad Regional Clinical Hospital	St Petersburg
Russian Federation	Petrov Research Inst. of Oncology	St Petersburg
Russian Federation	SRI of Hematology and Transfusiology	St. Petersburg
Slovakia	National Oncology Inst. ; Dept. of Haematology	Bratislava
Slovakia	Uni Hospital ; Dept. of Haematol. & Transfusion Medicine	Martin
Slovenia	Institute of Oncology Ljubljana	Ljubljana
Spain	Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia	Badalona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau; Servicio de Hematologia	Barcelona
Spain	Hospital Duran i Reynals; Servicio de Hematologia	Barcelona
Spain	Hospital Universitari Vall d'Hebron; Servicio de Hematologia	Barcelona
Spain	Hospital San Pedro De Alcantara; Servicio de Hematologia	Caceres
Spain	Hospital General Universitario de Elche; Servicio de Oncologia	Elche	Alicante
Spain	Hospital Universitario San Cecilio; Servicio de Oncologia	Granada
Spain	Complejo Hospitalario de Jaen- Hospital Universitario Medico Quirurgico; Servicio de Hematologia	Jaen
Spain	Hospital de Jerez de la Frontera; Servicio de Hematologia	Jerez de La Frontera	Cadiz
Spain	Hospital Universitario de Canarias;servicio de Hematologia	La Laguna	Tenerife
Spain	Hospital Universitario de Canarias;servicio de Oncologia	La Laguna	Tenerife
Spain	HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio Hematologia	Madrid
Spain	Hospital Clinico Universitario Virgen de la Victoria; Servicio de Hematologia	Malaga
Spain	Complejo Hospitalario Universitario de Ourense, Servicio de Hematologia	Orense
Spain	Hospital Univ. Central de Asturias; servicio de Hematologia	Oviedo	Asturias
Spain	Hospital Universitario Son Espases	Palma De Mallorca	Islas Baleares
Spain	Hospital Quiron de Madrid; Servicio de Hematologia	Pozuelo de Alarcon	Madrid
Spain	Hospital Arnau de Vilanova (Valencia) Servicio de Hematologia	Valencia
Spain	Complejo Hospitalario Zamora- H. Virgen de la Concha; Servicio de Hematología	Zamora
Spain	Hospital Royo Villanova; Servicio de Hematologia	Zaragoza
Sweden	Laenssjukhuset; Medicinkliniken/Hematologsektionen	Halmstad
Sweden	Sunderby Sjukhus; Medicinkliniken	Luleå
Sweden	Capio, S:T Gorans Hospital; Dept of Medicine	Stockholm
Sweden	Södersjukhuset, Medicinkliniken/Sektionen för Hematologi	Stockholm
Sweden	Uddevalla Sjukhus; Medicinkliniken	Uddevalla
Sweden	Västmanlands sjukhus Västerås, Onkologmottagningen	Västerås
Switzerland	Ospedale San Giovanni; Oncologia	Bellinzona
Switzerland	UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie	Zürich
Turkey	GATA (Gulhane Military Medical School)	Ankara
Turkey	Gazi Uni Medical School; Hematology	Ankara
Turkey	Hacettepe Uni Medical Faculty; Hematology	Ankara
Turkey	Istanbul Uni Capa Medical Faculty; Inst. of Oncology	Istanbul
Turkey	Marmara University Pendik Training and Research Hospital, Hematology Department	Istanbul
Turkey	Erciyes Uni ; Hematology	Kayseri
United Kingdom	Birmingham Heartlands Hospital; Department of Haematology	Birmingham
United Kingdom	Royal Bournemouth General Hospital; Haematology	Bournemouth
United Kingdom	Addenbrookes Hospital; Haematology	Cambridge
United Kingdom	Kent & Canterbury Hospital; Clinical Haematology	Canterbury
United Kingdom	Uni Hospital of Wales; Dept of Haematology	Cardiff
United Kingdom	Leicester Royal Infirmary; Dept of Haematology	Leicester
United Kingdom	Royal Liverpool Uni Hospital; Haematology	Liverpool
United Kingdom	The Royal Marsden Hospital; Dept of Medicine	London
United Kingdom	University College London, Department of Haematology	London
United Kingdom	Freeman Hospital	Newcastle upon Tyne
United Kingdom	Norfolk & Norwich Hospital; Dept of Haematology	Norwich
United Kingdom	Nottingham City Hospital; Dept of Haematology	Nottingham
United Kingdom	Churchill Hospital; Oxford Cancer and Haematology Centre	Oxford
United Kingdom	Derriford Hospital; Haematology	Plymouth
United Kingdom	Royal Marsden Hospital; Dept. of Medicine	Sutton

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Albania,  Argentina,  Austria,  Brazil,  Bulgaria,  Colombia,  Ecuador,  Egypt,  France,  Germany,  Greece,  Hungary,  Italy,  Lithuania,  Norway,  Romania,  Russian Federation,  Slovakia,  Slovenia,  Spain,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	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)
Secondary	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.	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)
Secondary	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.).	From day of first rituximab induction dose up to any new lymphoma treatment (up to approximately 87 months)
Secondary	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.	From day of first rituximab induction dose up to death (up to approximately 87 months)
Secondary	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.	From randomization (Maintenance II) up to death (up to approximately 24 months)
Secondary	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.	From day of first rituximab induction dose up to end of induction period (up to approximately 8 months)
Secondary	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		From day of first rituximab induction dose up to end of Maintenance I period (up to approximately 32 months)
Secondary	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.	From day of first rituximab induction dose up to disease progression or death, whichever occurs first (up to approximately 87 months)