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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)

Primary Purpose

Non-Hodgkin's Lymphoma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Chemotherapy (Induction Period)
Rituximab
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin's Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University "Mother Theresa" Hospital Center; Oncology Department
  • CEMIC Saavedra
  • Instituto Damic
  • Hospital Privado de Comunidad; Oncology
  • Lkh-Univ. Klinikum Graz; Klin. Abt. Für Hämatologie
  • Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
  • Kepler Universitätskliniken GmbH - Med Campus III; III. Medizinische Abteilung
  • Landeskrankenhaus Rankweil; Interne E
  • Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Hämatologie & Hämostaseologie
  • Centro de Tratamento Oncologico - CETRON
  • Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia
  • Hospital das Clinicas - UFRGS
  • Centro de Pesquisas Oncologicas - CEPON
  • Hospital de Cancer de Barretos
  • Instituto de Ensino e Pesquisa Sao Lucas - IEP
  • Hospital das Clinicas - FMUSP; Hematologia
  • Hospital Santa Marcelina;Oncologia
  • UMHAT Dr Georgi Stranski; Hematology
  • Tokuda Hospital Sofia; Hematology department
  • UMHAT Alexandrovska EAD; Hematology
  • Centro Javeriano de Oncología
  • Fundacion Santa Fe de Bogotá
  • Instituto Nacional de Cancerologia; Hematology
  • Hospital Abel Gilbert Ponton; Oncology
  • Teodoro Maldonado Carbo Hospital; Oncology Service
  • Hospital Solca Portoviejo; Oncologia
  • Hospital Solca Quito; Oncologia
  • Kasr Eieny Uni Hospital; Oncology (Nemrock)
  • Centre Hospitalier Uni Ire; Service Des Maladies Du Sang
  • CH Henri Mondor; Med Interne Neuro Endocrinologie
  • Centre Hospitalier de La Cote Basque; Hematologie
  • Hopital Jean Minjoz; Hematologie
  • Hopital Augustin Morvan; Hematologie
  • Institut d'Hématologie de Basse Normandie
  • CH Metropole de Savoie
  • Chu Estaing; Hematologie Clinique Adultes
  • Ch Sud Francilien; Hematologie Oncologie
  • Hopital Henri Mondor
  • Chu Site Du Bocage;Hematologie Clinique
  • Centre Hospitalier Departemental Les Oudairies
  • Hôpital Albert Michallon; Hematologie Clinique
  • Hopital Andre Mignot; Hematologie - Oncologie
  • Ch Du Mans; Medecine Hematologie Oncologie
  • Hopital Claude Huriez; Hematologie
  • Hopital Uni Ire Dupuytren; Hematologie
  • Hopital Nord; Laboratoire D'Hematologie
  • Hôpital Lapeyronie; Hématologie Oncologie Médicale
  • Hopital Emile Muller; Hematologie
  • Hopital Hotel Dieu Et Hme; Clinique Dermatologique
  • Centre Antoine Lacassagne;B4 Hematologie Cancerologie
  • Hopital Pitie Salpetriere; Hematologie Clinique
  • Hopital De Haut Leveque; Hematologie Clinique
  • Centre Henri Becquerel; Hematologie
  • Hopital Purpan; Hematologie Clinique
  • Gemeinschaftspraxis Dr. Bueckner und Dr. Nueckel
  • Klinikum Darmstadt GmbH; Med. Klinik V; Onkologie & Hämatologie
  • St. Johannes Hospital; Abt. für Hämatologie und Onkologie
  • BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie
  • Gemeinschaftspraxis Dr. med. J. Mohm und Dr. med. G. Prange-Krex; Fachaerzte fuer Innere Medizin
  • Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik
  • Internistisch-Onkologische Gemeinschaftspraxis; Dres. Rohrberg, Hurtz, Schma usw.
  • OncoResearch Lerchenfeld GmbH
  • Onkologische Schwerpunktpraxis (Eps-Gmbh)
  • Dres. Richard Hansen Susanne Pfitzner-Dempfle und Manfred Reeb
  • Dres. Barbara Tschechne Stefanie Luft und Wolf-Oliver Jordan
  • Onkologische Schwerpunktpraxis Lübeck
  • Onkologische Gemeinschaftspraxis
  • Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach
  • Dres. Michael Maasberg Marion Schmitz und Maria Theresia Keller
  • Klinikum Grosshadern der LMU
  • Staedtisches Krankenhaus Muenchen-Schwabing, Haematologie & Onkolgie
  • Hamatol Onkol Praxisgemeinschaft Dres H H-D Schick/D Schick
  • Klinikum rechts der Isar der TU München; III. Medizinischen Klinik (Hämatologie/Onkologie)
  • Praxis Dr.med. Jens Uhlig
  • Oncologianova GmbH
  • Klinik der Uni Regensburg; Hämatologie/Onkologie, Studienzentrale
  • Dres. Andreas Hübner, Andreas Lück und Petra Bruhn
  • Dres. Ulrich Banhardt und Thomas Fietz
  • Dres. Emil Höring Matthias Respondek und Ulrike Schwinger
  • General Hospital of Athens Evangelismos; Hematology
  • Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine
  • University Hospital of Ioannina; Hematology
  • University Hospital of Larissa; Hematology Dept.
  • University Hospital Of Patras; Dept. Of Internal Medicine-Hematology Division
  • Semmelweis University, First Dept of Medicine
  • St Laszlo Hospital, Pharmacy
  • National Institute of Oncology, A Dept of Internal Medicine
  • Uni of Debrecen; 2Nd Clinic of Internal Medicine
  • University of Pecs, I st Dept of Internal Medicine
  • A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica
  • Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica
  • Ospedale Cardarelli; Divisione Di Ematologia
  • A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
  • A.O.U. Policlinico di Modena-Dipartimento di Medicina Diagnostica, Clinica e di Sanità pubblica
  • A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica
  • Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol
  • A.O. Universitaria S. Martino Di Genova; Ematologia 1
  • Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora
  • Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
  • A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1
  • Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica
  • Ospedale Ferrarotto; Divisione Di Ematologia
  • Az. Osp. Di Careggi; Divisione Di Ematologia
  • Ospedale Santa Chiara; Unita Operativa Di Ematologia
  • A.O. Universitaria Senese; Ematologia
  • Azienda Sanitaria Di Bolzano; Ematologia E Centro Trapianto Mid.Osseo
  • Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia
  • Ospedale Ca Foncello; Ematologia
  • Uni Di Verona Policlinico G.B. Rossi; Divisione E Cattedra Di Ematologia
  • Seamen' Hospital' Dept. of haematology
  • Haukeland Universitetssykehus
  • Oslo Universitetssykehus HF; Radiumhospitalet
  • Helse Stavanger HF, Stavanger Universitetssjukehus; Klinikk for Blod og kreftsykdommer
  • St. Olavs Hospital HF, Kreftavdelingen, Gastrosentret
  • Policlinica de Diagnostic Rapid
  • County Clinical Emergency Hospital Brasov
  • Institutul Clinic Fundeni; Hematologie
  • Spitalul Clinic Coltea; Clinica de Hematologie
  • Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie
  • Spitalul Clinic municipal de Urgenta Timisoara; Clinica de Hematologie
  • Regional Oncology Center
  • N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis
  • Rus Med Academy for Postgraduate Education; Oncology Department
  • City Clin Hosp n.a. S.P.Botkin
  • Regional Clinical Hospital N.A. Semashko; Hematology
  • Leningrad Regional Clinical Hospital
  • Petrov Research Inst. of Oncology
  • SRI of Hematology and Transfusiology
  • National Oncology Inst. ; Dept. of Haematology
  • Uni Hospital ; Dept. of Haematol. & Transfusion Medicine
  • Institute of Oncology Ljubljana
  • Hospital General Universitario de Elche; Servicio de Oncologia
  • Hospital Univ. Central de Asturias; servicio de Hematologia
  • Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia
  • Hospital de Jerez de la Frontera; Servicio de Hematologia
  • Hospital Universitario Son Espases
  • Hospital Quiron de Madrid; Servicio de Hematologia
  • Hospital Universitario de Canarias;servicio de Hematologia
  • Hospital Universitario de Canarias;servicio de Oncologia
  • Hospital de la Santa Creu i Sant Pau; Servicio de Hematologia
  • Hospital Universitari Vall d'Hebron; Servicio de Hematologia
  • Hospital Duran i Reynals; Servicio de Hematologia
  • Hospital San Pedro De Alcantara; Servicio de Hematologia
  • Hospital Universitario San Cecilio; Servicio de Oncologia
  • Complejo Hospitalario de Jaen- Hospital Universitario Medico Quirurgico; Servicio de Hematologia
  • HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio Hematologia
  • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Hematologia
  • Complejo Hospitalario Universitario de Ourense, Servicio de Hematologia
  • Hospital Arnau de Vilanova (Valencia) Servicio de Hematologia
  • Complejo Hospitalario Zamora- H. Virgen de la Concha; Servicio de Hematología
  • Hospital Royo Villanova; Servicio de Hematologia
  • Laenssjukhuset; Medicinkliniken/Hematologsektionen
  • Sunderby Sjukhus; Medicinkliniken
  • Capio, S:T Gorans Hospital; Dept of Medicine
  • Södersjukhuset, Medicinkliniken/Sektionen för Hematologi
  • Uddevalla Sjukhus; Medicinkliniken
  • Västmanlands sjukhus Västerås, Onkologmottagningen
  • Ospedale San Giovanni; Oncologia
  • UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
  • GATA (Gulhane Military Medical School)
  • Hacettepe Uni Medical Faculty; Hematology
  • Gazi Uni Medical School; Hematology
  • Istanbul Uni Capa Medical Faculty; Inst. of Oncology
  • Marmara University Pendik Training and Research Hospital, Hematology Department
  • Erciyes Uni ; Hematology
  • Birmingham Heartlands Hospital; Department of Haematology
  • Royal Bournemouth General Hospital; Haematology
  • Addenbrookes Hospital; Haematology
  • Kent & Canterbury Hospital; Clinical Haematology
  • Uni Hospital of Wales; Dept of Haematology
  • Leicester Royal Infirmary; Dept of Haematology
  • Royal Liverpool Uni Hospital; Haematology
  • University College London, Department of Haematology
  • The Royal Marsden Hospital; Dept of Medicine
  • Freeman Hospital
  • Norfolk & Norwich Hospital; Dept of Haematology
  • Nottingham City Hospital; Dept of Haematology
  • Churchill Hospital; Oxford Cancer and Haematology Centre
  • Derriford Hospital; Haematology
  • Royal Marsden Hospital; Dept. of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Maintenance II Period Observation Only

Maintenance II Period Rituximab

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.).
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.
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.
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.
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
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.

Full Information

First Posted
October 19, 2011
Last Updated
July 16, 2019
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01461928
Brief Title
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
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 20, 2011 (Actual)
Primary Completion Date
June 2, 2018 (Actual)
Study Completion Date
June 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin's Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
692 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Maintenance II Period Observation Only
Arm Type
Other
Arm Description
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.
Arm Title
Maintenance II Period Rituximab
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Chemotherapy (Induction Period)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan, MabThera, RO0452294
Intervention Description
Participants will receive rituximab according to the regimen specified in individual arm.
Primary Outcome Measure Information:
Title
Maintenance II: Progression-free Survival (PFS) Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia
Description
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).
Time Frame
From randomization (Maintenance II) up to disease progression or death, whichever occurs first (up to approximately 24 months)
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs), Serious AEs, and Infusion/Administration-related Reactions (IRRs/ARRs)
Description
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.
Time Frame
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)
Title
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
Description
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.
Time Frame
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)
Title
Time to Next Lymphoma Treatment (TNLT)
Description
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.).
Time Frame
From day of first rituximab induction dose up to any new lymphoma treatment (up to approximately 87 months)
Title
Overall Survival
Description
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.
Time Frame
From day of first rituximab induction dose up to death (up to approximately 87 months)
Title
Maintenance II: Overall Survival
Description
Overall survival from randomization (OSrand) is defined as the time from date of randomization to the date of death, irrespective of cause.
Time Frame
From randomization (Maintenance II) up to death (up to approximately 24 months)
Title
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
Description
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.
Time Frame
From day of first rituximab induction dose up to end of induction period (up to approximately 8 months)
Title
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
Time Frame
From day of first rituximab induction dose up to end of Maintenance I period (up to approximately 32 months)
Title
Progression-free Survival (PFS) Using 1999 International Working Group (Cheson) Response Criteria for Lymphoma or by the Recommendations for Waldenström's Macroglobulinemia
Description
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.
Time Frame
From day of first rituximab induction dose up to disease progression or death, whichever occurs first (up to approximately 87 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
University "Mother Theresa" Hospital Center; Oncology Department
City
Tirana
ZIP/Postal Code
1000
Country
Albania
Facility Name
CEMIC Saavedra
City
Buenos Aires
ZIP/Postal Code
1431
Country
Argentina
Facility Name
Instituto Damic
City
Cordoba
ZIP/Postal Code
X5003DCE
Country
Argentina
Facility Name
Hospital Privado de Comunidad; Oncology
City
Mar Del Plata
ZIP/Postal Code
7600
Country
Argentina
Facility Name
Lkh-Univ. Klinikum Graz; Klin. Abt. Für Hämatologie
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Tiroler Landeskrankenanstalten Ges.M.B.H.; Innere Medizin Abt. Für Hämatologie & Onkologie
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Kepler Universitätskliniken GmbH - Med Campus III; III. Medizinische Abteilung
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Landeskrankenhaus Rankweil; Interne E
City
Rankweil
ZIP/Postal Code
6830
Country
Austria
Facility Name
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Hämatologie & Hämostaseologie
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Centro de Tratamento Oncologico - CETRON
City
Rio de janeiro
State/Province
RJ
ZIP/Postal Code
22250-906
Country
Brazil
Facility Name
Hospital da Cidade de Passo Fundo; Centro de Pesquisa em Oncologia
City
Passo Fundo
State/Province
RS
ZIP/Postal Code
99010-260
Country
Brazil
Facility Name
Hospital das Clinicas - UFRGS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-003
Country
Brazil
Facility Name
Centro de Pesquisas Oncologicas - CEPON
City
Florianopolis
State/Province
SC
ZIP/Postal Code
88034-000
Country
Brazil
Facility Name
Hospital de Cancer de Barretos
City
Barretos
State/Province
SP
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Instituto de Ensino e Pesquisa Sao Lucas - IEP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01236-030
Country
Brazil
Facility Name
Hospital das Clinicas - FMUSP; Hematologia
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Hospital Santa Marcelina;Oncologia
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
08270-070
Country
Brazil
Facility Name
UMHAT Dr Georgi Stranski; Hematology
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Tokuda Hospital Sofia; Hematology department
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
UMHAT Alexandrovska EAD; Hematology
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Centro Javeriano de Oncología
City
Bogota
Country
Colombia
Facility Name
Fundacion Santa Fe de Bogotá
City
Bogota
Country
Colombia
Facility Name
Instituto Nacional de Cancerologia; Hematology
City
Bogota
Country
Colombia
Facility Name
Hospital Abel Gilbert Ponton; Oncology
City
Guayaquil
ZIP/Postal Code
EC090104
Country
Ecuador
Facility Name
Teodoro Maldonado Carbo Hospital; Oncology Service
City
Guayaquil
ZIP/Postal Code
EC090150
Country
Ecuador
Facility Name
Hospital Solca Portoviejo; Oncologia
City
Portoviejo
ZIP/Postal Code
EC130104
Country
Ecuador
Facility Name
Hospital Solca Quito; Oncologia
City
Quito
ZIP/Postal Code
EC170124
Country
Ecuador
Facility Name
Kasr Eieny Uni Hospital; Oncology (Nemrock)
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
Facility Name
Centre Hospitalier Uni Ire; Service Des Maladies Du Sang
City
Angers Cedex 9
ZIP/Postal Code
49933
Country
France
Facility Name
CH Henri Mondor; Med Interne Neuro Endocrinologie
City
Aurillac
ZIP/Postal Code
15000
Country
France
Facility Name
Centre Hospitalier de La Cote Basque; Hematologie
City
Bayonne
ZIP/Postal Code
64109
Country
France
Facility Name
Hopital Jean Minjoz; Hematologie
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Hopital Augustin Morvan; Hematologie
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Institut d'Hématologie de Basse Normandie
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
CH Metropole de Savoie
City
CHAMBERY Cedex
ZIP/Postal Code
73011
Country
France
Facility Name
Chu Estaing; Hematologie Clinique Adultes
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Ch Sud Francilien; Hematologie Oncologie
City
Corbeil Essonnes
ZIP/Postal Code
91000
Country
France
Facility Name
Hopital Henri Mondor
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Chu Site Du Bocage;Hematologie Clinique
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Centre Hospitalier Departemental Les Oudairies
City
La Roche Sur Yon
ZIP/Postal Code
85925
Country
France
Facility Name
Hôpital Albert Michallon; Hematologie Clinique
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Hopital Andre Mignot; Hematologie - Oncologie
City
Le Chesnay
ZIP/Postal Code
78157
Country
France
Facility Name
Ch Du Mans; Medecine Hematologie Oncologie
City
Le Mans
ZIP/Postal Code
72037
Country
France
Facility Name
Hopital Claude Huriez; Hematologie
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Uni Ire Dupuytren; Hematologie
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Hopital Nord; Laboratoire D'Hematologie
City
Marseille
ZIP/Postal Code
13015
Country
France
Facility Name
Hôpital Lapeyronie; Hématologie Oncologie Médicale
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital Emile Muller; Hematologie
City
Mulhouse
ZIP/Postal Code
68070
Country
France
Facility Name
Hopital Hotel Dieu Et Hme; Clinique Dermatologique
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Centre Antoine Lacassagne;B4 Hematologie Cancerologie
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Hopital Pitie Salpetriere; Hematologie Clinique
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Hopital De Haut Leveque; Hematologie Clinique
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Centre Henri Becquerel; Hematologie
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Hopital Purpan; Hematologie Clinique
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Gemeinschaftspraxis Dr. Bueckner und Dr. Nueckel
City
Bochum
ZIP/Postal Code
44787
Country
Germany
Facility Name
Klinikum Darmstadt GmbH; Med. Klinik V; Onkologie & Hämatologie
City
Darmstadt
ZIP/Postal Code
64283
Country
Germany
Facility Name
St. Johannes Hospital; Abt. für Hämatologie und Onkologie
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf; Gemeinschaftspraxis Hämatologie-Onkologie
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Gemeinschaftspraxis Dr. med. J. Mohm und Dr. med. G. Prange-Krex; Fachaerzte fuer Innere Medizin
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Greifswald Klinik für Innere Medizin C und Poliklinik
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Internistisch-Onkologische Gemeinschaftspraxis; Dres. Rohrberg, Hurtz, Schma usw.
City
Halle
ZIP/Postal Code
06110
Country
Germany
Facility Name
OncoResearch Lerchenfeld GmbH
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis (Eps-Gmbh)
City
Jena
ZIP/Postal Code
07743
Country
Germany
Facility Name
Dres. Richard Hansen Susanne Pfitzner-Dempfle und Manfred Reeb
City
Kaiserslautern
ZIP/Postal Code
67655
Country
Germany
Facility Name
Dres. Barbara Tschechne Stefanie Luft und Wolf-Oliver Jordan
City
Lehrte
ZIP/Postal Code
31275
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis Lübeck
City
Lübeck
ZIP/Postal Code
23562
Country
Germany
Facility Name
Onkologische Gemeinschaftspraxis
City
Magdeburg
ZIP/Postal Code
39104
Country
Germany
Facility Name
Gemeinschaftspraxis Fr. Dr. med. Balser & Hr. Dr. med. Weidenbach
City
Marburg
ZIP/Postal Code
35037
Country
Germany
Facility Name
Dres. Michael Maasberg Marion Schmitz und Maria Theresia Keller
City
Mayen
ZIP/Postal Code
56727
Country
Germany
Facility Name
Klinikum Grosshadern der LMU
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
Facility Name
Staedtisches Krankenhaus Muenchen-Schwabing, Haematologie & Onkolgie
City
München
ZIP/Postal Code
80804
Country
Germany
Facility Name
Hamatol Onkol Praxisgemeinschaft Dres H H-D Schick/D Schick
City
München
ZIP/Postal Code
81241
Country
Germany
Facility Name
Klinikum rechts der Isar der TU München; III. Medizinischen Klinik (Hämatologie/Onkologie)
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Praxis Dr.med. Jens Uhlig
City
Naunhof
ZIP/Postal Code
04683
Country
Germany
Facility Name
Oncologianova GmbH
City
Recklinghausen
ZIP/Postal Code
45659
Country
Germany
Facility Name
Klinik der Uni Regensburg; Hämatologie/Onkologie, Studienzentrale
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Dres. Andreas Hübner, Andreas Lück und Petra Bruhn
City
Rostock
ZIP/Postal Code
18107
Country
Germany
Facility Name
Dres. Ulrich Banhardt und Thomas Fietz
City
Singen
ZIP/Postal Code
78224
Country
Germany
Facility Name
Dres. Emil Höring Matthias Respondek und Ulrike Schwinger
City
Stuttgart
ZIP/Postal Code
70190
Country
Germany
Facility Name
General Hospital of Athens Evangelismos; Hematology
City
Athens
ZIP/Postal Code
106 76
Country
Greece
Facility Name
Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Facility Name
University Hospital of Ioannina; Hematology
City
Ioannina
ZIP/Postal Code
455 00
Country
Greece
Facility Name
University Hospital of Larissa; Hematology Dept.
City
Larissa
ZIP/Postal Code
411100
Country
Greece
Facility Name
University Hospital Of Patras; Dept. Of Internal Medicine-Hematology Division
City
Patras
ZIP/Postal Code
265 00
Country
Greece
Facility Name
Semmelweis University, First Dept of Medicine
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
St Laszlo Hospital, Pharmacy
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
National Institute of Oncology, A Dept of Internal Medicine
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Uni of Debrecen; 2Nd Clinic of Internal Medicine
City
Debrecen
ZIP/Postal Code
4004
Country
Hungary
Facility Name
University of Pecs, I st Dept of Internal Medicine
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
A.O. Universitaria Federico II Di Napoli; Oncologia Ed Endocrinologia Clinica
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Ospedale Cardarelli; Divisione Di Ematologia
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
A.O.U. Policlinico di Modena-Dipartimento di Medicina Diagnostica, Clinica e di Sanità pubblica
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41100
Country
Italy
Facility Name
A.O. Universitaria S. Maria Della Misericordia Di Udine; Oncologia; Clinica Ematologica
City
Udine
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33100
Country
Italy
Facility Name
Universita' Degli Studi La Sapienza-Ist.Di Ematologia; Dip Biot Cel e Ematol
City
Roma
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
Facility Name
A.O. Universitaria S. Martino Di Genova; Ematologia 1
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
Ospedale Maggiore Di Milano; U.O. Ematologia I - Padiglione Marcora
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Facility Name
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20162
Country
Italy
Facility Name
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Facility Name
Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica
City
Bari
State/Province
Puglia
ZIP/Postal Code
70124
Country
Italy
Facility Name
Ospedale Ferrarotto; Divisione Di Ematologia
City
Via S. Sofia 78
State/Province
Sicilia
ZIP/Postal Code
95123
Country
Italy
Facility Name
Az. Osp. Di Careggi; Divisione Di Ematologia
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50135
Country
Italy
Facility Name
Ospedale Santa Chiara; Unita Operativa Di Ematologia
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56100
Country
Italy
Facility Name
A.O. Universitaria Senese; Ematologia
City
Siena
State/Province
Toscana
ZIP/Postal Code
53100
Country
Italy
Facility Name
Azienda Sanitaria Di Bolzano; Ematologia E Centro Trapianto Mid.Osseo
City
Bolzano
State/Province
Trentino-Alto Adige
ZIP/Postal Code
39100
Country
Italy
Facility Name
Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
Ospedale Ca Foncello; Ematologia
City
Treviso
State/Province
Veneto
ZIP/Postal Code
31100
Country
Italy
Facility Name
Uni Di Verona Policlinico G.B. Rossi; Divisione E Cattedra Di Ematologia
City
Verona
State/Province
Veneto
ZIP/Postal Code
37130
Country
Italy
Facility Name
Seamen' Hospital' Dept. of haematology
City
Klaipeda
ZIP/Postal Code
92288
Country
Lithuania
Facility Name
Haukeland Universitetssykehus
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Oslo Universitetssykehus HF; Radiumhospitalet
City
Oslo
ZIP/Postal Code
0310
Country
Norway
Facility Name
Helse Stavanger HF, Stavanger Universitetssjukehus; Klinikk for Blod og kreftsykdommer
City
Stavanger
ZIP/Postal Code
4011
Country
Norway
Facility Name
St. Olavs Hospital HF, Kreftavdelingen, Gastrosentret
City
Trondheim
ZIP/Postal Code
7030
Country
Norway
Facility Name
Policlinica de Diagnostic Rapid
City
Brasov
ZIP/Postal Code
500152
Country
Romania
Facility Name
County Clinical Emergency Hospital Brasov
City
Brasov
ZIP/Postal Code
500360
Country
Romania
Facility Name
Institutul Clinic Fundeni; Hematologie
City
Bucharest
ZIP/Postal Code
022338
Country
Romania
Facility Name
Spitalul Clinic Coltea; Clinica de Hematologie
City
Bucuresti
ZIP/Postal Code
030171
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie
City
Targu-mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
Spitalul Clinic municipal de Urgenta Timisoara; Clinica de Hematologie
City
Timisoara
ZIP/Postal Code
300079
Country
Romania
Facility Name
Regional Oncology Center
City
Chelyabinsk
ZIP/Postal Code
454087
Country
Russian Federation
Facility Name
N.N.Blokhin Russian Cancer Research Center; Dept. of Chemotherapy & Hemoblastosis
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Rus Med Academy for Postgraduate Education; Oncology Department
City
Moscow
ZIP/Postal Code
123995
Country
Russian Federation
Facility Name
City Clin Hosp n.a. S.P.Botkin
City
Moscow
ZIP/Postal Code
125101
Country
Russian Federation
Facility Name
Regional Clinical Hospital N.A. Semashko; Hematology
City
Nizhny Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Leningrad Regional Clinical Hospital
City
St Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Petrov Research Inst. of Oncology
City
St Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
SRI of Hematology and Transfusiology
City
St. Petersburg
ZIP/Postal Code
191024
Country
Russian Federation
Facility Name
National Oncology Inst. ; Dept. of Haematology
City
Bratislava
ZIP/Postal Code
833 10
Country
Slovakia
Facility Name
Uni Hospital ; Dept. of Haematol. & Transfusion Medicine
City
Martin
ZIP/Postal Code
036 59
Country
Slovakia
Facility Name
Institute of Oncology Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
Hospital General Universitario de Elche; Servicio de Oncologia
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Hospital Univ. Central de Asturias; servicio de Hematologia
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol; Servicio de Hematologia
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08915
Country
Spain
Facility Name
Hospital de Jerez de la Frontera; Servicio de Hematologia
City
Jerez de La Frontera
State/Province
Cadiz
ZIP/Postal Code
11407
Country
Spain
Facility Name
Hospital Universitario Son Espases
City
Palma De Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07014
Country
Spain
Facility Name
Hospital Quiron de Madrid; Servicio de Hematologia
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Hospital Universitario de Canarias;servicio de Hematologia
City
La Laguna
State/Province
Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hospital Universitario de Canarias;servicio de Oncologia
City
La Laguna
State/Province
Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau; Servicio de Hematologia
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron; Servicio de Hematologia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Duran i Reynals; Servicio de Hematologia
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital San Pedro De Alcantara; Servicio de Hematologia
City
Caceres
ZIP/Postal Code
10003
Country
Spain
Facility Name
Hospital Universitario San Cecilio; Servicio de Oncologia
City
Granada
ZIP/Postal Code
18003
Country
Spain
Facility Name
Complejo Hospitalario de Jaen- Hospital Universitario Medico Quirurgico; Servicio de Hematologia
City
Jaen
ZIP/Postal Code
23007
Country
Spain
Facility Name
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio Hematologia
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Hematologia
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Ourense, Servicio de Hematologia
City
Orense
ZIP/Postal Code
32005
Country
Spain
Facility Name
Hospital Arnau de Vilanova (Valencia) Servicio de Hematologia
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
Complejo Hospitalario Zamora- H. Virgen de la Concha; Servicio de Hematología
City
Zamora
ZIP/Postal Code
49002
Country
Spain
Facility Name
Hospital Royo Villanova; Servicio de Hematologia
City
Zaragoza
ZIP/Postal Code
50015
Country
Spain
Facility Name
Laenssjukhuset; Medicinkliniken/Hematologsektionen
City
Halmstad
ZIP/Postal Code
30185
Country
Sweden
Facility Name
Sunderby Sjukhus; Medicinkliniken
City
Luleå
ZIP/Postal Code
S-971 80
Country
Sweden
Facility Name
Capio, S:T Gorans Hospital; Dept of Medicine
City
Stockholm
ZIP/Postal Code
112 81
Country
Sweden
Facility Name
Södersjukhuset, Medicinkliniken/Sektionen för Hematologi
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
Facility Name
Uddevalla Sjukhus; Medicinkliniken
City
Uddevalla
ZIP/Postal Code
45180
Country
Sweden
Facility Name
Västmanlands sjukhus Västerås, Onkologmottagningen
City
Västerås
ZIP/Postal Code
72189
Country
Sweden
Facility Name
Ospedale San Giovanni; Oncologia
City
Bellinzona
ZIP/Postal Code
6500
Country
Switzerland
Facility Name
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
GATA (Gulhane Military Medical School)
City
Ankara
ZIP/Postal Code
06010
Country
Turkey
Facility Name
Hacettepe Uni Medical Faculty; Hematology
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Gazi Uni Medical School; Hematology
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Istanbul Uni Capa Medical Faculty; Inst. of Oncology
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Marmara University Pendik Training and Research Hospital, Hematology Department
City
Istanbul
ZIP/Postal Code
34300
Country
Turkey
Facility Name
Erciyes Uni ; Hematology
City
Kayseri
ZIP/Postal Code
38039
Country
Turkey
Facility Name
Birmingham Heartlands Hospital; Department of Haematology
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Royal Bournemouth General Hospital; Haematology
City
Bournemouth
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Addenbrookes Hospital; Haematology
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Kent & Canterbury Hospital; Clinical Haematology
City
Canterbury
ZIP/Postal Code
CT1 3NG
Country
United Kingdom
Facility Name
Uni Hospital of Wales; Dept of Haematology
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
Leicester Royal Infirmary; Dept of Haematology
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Royal Liverpool Uni Hospital; Haematology
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
University College London, Department of Haematology
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
The Royal Marsden Hospital; Dept of Medicine
City
London
ZIP/Postal Code
SW3 5PT
Country
United Kingdom
Facility Name
Freeman Hospital
City
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Norfolk & Norwich Hospital; Dept of Haematology
City
Norwich
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
Nottingham City Hospital; Dept of Haematology
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Churchill Hospital; Oxford Cancer and Haematology Centre
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
Derriford Hospital; Haematology
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Facility Name
Royal Marsden Hospital; Dept. of Medicine
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34134469
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.
Results Reference
derived
PubMed Identifier
27695295
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.
Results Reference
derived
PubMed Identifier
24720836
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.
Results Reference
derived

Learn more about this trial

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

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