MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma.

A Study to Evaluate the Safety of MabThera (Rituximab) Maintenance Therapy in Patients With Follicular Non-Hodgkin's Lymphoma Who Have Responded to Induction Therapy.

This single arm study will evaluate the safety and efficacy of MabThera maintenance therapy following a MabThera-containing induction regimen in first line or relapsed patients with follicular non-Hodgkin's lymphoma. All patients will receive MabThera 375mg/m2 body surface area, as an intravenous infusion, every 8 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.

Study Overview

• Status: Completed
• Conditions: Non-Hodgkin's Lymphoma
• Intervention / Treatment: Drug: rituximab [MabThera/Rituxan]

• Study Type: Interventional
• Enrollment (Actual): 545
• Phase: Phase 4

Contacts and Locations

Study Locations

• Albania
  • Tirana, Albania, 1000
    • University "Mother Theresa" Hospital Center; Oncology Department
• Argentina
  • Bahia Blanca, Argentina, 8001
    • Instituo Lavalle de Oncologia; Hematology
  • Buenos Aires, Argentina, 1425
    • Academia Nacional de Medicina; Inst. de Cardiologia
  • Buenos Aires, Argentina, C1114AAN
    • Fundaleu; Haematology
  • Buenos Aires, Argentina, C1437JCP
    • Hospital Churruca Visca; Haematology
  • Corrientes, Argentina, 3400
    • Hospital Jr Vidal; Jefe de Servicio de Clinica Medica/Hematologia
  • Córdoba, Argentina, 5000
    • Sanatorio Allende; Haematology
  • Córdoba, Argentina, 5016
    • HOSPITAL PRIVADO - CENTRO MEDICO DE CÓRDOBA; Dpto Oncología
  • La Plata, Argentina, B1904CFS
    • Hospital General San Martin; Haematology
• Australia
  • New South Wales
    • Liverpool, New South Wales, Australia, 2170
      • Liverpool Hospital; Haematology
    • Wollongong, New South Wales, Australia, 2500
      • Wollongong Hospital; Cancer Services
  • Queensland
    • Brisbane, Queensland, Australia, 4006
      • Royal Brisbane Hospital; Oncology Department
    • South Brisbane, Queensland, Australia, 4101
      • Haematology & Oncology Clinics of Australia, Mater Medical Centre
  • Western Australia
    • Perth, Western Australia, Australia, 6000
      • Mount Medical Center
• Bosnia and Herzegovina
  • Banja Luka, Bosnia and Herzegovina, 88000
    • University Clinical Center of the Republic of Srpska, Clinic for Internal Disease, Hematology Dept
  • Kasindo, Bosnia and Herzegovina, 71123
    • Inst. of Hematology
  • Mostar, Bosnia and Herzegovina, 88000
    • Uni Hospital Mostar
  • Sarajevo, Bosnia and Herzegovina, 71000
    • Clinic of Oncology, University Clinical Center Sarajevo
• Brazil
  • BA
    • Salvador, BA, Brazil, 40110-150
      • CEHON
    • Salvador, Bahia, BA, Brazil, 40170-380
      • Nucleo de Oncologia da Bahia - NOB
  • MG
    • Belo Horizonte, MG, Brazil, 30140-083
      • OncoMed
  • RJ
    • Rio de Janeiro, RJ, Brazil, 22640-000
      • Centro de Tratamento Oncologico - Oncoclinica
  • RS
    • Porto Alegre, RS, Brazil, 90610-000
      • Hospital Sao Lucas - PUCRS
    • Porto Alegre, RS, Brazil, 90470-340
      • Hospital Mae de Deus
    • Porto Alegre, RS, Brazil, 90035-903
      • Hospital das Clinicas - UFRGS; Medicina Interna
  • SC
    • Florianopolis, SC, Brazil, 88034-000
      • Centro de Pesquisas Oncologicas - CEPON
  • SP
    • Campinas, SP, Brazil, 13083-878
      • Hospital das Clinicas - UNICAMP; Hemoterapia
    • Piracicaba, SP, Brazil, 13419-155
      • Clinica Oncologica De Piracicaba Sc
    • Sao Paulo, SP, Brazil, 01323-020
      • Hospital Alemao Oswaldo Cruz; Oncologia
    • Sao Paulo, SP, Brazil, 04029-000
      • Hospital Estadual do Servidor Publico; Hematologia
    • Sao Paulo, SP, Brazil, 05403-000
      • Hospital das Clinicas - FMUSP, Oncologia
• Bulgaria
  • Pleven, Bulgaria, 5800
    • UMHAT Dr Georgi Stranski; Hematology
  • Plovdiv, Bulgaria, 4002
    • Umhat S. George; Hematology
  • Sofia, Bulgaria, 1431
    • UMHAT Alexandrovska EAD; Hematology
  • Sofia, Bulgaria, 1757
    • National Center of Hematology & Transfusiology; Clinical Unit, Clinic of Hematology
  • Varna, Bulgaria, 9010
    • Mhat Sveta Marina; Dept. of Haematology
• Colombia
  • Bucaramanga, Colombia
    • Centro Médico Carlos Ardila Lule
  • Medellin-Antioquia, Colombia
    • Hospital Pablo Tobon Uribe
• Croatia
  • Split, Croatia, 21000
    • Clinical Hospital Centre Split; Dept Of Hematology
  • Zagreb, Croatia, 10000
    • Clinical Hospital Centre Dubrava; Hematology Department
  • Zagreb, Croatia, 10000
    • University Hospital Center Zagreb; Haematology Department
• Ecuador
  • Cuenca, Ecuador
    • Hospital José Carrasco; Oncology Service
  • Quito, Ecuador, 2569
    • Hospital Carlos Andrade Marin; Servicio de Oncología
• Egypt
  • Cairo, Egypt, 11737
    • Oncology & Radiotherapy Centre; Oncology
• Finland
  • Haemeenlinna, Finland, 13530
    • Kanta-Hämeen Keskussairaala; Dept of Internal Medicine, Hematology
  • Kotka, Finland, 48210
    • Kymenlaakson keskussairaala
  • Lahti, Finland, 15850
    • Päijät-Hämeen Keskussairaala; Dept of Internal Medicine, Hematology
  • Pori, Finland, 28500
    • Satakunnan Keskussairaala; Sisaetauti Osasto
• Germany
  • Bad Soden, Germany, 65812
    • Internist; Praxis Für Haemotologie & Onkologie
  • Berlin, Germany, 10707
    • Onkologische Schwerpunktpraxis Kurfürstendamm
  • Berlin, Germany, 10117
    • Dres.Christian Sperling und Claudia Schelenz
  • Bonn, Germany, 53127
    • Universitätsklinikum Bonn; Medizinische Klinik und Poliklinik I; Allgemeine Innere Medizin
  • Braunschweig, Germany, 38100
    • Dres. Matthias Adler Oliver Marschal und Andreas Pies
  • Duisburg, Germany, 47051
    • Gemeinschaftspraxis
  • Düsseldorf, Germany, 40211
    • Internistische Praxis Dr. Plingen
  • Erlangen, Germany, 91052
    • Internistische Schwerpunktpraxis Erlangen
  • Freiburg, Germany, 79110
    • Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
  • Gütersloh, Germany, 33332
    • Onkologische Gemeinschaftspraxis, Prof. Dr. Gropp, Dr. Depenbusch und Dr. Rösel
  • Hamburg, Germany, 20259
    • Überörtliche Gemeinschaftspraxis Schwerpunkt Hämatologie, internistische Onkologie & Palliativmed.
  • Hamburg, Germany, 22457
    • Onkologische Schwerpunktpraxis; Herrn Dr. Med. Bertram
  • Heidelberg, Germany, 69115
    • Dres.Andreas Karcher und Stefan Fuxius
  • Heidelberg, Germany, 69120
    • Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V
  • Jena, Germany, 07743
    • Onkologische Schwerpunktpraxis (Eps-Gmbh)
  • Lüdenscheid, Germany, 58515
    • Märkische Kliniken GmbH, Klinikum Lüdenscheid; Hämatologie / Onkologie
  • Mutlangen, Germany, 73557
    • Stauferklinikum Schwäb.Gmünd
  • Mülheim, Germany, 45468
    • Gemeinschaftspraxis Dres. Schröder, Sieg
  • München, Germany, 80335
    • Onko. Gemeinschaftspraxis Dres. Tigges/ Böning/ Abenhardt/ Bosse
  • Nordhorn, Germany, 48527
    • Dres.Ulrich Hutzschenreuter und Uwe Sauer
  • Oldenburg, Germany, 26121
    • Onkologische Praxis Oldenburg; Dres. Otremba, Reschke, Zirpel, Kühn und Ruff
  • Recklinghausen, Germany, 45657
    • Praxis für Onkologie und Hämatologie
  • Schwäbisch-Hall, Germany, 74523
    • Diakonie-Klinikum Klinik für Innere Medizin III Abt.Hämatologie, intern. Onkologie und Palliativmedi
  • Stuttgart, Germany, 70176
    • Internistische Gemeinschaftspraxis Dres. Hoering/Von Ehr/Responde
  • Wuerselen, Germany, 52146
    • Haematologisch-Onkologische Praxis; Dr. med. Christoph Maintz und Matthias Groschek
• Greece
  • Athens, Greece, 11524
    • Laiko General Hospital - Uni of Athens; 1St Dept. of Internal Medicine
  • Athens, Greece, 124 62
    • Attiko Hospital; Haematology Clinic
  • Thessaloniki, Greece, 54007
    • Theagenio Anticancer Hospital; Dept. of Haematology
• Israel
  • Haifa, Israel, 3109601
    • Rambam Medical Center; Heamatology & Bone Marrow Transplantation
  • Holon, Israel, 5810001
    • Wolfson Mc; Haematology
  • Jerusalem, Israel, 9112001
    • Hadassah Ein Karem Hospital; Haematology
  • Ramat Gan, Israel, 52662
    • Chaim Sheba Medical Center; Hematology BMT & CBB
  • Tel Aviv, Israel, 6423906
    • Ichilov Sourasky Medical Center; Heamatology
• Italy
  • Abruzzo
    • Pescara, Abruzzo, Italy, 65100
      • Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia
  • Calabria
    • Catanzaro, Calabria, Italy, 88100
      • Az. Osp. Pugliese; Dh Oncologico
  • Campania
    • Napoli, Campania, Italy, 80100
      • Ospedale S. Gennaro; Divisione Di Ematologia
    • Napoli, Campania, Italy, 80131
      • Ospedale Cardarelli; Divisione Di Ematologia
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40138
      • A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
    • Ferrara, Emilia-Romagna, Italy, 44100
      • Arcispedale S. Anna; Sezione Di Ematologia
    • Modena, Emilia-Romagna, Italy, 41100
      • A.O.U. Policlinico di Modena-Dipartimento di Medicina Diagnostica, Clinica e di Sanità pubblica
    • Modena, Emilia-Romagna, Italy, 41100
      • A.O. Universitaria Policlinico Di Modena; Ematologia
  • Friuli-Venezia Giulia
    • Aviano, Friuli-Venezia Giulia, Italy, 33081
      • Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
  • Lazio
    • Roma, Lazio, Italy, 00133
      • Az. Osp. Uni Ria Policlinico Tor Vergata; Unita Di Ematologia
    • Roma, Lazio, Italy, 00144
      • Ospedale S. Eugenio; Divisione Di Ematologia
    • Roma, Lazio, Italy, 00161
      • Univ. Cattolica La Sapienza; Cattedra Di Ematologia
    • Roma, Lazio, Italy, 00168
      • Uni Cattolica; Divisione Di Ematologia
  • Liguria
    • Genova, Liguria, Italy, 16132
      • A.O. Universitaria S. Martino Di Genova; Ematologia 1
  • Lombardia
    • Brescia, Lombardia, Italy, 25123
      • A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia
    • Milano, Lombardia, Italy, 20162
      • Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
    • Milano, Lombardia, Italy, 20132
      • Istituto S. Raffaele Monte Tabor; Divisione Ematologia E Utmo
    • Milano, Lombardia, Italy, 20133
      • Ist. Nazionale Per Lo Studio E Cura Dei Tumori; Div. Ematologia Trapianto Midollo Osseo Allogenico
    • Monza, Lombardia, Italy, 20052
      • ASST DI MONZA; Ematologia
    • Pavia, Lombardia, Italy, 27100
      • Irccs Policlinico San Matteo; Divisione Di Ematologia
  • Marche
    • Pesaro, Marche, Italy, 61100
      • Ospedale Civile; S.C. Ematologia
    • Torrette Di Ancona, Marche, Italy, 60020
      • A.O. Univ.Ospedali Riuniti Umerto I -G.M.Lancisi G.Salesi; U.O. Clinica Di Ematologia
  • Piemonte
    • Candiolo, Piemonte, Italy, 10060
      • Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
    • Cuneo, Piemonte, Italy, 12100
      • Az. Osp. S. Croce Ospedale Generale; Sezione Di Ematologia
    • Novara, Piemonte, Italy, 28100
      • Univ. Piemonte Est Amedeo Avogadro; Div.Ematologia- Dip.Clinica Med.Sperim.& Ircad
    • Torino, Piemonte, Italy, 10126
      • A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1
    • Torino, Piemonte, Italy, 10126
      • A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia
  • Puglia
    • Bari, Puglia, Italy, 70124
      • Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica
    • Lecce, Puglia, Italy, 73100
      • Ospedale Vito Fazzi; Div. Oncoematologia
    • Tricase - Le, Puglia, Italy, 73039
      • Az. Osp. C. Panico; Rep. Ematologia E Trapianto
  • Sardegna
    • Cagliari, Sardegna, Italy, 09121
      • Ospedale Oncologico A Businco-Cagliari; Ematologia Sez.
  • Sicilia
    • Palermo, Sicilia, Italy, 90146
      • Ospedale V. Cervello; U.O. Ematologia E Trapianti
    • Via S. Sofia 78, Sicilia, Italy, 95123
      • Ospedale Ferrarotto; Divisione Di Ematologia
  • Toscana
    • Firenze, Toscana, Italy, 50135
      • Az. Osp. Di Careggi; Divisione Di Ematologia
    • Pisa, Toscana, Italy, 56100
      • Ospedale Santa Chiara; Unita Operativa Di Ematologia
    • Siena, Toscana, Italy, 53100
      • A.O. Universitaria Senese; Ematologia
  • Umbria
    • Perugia, Umbria, Italy, 06100
      • Azienda Ospedaliera S. Maria della Misericordia; Ematologia
  • Veneto
    • Padova, Veneto, Italy, 35128
      • Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia
    • Vicenza, Veneto, Italy, 36100
      • Ospedale Di Vicenza; Nefrologia, Ematologia
• Mexico
  • Chihuahua, Mexico, 31100
    • Issste; Haematology
  • Chihuahua, Mexico, 31238
    • Hospital Cima (Centro Internacional de Medicina) ; Haematology
  • Mexico City, Mexico, 02720
    • Hospital Central de Pemex Norte Azcapotzalco
  • Mexico City, Mexico, 11520
    • Hospital Español de Mexico
  • Monterrey, Mexico, 64380
    • Hospital Regional Issste; Oncologia
  • Obregon, Mexico, 85000
    • Clinca San Jose; Haematology
  • Puebla, Mexico, 72530
    • Issstep Puebla, ; Haematology
• Romania
  • Brasov, Romania, 500326
    • Spitalul Clinic Judetean de Urgenta Brasov,Clinica de Hematologie
  • Bucharest, Romania, 022328
    • Fundeni Clinical Inst. ; Hematology Dept
  • Bucuresti, Romania, 030171
    • Spitalul Clinic Coltea; Clinica de Hematologie
  • Cluj-Napoca, Romania, 400015
    • Oncology Inst. Cluj-Napoca; Cancer Dept
  • Iasi, Romania, 700111
    • Spitalul Clinic Judetean de Urgenta Sf. Spiridon Iasi, Clinica de Hematologie
  • Targu-mures, Romania, 540136
    • Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie
• Russian Federation
  • Belgorod, Russian Federation, ND
    • Regional Clinical Hospital; Hematology
  • Kazan, Russian Federation, 420029
    • Clinical Oncology Dispensary of Ministry of Health of Tatarstan
  • Moscow, Russian Federation, 115478
    • Blokhin Cancer Research Center; Clinical Oncology
  • Moscow, Russian Federation, 125101
    • City Clinical Hospital After Botkin; Hematology
  • Moscow, Russian Federation, 129110
    • Vladimirskiy Regional Scientific Research Inst. ; Hematology
  • Nizhny Novgorod, Russian Federation, 603126
    • Regional Clinical Hospital N.A. Semashko; Hematology
  • Novosibirsk, Russian Federation, 630051
    • City Hematological Center of Clinical Hospital #2; Hematology
  • Rostov-na-donu, Russian Federation, 344022
    • Rostov State Medical Uni ; Hematology
  • St Petersburg, Russian Federation, 191024
    • Research Inst. of Hematology & Blood Transfusion ; Hematology
  • St Petersburg, Russian Federation, 197022
    • Pavlov State Medical Uni ; Bone Marrow Transplantation Clinic
  • St Petersburg, Russian Federation
    • Leningrad Regional Clinical Hospital; Hematology #1
  • Stavropol, Russian Federation, ND
    • Stavropol Clinical Oncology Dispansary
  • UFA, Russian Federation, 450054
    • Bashkirian Republican Clinical Oncology Dispensary
  • Ulyanovsk, Russian Federation, ND
    • Ulyanovsk Regional Oncology Dispensary; Chemotherapy
  • Volgograd, Russian Federation, 400138
    • Regional Oncology Center; Chemotherapy
  • Yaroslavl, Russian Federation, 150062
    • Regional Clinical Hospital; Hematology
• Slovakia
  • Banska Bystrica, Slovakia, 975 17
    • Fakultna Nemocnica Roosevelta; Dept. of Haematology
  • Bratislava, Slovakia, 833 10
    • National Oncology Inst. ; Dept. of Haematology
  • Kosice, Slovakia, 040 66
    • Uni Hospital; Clinic of Haematology
  • Martin, Slovakia, 036 59
    • Uni Hospital ; Dept. of Haematol. & Transfusion Medicine
• Slovenia
  • Ljubljana, Slovenia, 1000
    • Institute of Oncology Ljubljana
• Spain
  • Burgos, Spain, 09006
    • Complejo Asistencial Universitario De Burgos; Servicio de Oncologia
  • Castellon, Spain, 12004
    • Hospital General de Castellon; Servicio de Hematologia
  • Ciudad Real, Spain, 13005
    • Hospital Generla de Ciudad Real; Servicio de Oncologia
  • Jaen, Spain, 23007
    • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
  • Leon, Spain, 24411
    • Hospital El Bierzo; Servicio de Oncologia
  • Malaga, Spain, 29600
    • Hospital Costa del Sol; Servicio de Hematologia
  • Murcia, Spain, 30120
    • Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena; Servicio de Hematologia
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
• Sweden
  • Halmstad, Sweden, 30185
    • Laenssjukhuset; Medicinkliniken/Hematologsektionen
  • Luleå, Sweden, S-971 80
    • Sunderby Sjukhus; Medicinkliniken
  • Malmö, Sweden, 205 02
    • Skånes Universitetssjukhus; Kliniska Forskningsenheten Onkologimottagning medicinsk behandling
  • Sundsvall, Sweden, 85186
    • Länssjukhuset Sundsvall-Härnösand, Medicinkliniken
  • Uddevalla, Sweden, 45180
    • Uddevalla Sjukhus; Medicinkliniken
  • Uppsala, Sweden, 75185
    • Akademiska sjukhuset, Onkologkliniken
• Switzerland
  • Cham, Switzerland, 6330
    • Andreas Klinik; Onko-Hämatologisches Zentrum Cham Zug
  • Chur, Switzerland, 7000
    • Kantonsspital Graubünden;Onkologie und Hämatologie
  • Locarno, Switzerland, 6601
    • Clinica Santa Chiara; Oncologia / Ematologia
  • Zürich, Switzerland, 8091
    • UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
• Turkey
  • Ankara, Turkey, 06100
    • Ankara Numune Egitim Ve Arastirma Hastanesi; Hematoloji Klinigi
  • Ankara, Turkey, 06100
    • Hacettepe Uni Medical Faculty; Hematology
  • Ankara, Turkey, 06500
    • Gazi Uni Medical School; Hematology
  • Istanbul, Turkey, 34390
    • Istanbul Uni Capa Hospital; Hematology
  • Izmir, Turkey, 35100
    • Ege Uni Medical School; Hematology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• adult patients, >=18 years of age;
• histologically confirmed grade 1, 2 or 3a follicular non-Hodgkin's lymphoma;
• patients who have received adequate (>=8 cycles) induction therapy with MabThera as first line treatment, or treatment for relapsed disease;
• demonstrated partial or complete response to induction therapy.

Exclusion Criteria:

• stable or progressive disease after most recent induction therapy;
• transformation to high grade lymphoma;
• patients with prior or concomitant malignancies, except non-melanoma skin cancer or adequately treated in situ cancer of the cervix.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: rituximab [MabThera/Rituxan]; 375mg/m2 iv every 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With an Adverse Event (AE) - Overall Summary	Data presented include percentage of participants with any AE, any infusion-related AE, any serious adverse event (SAE), any infusion-related SAE (counted separately from SAEs), death, and participants with toxicity as the primary cause for treatment discontinuation.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival - Percentage of Participants With an Event	PFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression or death by any cause. Participants who experienced none of these events at the time of analysis (clinical cutoff) and participants who were lost to follow-up were censored at their last clinical assessment date.	Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Progression-Free Survival - Time to Event	PFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression or death by any cause. Participants who experienced none of these events at the time of analysis (clinical cutoff) and participants who were lost to follow-up were censored at their last clinical assessment date.	Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Event-Free Survival (EFS) - Percentage of Participants With an Event	The percentage of participants who experienced PD or death or required a next or new lymphoma treatment over a study period of 2 years with 1 year of follow-up. EFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression, death by any cause, or the institution of new anti-lymphoma treatment. Participants who experienced none of these events at the end of the study and participants who were lost to follow-up were censored at their last clinical assessment date.	Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Event-Free Survival (EFS) - Time to Event	EFS was measured from the day of first rituximab maintenance infusion until the date of first documented disease progression, death by any cause, or the institution of new anti-lymphoma treatment. Participants who experienced none of these events at the end of the study and participants who were lost to follow-up were censored at their last clinical assessment date.	Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Overall Survival (OS) - Percentage of Participants With an Event	As a measure of overall survival (OS), the percentage of participants who died over the study period of 2 years with 1 year of follow-up. OS was determined from the day of first rituximab maintenance infusion until the date of death irrespective of cause. Participants who had not died at the time of end of the whole study and participants who were lost to follow up were censored at the date of the last contact.	Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Overall Survival (OS) - Time to Event	OS was determined from the day of first rituximab maintenance infusion until the date of death irrespective of cause. Participants who had not died at the time of end of the whole study and participants who were lost to follow up were censored at the date of the last contact.	Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Time to Next Lymphoma Treatment (NLT) - Percentage of Participants With an Event	As a measure of time to NLT (TNLT), the percentage of participants with new lymphoma treatment over a study period of 2 years with 1 year of follow-up. TNLT was measured from the date of first rituximab maintenance infusion to the date of first documented intake of any new anti-lymphoma treatment (chemotherapy, radiotherapy, immunotherapy, etc). Participants who did not have documentation that an NLT had started and participants who were lost to follow up were censored at their last visit where the assessment for start of any new lymphoma medication was actually made.	Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Time to NLT - Time to Event	TNLT was measured from the date of first rituximab maintenance infusion to the date of first documented intake of any new anti-lymphoma treatment (chemotherapy, radiotherapy, immunotherapy, etc). Participants who did not have documentation that an NLT had started and participants who were lost to follow up were censored at their last visit where the assessment for start of any new lymphoma medication was actually made.	Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Percentage of Participants With Response by Best Response to Study Treatment	Percentage of participants with complete response (CR), unconfirmed CR (CRu), no change, or progressive disease (PD). For each participant, the last response to induction therapy immediately prior to study entry was compared to the best response observed during rituximab maintenance therapy. Where possible, assessment of response was based on the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphoma (NHL).	Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Percentage of Participants With PR Who Converted to CRu	Percentage of participants with PR or CR(u) conversion while on rituximab maintenance therapy over a study period of 2 years with 1 year of follow-up. For each participant, the last response to induction therapy immediately prior to study entry was compared to the best response observed during rituximab maintenance therapy. Assessment and definition of response was based on the International Workshop to Standardize Response Criteria for NHL.	Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• Witzens-Harig M, Foa R, Di Rocco A, van Hazel G, Chamone DF, Rowe JM, Arcaini L, Poddubnaya I, Ho AD, Ivanova V, Vranovsky A, Thurley D, Oertel S. Maintenance with rituximab is safe and not associated with severe or uncommon infections in patients with follicular lymphoma: results from the phase IIIb MAXIMA study. Ann Hematol. 2014 Oct;93(10):1717-24. doi: 10.1007/s00277-014-2103-3. Epub 2014 May 14. Erratum In: Ann Hematol. 2014 Oct;93(10):1807.

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2006
• Primary Completion (Actual): May 26, 2011
• Study Completion (Actual): May 26, 2011

Study Registration Dates

• First Submitted: January 31, 2007
• First Submitted That Met QC Criteria: January 31, 2007
• First Posted (Estimate): February 1, 2007

Study Record Updates

• Last Update Posted (Actual): August 14, 2017
• Last Update Submitted That Met QC Criteria: July 5, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Lymphoma, Non-Hodgkin; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Rituximab
• Other Study ID Numbers: MO19872