Clinical trial NCT00430352: MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-Hodgkin's Lymphoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-02-01
Enrollment: 545
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants With an Adverse Event (AE) - Overall Summary
timeFrame: 24 months
Secondary outcomes:
measure: Progression-Free Survival - Percentage of Participants With an Event
timeFrame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
measure: Progression-Free Survival - Time to Event
timeFrame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
measure: Event-Free Survival (EFS) - Percentage of Participants With an Event
timeFrame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
measure: Event-Free Survival (EFS) - Time to Event
timeFrame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
measure: Overall Survival (OS) - Percentage of Participants With an Event
timeFrame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
measure: Overall Survival (OS) - Time to Event
timeFrame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
measure: Time to Next Lymphoma Treatment (NLT) - Percentage of Participants With an Event
timeFrame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
measure: Time to NLT - Time to Event
timeFrame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
measure: Percentage of Participants With Response by Best Response to Study Treatment
timeFrame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
measure: Percentage of Participants With PR Who Converted to CRu
timeFrame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Other outcomes:
Locations:
city: Tirana
country: Albania
facility: University "Mother Theresa" Hospital Center; Oncology Department
city: Bahia Blanca
country: Argentina
facility: Instituo Lavalle de Oncologia; Hematology
city: Buenos Aires
country: Argentina
facility: Academia Nacional de Medicina; Inst. de Cardiologia
city: Buenos Aires
country: Argentina
facility: Fundaleu; Haematology
city: Buenos Aires
country: Argentina
facility: Hospital Churruca Visca; Haematology
city: Corrientes
country: Argentina
facility: Hospital Jr Vidal; Jefe de Servicio de Clinica Medica/Hematologia
city: Córdoba
country: Argentina
facility: Sanatorio Allende; Haematology
city: Córdoba
country: Argentina
facility: HOSPITAL PRIVADO - CENTRO MEDICO DE CÓRDOBA; Dpto Oncología
city: La Plata
country: Argentina
facility: Hospital General San Martin; Haematology
city: Liverpool
country: Australia
facility: Liverpool Hospital; Haematology
state: New South Wales
city: Wollongong
country: Australia
facility: Wollongong Hospital; Cancer Services
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane Hospital; Oncology Department
state: Queensland
city: South Brisbane
country: Australia
facility: Haematology & Oncology Clinics of Australia, Mater Medical Centre
state: Queensland
city: Perth
country: Australia
facility: Mount Medical Center
state: Western Australia
city: Banja Luka
country: Bosnia and Herzegovina
facility: University Clinical Center of the Republic of Srpska, Clinic for Internal Disease, Hematology Dept
city: Kasindo
country: Bosnia and Herzegovina
facility: Inst. of Hematology
city: Mostar
country: Bosnia and Herzegovina
facility: Uni Hospital Mostar
city: Sarajevo
country: Bosnia and Herzegovina
facility: Clinic of Oncology, University Clinical Center Sarajevo
city: Salvador, Bahia
country: Brazil
facility: Nucleo de Oncologia da Bahia - NOB
state: BA
city: Salvador
country: Brazil
facility: CEHON
state: BA
city: Belo Horizonte
country: Brazil
facility: ONCOMED
state: MG
city: Rio de Janeiro
country: Brazil
facility: Centro de Tratamento Oncologico - Oncoclinica
state: RJ
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas - UFRGS; Medicina Interna
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Mae de Deus
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas - PUCRS
state: RS
city: Florianopolis
country: Brazil
facility: Centro de Pesquisas Oncologicas - CEPON
state: SC
city: Campinas
country: Brazil
facility: Hospital das Clinicas - UNICAMP; Hemoterapia
state: SP
city: Piracicaba
country: Brazil
facility: Clinica Oncologica De Piracicaba Sc
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Alemao Oswaldo Cruz; Oncologia
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital Estadual do Servidor Publico; Hematologia
state: SP
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas - FMUSP, Oncologia
state: SP
city: Pleven
country: Bulgaria
facility: UMHAT Dr Georgi Stranski; Hematology
city: Plovdiv
country: Bulgaria
facility: Umhat S. George; Hematology
city: Sofia
country: Bulgaria
facility: UMHAT Alexandrovska EAD; Hematology
city: Sofia
country: Bulgaria
facility: National Center of Hematology & Transfusiology; Clinical Unit, Clinic of Hematology
city: Varna
country: Bulgaria
facility: Mhat Sveta Marina; Dept. of Haematology
city: Bucaramanga
country: Colombia
facility: Centro Médico Carlos Ardila Lule
city: Medellin-Antioquia
country: Colombia
facility: Hospital Pablo Tobon Uribe
city: Split
country: Croatia
facility: Clinical Hospital Centre Split; Dept Of Hematology
city: Zagreb
country: Croatia
facility: Clinical Hospital Centre Dubrava; Hematology Department
city: Zagreb
country: Croatia
facility: University Hospital Center Zagreb; Haematology Department
city: Cuenca
country: Ecuador
facility: Hospital José Carrasco; Oncology Service
city: Quito
country: Ecuador
facility: Hospital Carlos Andrade Marin; Servicio de Oncología
city: Cairo
country: Egypt
facility: Oncology & Radiotherapy Centre; Oncology
city: Haemeenlinna
country: Finland
facility: Kanta-Hämeen Keskussairaala; Dept of Internal Medicine, Hematology
city: Kotka
country: Finland
facility: Kymenlaakson keskussairaala
city: Lahti
country: Finland
facility: Päijät-Hämeen Keskussairaala; Dept of Internal Medicine, Hematology
city: Pori
country: Finland
facility: Satakunnan Keskussairaala; Sisaetauti Osasto
city: Bad Soden
country: Germany
facility: Internist; Praxis Für Haemotologie & Onkologie
city: Berlin
country: Germany
facility: Dres.Christian Sperling und Claudia Schelenz
city: Berlin
country: Germany
facility: Onkologische Schwerpunktpraxis Kurfürstendamm
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn; Medizinische Klinik und Poliklinik I; Allgemeine Innere Medizin
city: Braunschweig
country: Germany
facility: Dres. Matthias Adler Oliver Marschal und Andreas Pies
city: Duisburg
country: Germany
facility: Gemeinschaftspraxis
city: Düsseldorf
country: Germany
facility: Internistische Praxis Dr. Plingen
city: Erlangen
country: Germany
facility: Internistische Schwerpunktpraxis Erlangen
city: Freiburg
country: Germany
facility: Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
city: Gütersloh
country: Germany
facility: Onkologische Gemeinschaftspraxis, Prof. Dr. Gropp, Dr. Depenbusch und Dr. Rösel
city: Hamburg
country: Germany
facility: Überörtliche Gemeinschaftspraxis Schwerpunkt Hämatologie, internistische Onkologie & Palliativmed.
city: Hamburg
country: Germany
facility: Onkologische Schwerpunktpraxis; Herrn Dr. Med. Bertram
city: Heidelberg
country: Germany
facility: Dres.Andreas Karcher und Stefan Fuxius
city: Heidelberg
country: Germany
facility: Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V
city: Jena
country: Germany
facility: Onkologische Schwerpunktpraxis (Eps-Gmbh)
city: Lüdenscheid
country: Germany
facility: Märkische Kliniken GmbH, Klinikum Lüdenscheid; Hämatologie / Onkologie
city: Mutlangen
country: Germany
facility: Stauferklinikum Schwäb.Gmünd
city: Mülheim
country: Germany
facility: Gemeinschaftspraxis Dres. Schröder, Sieg
city: München
country: Germany
facility: Onko. Gemeinschaftspraxis Dres. Tigges/ Böning/ Abenhardt/ Bosse
city: Nordhorn
country: Germany
facility: Dres.Ulrich Hutzschenreuter und Uwe Sauer
city: Oldenburg
country: Germany
facility: Onkologische Praxis Oldenburg; Dres. Otremba, Reschke, Zirpel, Kühn und Ruff
city: Recklinghausen
country: Germany
facility: Praxis für Onkologie und Hämatologie
city: Schwäbisch-Hall
country: Germany
facility: Diakonie-Klinikum Klinik für Innere Medizin III Abt.Hämatologie, intern. Onkologie und Palliativmedi
city: Stuttgart
country: Germany
facility: Internistische Gemeinschaftspraxis Dres. Hoering/Von Ehr/Responde
city: Wuerselen
country: Germany
facility: Haematologisch-Onkologische Praxis; Dr. med. Christoph Maintz und Matthias Groschek
city: Athens
country: Greece
facility: Laiko General Hospital - Uni of Athens; 1St Dept. of Internal Medicine
city: Athens
country: Greece
facility: Attiko Hospital; Haematology Clinic
city: Thessaloniki
country: Greece
facility: Theagenio Anticancer Hospital; Dept. of Haematology
city: Haifa
country: Israel
facility: Rambam Medical Center; Heamatology & Bone Marrow Transplantation
city: Holon
country: Israel
facility: Wolfson Mc; Haematology
city: Jerusalem
country: Israel
facility: Hadassah Ein Karem Hospital; Haematology
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center; Hematology BMT & CBB
city: Tel Aviv
country: Israel
facility: Ichilov Sourasky Medical Center; Heamatology
city: Pescara
country: Italy
facility: Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia
state: Abruzzo
city: Catanzaro
country: Italy
facility: Az. Osp. Pugliese; Dh Oncologico
state: Calabria
city: Napoli
country: Italy
facility: Ospedale S. Gennaro; Divisione Di Ematologia
state: Campania
city: Napoli
country: Italy
facility: Ospedale Cardarelli; Divisione Di Ematologia
state: Campania
city: Bologna
country: Italy
facility: A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
state: Emilia-Romagna
city: Ferrara
country: Italy
facility: Arcispedale S. Anna; Sezione Di Ematologia
state: Emilia-Romagna
city: Modena
country: Italy
facility: A.O. Universitaria Policlinico Di Modena; Ematologia
state: Emilia-Romagna
city: Modena
country: Italy
facility: A.O.U. Policlinico di Modena-Dipartimento di Medicina Diagnostica, Clinica e di Sanità pubblica
state: Emilia-Romagna
city: Aviano
country: Italy
facility: Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: Az. Osp. Uni Ria Policlinico Tor Vergata; Unita Di Ematologia
state: Lazio
city: Roma
country: Italy
facility: Ospedale S. Eugenio; Divisione Di Ematologia
state: Lazio
city: Roma
country: Italy
facility: Univ. Cattolica La Sapienza; Cattedra Di Ematologia
state: Lazio
city: Roma
country: Italy
facility: Uni Cattolica; Divisione Di Ematologia
state: Lazio
city: Genova
country: Italy
facility: A.O. Universitaria S. Martino Di Genova; Ematologia 1
state: Liguria
city: Brescia
country: Italy
facility: A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia
state: Lombardia
city: Milano
country: Italy
facility: Istituto S. Raffaele Monte Tabor; Divisione Ematologia E Utmo
state: Lombardia
city: Milano
country: Italy
facility: Ist. Nazionale Per Lo Studio E Cura Dei Tumori; Div. Ematologia Trapianto Midollo Osseo Allogenico
state: Lombardia
city: Milano
country: Italy
facility: Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
state: Lombardia
city: Monza
country: Italy
facility: ASST DI MONZA; Ematologia
state: Lombardia
city: Pavia
country: Italy
facility: Irccs Policlinico San Matteo; Divisione Di Ematologia
state: Lombardia
city: Pesaro
country: Italy
facility: Ospedale Civile; S.C. Ematologia
state: Marche
city: Torrette Di Ancona
country: Italy
facility: A.O. Univ.Ospedali Riuniti Umerto I -G.M.Lancisi G.Salesi; U.O. Clinica Di Ematologia
state: Marche
city: Candiolo
country: Italy
facility: Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
state: Piemonte
city: Cuneo
country: Italy
facility: Az. Osp. S. Croce Ospedale Generale; Sezione Di Ematologia
state: Piemonte
city: Novara
country: Italy
facility: Univ. Piemonte Est Amedeo Avogadro; Div.Ematologia- Dip.Clinica Med.Sperim.& Ircad
state: Piemonte
city: Torino
country: Italy
facility: A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1
state: Piemonte
city: Torino
country: Italy
facility: A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia
state: Piemonte
city: Bari
country: Italy
facility: Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica
state: Puglia
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi; Div. Oncoematologia
state: Puglia
city: Tricase - Le
country: Italy
facility: Az. Osp. C. Panico; Rep. Ematologia E Trapianto
state: Puglia
city: Cagliari
country: Italy
facility: Ospedale Oncologico A Businco-Cagliari; Ematologia Sez.
state: Sardegna
city: Palermo
country: Italy
facility: Ospedale V. Cervello; U.O. Ematologia E Trapianti
state: Sicilia
city: Via S. Sofia 78
country: Italy
facility: Ospedale Ferrarotto; Divisione Di Ematologia
state: Sicilia
city: Firenze
country: Italy
facility: Az. Osp. Di Careggi; Divisione Di Ematologia
state: Toscana
city: Pisa
country: Italy
facility: Ospedale Santa Chiara; Unita Operativa Di Ematologia
state: Toscana
city: Siena
country: Italy
facility: A.O. Universitaria Senese; Ematologia
state: Toscana
city: Perugia
country: Italy
facility: Azienda Ospedaliera S. Maria della Misericordia; Ematologia
state: Umbria
city: Padova
country: Italy
facility: Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia
state: Veneto
city: Vicenza
country: Italy
facility: Ospedale Di Vicenza; Nefrologia, Ematologia
state: Veneto
city: Chihuahua
country: Mexico
facility: Issste; Haematology
city: Chihuahua
country: Mexico
facility: Hospital Cima (Centro Internacional de Medicina) ; Haematology
city: Mexico City
country: Mexico
facility: Hospital Central de Pemex Norte Azcapotzalco
city: Mexico City
country: Mexico
facility: Hospital Español de Mexico
city: Monterrey
country: Mexico
facility: Hospital Regional Issste; Oncologia
city: Obregon
country: Mexico
facility: Clinca San Jose; Haematology
city: Puebla
country: Mexico
facility: Issstep Puebla, ; Haematology
city: Brasov
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Brasov,Clinica de Hematologie
city: Bucharest
country: Romania
facility: Fundeni Clinical Inst. ; Hematology Dept
city: Bucuresti
country: Romania
facility: Spitalul Clinic Coltea; Clinica de Hematologie
city: Cluj-Napoca
country: Romania
facility: Oncology Inst. Cluj-Napoca; Cancer Dept
city: Iasi
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Sf. Spiridon Iasi, Clinica de Hematologie
city: Targu-mures
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie
city: Belgorod
country: Russian Federation
facility: Regional Clinical Hospital; Hematology
city: Kazan
country: Russian Federation
facility: Clinical Oncology Dispensary of Ministry of Health of Tatarstan
city: Moscow
country: Russian Federation
facility: Blokhin Cancer Research Center; Clinical Oncology
city: Moscow
country: Russian Federation
facility: City Clinical Hospital After Botkin; Hematology
city: Moscow
country: Russian Federation
facility: Vladimirskiy Regional Scientific Research Inst. ; Hematology
city: Nizhny Novgorod
country: Russian Federation
facility: Regional Clinical Hospital N.A. Semashko; Hematology
city: Novosibirsk
country: Russian Federation
facility: City Hematological Center of Clinical Hospital #2; Hematology
city: Rostov-na-donu
country: Russian Federation
facility: Rostov State Medical Uni ; Hematology
city: St Petersburg
country: Russian Federation
facility: Research Inst. of Hematology & Blood Transfusion ; Hematology
city: St Petersburg
country: Russian Federation
facility: Pavlov State Medical Uni ; Bone Marrow Transplantation Clinic
city: St Petersburg
country: Russian Federation
facility: Leningrad Regional Clinical Hospital; Hematology #1
city: Stavropol
country: Russian Federation
facility: Stavropol Clinical Oncology Dispansary
city: UFA
country: Russian Federation
facility: Bashkirian Republican Clinical Oncology Dispensary
city: Ulyanovsk
country: Russian Federation
facility: Ulyanovsk Regional Oncology Dispensary; Chemotherapy
city: Volgograd
country: Russian Federation
facility: Regional Oncology Center; Chemotherapy
city: Yaroslavl
country: Russian Federation
facility: Regional Clinical Hospital; Hematology
city: Banska Bystrica
country: Slovakia
facility: Fakultna Nemocnica Roosevelta; Dept. of Haematology
city: Bratislava
country: Slovakia
facility: National Oncology Inst. ; Dept. of Haematology
city: Kosice
country: Slovakia
facility: Uni Hospital; Clinic of Haematology
city: Martin
country: Slovakia
facility: Uni Hospital ; Dept. of Haematol. & Transfusion Medicine
city: Ljubljana
country: Slovenia
facility: Institute of Oncology Ljubljana
city: Burgos
country: Spain
facility: Complejo Asistencial Universitario De Burgos; Servicio de Oncologia
city: Castellon
country: Spain
facility: Hospital General de Castellon; Servicio de Hematologia
city: Ciudad Real
country: Spain
facility: Hospital Generla de Ciudad Real; Servicio de Oncologia
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
city: Leon
country: Spain
facility: Hospital El Bierzo; Servicio de Oncologia
city: Malaga
country: Spain
facility: Hospital Costa del Sol; Servicio de Hematologia
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena; Servicio de Hematologia
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
city: Halmstad
country: Sweden
facility: Laenssjukhuset; Medicinkliniken/Hematologsektionen
city: Luleå
country: Sweden
facility: Sunderby Sjukhus; Medicinkliniken
city: Malmö
country: Sweden
facility: Skånes Universitetssjukhus; Kliniska Forskningsenheten Onkologimottagning medicinsk behandling
city: Sundsvall
country: Sweden
facility: Länssjukhuset Sundsvall-Härnösand, Medicinkliniken
city: Uddevalla
country: Sweden
facility: Uddevalla Sjukhus; Medicinkliniken
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset, Onkologkliniken
city: Cham
country: Switzerland
facility: Andreas Klinik; Onko-Hämatologisches Zentrum Cham Zug
city: Chur
country: Switzerland
facility: Kantonsspital Graubünden;Onkologie und Hämatologie
city: Locarno
country: Switzerland
facility: Clinica Santa Chiara; Oncologia / Ematologia
city: Zürich
country: Switzerland
facility: UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
city: Ankara
country: Turkey
facility: Ankara Numune Egitim Ve Arastirma Hastanesi; Hematoloji Klinigi
city: Ankara
country: Turkey
facility: Hacettepe Uni Medical Faculty; Hematology
city: Ankara
country: Turkey
facility: Gazi Uni Medical School; Hematology
city: Istanbul
country: Turkey
facility: Istanbul Uni Capa Hospital; Hematology
city: Izmir
country: Turkey
facility: Ege Uni Medical School; Hematology
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.