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.
1 other identifier
interventional
545
23 countries
177
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2006
Longer than P75 for phase_4
177 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 4, 2006
CompletedFirst Submitted
Initial submission to the registry
January 31, 2007
CompletedFirst Posted
Study publicly available on registry
February 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 26, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 26, 2011
CompletedResults Posted
Study results publicly available
June 8, 2015
CompletedAugust 14, 2017
July 1, 2017
4.7 years
January 31, 2007
September 4, 2014
July 5, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Progression-Free Survival - Percentage of Participants With an Event
Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Progression-Free Survival - Time to Event
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
Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Event-Free Survival (EFS) - Time to Event
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
Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
- +5 more secondary outcomes
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (178)
University "Mother Theresa" Hospital Center; Oncology Department
Tirana, 1000, Albania
Instituo Lavalle de Oncologia; Hematology
Bahía Blanca, 8001, Argentina
Academia Nacional de Medicina; Inst. de Cardiologia
Buenos Aires, 1425, Argentina
Fundaleu; Haematology
Buenos Aires, C1114AAN, Argentina
Hospital Churruca Visca; Haematology
Buenos Aires, C1437JCP, Argentina
Hospital Jr Vidal; Jefe de Servicio de Clinica Medica/Hematologia
Corrientes, 3400, Argentina
Sanatorio Allende; Haematology
Córdoba, 5000, Argentina
HOSPITAL PRIVADO - CENTRO MEDICO DE CÓRDOBA; Dpto Oncología
Córdoba, 5016, Argentina
Hospital General San Martin; Haematology
La Plata, B1904CFS, Argentina
Liverpool Hospital; Haematology
Liverpool, New South Wales, 2170, Australia
Wollongong Hospital; Cancer Services
Wollongong, New South Wales, 2500, Australia
Royal Brisbane Hospital; Oncology Department
Brisbane, Queensland, 4006, Australia
Haematology & Oncology Clinics of Australia, Mater Medical Centre
South Brisbane, Queensland, 4101, Australia
Mount Medical Center
Perth, Western Australia, 6000, Australia
University Clinical Center of the Republic of Srpska, Clinic for Internal Disease, Hematology Dept
Banja Luka, 88000, Bosnia and Herzegovina
Inst. of Hematology
Kasindo, 71123, Bosnia and Herzegovina
Uni Hospital Mostar
Mostar, 88000, Bosnia and Herzegovina
Clinic of Oncology, University Clinical Center Sarajevo
Sarajevo, 71000, Bosnia and Herzegovina
CEHON
Salvador, Estado de Bahia, 40110-150, Brazil
Nucleo de Oncologia da Bahia - NOB
Salvador, Bahia, Estado de Bahia, 40170-380, Brazil
ONCOMED
Belo Horizonte, Minas Gerais, 30140-083, Brazil
Centro de Tratamento Oncologico - Oncoclinica
Rio de Janeiro, Rio de Janeiro, 22640-000, Brazil
Hospital das Clinicas - UFRGS; Medicina Interna
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Hospital Mae de Deus
Porto Alegre, Rio Grande do Sul, 90470-340, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Centro de Pesquisas Oncologicas - CEPON
Florianópolis, Santa Catarina, 88034-000, Brazil
Hospital das Clinicas - UNICAMP; Hemoterapia
Campinas, São Paulo, 13083-878, Brazil
Clinica Oncologica De Piracicaba Sc
Piracicaba, São Paulo, 13419-155, Brazil
Hospital Alemao Oswaldo Cruz; Oncologia
São Paulo, São Paulo, 01323-020, Brazil
Hospital Estadual do Servidor Publico; Hematologia
São Paulo, São Paulo, 04029-000, Brazil
Hospital das Clinicas - FMUSP, Oncologia
São Paulo, São Paulo, 05403-000, Brazil
UMHAT Dr Georgi Stranski; Hematology
Pleven, 5800, Bulgaria
Umhat S. George; Hematology
Plovdiv, 4002, Bulgaria
UMHAT Alexandrovska EAD; Hematology
Sofia, 1431, Bulgaria
National Center of Hematology & Transfusiology; Clinical Unit, Clinic of Hematology
Sofia, 1757, Bulgaria
Mhat Sveta Marina; Dept. of Haematology
Varna, 9010, Bulgaria
Centro Médico Carlos Ardila Lule
Bucaramanga, Colombia
Hospital Pablo Tobon Uribe
Medellin-Antioquia, Colombia
Clinical Hospital Centre Split; Dept Of Hematology
Split, 21000, Croatia
Clinical Hospital Centre Dubrava; Hematology Department
Zagreb, 10000, Croatia
University Hospital Center Zagreb; Haematology Department
Zagreb, 10000, Croatia
Hospital José Carrasco; Oncology Service
Cuenca, Ecuador
Hospital Carlos Andrade Marin; Servicio de Oncología
Quito, 2569, Ecuador
Oncology & Radiotherapy Centre; Oncology
Cairo, 11737, Egypt
Kanta-Hämeen Keskussairaala; Dept of Internal Medicine, Hematology
Hämeenlinna, 13530, Finland
Kymenlaakson keskussairaala
Kotka, 48210, Finland
Päijät-Hämeen Keskussairaala; Dept of Internal Medicine, Hematology
Lahti, 15850, Finland
Satakunnan Keskussairaala; Sisaetauti Osasto
Pori, 28500, Finland
Internist; Praxis Für Haemotologie & Onkologie
Bad Soden, 65812, Germany
Dres.Christian Sperling und Claudia Schelenz
Berlin, 10117, Germany
Onkologische Schwerpunktpraxis Kurfürstendamm
Berlin, 10707, Germany
Universitätsklinikum Bonn; Medizinische Klinik und Poliklinik I; Allgemeine Innere Medizin
Bonn, 53127, Germany
Dres. Matthias Adler Oliver Marschal und Andreas Pies
Braunschweig, 38100, Germany
Gemeinschaftspraxis
Duisburg, 47051, Germany
Internistische Praxis Dr. Plingen
Düsseldorf, 40211, Germany
Internistische Schwerpunktpraxis Erlangen
Erlangen, 91052, Germany
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
Freiburg im Breisgau, 79110, Germany
Onkologische Gemeinschaftspraxis, Prof. Dr. Gropp, Dr. Depenbusch und Dr. Rösel
Gütersloh, 33332, Germany
Überörtliche Gemeinschaftspraxis Schwerpunkt Hämatologie, internistische Onkologie & Palliativmed.
Hamburg, 20259, Germany
Onkologische Schwerpunktpraxis; Herrn Dr. Med. Bertram
Hamburg, 22457, Germany
Dres.Andreas Karcher und Stefan Fuxius
Heidelberg, 69115, Germany
Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V
Heidelberg, 69120, Germany
Onkologische Schwerpunktpraxis (Eps-Gmbh)
Jena, 07743, Germany
Märkische Kliniken GmbH, Klinikum Lüdenscheid; Hämatologie / Onkologie
Lüdenscheid, 58515, Germany
Stauferklinikum Schwäb.Gmünd
Mutlangen, 73557, Germany
Gemeinschaftspraxis Dres. Schröder, Sieg
Mülheim, 45468, Germany
Onko. Gemeinschaftspraxis Dres. Tigges/ Böning/ Abenhardt/ Bosse
München, 80335, Germany
Dres.Ulrich Hutzschenreuter und Uwe Sauer
Nordhorn, 48527, Germany
Onkologische Praxis Oldenburg; Dres. Otremba, Reschke, Zirpel, Kühn und Ruff
Oldenburg, 26121, Germany
Praxis für Onkologie und Hämatologie
Recklinghausen, 45657, Germany
Diakonie-Klinikum Klinik für Innere Medizin III Abt.Hämatologie, intern. Onkologie und Palliativmedi
Schwäbisch Hall, 74523, Germany
Internistische Gemeinschaftspraxis Dres. Hoering/Von Ehr/Responde
Stuttgart, 70176, Germany
Haematologisch-Onkologische Praxis; Dr. med. Christoph Maintz und Matthias Groschek
Würselen, 52146, Germany
Laiko General Hospital - Uni of Athens; 1St Dept. of Internal Medicine
Athens, 11524, Greece
Attiko Hospital; Haematology Clinic
Athens, 124 62, Greece
Theagenio Anticancer Hospital; Dept. of Haematology
Thessaloniki, 54007, Greece
Rambam Medical Center; Heamatology & Bone Marrow Transplantation
Haifa, 3109601, Israel
Wolfson Mc; Haematology
Holon, 5810001, Israel
Hadassah Ein Karem Hospital; Haematology
Jerusalem, 9112001, Israel
Chaim Sheba Medical Center; Hematology BMT & CBB
Ramat Gan, 52662, Israel
Ichilov Sourasky Medical Center; Heamatology
Tel Aviv, 6423906, Israel
Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia
Pescara, Abruzzo, 65100, Italy
Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica
Bari, Apulia, 70124, Italy
Ospedale Vito Fazzi; Div. Oncoematologia
Lecce, Apulia, 73100, Italy
Az. Osp. C. Panico; Rep. Ematologia E Trapianto
Tricase - Le, Apulia, 73039, Italy
Az. Osp. Pugliese; Dh Oncologico
Catanzaro, Calabria, 88100, Italy
Ospedale S. Gennaro; Divisione Di Ematologia
Napoli, Campania, 80100, Italy
Ospedale Cardarelli; Divisione Di Ematologia
Napoli, Campania, 80131, Italy
A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna
Bologna, Emilia-Romagna, 40138, Italy
Arcispedale S. Anna; Sezione Di Ematologia
Ferrara, Emilia-Romagna, 44100, Italy
A.O. Universitaria Policlinico Di Modena; Ematologia
Modena, Emilia-Romagna, 41100, Italy
A.O.U. Policlinico di Modena-Dipartimento di Medicina Diagnostica, Clinica e di Sanità pubblica
Modena, Emilia-Romagna, 41100, Italy
Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
Aviano, Friuli Venezia Giulia, 33081, Italy
Az. Osp. Uni Ria Policlinico Tor Vergata; Unita Di Ematologia
Rome, Lazio, 00133, Italy
Ospedale S. Eugenio; Divisione Di Ematologia
Rome, Lazio, 00144, Italy
Univ. Cattolica La Sapienza; Cattedra Di Ematologia
Rome, Lazio, 00161, Italy
Uni Cattolica; Divisione Di Ematologia
Rome, Lazio, 00168, Italy
A.O. Universitaria S. Martino Di Genova; Ematologia 1
Genoa, Liguria, 16132, Italy
A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia
Brescia, Lombardy, 25123, Italy
Istituto S. Raffaele Monte Tabor; Divisione Ematologia E Utmo
Milan, Lombardy, 20132, Italy
Ist. Nazionale Per Lo Studio E Cura Dei Tumori; Div. Ematologia Trapianto Midollo Osseo Allogenico
Milan, Lombardy, 20133, Italy
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
Milan, Lombardy, 20162, Italy
ASST DI MONZA; Ematologia
Monza, Lombardy, 20052, Italy
Irccs Policlinico San Matteo; Divisione Di Ematologia
Pavia, Lombardy, 27100, Italy
Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico
Candiolo, Piedmont, 10060, Italy
Az. Osp. S. Croce Ospedale Generale; Sezione Di Ematologia
Cuneo, Piedmont, 12100, Italy
Univ. Piemonte Est Amedeo Avogadro; Div.Ematologia- Dip.Clinica Med.Sperim.& Ircad
Novara, Piedmont, 28100, Italy
A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1
Turin, Piedmont, 10126, Italy
A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia
Turin, Piedmont, 10126, Italy
Ospedale Oncologico A Businco-Cagliari; Ematologia Sez.
Cagliari, Sardinia, 09121, Italy
Ospedale V. Cervello; U.O. Ematologia E Trapianti
Palermo, Sicily, 90146, Italy
Ospedale Ferrarotto; Divisione Di Ematologia
Via S. Sofia 78, Sicily, 95123, Italy
Ospedale Civile; S.C. Ematologia
Pesaro, The Marches, 61100, Italy
A.O. Univ.Ospedali Riuniti Umerto I -G.M.Lancisi G.Salesi; U.O. Clinica Di Ematologia
Torrette Di Ancona, The Marches, 60020, Italy
Az. Osp. Di Careggi; Divisione Di Ematologia
Florence, Tuscany, 50135, Italy
Ospedale Santa Chiara; Unita Operativa Di Ematologia
Pisa, Tuscany, 56100, Italy
A.O. Universitaria Senese; Ematologia
Siena, Tuscany, 53100, Italy
Azienda Ospedaliera S. Maria della Misericordia; Ematologia
Perugia, Umbria, 06100, Italy
Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia
Padua, Veneto, 35128, Italy
Ospedale Di Vicenza; Nefrologia, Ematologia
Vicenza, Veneto, 36100, Italy
Issste; Haematology
Chihuahua City, 31100, Mexico
Hospital Cima (Centro Internacional de Medicina) ; Haematology
Chihuahua City, 31238, Mexico
Hospital Central de Pemex Norte Azcapotzalco
Mexico City, 02720, Mexico
Hospital Español de Mexico
Mexico City, 11520, Mexico
Hospital Regional Issste; Oncologia
Monterrey, 64380, Mexico
Clinca San Jose; Haematology
Obregón, 85000, Mexico
Issstep Puebla, ; Haematology
Puebla City, 72530, Mexico
Spitalul Clinic Judetean de Urgenta Brasov,Clinica de Hematologie
Brasov, 500326, Romania
Fundeni Clinical Inst. ; Hematology Dept
Bucharest, 022328, Romania
Spitalul Clinic Coltea; Clinica de Hematologie
Bucharest, 030171, Romania
Oncology Inst. Cluj-Napoca; Cancer Dept
Cluj-Napoca, 400015, Romania
Spitalul Clinic Judetean de Urgenta Sf. Spiridon Iasi, Clinica de Hematologie
Iași, 700111, Romania
Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie
Târgu Mureş, 540136, Romania
Regional Clinical Hospital; Hematology
Belgorod, ND, Russia
Clinical Oncology Dispensary of Ministry of Health of Tatarstan
Kazan', 420029, Russia
Blokhin Cancer Research Center; Clinical Oncology
Moscow, 115478, Russia
City Clinical Hospital After Botkin; Hematology
Moscow, 125101, Russia
Vladimirskiy Regional Scientific Research Inst. ; Hematology
Moscow, 129110, Russia
Regional Clinical Hospital N.A. Semashko; Hematology
Nizhny Novgorod, 603126, Russia
City Hematological Center of Clinical Hospital #2; Hematology
Novosibirsk, 630051, Russia
Rostov State Medical Uni ; Hematology
Rostov-on-Don, 344022, Russia
Research Inst. of Hematology & Blood Transfusion ; Hematology
Saint Petersburg, 191024, Russia
Pavlov State Medical Uni ; Bone Marrow Transplantation Clinic
Saint Petersburg, 197022, Russia
Leningrad Regional Clinical Hospital; Hematology #1
Saint Petersburg, Russia
Stavropol Clinical Oncology Dispansary
Stavropol, ND, Russia
Bashkirian Republican Clinical Oncology Dispensary
Ufa, 450054, Russia
Ulyanovsk Regional Oncology Dispensary; Chemotherapy
Ulyanovsk, ND, Russia
Regional Oncology Center; Chemotherapy
Volgograd, 400138, Russia
Regional Clinical Hospital; Hematology
Yaroslavl, 150062, Russia
Fakultna Nemocnica Roosevelta; Dept. of Haematology
Banská Bystrica, 975 17, Slovakia
National Oncology Inst. ; Dept. of Haematology
Bratislava, 833 10, Slovakia
Uni Hospital; Clinic of Haematology
Košice, 040 66, Slovakia
Uni Hospital ; Dept. of Haematol. & Transfusion Medicine
Martin, 036 59, Slovakia
Institute of Oncology Ljubljana
Ljubljana, 1000, Slovenia
Hospital General de Castellon; Servicio de Hematologia
Castellon, Castellon, 12004, Spain
Complejo Asistencial Universitario De Burgos; Servicio de Oncologia
Burgos, 09006, Spain
Hospital Generla de Ciudad Real; Servicio de Oncologia
Ciudad Real, 13005, Spain
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
Jaén, 23007, Spain
Hospital El Bierzo; Servicio de Oncologia
León, 24411, Spain
Hospital Costa del Sol; Servicio de Hematologia
Málaga, 29600, Spain
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
Murcia, 30120, Spain
Hospital Universitario Virgen Macarena; Servicio de Hematologia
Seville, 41009, Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia, 46010, Spain
Laenssjukhuset; Medicinkliniken/Hematologsektionen
Halmstad, 30185, Sweden
Sunderby Sjukhus; Medicinkliniken
Luleå, S-971 80, Sweden
Skånes Universitetssjukhus; Kliniska Forskningsenheten Onkologimottagning medicinsk behandling
Malmo, 205 02, Sweden
Länssjukhuset Sundsvall-Härnösand, Medicinkliniken
Sundsvall, 85186, Sweden
Uddevalla Sjukhus; Medicinkliniken
Uddevalla, 45180, Sweden
Akademiska sjukhuset, Onkologkliniken
Uppsala, 75185, Sweden
Andreas Klinik; Onko-Hämatologisches Zentrum Cham Zug
Cham, 6330, Switzerland
Kantonsspital Graubünden;Onkologie und Hämatologie
Chur, 7000, Switzerland
Clinica Santa Chiara; Oncologia / Ematologia
Locarno, 6601, Switzerland
UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie
Zurich, 8091, Switzerland
Ankara Numune Egitim Ve Arastirma Hastanesi; Hematoloji Klinigi
Ankara, 06100, Turkey (Türkiye)
Hacettepe Uni Medical Faculty; Hematology
Ankara, 06100, Turkey (Türkiye)
Gazi Uni Medical School; Hematology
Ankara, 06500, Turkey (Türkiye)
Istanbul Uni Capa Hospital; Hematology
Istanbul, 34390, Turkey (Türkiye)
Ege Uni Medical School; Hematology
Izmir, 35100, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 24824768DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2007
First Posted
February 1, 2007
Study Start
September 4, 2006
Primary Completion
May 26, 2011
Study Completion
May 26, 2011
Last Updated
August 14, 2017
Results First Posted
June 8, 2015
Record last verified: 2017-07