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

NCT ID: NCT00430352

Last Updated: 2017-08-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 545 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-04
• Study Completion Date: 2011-05-26

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.

Conditions

Non-Hodgkin's Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

rituximab [MabThera/Rituxan]

Intervention Type: DRUG

375mg/m2 iv every 8 weeks

Interventions

rituximab [MabThera/Rituxan]

375mg/m2 iv every 8 weeks

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

University "Mother Theresa" Hospital Center; Oncology Department

Tirana, , Albania

Instituo Lavalle de Oncologia; Hematology

Bahía Blanca, , Argentina

Academia Nacional de Medicina; Inst. de Cardiologia

Buenos Aires, , Argentina

Fundaleu; Haematology

Buenos Aires, , Argentina

Hospital Churruca Visca; Haematology

Buenos Aires, , Argentina

Hospital Jr Vidal; Jefe de Servicio de Clinica Medica/Hematologia

Corrientes, , Argentina

Sanatorio Allende; Haematology

Córdoba, , Argentina

HOSPITAL PRIVADO - CENTRO MEDICO DE CÓRDOBA; Dpto Oncología

Córdoba, , Argentina

Hospital General San Martin; Haematology

La Plata, , Argentina

Liverpool Hospital; Haematology

Liverpool, New South Wales, Australia

Wollongong Hospital; Cancer Services

Wollongong, New South Wales, Australia

Royal Brisbane Hospital; Oncology Department

Brisbane, Queensland, Australia

Haematology & Oncology Clinics of Australia, Mater Medical Centre

South Brisbane, Queensland, Australia

Mount Medical Center

Perth, Western Australia, Australia

University Clinical Center of the Republic of Srpska, Clinic for Internal Disease, Hematology Dept

Banja Luka, , Bosnia and Herzegovina

Inst. of Hematology

Kasindo, , Bosnia and Herzegovina

Uni Hospital Mostar

Mostar, , Bosnia and Herzegovina

Clinic of Oncology, University Clinical Center Sarajevo

Sarajevo, , Bosnia and Herzegovina

CEHON

Salvador, Estado de Bahia, Brazil

Nucleo de Oncologia da Bahia - NOB

Salvador, Bahia, Estado de Bahia, Brazil

ONCOMED

Belo Horizonte, Minas Gerais, Brazil

Centro de Tratamento Oncologico - Oncoclinica

Rio de Janeiro, Rio de Janeiro, Brazil

Hospital das Clinicas - UFRGS; Medicina Interna

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Mae de Deus

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Centro de Pesquisas Oncologicas - CEPON

Florianópolis, Santa Catarina, Brazil

Hospital das Clinicas - UNICAMP; Hemoterapia

Campinas, São Paulo, Brazil

Clinica Oncologica De Piracicaba Sc

Piracicaba, São Paulo, Brazil

Hospital Alemao Oswaldo Cruz; Oncologia

São Paulo, São Paulo, Brazil

Hospital Estadual do Servidor Publico; Hematologia

São Paulo, São Paulo, Brazil

Hospital das Clinicas - FMUSP, Oncologia

São Paulo, São Paulo, Brazil

UMHAT Dr Georgi Stranski; Hematology

Pleven, , Bulgaria

Umhat S. George; Hematology

Plovdiv, , Bulgaria

UMHAT Alexandrovska EAD; Hematology

Sofia, , Bulgaria

National Center of Hematology & Transfusiology; Clinical Unit, Clinic of Hematology

Sofia, , Bulgaria

Mhat Sveta Marina; Dept. of Haematology

Varna, , Bulgaria

Centro Médico Carlos Ardila Lule

Bucaramanga, , Colombia

Hospital Pablo Tobon Uribe

Medellin-Antioquia, , Colombia

Clinical Hospital Centre Split; Dept Of Hematology

Split, , Croatia

Clinical Hospital Centre Dubrava; Hematology Department

Zagreb, , Croatia

University Hospital Center Zagreb; Haematology Department

Zagreb, , Croatia

Hospital José Carrasco; Oncology Service

Cuenca, , Ecuador

Hospital Carlos Andrade Marin; Servicio de Oncología

Quito, , Ecuador

Oncology & Radiotherapy Centre; Oncology

Cairo, , Egypt

Kanta-Hämeen Keskussairaala; Dept of Internal Medicine, Hematology

Hämeenlinna, , Finland

Kymenlaakson keskussairaala

Kotka, , Finland

Päijät-Hämeen Keskussairaala; Dept of Internal Medicine, Hematology

Lahti, , Finland

Satakunnan Keskussairaala; Sisaetauti Osasto

Pori, , Finland

Internist; Praxis Für Haemotologie & Onkologie

Bad Soden, , Germany

Dres.Christian Sperling und Claudia Schelenz

Berlin, , Germany

Onkologische Schwerpunktpraxis Kurfürstendamm

Berlin, , Germany

Universitätsklinikum Bonn; Medizinische Klinik und Poliklinik I; Allgemeine Innere Medizin

Bonn, , Germany

Dres. Matthias Adler Oliver Marschal und Andreas Pies

Braunschweig, , Germany

Gemeinschaftspraxis

Duisburg, , Germany

Internistische Praxis Dr. Plingen

Düsseldorf, , Germany

Internistische Schwerpunktpraxis Erlangen

Erlangen, , Germany

Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

Freiburg im Breisgau, , Germany

Onkologische Gemeinschaftspraxis, Prof. Dr. Gropp, Dr. Depenbusch und Dr. Rösel

Gütersloh, , Germany

Überörtliche Gemeinschaftspraxis Schwerpunkt Hämatologie, internistische Onkologie & Palliativmed.

Hamburg, , Germany

Onkologische Schwerpunktpraxis; Herrn Dr. Med. Bertram

Hamburg, , Germany

Dres.Andreas Karcher und Stefan Fuxius

Heidelberg, , Germany

Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V

Heidelberg, , Germany

Onkologische Schwerpunktpraxis (Eps-Gmbh)

Jena, , Germany

Märkische Kliniken GmbH, Klinikum Lüdenscheid; Hämatologie / Onkologie

Lüdenscheid, , Germany

Stauferklinikum Schwäb.Gmünd

Mutlangen, , Germany

Gemeinschaftspraxis Dres. Schröder, Sieg

Mülheim, , Germany

Onko. Gemeinschaftspraxis Dres. Tigges/ Böning/ Abenhardt/ Bosse

München, , Germany

Dres.Ulrich Hutzschenreuter und Uwe Sauer

Nordhorn, , Germany

Onkologische Praxis Oldenburg; Dres. Otremba, Reschke, Zirpel, Kühn und Ruff

Oldenburg, , Germany

Praxis für Onkologie und Hämatologie

Recklinghausen, , Germany

Diakonie-Klinikum Klinik für Innere Medizin III Abt.Hämatologie, intern. Onkologie und Palliativmedi

Schwäbisch Hall, , Germany

Internistische Gemeinschaftspraxis Dres. Hoering/Von Ehr/Responde

Stuttgart, , Germany

Haematologisch-Onkologische Praxis; Dr. med. Christoph Maintz und Matthias Groschek

Würselen, , Germany

Laiko General Hospital - Uni of Athens; 1St Dept. of Internal Medicine

Athens, , Greece

Attiko Hospital; Haematology Clinic

Athens, , Greece

Theagenio Anticancer Hospital; Dept. of Haematology

Thessaloniki, , Greece

Rambam Medical Center; Heamatology & Bone Marrow Transplantation

Haifa, , Israel

Wolfson Mc; Haematology

Holon, , Israel

Hadassah Ein Karem Hospital; Haematology

Jerusalem, , Israel

Chaim Sheba Medical Center; Hematology BMT & CBB

Ramat Gan, , Israel

Ichilov Sourasky Medical Center; Heamatology

Tel Aviv, , Israel

Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia

Pescara, Abruzzo, Italy

Uni Degli Studi Di Bari, Policlinico; Cattedra Di Ematologia,Dipart. Di Medicina Interna E Publica

Bari, Apulia, Italy

Ospedale Vito Fazzi; Div. Oncoematologia

Lecce, Apulia, Italy

Az. Osp. C. Panico; Rep. Ematologia E Trapianto

Tricase - Le, Apulia, Italy

Az. Osp. Pugliese; Dh Oncologico

Catanzaro, Calabria, Italy

Ospedale S. Gennaro; Divisione Di Ematologia

Napoli, Campania, Italy

Ospedale Cardarelli; Divisione Di Ematologia

Napoli, Campania, Italy

A.O. Universitaria Policlinico S.Orsola-Malpighi Di Bologna

Bologna, Emilia-Romagna, Italy

Arcispedale S. Anna; Sezione Di Ematologia

Ferrara, Emilia-Romagna, Italy

A.O. Universitaria Policlinico Di Modena; Ematologia

Modena, Emilia-Romagna, Italy

A.O.U. Policlinico di Modena-Dipartimento di Medicina Diagnostica, Clinica e di Sanità pubblica

Modena, Emilia-Romagna, Italy

Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica

Aviano, Friuli Venezia Giulia, Italy

Az. Osp. Uni Ria Policlinico Tor Vergata; Unita Di Ematologia

Rome, Lazio, Italy

Ospedale S. Eugenio; Divisione Di Ematologia

Rome, Lazio, Italy

Univ. Cattolica La Sapienza; Cattedra Di Ematologia

Rome, Lazio, Italy

Uni Cattolica; Divisione Di Ematologia

Rome, Lazio, Italy

A.O. Universitaria S. Martino Di Genova; Ematologia 1

Genoa, Liguria, Italy

A.O. Spedali Civili Di Brescia-P.O. Spedali Civili;U.O. Ematologia

Brescia, Lombardy, Italy

Istituto S. Raffaele Monte Tabor; Divisione Ematologia E Utmo

Milan, Lombardy, Italy

Ist. Nazionale Per Lo Studio E Cura Dei Tumori; Div. Ematologia Trapianto Midollo Osseo Allogenico

Milan, Lombardy, Italy

Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

Milan, Lombardy, Italy

ASST DI MONZA; Ematologia

Monza, Lombardy, Italy

Irccs Policlinico San Matteo; Divisione Di Ematologia

Pavia, Lombardy, Italy

Fondazione Del Piemonte Per L'oncologia Ircc Di Candiolo; Dipartimento Oncologico

Candiolo, Piedmont, Italy

Az. Osp. S. Croce Ospedale Generale; Sezione Di Ematologia

Cuneo, Piedmont, Italy

Univ. Piemonte Est Amedeo Avogadro; Div.Ematologia- Dip.Clinica Med.Sperim.& Ircad

Novara, Piedmont, Italy

A.O. Universitaria S. Giovanni Battista-Molinette Di Torino; Ematologia 1

Turin, Piedmont, Italy

A.O.U. Citta' Della Salute E Della Scienza-P.O. Molinette;S.C. Ematologia

Turin, Piedmont, Italy

Ospedale Oncologico A Businco-Cagliari; Ematologia Sez.

Cagliari, Sardinia, Italy

Ospedale V. Cervello; U.O. Ematologia E Trapianti

Palermo, Sicily, Italy

Ospedale Ferrarotto; Divisione Di Ematologia

Via S. Sofia 78, Sicily, Italy

Ospedale Civile; S.C. Ematologia

Pesaro, The Marches, Italy

A.O. Univ.Ospedali Riuniti Umerto I -G.M.Lancisi G.Salesi; U.O. Clinica Di Ematologia

Torrette Di Ancona, The Marches, Italy

Az. Osp. Di Careggi; Divisione Di Ematologia

Florence, Tuscany, Italy

Ospedale Santa Chiara; Unita Operativa Di Ematologia

Pisa, Tuscany, Italy

A.O. Universitaria Senese; Ematologia

Siena, Tuscany, Italy

Azienda Ospedaliera S. Maria della Misericordia; Ematologia

Perugia, Umbria, Italy

Uni Degli Studi; Dip.Med.Clinica E Sperim. Ematologia

Padua, Veneto, Italy

Ospedale Di Vicenza; Nefrologia, Ematologia

Vicenza, Veneto, Italy

Issste; Haematology

Chihuahua City, , Mexico

Hospital Cima (Centro Internacional de Medicina) ; Haematology

Chihuahua City, , Mexico

Hospital Central de Pemex Norte Azcapotzalco

Mexico City, , Mexico

Hospital Español de Mexico

Mexico City, , Mexico

Hospital Regional Issste; Oncologia

Monterrey, , Mexico

Clinca San Jose; Haematology

Obregón, , Mexico

Issstep Puebla, ; Haematology

Puebla City, , Mexico

Spitalul Clinic Judetean de Urgenta Brasov,Clinica de Hematologie

Brasov, , Romania

Fundeni Clinical Inst. ; Hematology Dept

Bucharest, , Romania

Spitalul Clinic Coltea; Clinica de Hematologie

Bucharest, , Romania

Oncology Inst. Cluj-Napoca; Cancer Dept

Cluj-Napoca, , Romania

Spitalul Clinic Judetean de Urgenta Sf. Spiridon Iasi, Clinica de Hematologie

Iași, , Romania

Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie

Târgu Mureş, , Romania

Regional Clinical Hospital; Hematology

Belgorod, , Russia

Clinical Oncology Dispensary of Ministry of Health of Tatarstan

Kazan', , Russia

Blokhin Cancer Research Center; Clinical Oncology

Moscow, , Russia

City Clinical Hospital After Botkin; Hematology

Moscow, , Russia

Vladimirskiy Regional Scientific Research Inst. ; Hematology

Moscow, , Russia

Regional Clinical Hospital N.A. Semashko; Hematology

Nizhny Novgorod, , Russia

City Hematological Center of Clinical Hospital #2; Hematology

Novosibirsk, , Russia

Rostov State Medical Uni ; Hematology

Rostov-on-Don, , Russia

Research Inst. of Hematology & Blood Transfusion ; Hematology

Saint Petersburg, , Russia

Pavlov State Medical Uni ; Bone Marrow Transplantation Clinic

Saint Petersburg, , Russia

Leningrad Regional Clinical Hospital; Hematology #1

Saint Petersburg, , Russia

Stavropol Clinical Oncology Dispansary

Stavropol, , Russia

Bashkirian Republican Clinical Oncology Dispensary

Ufa, , Russia

Ulyanovsk Regional Oncology Dispensary; Chemotherapy

Ulyanovsk, , Russia

Regional Oncology Center; Chemotherapy

Volgograd, , Russia

Regional Clinical Hospital; Hematology

Yaroslavl, , Russia

Fakultna Nemocnica Roosevelta; Dept. of Haematology

Banská Bystrica, , Slovakia

National Oncology Inst. ; Dept. of Haematology

Bratislava, , Slovakia

Uni Hospital; Clinic of Haematology

Košice, , Slovakia

Uni Hospital ; Dept. of Haematol. & Transfusion Medicine

Martin, , Slovakia

Institute of Oncology Ljubljana

Ljubljana, , Slovenia

Hospital General de Castellon; Servicio de Hematologia

Castellon, Castellon, Spain

Complejo Asistencial Universitario De Burgos; Servicio de Oncologia

Burgos, , Spain

Hospital Generla de Ciudad Real; Servicio de Oncologia

Ciudad Real, , Spain

Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

Jaén, , Spain

Hospital El Bierzo; Servicio de Oncologia

León, , Spain

Hospital Costa del Sol; Servicio de Hematologia

Málaga, , Spain

Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia

Murcia, , Spain

Hospital Universitario Virgen Macarena; Servicio de Hematologia

Seville, , Spain

Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

Valencia, , Spain

Laenssjukhuset; Medicinkliniken/Hematologsektionen

Halmstad, , Sweden

Sunderby Sjukhus; Medicinkliniken

Luleå, , Sweden

Skånes Universitetssjukhus; Kliniska Forskningsenheten Onkologimottagning medicinsk behandling

Malmo, , Sweden

Länssjukhuset Sundsvall-Härnösand, Medicinkliniken

Sundsvall, , Sweden

Uddevalla Sjukhus; Medicinkliniken

Uddevalla, , Sweden

Akademiska sjukhuset, Onkologkliniken

Uppsala, , Sweden

Andreas Klinik; Onko-Hämatologisches Zentrum Cham Zug

Cham, , Switzerland

Kantonsspital Graubünden;Onkologie und Hämatologie

Chur, , Switzerland

Clinica Santa Chiara; Oncologia / Ematologia

Locarno, , Switzerland

UniversitätsSpital Zürich; Zentrum für Hämatologie und Onkologie, Klinik für Onkologie

Zurich, , Switzerland

Ankara Numune Egitim Ve Arastirma Hastanesi; Hematoloji Klinigi

Ankara, , Turkey (Türkiye)

Hacettepe Uni Medical Faculty; Hematology

Ankara, , Turkey (Türkiye)

Gazi Uni Medical School; Hematology

Ankara, , Turkey (Türkiye)

Istanbul Uni Capa Hospital; Hematology

Istanbul, , Turkey (Türkiye)

Ege Uni Medical School; Hematology

Izmir, , Turkey (Türkiye)

Countries

Albania; Argentina; Australia; Bosnia and Herzegovina; Brazil; Bulgaria; Colombia; Croatia; Ecuador; Egypt; Finland; Germany; Greece; Israel; Italy; Mexico; Romania; Russia; Slovakia; Slovenia; Spain; Sweden; Switzerland; Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 24824768 (View on PubMed)

Other Identifiers

MO19872

Identifier Type: -

Identifier Source: org_study_id