AzTrials
AzTrials

Non-Hodgkin's LymphomaPhase 4NCT00430352

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

A Phase 4 study testing rituximab [MabThera/Rituxan] in people with Non-Hodgkin's Lymphoma, run by Hoffmann-La Roche at 178 sites in 24 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Hodgkin's Lymphoma
What is being tested?
rituximab [MabThera/Rituxan]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
545 participants
Where
178 sitesin 24 countries
Study dates
4 Sep 2006to 26 May 2011
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

178 sites in 24 countries.

178 sites in 24 countries

Italy39 sites

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

    Aviano, Friuli Venezia Giulia, 33081

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

    Bari, Apulia, 70124

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

    Bologna, Emilia-Romagna, 40138

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

    Brescia, Lombardy, 25123

  • Ospedale Oncologico A Businco-Cagliari; Ematologia Sez.

    Cagliari, Sardinia, 09121

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

    Candiolo, Piedmont, 10060

  • Az. Osp. Pugliese; Dh Oncologico

    Catanzaro, Calabria, 88100

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

    Cuneo, Piedmont, 12100

  • Arcispedale S. Anna; Sezione Di Ematologia

    Ferrara, Emilia-Romagna, 44100

  • Az. Osp. Di Careggi; Divisione Di Ematologia

    Florence, Tuscany, 50135

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

    Genoa, Liguria, 16132

  • Ospedale Vito Fazzi; Div. Oncoematologia

    Lecce, Apulia, 73100

  • Istituto S. Raffaele Monte Tabor; Divisione Ematologia E Utmo

    Milan, Lombardy, 20132

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

    Milan, Lombardy, 20133

  • Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia

    Milan, Lombardy, 20162

  • A.O. Universitaria Policlinico Di Modena; Ematologia

    Modena, Emilia-Romagna, 41100

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

    Modena, Emilia-Romagna, 41100

  • ASST DI MONZA; Ematologia

    Monza, Lombardy, 20052

  • Ospedale S. Gennaro; Divisione Di Ematologia

    Naples, Campania, 80100

  • Ospedale Cardarelli; Divisione Di Ematologia

    Naples, Campania, 80131

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

    Novara, Piedmont, 28100

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

    Padova, Veneto, 35128

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

    Palermo, Sicily, 90146

  • Irccs Policlinico San Matteo; Divisione Di Ematologia

    Pavia, Lombardy, 27100

  • Azienda Ospedaliera S. Maria della Misericordia; Ematologia

    Perugia, Umbria, 06100

  • Ospedale Civile; S.C. Ematologia

    Pesaro, The Marches, 61100

  • Ospedale Civile Dello Spirito Santo; Divisione Di Ematologia

    Pescara, Abruzzo, 65100

  • Ospedale Santa Chiara; Unita Operativa Di Ematologia

    Pisa, Tuscany, 56100

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

    Rome, Lazio, 00133

  • Ospedale S. Eugenio; Divisione Di Ematologia

    Rome, Lazio, 00144

  • Univ. Cattolica La Sapienza; Cattedra Di Ematologia

    Rome, Lazio, 00161

  • Uni Cattolica; Divisione Di Ematologia

    Rome, Lazio, 00168

  • A.O. Universitaria Senese; Ematologia

    Siena, Tuscany, 53100

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

    Torrette Di Ancona, The Marches, 60020

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

    Tricase - Le, Apulia, 73039

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

    Turin, Piedmont, 10126

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

    Turin, Piedmont, 10126

  • Ospedale Ferrarotto; Divisione Di Ematologia

    Via S. Sofia 78, Sicily, 95123

  • Ospedale Di Vicenza; Nefrologia, Ematologia

    Vicenza, Veneto, 36100

Other trials in Italy

Germany25 sites

  • Internist; Praxis Für Haemotologie & Onkologie

    Bad Soden, 65812

  • Dres.Christian Sperling und Claudia Schelenz

    Berlin, 10117

  • Onkologische Schwerpunktpraxis Kurfürstendamm

    Berlin, 10707

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

    Bonn, 53127

  • Dres. Matthias Adler Oliver Marschal und Andreas Pies

    Braunschweig, 38100

  • Gemeinschaftspraxis

    Duisburg, 47051

  • Internistische Praxis Dr. Plingen

    Düsseldorf, 40211

  • Internistische Schwerpunktpraxis Erlangen

    Erlangen, 91052

  • Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

    Freiburg im Breisgau, 79110

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

    Gütersloh, 33332

  • Überörtliche Gemeinschaftspraxis Schwerpunkt Hämatologie, internistische Onkologie & Palliativmed.

    Hamburg, 20259

  • Onkologische Schwerpunktpraxis; Herrn Dr. Med. Bertram

    Hamburg, 22457

  • Dres.Andreas Karcher und Stefan Fuxius

    Heidelberg, 69115

  • Uniklinik Heidelberg, Medizinische Klinik & Poliklinik V

    Heidelberg, 69120

  • Onkologische Schwerpunktpraxis (Eps-Gmbh)

    Jena, 07743

  • Märkische Kliniken GmbH, Klinikum Lüdenscheid; Hämatologie / Onkologie

    Lüdenscheid, 58515

  • Gemeinschaftspraxis Dres. Schröder, Sieg

    Mülheim, 45468

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

    München, 80335

  • Stauferklinikum Schwäb.Gmünd

    Mutlangen, 73557

  • Dres.Ulrich Hutzschenreuter und Uwe Sauer

    Nordhorn, 48527

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

    Oldenburg, 26121

  • Praxis für Onkologie und Hämatologie

    Recklinghausen, 45657

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

    Schwäbisch Hall, 74523

  • Internistische Gemeinschaftspraxis Dres. Hoering/Von Ehr/Responde

    Stuttgart, 70176

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

    Würselen, 52146

Other trials in Germany

Russia16 sites

  • Regional Clinical Hospital; Hematology

    Belgorod, ND

  • Clinical Oncology Dispensary of Ministry of Health of Tatarstan

    Kazan', 420029

  • Blokhin Cancer Research Center; Clinical Oncology

    Moscow, 115478

  • City Clinical Hospital After Botkin; Hematology

    Moscow, 125101

  • Vladimirskiy Regional Scientific Research Inst. ; Hematology

    Moscow, 129110

  • Regional Clinical Hospital N.A. Semashko; Hematology

    Nizhny Novgorod, 603126

  • City Hematological Center of Clinical Hospital #2; Hematology

    Novosibirsk, 630051

  • Rostov State Medical Uni ; Hematology

    Rostov-on-Don, 344022

  • Research Inst. of Hematology & Blood Transfusion ; Hematology

    Saint Petersburg, 191024

  • Pavlov State Medical Uni ; Bone Marrow Transplantation Clinic

    Saint Petersburg, 197022

  • Leningrad Regional Clinical Hospital; Hematology #1

    Saint Petersburg

  • Stavropol Clinical Oncology Dispansary

    Stavropol, ND

  • Bashkirian Republican Clinical Oncology Dispensary

    Ufa, 450054

  • Ulyanovsk Regional Oncology Dispensary; Chemotherapy

    Ulyanovsk, ND

  • Regional Oncology Center; Chemotherapy

    Volgograd, 400138

  • Regional Clinical Hospital; Hematology

    Yaroslavl, 150062

Other trials in Russia

Brazil13 sites

  • ONCOMED

    Belo Horizonte, Minas Gerais, 30140-083

  • Hospital das Clinicas - UNICAMP; Hemoterapia

    Campinas, São Paulo, 13083-878

  • Centro de Pesquisas Oncologicas - CEPON

    Florianópolis, Santa Catarina, 88034-000

  • Clinica Oncologica De Piracicaba Sc

    Piracicaba, São Paulo, 13419-155

  • Hospital das Clinicas - UFRGS; Medicina Interna

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital Mae de Deus

    Porto Alegre, Rio Grande do Sul, 90470-340

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Centro de Tratamento Oncologico - Oncoclinica

    Rio de Janeiro, Rio de Janeiro, 22640-000

  • CEHON

    Salvador, Estado de Bahia, 40110-150

  • Nucleo de Oncologia da Bahia - NOB

    Salvador, Bahia, Estado de Bahia, 40170-380

  • Hospital Alemao Oswaldo Cruz; Oncologia

    São Paulo, São Paulo, 01323-020

  • Hospital Estadual do Servidor Publico; Hematologia

    São Paulo, São Paulo, 04029-000

  • Hospital das Clinicas - FMUSP, Oncologia

    São Paulo, São Paulo, 05403-000

Other trials in Brazil

Spain9 sites

  • Complejo Asistencial Universitario De Burgos; Servicio de Oncologia

    Burgos, 09006

  • Hospital General de Castellon; Servicio de Hematologia

    Castellon, Castellon, 12004

  • Hospital Generla de Ciudad Real; Servicio de Oncologia

    Ciudad Real, 13005

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

    Jaén, 23007

  • Hospital El Bierzo; Servicio de Oncologia

    León, 24411

  • Hospital Costa del Sol; Servicio de Hematologia

    Málaga, 29600

  • Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia

    Murcia, 30120

  • Hospital Universitario Virgen Macarena; Servicio de Hematologia

    Seville, 41009

  • Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia

    Valencia, 46010

Other trials in Spain

Argentina8 sites

  • Instituo Lavalle de Oncologia; Hematology

    Bahía Blanca, 8001

  • Academia Nacional de Medicina; Inst. de Cardiologia

    Buenos Aires, 1425

  • Fundaleu; Haematology

    Buenos Aires, C1114AAN

  • Hospital Churruca Visca; Haematology

    Buenos Aires, C1437JCP

  • Sanatorio Allende; Haematology

    Córdoba, 5000

  • HOSPITAL PRIVADO - CENTRO MEDICO DE CÓRDOBA; Dpto Oncología

    Córdoba, 5016

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

    Corrientes, 3400

  • Hospital General San Martin; Haematology

    La Plata, B1904CFS

Other trials in Argentina

Mexico7 sites

  • Issste; Haematology

    Chihuahua City, 31100

  • Hospital Cima (Centro Internacional de Medicina) ; Haematology

    Chihuahua City, 31238

  • Hospital Central de Pemex Norte Azcapotzalco

    Mexico City, 02720

  • Hospital Español de Mexico

    Mexico City, 11520

  • Hospital Regional Issste; Oncologia

    Monterrey, 64380

  • Clinca San Jose; Haematology

    Obregón, 85000

  • Issstep Puebla, ; Haematology

    Puebla City, 72530

Other trials in Mexico

Romania6 sites

  • Spitalul Clinic Judetean de Urgenta Brasov,Clinica de Hematologie

    Brasov, 500326

  • Fundeni Clinical Inst. ; Hematology Dept

    Bucharest, 022328

  • Spitalul Clinic Coltea; Clinica de Hematologie

    Bucharest, 030171

  • Oncology Inst. Cluj-Napoca; Cancer Dept

    Cluj-Napoca, 400015

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

    Iași, 700111

  • Spitalul Clinic Judetean de Urgenta Targu-Mures; compartiment Hematologie

    Târgu Mureş, 540136

Other trials in Romania

Sweden6 sites

  • Laenssjukhuset; Medicinkliniken/Hematologsektionen

    Halmstad, 30185

  • Sunderby Sjukhus; Medicinkliniken

    Luleå, S-971 80

  • Skånes Universitetssjukhus; Kliniska Forskningsenheten Onkologimottagning medicinsk behandling

    Malmö, 205 02

  • Länssjukhuset Sundsvall-Härnösand, Medicinkliniken

    Sundsvall, 85186

  • Uddevalla Sjukhus; Medicinkliniken

    Uddevalla, 45180

  • Akademiska sjukhuset, Onkologkliniken

    Uppsala, 75185

Other trials in Sweden

Australia5 sites

  • Royal Brisbane Hospital; Oncology Department

    Brisbane, Queensland, 4006

  • Liverpool Hospital; Haematology

    Liverpool, New South Wales, 2170

  • Mount Medical Center

    Perth, Western Australia, 6000

  • Haematology & Oncology Clinics of Australia, Mater Medical Centre

    South Brisbane, Queensland, 4101

  • Wollongong Hospital; Cancer Services

    Wollongong, New South Wales, 2500

Other trials in Australia

Bulgaria5 sites

  • UMHAT Dr Georgi Stranski; Hematology

    Pleven, 5800

  • Umhat S. George; Hematology

    Plovdiv, 4002

  • UMHAT Alexandrovska EAD; Hematology

    Sofia, 1431

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

    Sofia, 1757

  • Mhat Sveta Marina; Dept. of Haematology

    Varna, 9010

Other trials in Bulgaria

Israel5 sites

  • Rambam Medical Center; Heamatology & Bone Marrow Transplantation

    Haifa, 3109601

  • Wolfson Mc; Haematology

    Holon, 5810001

  • Hadassah Ein Karem Hospital; Haematology

    Jerusalem, 9112001

  • Chaim Sheba Medical Center; Hematology BMT & CBB

    Ramat Gan, 52662

  • Ichilov Sourasky Medical Center; Heamatology

    Tel Aviv, 6423906

Other trials in Israel

Turkey (Türkiye)5 sites

  • Ankara Numune Egitim Ve Arastirma Hastanesi; Hematoloji Klinigi

    Ankara, 06100

  • Hacettepe Uni Medical Faculty; Hematology

    Ankara, 06100

  • Gazi Uni Medical School; Hematology

    Ankara, 06500

  • Istanbul Uni Capa Hospital; Hematology

    Istanbul, 34390

  • Ege Uni Medical School; Hematology

    Izmir, 35100

Other trials in Turkey (Türkiye)

Bosnia and Herzegovina4 sites

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

    Banja Luka, 88000

  • Inst. of Hematology

    Kasindo, 71123

  • Uni Hospital Mostar

    Mostar, 88000

  • Clinic of Oncology, University Clinical Center Sarajevo

    Sarajevo, 71000

Other trials in Bosnia and Herzegovina

Finland4 sites

  • Kanta-Hämeen Keskussairaala; Dept of Internal Medicine, Hematology

    Hämeenlinna, 13530

  • Kymenlaakson keskussairaala

    Kotka, 48210

  • Päijät-Hämeen Keskussairaala; Dept of Internal Medicine, Hematology

    Lahti, 15850

  • Satakunnan Keskussairaala; Sisaetauti Osasto

    Pori, 28500

Other trials in Finland

Slovakia4 sites

  • Fakultna Nemocnica Roosevelta; Dept. of Haematology

    Banská Bystrica, 975 17

  • National Oncology Inst. ; Dept. of Haematology

    Bratislava, 833 10

  • Uni Hospital; Clinic of Haematology

    Košice, 040 66

  • Uni Hospital ; Dept. of Haematol. & Transfusion Medicine

    Martin, 036 59

Other trials in Slovakia

Switzerland4 sites

  • Andreas Klinik; Onko-Hämatologisches Zentrum Cham Zug

    Cham, 6330

  • Kantonsspital Graubünden;Onkologie und Hämatologie

    Chur, 7000

  • Clinica Santa Chiara; Oncologia / Ematologia

    Locarno, 6601

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

    Zurich, 8091

Other trials in Switzerland

Croatia3 sites

  • Clinical Hospital Centre Split; Dept Of Hematology

    Split, 21000

  • Clinical Hospital Centre Dubrava; Hematology Department

    Zagreb, 10000

  • University Hospital Center Zagreb; Haematology Department

    Zagreb, 10000

Other trials in Croatia

Greece3 sites

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

    Athens, 11524

  • Attiko Hospital; Haematology Clinic

    Athens, 124 62

  • Theagenio Anticancer Hospital; Dept. of Haematology

    Thessaloniki, 54007

Other trials in Greece

Colombia2 sites

  • Centro Médico Carlos Ardila Lule

    Bucaramanga

  • Hospital Pablo Tobon Uribe

    Medellin-Antioquia

Other trials in Colombia

Ecuador2 sites

  • Hospital José Carrasco; Oncology Service

    Cuenca

  • Hospital Carlos Andrade Marin; Servicio de Oncología

    Quito, 2569

Other trials in Ecuador

Albania1 site

  • University "Mother Theresa" Hospital Center; Oncology Department

    Tirana, 1000

Other trials in Albania

Egypt1 site

  • Oncology & Radiotherapy Centre; Oncology

    Cairo, 11737

Other trials in Egypt

Slovenia1 site

  • Institute of Oncology Ljubljana

    Ljubljana, 1000

Other trials in Slovenia

About this study

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.

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.

Being tested
rituximab [MabThera/Rituxan]
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rituximab [MabThera/Rituxan]Drug

    375mg/m2 iv every 8 weeks

Study groups in NCT00430352
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: rituximab [MabThera/Rituxan]

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 months

Secondary outcomes (10)

  1. 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.

    Measured: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose

  2. 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.

    Measured: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose

  3. 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.

    Measured: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose

  4. 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.

    Measured: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose

  5. 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.

    Measured: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose

  6. 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.

    Measured: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose

  7. 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.

    Measured: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose

  8. 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.

    Measured: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose

  9. 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).

    Measured: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose

  10. 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.

    Measured: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2007 (estimated)
  2. Study start4 Sep 2006
  3. Primary completion26 May 2011
  4. Study completion26 May 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
545 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00430352
Sponsor's protocol ID
MO19872
Status last verified
Jul 2017
First submitted
31 Jan 2007
Last updated
14 Aug 2017

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.

    PubMed 24824768

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing rituximab [MabThera/Rituxan] in people with Non-Hodgkin's Lymphoma, run by Hoffmann-La Roche at 178 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 178 sites in Italy, Germany, Russia, Brazil, Spain and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With an Adverse Event (AE) - Overall Summary (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00430352, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in