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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00430352
First received: January 31, 2007
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Non-Hodgkin's Lymphoma
Drug: rituximab [MabThera/Rituxan]
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Incidence of all, and of grade 3/4, adverse events. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • PFS, event free survival, overall survival, time to next lymphoma treatment, PR to CR conversion rate. [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Enrollment: 543
Study Start Date: September 2006
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: rituximab [MabThera/Rituxan]
375mg/m2 iv every 8 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430352

  Hide Study Locations
Locations
Albania
Tirana, Albania, 1000
Argentina
Bahia Blanca, Argentina, 8001
Buenos Aires, Argentina, C1114AAN
Buenos Aires, Argentina, C1437JCP
Buenos Aires, Argentina, 1425
Corrientes, Argentina, 3400
Córdoba, Argentina, 5000
Córdoba, Argentina, 5016
La Plata, Argentina, B1904CFS
Australia
Brisbane, Australia, 4006
Liverpool, Australia, 2170
Perth, Australia, 6000
South Brisbane, Australia, 4101
Wollongong, Australia, 2500
Bosnia and Herzegovina
Banja Luka, Bosnia and Herzegovina, 88000
Kasindo, Bosnia and Herzegovina, 71123
Mostar, Bosnia and Herzegovina, 88000
Sarajevo, Bosnia and Herzegovina, 71000
Brazil
Belo Horizonte, Brazil, 30140-083
Campinas, Brazil, 13083-878
Florianopolis, Brazil, 88020-200
Piracicaba, Brazil, 13419-155
Porto Alegre, Brazil, 90035-903
Porto Alegre, Brazil, 90610-000
Porto Alegre, Brazil, 90035-001
Rio de Janeiro, Brazil, 22640-000
Salvador, Brazil, 40170-110
Salvador, Brazil, 40110-150
Sao Paulo, Brazil, 1323020
Sao Paulo, Brazil, 05403
Sao Paulo, Brazil, 04039-901
Bulgaria
Pleven, Bulgaria, 5800
Plovdiv, Bulgaria, 4002
Sofia, Bulgaria, 1757
Sofia, Bulgaria, 1431
Varna, Bulgaria, 9002
Colombia
Bucaramanga, Colombia
Medellin, Colombia
Croatia
Split, Croatia, 21000
Zagreb, Croatia, 10000
Ecuador
Cuenca, Ecuador
Quito, Ecuador, 2569
Egypt
Cairo, Egypt, 11737
Finland
Haemeenlinna, Finland, 13530
Kotka, Finland, 48210
Kuopio, Finland, 70211
Lahti, Finland, 15850
Pori, Finland, 28500
Germany
Bad Soden, Germany, 65812
Berlin, Germany, 10707
Berlin, Germany, 10117
Bonn, Germany, 53127
Braunschweig, Germany, 38100
Duisburg, Germany, 47051
Düsseldorf, Germany, 40211
Erlangen, Germany, 91052
Freiburg, Germany, 79106
Gütersloh, Germany, 33332
Hamburg, Germany, 20095
Hamburg, Germany, 22457
Heidelberg, Germany, 69120
Heidelberg, Germany, 69115
Jena, Germany, 07743
Lüdenscheid, Germany, 58515
Minden, Germany, 32427
Mutlangen, Germany, 73557
Mülheim, Germany, 45468
München, Germany, 80335
Nordhorn, Germany, 48527
Oldenburg, Germany, 26121
Recklinghausen, Germany, 45657
Schwäbisch Hall, Germany, 74523
Stuttgart, Germany, 70176
Troisdorf, Germany, 53840
Wuerselen, Germany, 52146
Greece
Athens, Greece, 12462
Athens, Greece, 11524
Thessaloniki, Greece, 54007
Israel
Haifa, Israel, 31096
Holon, Israel, 58251
Jerusalem, Israel, 91120
Ramat Gan, Israel, 52662
Tel Aviv, Israel, 64239
Italy
Aviano, Italy, 33081
Bari, Italy, 70124
Bologna, Italy, 40138
Brescia, Italy, 25123
Cagliari, Italy, 09121
Candiolo, Italy, 10060
Catania, Italy, 95124
Catanzaro, Italy, 88100
Cuneo, Italy, 12100
Ferrara, Italy, 44100
Firenze, Italy, 50135
Genova, Italy, 16132
Lecce, Italy, 73100
Milano, Italy, 20162
Milano, Italy, 20132
Milano, Italy, 20133
Modena, Italy, 41100
Monza, Italy, 20052
Napoli, Italy, 80100
Napoli, Italy, 80131
Novara, Italy, 28100
Padova, Italy, 35128
Palermo, Italy, 90146
Pavia, Italy, 27100
Perugia, Italy, 06100
Pesaro, Italy, 61100
Pescara, Italy, 65100
Pisa, Italy, 56100
Roma, Italy, 00161
Roma, Italy, 00168
Roma, Italy, 00133
Roma, Italy, 00144
Siena, Italy, 53100
Torino, Italy, 10126
Torrette Di Ancona, Italy, 60020
Tricase - Le, Italy, 73039
Vicenza, Italy, 36100
Mexico
Chihuahua, Mexico, 31100
Chihuahua, Mexico, 31238
Mexico City, Mexico, 02720
Mexico City, Mexico, 11520
Monterrey, Mexico, 64380
Obregon, Mexico, 85000
Puebla, Mexico, 72530
Romania
Brasov, Romania, 500326
Bucharest, Romania, 022328
Bucuresti, Romania, 030171
Cluj-napoca, Romania, 400015
Targu-mures, Romania, 540136
Russian Federation
Belgorod, Russian Federation, ND
Kazan, Russian Federation, 420029
Moscow, Russian Federation, 129110
Moscow, Russian Federation, 125101
Moscow, Russian Federation, 115478
Nizhny Novgorod, Russian Federation, 603126
Novosibirsk, Russian Federation, 630051
Rostov-na-donu, Russian Federation, 344022
St Petersburg, Russian Federation, 197022
St Petersburg, Russian Federation
St Petersburg, Russian Federation, 191024
Stavropol, Russian Federation, ND
UFA, Russian Federation, 450054
Ulyanovsk, Russian Federation, ND
Volgograd, Russian Federation, 400138
Yaroslavl, Russian Federation, 150062
Slovakia
Banska Bystrica, Slovakia, 975 17
Bratislava, Slovakia, 833 10
Kosice, Slovakia, 040 66
Martin, Slovakia, 036 59
Slovenia
Ljubljana, Slovenia, 1000
Spain
Burgos, Spain, 09005
Castellon, Spain, 12004
Ciudad Real, Spain, 13005
El Palmar Murcia, Spain, 30120
Jaen, Spain, 23007
Leon, Spain, 24411
Malaga, Spain, 29600
Sevilla, Spain, 41009
Valencia, Spain, 46010
Sweden
Halmstad, Sweden, 30185
Luleå, Sweden, S-971 80
Malmoe, Sweden, 20502
Sundsvall, Sweden, 85186
Uddevalla, Sweden, 45180
Uppsala, Sweden, 751 85
Switzerland
Cham, Switzerland, 6330
Chur, Switzerland, 7000
Locarno, Switzerland, 6601
Zürich, Switzerland, 8091
Turkey
Ankara, Turkey, 06500
Ankara, Turkey, 06100
Istanbul, Turkey, 34390
Izmir, Turkey, 35100
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00430352     History of Changes
Other Study ID Numbers: MO19872
Study First Received: January 31, 2007
Last Updated: January 14, 2013
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Rituximab
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014