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: June 3, 2015
Last verified: June 2015
  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:
  • Percentage of Participants With an Adverse Event (AE) - Overall Summary [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Progression-Free Survival - Percentage of Participants With an Event [ Time Frame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose ] [ Designated as safety issue: No ]
    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.

  • Progression-Free Survival - Time to Event [ Time Frame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose ] [ Designated as safety issue: No ]
    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.

  • Event-Free Survival (EFS) - Percentage of Participants With an Event [ Time Frame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose ] [ Designated as safety issue: No ]
    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.

  • Event-Free Survival (EFS) - Time to Event [ Time Frame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose ] [ Designated as safety issue: No ]
    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.

  • Overall Survival (OS) - Percentage of Participants With an Event [ Time Frame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose ] [ Designated as safety issue: No ]
    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.

  • Overall Survival (OS) - Time to Event [ Time Frame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose ] [ Designated as safety issue: No ]
    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.

  • Time to Next Lymphoma Treatment (NLT) - Percentage of Participants With an Event [ Time Frame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose ] [ Designated as safety issue: No ]
    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.

  • Time to NLT - Time to Event [ Time Frame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With Response by Best Response to Study Treatment [ Time Frame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose ] [ Designated as safety issue: No ]
    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).

  • Percentage of Participants With PR Who Converted to CRu [ Time Frame: Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose ] [ Designated as safety issue: No ]
    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.


Enrollment: 545
Study Start Date: September 2006
Study Completion Date: May 2011
Primary Completion Date: May 2011 (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   (Adult, Senior)
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, C1437JCP
Buenos Aires, Argentina, C1114AAN
Buenos Aires, Argentina, 1425
Corrientes, Argentina, 3400
Córdoba, Argentina, 5000
Córdoba, Argentina, 5016
La Plata, Argentina, B1904CFS
Australia, New South Wales
Liverpool, New South Wales, Australia, 2170
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
Brisbane, Queensland, Australia, 4006
South Brisbane, Queensland, Australia, 4101
Australia, Western Australia
Perth, Western Australia, Australia, 6000
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
Salvador, BA, Brazil, 40110-150
Salvador, BA, Brazil, 40170-110
Belo Horizonte, MG, Brazil, 30140-083
Rio de Janeiro, RJ, Brazil, 22640-000
Porto Alegre, RS, Brazil, 90035-001
Porto Alegre, RS, Brazil, 90035-903
Porto Alegre, RS, Brazil, 90610-000
Florianopolis, SC, Brazil, 88034-000
Campinas, SP, Brazil, 13083-878
Piracicaba, SP, Brazil, 13419-155
Sao Paulo, SP, Brazil, 01323-020
Sao Paulo, SP, Brazil, 04029-000
Sao Paulo, SP, Brazil, 05403-000
Bulgaria
Pleven, Bulgaria, 5800
Plovdiv, Bulgaria, 4002
Sofia, Bulgaria, 1431
Sofia, Bulgaria, 1757
Varna, Bulgaria, 9010
Colombia
Bucaramanga, Colombia
Medellin-Antioquia, 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, 10117
Berlin, Germany, 10707
Bonn, Germany, 53127
Braunschweig, Germany, 38100
Duisburg, Germany, 47051
Düsseldorf, Germany, 40211
Erlangen, Germany, 91052
Freiburg, Germany, 79110
Gütersloh, Germany, 33332
Hamburg, Germany, 20095
Hamburg, Germany, 22457
Heidelberg, Germany, 69115
Heidelberg, Germany, 69120
Jena, Germany, 07743
Lüdenscheid, Germany, 58515
Mutlangen, Germany, 73557
Mülheim, Germany, 45468
München, Germany, 80335
Nordhorn, Germany, 48527
Oldenburg, Germany, 26121
Porta Westfalica, Germany, 32457
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, 5810001
Jerusalem, Israel, 91120
Ramat Gan, Israel, 52662
Tel Aviv, Israel, 6423906
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, 20132
Milano, Italy, 20133
Milano, Italy, 20162
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, 00133
Roma, Italy, 00144
Roma, Italy, 00161
Roma, Italy, 00168
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
Iasi, Romania, 700111
Targu-mures, Romania, 540136
Russian Federation
Belgorod, Russian Federation, ND
Kazan, Russian Federation, 420029
Moscow, Russian Federation, 115478
Moscow, Russian Federation, 125101
Moscow, Russian Federation, 129110
Nizhny Novgorod, Russian Federation, 603126
Novosibirsk, Russian Federation, 630051
Rostov-na-donu, Russian Federation, 344022
St Petersburg, Russian Federation, 191024
St Petersburg, Russian Federation, 197022
St Petersburg, Russian Federation
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, 09006
Castellon, Spain, 12004
Ciudad Real, Spain, 13005
Jaen, Spain, 23007
Leon, Spain, 24411
Malaga, Spain, 29600
Murcia, Spain, 30120
Sevilla, Spain, 41009
Valencia, Spain, 46010
Sweden
Halmstad, Sweden, 30185
Luleå, Sweden, S-971 80
Malmo, Sweden, 205 02
Sundsvall, Sweden, 85186
Uddevalla, Sweden, 45180
Uppsala, Sweden, 75185
Switzerland
Cham, Switzerland, 6330
Chur, Switzerland, 7000
Locarno, Switzerland, 6601
Zürich, Switzerland, 8091
Turkey
Ankara, Turkey, 06100
Ankara, Turkey, 06500
Istanbul, Turkey, 34390
Izmir, Turkey, 35100
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

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
Results First Received: September 4, 2014
Last Updated: June 3, 2015
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on July 21, 2016