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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00430352




Registration number
NCT00430352
Ethics application status
Date submitted
31/01/2007
Date registered
1/02/2007
Date last updated
14/08/2017

Titles & IDs
Public title
MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma.
Scientific 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.
Secondary ID [1] 0 0
MO19872
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Hodgkin's Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - rituximab [MabThera/Rituxan]

Experimental: 1 -


Treatment: Drugs: rituximab [MabThera/Rituxan]
375mg/m2 iv every 8 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With an Adverse Event (AE) - Overall Summary
Timepoint [1] 0 0
24 months
Secondary outcome [1] 0 0
Progression-Free Survival - Percentage of Participants With an Event
Timepoint [1] 0 0
Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Secondary outcome [2] 0 0
Progression-Free Survival - Time to Event
Timepoint [2] 0 0
Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Secondary outcome [3] 0 0
Event-Free Survival (EFS) - Percentage of Participants With an Event
Timepoint [3] 0 0
Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Secondary outcome [4] 0 0
Event-Free Survival (EFS) - Time to Event
Timepoint [4] 0 0
Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Secondary outcome [5] 0 0
Overall Survival (OS) - Percentage of Participants With an Event
Timepoint [5] 0 0
Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Secondary outcome [6] 0 0
Overall Survival (OS) - Time to Event
Timepoint [6] 0 0
Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Secondary outcome [7] 0 0
Time to Next Lymphoma Treatment (NLT) - Percentage of Participants With an Event
Timepoint [7] 0 0
Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Secondary outcome [8] 0 0
Time to NLT - Time to Event
Timepoint [8] 0 0
Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Secondary outcome [9] 0 0
Percentage of Participants With Response by Best Response to Study Treatment
Timepoint [9] 0 0
Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
Secondary outcome [10] 0 0
Percentage of Participants With PR Who Converted to CRu
Timepoint [10] 0 0
Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/09/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/05/2011
Sample size
Target
Accrual to date
Final
545
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
Liverpool Hospital; Haematology - Liverpool
Recruitment hospital [2] 0 0
Wollongong Hospital; Cancer Services - Wollongong
Recruitment hospital [3] 0 0
Royal Brisbane Hospital; Oncology Department - Brisbane
Recruitment hospital [4] 0 0
Haematology & Oncology Clinics of Australia, Mater Medical Centre - South Brisbane
Recruitment hospital [5] 0 0
Mount Medical Center - Perth
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2500 - Wollongong
Recruitment postcode(s) [3] 0 0
4006 - Brisbane
Recruitment postcode(s) [4] 0 0
4101 - South Brisbane
Recruitment postcode(s) [5] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Albania
State/province [1] 0 0
Tirana
Country [2] 0 0
Argentina
State/province [2] 0 0
Bahia Blanca
Country [3] 0 0
Argentina
State/province [3] 0 0
Buenos Aires
Country [4] 0 0
Argentina
State/province [4] 0 0
Corrientes
Country [5] 0 0
Argentina
State/province [5] 0 0
Córdoba
Country [6] 0 0
Argentina
State/province [6] 0 0
La Plata
Country [7] 0 0
Bosnia and Herzegovina
State/province [7] 0 0
Banja Luka
Country [8] 0 0
Bosnia and Herzegovina
State/province [8] 0 0
Kasindo
Country [9] 0 0
Bosnia and Herzegovina
State/province [9] 0 0
Mostar
Country [10] 0 0
Bosnia and Herzegovina
State/province [10] 0 0
Sarajevo
Country [11] 0 0
Brazil
State/province [11] 0 0
BA
Country [12] 0 0
Brazil
State/province [12] 0 0
MG
Country [13] 0 0
Brazil
State/province [13] 0 0
RJ
Country [14] 0 0
Brazil
State/province [14] 0 0
RS
Country [15] 0 0
Brazil
State/province [15] 0 0
SC
Country [16] 0 0
Brazil
State/province [16] 0 0
SP
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Pleven
Country [18] 0 0
Bulgaria
State/province [18] 0 0
Plovdiv
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Sofia
Country [20] 0 0
Bulgaria
State/province [20] 0 0
Varna
Country [21] 0 0
Colombia
State/province [21] 0 0
Bucaramanga
Country [22] 0 0
Colombia
State/province [22] 0 0
Medellin-Antioquia
Country [23] 0 0
Croatia
State/province [23] 0 0
Split
Country [24] 0 0
Croatia
State/province [24] 0 0
Zagreb
Country [25] 0 0
Ecuador
State/province [25] 0 0
Cuenca
Country [26] 0 0
Ecuador
State/province [26] 0 0
Quito
Country [27] 0 0
Egypt
State/province [27] 0 0
Cairo
Country [28] 0 0
Finland
State/province [28] 0 0
Haemeenlinna
Country [29] 0 0
Finland
State/province [29] 0 0
Kotka
Country [30] 0 0
Finland
State/province [30] 0 0
Lahti
Country [31] 0 0
Finland
State/province [31] 0 0
Pori
Country [32] 0 0
Germany
State/province [32] 0 0
Bad Soden
Country [33] 0 0
Germany
State/province [33] 0 0
Berlin
Country [34] 0 0
Germany
State/province [34] 0 0
Bonn
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Germany
State/province [35] 0 0
Braunschweig
Country [36] 0 0
Germany
State/province [36] 0 0
Duisburg
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Germany
State/province [37] 0 0
Düsseldorf
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Germany
State/province [38] 0 0
Erlangen
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Germany
State/province [39] 0 0
Freiburg
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Germany
State/province [40] 0 0
Gütersloh
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Germany
State/province [41] 0 0
Hamburg
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Germany
State/province [42] 0 0
Heidelberg
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Germany
State/province [43] 0 0
Jena
Country [44] 0 0
Germany
State/province [44] 0 0
Lüdenscheid
Country [45] 0 0
Germany
State/province [45] 0 0
Mutlangen
Country [46] 0 0
Germany
State/province [46] 0 0
Mülheim
Country [47] 0 0
Germany
State/province [47] 0 0
München
Country [48] 0 0
Germany
State/province [48] 0 0
Nordhorn
Country [49] 0 0
Germany
State/province [49] 0 0
Oldenburg
Country [50] 0 0
Germany
State/province [50] 0 0
Recklinghausen
Country [51] 0 0
Germany
State/province [51] 0 0
Schwäbisch-Hall
Country [52] 0 0
Germany
State/province [52] 0 0
Stuttgart
Country [53] 0 0
Germany
State/province [53] 0 0
Wuerselen
Country [54] 0 0
Greece
State/province [54] 0 0
Athens
Country [55] 0 0
Greece
State/province [55] 0 0
Thessaloniki
Country [56] 0 0
Israel
State/province [56] 0 0
Haifa
Country [57] 0 0
Israel
State/province [57] 0 0
Holon
Country [58] 0 0
Israel
State/province [58] 0 0
Jerusalem
Country [59] 0 0
Israel
State/province [59] 0 0
Ramat Gan
Country [60] 0 0
Israel
State/province [60] 0 0
Tel Aviv
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Italy
State/province [61] 0 0
Abruzzo
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Italy
State/province [62] 0 0
Calabria
Country [63] 0 0
Italy
State/province [63] 0 0
Campania
Country [64] 0 0
Italy
State/province [64] 0 0
Emilia-Romagna
Country [65] 0 0
Italy
State/province [65] 0 0
Friuli-Venezia Giulia
Country [66] 0 0
Italy
State/province [66] 0 0
Lazio
Country [67] 0 0
Italy
State/province [67] 0 0
Liguria
Country [68] 0 0
Italy
State/province [68] 0 0
Lombardia
Country [69] 0 0
Italy
State/province [69] 0 0
Marche
Country [70] 0 0
Italy
State/province [70] 0 0
Piemonte
Country [71] 0 0
Italy
State/province [71] 0 0
Puglia
Country [72] 0 0
Italy
State/province [72] 0 0
Sardegna
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Italy
State/province [73] 0 0
Sicilia
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Italy
State/province [74] 0 0
Toscana
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Italy
State/province [75] 0 0
Umbria
Country [76] 0 0
Italy
State/province [76] 0 0
Veneto
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Mexico
State/province [77] 0 0
Chihuahua
Country [78] 0 0
Mexico
State/province [78] 0 0
Mexico City
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Mexico
State/province [79] 0 0
Monterrey
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Mexico
State/province [80] 0 0
Obregon
Country [81] 0 0
Mexico
State/province [81] 0 0
Puebla
Country [82] 0 0
Romania
State/province [82] 0 0
Brasov
Country [83] 0 0
Romania
State/province [83] 0 0
Bucharest
Country [84] 0 0
Romania
State/province [84] 0 0
Bucuresti
Country [85] 0 0
Romania
State/province [85] 0 0
Cluj-Napoca
Country [86] 0 0
Romania
State/province [86] 0 0
Iasi
Country [87] 0 0
Romania
State/province [87] 0 0
Targu-mures
Country [88] 0 0
Russian Federation
State/province [88] 0 0
Belgorod
Country [89] 0 0
Russian Federation
State/province [89] 0 0
Kazan
Country [90] 0 0
Russian Federation
State/province [90] 0 0
Moscow
Country [91] 0 0
Russian Federation
State/province [91] 0 0
Nizhny Novgorod
Country [92] 0 0
Russian Federation
State/province [92] 0 0
Novosibirsk
Country [93] 0 0
Russian Federation
State/province [93] 0 0
Rostov-na-donu
Country [94] 0 0
Russian Federation
State/province [94] 0 0
St Petersburg
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Russian Federation
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Stavropol
Country [96] 0 0
Russian Federation
State/province [96] 0 0
UFA
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Russian Federation
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Ulyanovsk
Country [98] 0 0
Russian Federation
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Volgograd
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Russian Federation
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Yaroslavl
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Slovakia
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Banska Bystrica
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Slovakia
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Bratislava
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Slovakia
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Kosice
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Slovakia
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Martin
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Slovenia
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Ljubljana
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Spain
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Burgos
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Spain
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Castellon
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Spain
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Ciudad Real
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Spain
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Jaen
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Spain
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Leon
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Spain
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Malaga
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Spain
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Murcia
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Spain
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Sevilla
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Spain
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Valencia
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Sweden
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Halmstad
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Sweden
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Luleå
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Sweden
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Malmö
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Sweden
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Sundsvall
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Sweden
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Uddevalla
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Sweden
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Uppsala
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Switzerland
State/province [120] 0 0
Cham
Country [121] 0 0
Switzerland
State/province [121] 0 0
Chur
Country [122] 0 0
Switzerland
State/province [122] 0 0
Locarno
Country [123] 0 0
Switzerland
State/province [123] 0 0
Zürich
Country [124] 0 0
Turkey
State/province [124] 0 0
Ankara
Country [125] 0 0
Turkey
State/province [125] 0 0
Istanbul
Country [126] 0 0
Turkey
State/province [126] 0 0
Izmir

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00430352