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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - 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.
Timepoint [1] 0 0
24 months
Secondary outcome [1] 0 0
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.
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 - 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.
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 - 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.
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 - 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.
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 - 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.
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 - 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.
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 - 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.
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 - 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.
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 - 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).
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 - 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.
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
Gender
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
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Country [35] 0 0
Germany
State/province [35] 0 0
Braunschweig
Country [36] 0 0
Germany
State/province [36] 0 0
Duisburg
Country [37] 0 0
Germany
State/province [37] 0 0
Düsseldorf
Country [38] 0 0
Germany
State/province [38] 0 0
Erlangen
Country [39] 0 0
Germany
State/province [39] 0 0
Freiburg
Country [40] 0 0
Germany
State/province [40] 0 0
Gütersloh
Country [41] 0 0
Germany
State/province [41] 0 0
Hamburg
Country [42] 0 0
Germany
State/province [42] 0 0
Heidelberg
Country [43] 0 0
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
Country [61] 0 0
Italy
State/province [61] 0 0
Abruzzo
Country [62] 0 0
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
Country [73] 0 0
Italy
State/province [73] 0 0
Sicilia
Country [74] 0 0
Italy
State/province [74] 0 0
Toscana
Country [75] 0 0
Italy
State/province [75] 0 0
Umbria
Country [76] 0 0
Italy
State/province [76] 0 0
Veneto
Country [77] 0 0
Mexico
State/province [77] 0 0
Chihuahua
Country [78] 0 0
Mexico
State/province [78] 0 0
Mexico City
Country [79] 0 0
Mexico
State/province [79] 0 0
Monterrey
Country [80] 0 0
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
Country [95] 0 0
Russian Federation
State/province [95] 0 0
Stavropol
Country [96] 0 0
Russian Federation
State/province [96] 0 0
UFA
Country [97] 0 0
Russian Federation
State/province [97] 0 0
Ulyanovsk
Country [98] 0 0
Russian Federation
State/province [98] 0 0
Volgograd
Country [99] 0 0
Russian Federation
State/province [99] 0 0
Yaroslavl
Country [100] 0 0
Slovakia
State/province [100] 0 0
Banska Bystrica
Country [101] 0 0
Slovakia
State/province [101] 0 0
Bratislava
Country [102] 0 0
Slovakia
State/province [102] 0 0
Kosice
Country [103] 0 0
Slovakia
State/province [103] 0 0
Martin
Country [104] 0 0
Slovenia
State/province [104] 0 0
Ljubljana
Country [105] 0 0
Spain
State/province [105] 0 0
Burgos
Country [106] 0 0
Spain
State/province [106] 0 0
Castellon
Country [107] 0 0
Spain
State/province [107] 0 0
Ciudad Real
Country [108] 0 0
Spain
State/province [108] 0 0
Jaen
Country [109] 0 0
Spain
State/province [109] 0 0
Leon
Country [110] 0 0
Spain
State/province [110] 0 0
Malaga
Country [111] 0 0
Spain
State/province [111] 0 0
Murcia
Country [112] 0 0
Spain
State/province [112] 0 0
Sevilla
Country [113] 0 0
Spain
State/province [113] 0 0
Valencia
Country [114] 0 0
Sweden
State/province [114] 0 0
Halmstad
Country [115] 0 0
Sweden
State/province [115] 0 0
Luleå
Country [116] 0 0
Sweden
State/province [116] 0 0
Malmö
Country [117] 0 0
Sweden
State/province [117] 0 0
Sundsvall
Country [118] 0 0
Sweden
State/province [118] 0 0
Uddevalla
Country [119] 0 0
Sweden
State/province [119] 0 0
Uppsala
Country [120] 0 0
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
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.
Trial website
https://clinicaltrials.gov/show/NCT00430352
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

Summary results
Other publications