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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
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
N/A
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
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Albania
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Tirana
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Argentina
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Bahia Blanca
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Kasindo
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Mostar
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Sarajevo
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BA
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MG
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Pleven
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Lahti
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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/ct2/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

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/ct2/show/NCT00430352