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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.
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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.
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Secondary ID [1]
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0
MO19872
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Hodgkin's Lymphoma
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0
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Condition category
Condition code
Cancer
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0
0
0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
0
0
0
0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - rituximab [MabThera/Rituxan]
Experimental: 1 -
Treatment: Drugs: rituximab [MabThera/Rituxan]
375mg/m2 iv every 8 weeks
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Intervention code [1]
0
0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With an Adverse Event (AE) - Overall Summary
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Assessment method [1]
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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.
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Timepoint [1]
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0
24 months
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Secondary outcome [1]
0
0
Progression-Free Survival - Percentage of Participants With an Event
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Assessment method [1]
0
0
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.
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Timepoint [1]
0
0
Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
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Secondary outcome [2]
0
0
Progression-Free Survival - Time to Event
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Assessment method [2]
0
0
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.
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Timepoint [2]
0
0
Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
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Secondary outcome [3]
0
0
Event-Free Survival (EFS) - Percentage of Participants With an Event
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Assessment method [3]
0
0
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.
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Timepoint [3]
0
0
Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
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Secondary outcome [4]
0
0
Event-Free Survival (EFS) - Time to Event
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Assessment method [4]
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0
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.
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Timepoint [4]
0
0
Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
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Secondary outcome [5]
0
0
Overall Survival (OS) - Percentage of Participants With an Event
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Assessment method [5]
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0
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.
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Timepoint [5]
0
0
Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
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Secondary outcome [6]
0
0
Overall Survival (OS) - Time to Event
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Assessment method [6]
0
0
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.
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Timepoint [6]
0
0
Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
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Secondary outcome [7]
0
0
Time to Next Lymphoma Treatment (NLT) - Percentage of Participants With an Event
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Assessment method [7]
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0
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.
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Timepoint [7]
0
0
Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
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Secondary outcome [8]
0
0
Time to NLT - Time to Event
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Assessment method [8]
0
0
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.
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Timepoint [8]
0
0
Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
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Secondary outcome [9]
0
0
Percentage of Participants With Response by Best Response to Study Treatment
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Assessment method [9]
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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).
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Timepoint [9]
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0
Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
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Secondary outcome [10]
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Percentage of Participants With PR Who Converted to CRu
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Assessment method [10]
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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.
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Timepoint [10]
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0
Baseline, every 8 weeks during treatment, and 3, 6, 9 and 12 months after last dose
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/09/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
26/05/2011
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Sample size
Target
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Accrual to date
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Final
545
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
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Recruitment hospital [1]
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0
Liverpool Hospital; Haematology - Liverpool
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Recruitment hospital [2]
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0
Wollongong Hospital; Cancer Services - Wollongong
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Recruitment hospital [3]
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0
Royal Brisbane Hospital; Oncology Department - Brisbane
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Recruitment hospital [4]
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Haematology & Oncology Clinics of Australia, Mater Medical Centre - South Brisbane
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Recruitment hospital [5]
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Mount Medical Center - Perth
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Recruitment postcode(s) [1]
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2170 - Liverpool
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Recruitment postcode(s) [2]
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2500 - Wollongong
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Recruitment postcode(s) [3]
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4006 - Brisbane
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Recruitment postcode(s) [4]
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4101 - South Brisbane
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Recruitment postcode(s) [5]
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6000 - Perth
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Recruitment outside Australia
Country [1]
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0
Albania
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State/province [1]
0
0
Tirana
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Country [2]
0
0
Argentina
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State/province [2]
0
0
Bahia Blanca
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0
0
Argentina
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State/province [3]
0
0
Buenos Aires
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Country [4]
0
0
Argentina
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State/province [4]
0
0
Corrientes
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0
0
Argentina
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State/province [5]
0
0
Córdoba
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Country [6]
0
0
Argentina
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State/province [6]
0
0
La Plata
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Country [7]
0
0
Bosnia and Herzegovina
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State/province [7]
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Banja Luka
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Country [8]
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Bosnia and Herzegovina
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State/province [8]
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Kasindo
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Bosnia and Herzegovina
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State/province [9]
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Mostar
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Bosnia and Herzegovina
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State/province [10]
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Sarajevo
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Country [11]
0
0
Brazil
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State/province [11]
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BA
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Country [12]
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Brazil
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State/province [12]
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MG
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Country [13]
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Brazil
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State/province [13]
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RJ
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Country [14]
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Brazil
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State/province [14]
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RS
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Country [15]
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Brazil
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State/province [15]
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SC
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Brazil
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SP
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Bulgaria
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State/province [17]
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Pleven
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Country [18]
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Bulgaria
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State/province [18]
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Plovdiv
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Bulgaria
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State/province [19]
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Sofia
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Bulgaria
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State/province [20]
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Varna
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Country [21]
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Colombia
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State/province [21]
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Bucaramanga
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Country [22]
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Colombia
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State/province [22]
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Medellin-Antioquia
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Country [23]
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Croatia
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State/province [23]
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Split
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Country [24]
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Croatia
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State/province [24]
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Zagreb
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Country [25]
0
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Ecuador
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State/province [25]
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Cuenca
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Ecuador
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State/province [26]
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Quito
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Country [27]
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Egypt
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State/province [27]
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Cairo
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Country [28]
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Finland
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State/province [28]
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Haemeenlinna
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Country [29]
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Finland
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State/province [29]
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Kotka
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Country [30]
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Finland
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State/province [30]
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Lahti
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Country [31]
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Finland
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State/province [31]
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Pori
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Country [32]
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Germany
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State/province [32]
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Bad Soden
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Braunschweig
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Germany
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Duisburg
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Germany
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Düsseldorf
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Germany
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State/province [38]
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Erlangen
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Germany
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State/province [39]
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Freiburg
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Germany
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State/province [40]
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Gütersloh
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Germany
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State/province [41]
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Hamburg
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Germany
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State/province [42]
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Heidelberg
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Germany
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Jena
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Germany
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State/province [44]
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Lüdenscheid
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Germany
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State/province [45]
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Mutlangen
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Germany
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Mülheim
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0
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Germany
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München
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Country [48]
0
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Germany
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State/province [48]
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Nordhorn
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Country [49]
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Germany
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State/province [49]
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Oldenburg
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Country [50]
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Germany
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State/province [50]
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Recklinghausen
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Germany
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State/province [51]
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Schwäbisch-Hall
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Germany
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State/province [52]
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Stuttgart
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Germany
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State/province [53]
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Wuerselen
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Country [54]
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Greece
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State/province [54]
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Athens
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Country [55]
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Greece
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State/province [55]
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Thessaloniki
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Country [56]
0
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Israel
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State/province [56]
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Haifa
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Country [57]
0
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Israel
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State/province [57]
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Holon
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Country [58]
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Israel
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State/province [58]
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Jerusalem
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Country [59]
0
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Israel
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State/province [59]
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Ramat Gan
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Country [60]
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Israel
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State/province [60]
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Tel Aviv
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Country [61]
0
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Italy
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State/province [61]
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Abruzzo
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Country [62]
0
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Italy
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State/province [62]
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Calabria
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0
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Italy
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State/province [63]
0
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Campania
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Country [64]
0
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Italy
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State/province [64]
0
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Emilia-Romagna
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Country [65]
0
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Italy
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State/province [65]
0
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Friuli-Venezia Giulia
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Country [66]
0
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Italy
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State/province [66]
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Lazio
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Country [67]
0
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Italy
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State/province [67]
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Liguria
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Country [68]
0
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Italy
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State/province [68]
0
0
Lombardia
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Country [69]
0
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Italy
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State/province [69]
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Marche
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Country [70]
0
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Italy
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State/province [70]
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Piemonte
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0
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Italy
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Puglia
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0
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Italy
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State/province [72]
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Sardegna
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0
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Italy
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State/province [73]
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Sicilia
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Country [74]
0
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Italy
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State/province [74]
0
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Toscana
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Country [75]
0
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Italy
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State/province [75]
0
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Umbria
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Country [76]
0
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Italy
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State/province [76]
0
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Veneto
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Country [77]
0
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Mexico
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State/province [77]
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Chihuahua
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Country [78]
0
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Mexico
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State/province [78]
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Mexico City
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Country [79]
0
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Mexico
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State/province [79]
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Monterrey
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Country [80]
0
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Mexico
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State/province [80]
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Obregon
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Country [81]
0
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Mexico
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State/province [81]
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Puebla
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Country [82]
0
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Romania
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State/province [82]
0
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Brasov
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Country [83]
0
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Romania
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State/province [83]
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0
Bucharest
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Country [84]
0
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Romania
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State/province [84]
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Bucuresti
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Romania
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State/province [85]
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Cluj-Napoca
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Romania
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State/province [86]
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Iasi
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Romania
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State/province [87]
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Targu-mures
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0
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Russian Federation
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Belgorod
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Russian Federation
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State/province [91]
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Nizhny Novgorod
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Russian Federation
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State/province [92]
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Novosibirsk
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Russian Federation
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Rostov-na-donu
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Russian Federation
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St Petersburg
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Russian Federation
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Stavropol
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Russian Federation
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UFA
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Russian Federation
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Ulyanovsk
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0
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Russian Federation
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Volgograd
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Russian Federation
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Yaroslavl
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0
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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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0
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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
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Cham
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Switzerland
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Chur
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Switzerland
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Locarno
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Switzerland
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Zürich
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Turkey
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Ankara
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Turkey
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Istanbul
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Turkey
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Izmir
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/study/NCT00430352
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Trial related presentations / publications
Witzens-Harig M, Foa R, Di Rocco A, van Hazel G, Chamone DF, Rowe JM, Arcaini L, Poddubnaya I, Ho AD, Ivanova V, Vranovsky A, Thurley D, Oertel S. Maintenance with rituximab is safe and not associated with severe or uncommon infections in patients with follicular lymphoma: results from the phase IIIb MAXIMA study. Ann Hematol. 2014 Oct;93(10):1717-24. doi: 10.1007/s00277-014-2103-3. Epub 2014 May 14. Erratum In: Ann Hematol. 2014 Oct;93(10):1807.
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Public notes
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Contacts
Principal investigator
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Clinical Trials
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Hoffmann-La Roche
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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
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