A Pharmacokinetic Study of Subcutaneous and Intravenous Rituximab in Participants With Follicular Lymphoma
NCT ID: NCT00930514
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
281 participants
INTERVENTIONAL
2009-09-30
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PARALLEL
TREATMENT
NONE
Study Groups
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Rituximab IV 375 mg/m^2 (Stage 1: Cohort A)
Rituximab
Rituximab intravenous infusion 375 milligram per square meter (mg/m\^2) administered every 2 or 3 months.
Rituximab IV 375 mg/m^2 (Stage 2: Cohort E)
Rituximab
Rituximab intravenous infusion 375 milligram per square meter (mg/m\^2) administered every 2 or 3 months.
Rituximab SC 1400 mg (Stage 2: Cohort F)
Rituximab
Rituximab subcutaneous injection at 1400 mg dose level, administered every 2 or 3 months.
Rituximab
Rituximab subcutaneous injection at 800 mg/m\^2 dose level, administered every 2 or 3 months.
Rituximab SC 375 mg/m^2 (Stage 1: Cohort B)
Rituximab
Rituximab subcutaneous injection 375 mg/m\^2 administered every 2 or 3 months.
Rituximab SC 625 mg/m^2 (Stage 1: Cohort C)
Rituximab
Rituximab subcutaneous injection 625 mg/m\^2 administered every 2 or 3 months.
Rituximab SC 800 mg/m^2 (Stage 1: Cohort D)
Rituximab
Rituximab subcutaneous injection at 800 mg/m\^2 dose level, administered every 2 or 3 months.
Interventions
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Rituximab
Rituximab subcutaneous injection at 1400 mg dose level, administered every 2 or 3 months.
Rituximab
Rituximab subcutaneous injection at 800 mg/m\^2 dose level, administered every 2 or 3 months.
Rituximab
Rituximab subcutaneous injection 625 mg/m\^2 administered every 2 or 3 months.
Rituximab
Rituximab intravenous infusion 375 milligram per square meter (mg/m\^2) administered every 2 or 3 months.
Rituximab
Rituximab subcutaneous injection 375 mg/m\^2 administered every 2 or 3 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented partial or complete response a the end of induction treatment with rituximab
* Must have completed induction treatment, and received at least 1 dose of intravenous rituximab maintenance treatment
* Eastern Cooperative Oncology Group (ECOG) performance status of less than and equal to (\<=) 2
* Life expectancy of greater than and equal to (\>=) 6 months
Exclusion Criteria
* Presence or history of central nervous system disease
* History of malignancy other than follicular NHL
* Recent major surgery (within 4 weeks prior to screening), excluding lymph node biopsy
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Córdoba, , Argentina
Rosario, , Argentina
Kogarah, New South Wales, Australia
Sydney, New South Wales, Australia
Kurralta Park, South Australia, Australia
Fitzroy, Victoria, Australia
Porto Alegre, Rio Grande do Sul, Brazil
Barretos, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Calgary, Alberta, Canada
St. John's, Newfoundland and Labrador, Canada
Halifax, Nova Scotia, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Brno, , Czechia
Hradec Králové, , Czechia
Prague, , Czechia
Herlev, , Denmark
Guayaquil, , Ecuador
Quito, , Ecuador
Helsinki, , Finland
Tampere, , Finland
Turku, , Finland
Marseille, , France
Montpellier, , France
Reims, , France
Haifa, , Israel
Jerusalem, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Bergamo, Lombardy, Italy
Milan, Lombardy, Italy
Turin, Piedmont, Italy
Pisa, Tuscany, Italy
Aguascalientes, , Mexico
Mexico City, Distrito Federal, , Mexico
Monterrey, , Mexico
Oslo, , Norway
Lima, , Peru
Lima, , Peru
Warsaw, , Poland
Wroclaw, , Poland
Moscow, , Russia
Bratislava, , Slovakia
Seoul, , South Korea
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Salamanca, Salamanca, Spain
Seville, Sevilla, Spain
Huddinge, , Sweden
Sundsvall, , Sweden
Umeå, , Sweden
Uppsala, , Sweden
Basel, , Switzerland
Cambridge, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Nottingham, , United Kingdom
Countries
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References
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Salar A, Avivi I, Bittner B, Bouabdallah R, Brewster M, Catalani O, Follows G, Haynes A, Hourcade-Potelleret F, Janikova A, Larouche JF, McIntyre C, Pedersen M, Pereira J, Sayyed P, Shpilberg O, Tumyan G. Comparison of subcutaneous versus intravenous administration of rituximab as maintenance treatment for follicular lymphoma: results from a two-stage, phase IB study. J Clin Oncol. 2014 Jun 10;32(17):1782-91. doi: 10.1200/JCO.2013.52.2631. Epub 2014 May 12.
Mao CP, Brovarney MR, Dabbagh K, Birnbock HF, Richter WF, Del Nagro CJ. Subcutaneous versus intravenous administration of rituximab: pharmacokinetics, CD20 target coverage and B-cell depletion in cynomolgus monkeys. PLoS One. 2013 Nov 12;8(11):e80533. doi: 10.1371/journal.pone.0080533. eCollection 2013.
Other Identifiers
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2008-008490-60
Identifier Type: -
Identifier Source: secondary_id
BP22333
Identifier Type: -
Identifier Source: org_study_id