A Study of Ocrelizumab in Participants With Follicular Non-Hodgkin's Lymphoma (NHL)
NCT ID: NCT02723071
Last Updated: 2016-03-30
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/PHASE2
48 participants
INTERVENTIONAL
2005-05-31
2008-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A: Ocrelizumab 200 mg/m^2
Participants will receive a total of 8 infusions of ocrelizumab 200 milligram per square meter (mg/m\^2) given at intervals of 3 weeks, until disease progression or unacceptable toxicity.
Ocrelizumab
Participants will receive a total of 8 intravenous (IV) infusions of ocrelizumab given at intervals of 3 weeks, until disease progression or unacceptable toxicity.
Cohort B: Ocrelizumab 375 mg/m^2
Participants will receive a total of 8 infusions of ocrelizumab 375 mg/m\^2 given at intervals of 3 weeks, until disease progression or unacceptable toxicity.
Ocrelizumab
Participants will receive a total of 8 intravenous (IV) infusions of ocrelizumab given at intervals of 3 weeks, until disease progression or unacceptable toxicity.
Cohort C: Ocrelizumab 375/750 mg/m^2
Participants will receive first infusion of ocrelizumab 375 mg/m\^2 followed by 7 infusions of 750 mg/m\^2 given at intervals of 3 weeks, until disease progression or unacceptable toxicity.
Ocrelizumab
Participants will receive a total of 8 intravenous (IV) infusions of ocrelizumab given at intervals of 3 weeks, until disease progression or unacceptable toxicity.
Interventions
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Ocrelizumab
Participants will receive a total of 8 intravenous (IV) infusions of ocrelizumab given at intervals of 3 weeks, until disease progression or unacceptable toxicity.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented history of response, or stable disease more than 6 months in duration, to a rituximab-containing regimen that was the last treatment before enrollment in the study
* No evidence of hepatitis B or C
Exclusion Criteria
* History of severe allergic or anaphylactic reaction to humanized or murine monoclonal antibodies, or known sensitivity or allergy to murine products
* Major nondiagnostic surgery within 4 weeks of Screening
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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Melbourne, , Australia
Perth, , Australia
Woolloongabba, , Australia
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Halifax, Nova Scotia, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Créteil, , France
Lille, , France
Nantes, , France
Pierre-Bénite, , France
Rennes, , France
Bergamo, , Italy
Roma, , Italy
Torino, , Italy
Huddinge, , Sweden
Lund, , Sweden
Malmo, , Sweden
Umeå, , Sweden
Bern, , Switzerland
Geneva, , Switzerland
Lugano, , Switzerland
Countries
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Other Identifiers
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2004-004110-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BO18414
Identifier Type: -
Identifier Source: org_study_id
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