A Study of Ocrelizumab in Participants With Follicular Non-Hodgkin's Lymphoma (NHL)

NCT ID: NCT02723071

Last Updated: 2016-03-30

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2008-01-31

Brief Summary

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This study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy of ocrelizumab in participants with progressive follicular NHL.

Detailed Description

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Conditions

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Non-Hodgkin's Lymphoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Ocrelizumab

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Ocrelizumab

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

Ocrelizumab

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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RO4964913

Eligibility Criteria

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Inclusion Criteria

* Follicular NHL
* 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

* Prior monoclonal antibody therapy other than rituximab, anti-cancer vaccine, or radioimmunotherapy for cancer
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Melbourne, , Australia

Site Status

Perth, , Australia

Site Status

Woolloongabba, , Australia

Site Status

Edmonton, Alberta, Canada

Site Status

Vancouver, British Columbia, Canada

Site Status

Halifax, Nova Scotia, Canada

Site Status

Ottawa, Ontario, Canada

Site Status

Toronto, Ontario, Canada

Site Status

Créteil, , France

Site Status

Lille, , France

Site Status

Nantes, , France

Site Status

Pierre-Bénite, , France

Site Status

Rennes, , France

Site Status

Bergamo, , Italy

Site Status

Roma, , Italy

Site Status

Torino, , Italy

Site Status

Huddinge, , Sweden

Site Status

Lund, , Sweden

Site Status

Malmo, , Sweden

Site Status

Umeå, , Sweden

Site Status

Bern, , Switzerland

Site Status

Geneva, , Switzerland

Site Status

Lugano, , Switzerland

Site Status

Countries

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Australia Canada France Italy Sweden Switzerland

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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