A Study of MabThera/Rituxan (Rituximab) in Patients With Non-Bulky Follicular Non-Hodgkin's Lymphoma

NCT ID: NCT01392716

Last Updated: 2016-11-02

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

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-10-31

Study Completion Date

2006-02-28

Brief Summary

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This study will evaluate the efficacy and safety of MabThera/Rituxan (rituximab) in treatment-naive patients with non-bulky follicular non-Hodgkin's lymphoma. The anticipated time on study treatment is 3 months.

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

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single arm

Group Type EXPERIMENTAL

rituximab [MabThera/Rituxan]

Intervention Type DRUG

375 mg/m2 intravenously once a week for 4 weeks

Interventions

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rituximab [MabThera/Rituxan]

375 mg/m2 intravenously once a week for 4 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients 18-75 years of age
* Newly diagnosed non-bulky follicular non-Hodgkin's lymphoma
* \>/=1 measurable lesion
* No prior treatment (no corticosteroids or radiotherapy)

Exclusion Criteria

* Transformed follicular lymphoma
* Cerebral or meningeal lymphomaotus localization
* Uncontrolled concurrent infection
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 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_CHAIR

Hoffmann-La Roche

Locations

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Angers, , France

Site Status

Besançon, , France

Site Status

Bordeaux, , France

Site Status

Clamart, , France

Site Status

Créteil, , France

Site Status

Le Mans, , France

Site Status

Lyon, , France

Site Status

Nantes, , France

Site Status

Nice, , France

Site Status

Paris, , France

Site Status

Paris, , France

Site Status

Pierre-Bénite, , France

Site Status

Poitiers, , France

Site Status

Rouen, , France

Site Status

Tours, , France

Site Status

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

Other Identifiers

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M39006

Identifier Type: -

Identifier Source: org_study_id