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NCT00576758 · ClinicalTrials.gov registry record · Phase 2

GAUSS: A Study of Obinutuzumab (RO5072759) in Patients With Indolent Non-Hodgkin's Lymphoma

A Phase 2 study of Non-Hodgkin's Lymphoma, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 2
Development phase
175
Enrollment target
20
Study locations

NCT00576758 is a Phase 2 study of Non-Hodgkin's Lymphoma that has completed, run by Hoffmann-La Roche. The registered enrollment target is 175 participants, below the 219-participant average among 63 other Non-Hodgkin's Lymphoma trials with a reported enrollment target (20% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT00576758, a Phase 2 study of Non-Hodgkin's Lymphoma, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 2
Development phase
175 participants
Enrollment target
20
Study locations

Study Summary

This study will investigate the efficacy of weekly intravenous obinutuzumab \[GA101 (RO5072759)\] monotherapy, in patients with relapsed CD20+ indolent Non-Hodgkin's Lymphoma. Patients will be randomized to receive either GA101 or rituximab, given as four weekly infusions. At the conclusion of the initial trial patients may be eligible to continue therapy up to 24 months. The anticipated time on study treatment is 3- 24 months, and the target sample size is 100-500 individuals.

Conditions Studied

Non-Hodgkin's Lymphoma

Interventions

  • DRUG rituximab
  • DRUG obinutuzumab (RO5072759)

Study Locations (20)

Other

  • - Buenos Aires
  • - Buenos Aires
  • - Buenos Aires
  • - Innsbruck
  • - Salzburg
  • - Vienna
  • - Brussels

Florida

  • - Gainesville
  • - Tampa

New York

  • - New York
  • - Rochester

California

  • - Los Angeles

Colorado

  • - Denver

Georgia

  • - Augusta

Maryland

  • - Cumberland

New Jersey

  • - Hackensack

Trial Details

FieldValue
Enrollment Target 175 participants
Start Date 2008-01
Est. Completion 2013-03
Phase Phase 2

Sponsor

Hoffmann-La Roche

909 total trials

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What the Registry Record Tells You About NCT00576758

The ClinicalTrials.gov registry entry for NCT00576758 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 175 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 219-participant average among 63 other Non-Hodgkin's Lymphoma trials with a reported enrollment target (20% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Non-Hodgkin's Lymphoma appearing as the primary indexed condition, and to 2 interventions - of which rituximab is the first listed.

NCT00576758 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Other, Florida, New York.

Frequently Asked Questions

What is clinical trial NCT00576758 about?

NCT00576758 is a clinical study titled "GAUSS: A Study of Obinutuzumab (RO5072759) in Patients With Indolent Non-Hodgkin's Lymphoma". This study will investigate the efficacy of weekly intravenous obinutuzumab \[GA101 (RO5072759)\] monotherapy, in patients with relapsed CD20+ indolent Non-Hodgkin's Lymphoma. Patients will be randomized to receive either GA101 or rituximab, given as four weekly infusions. At the conclusion of the i...

What is the current status of trial NCT00576758?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 175 participants. The study started on 2008-01. Estimated completion is 2013-03.

What conditions does trial NCT00576758 study?

This clinical trial studies the following conditions: Non-Hodgkin's Lymphoma.

What interventions are being tested in trial NCT00576758?

The interventions under investigation include: rituximab (DRUG), obinutuzumab (RO5072759) (DRUG).

Who is sponsoring clinical trial NCT00576758?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00576758 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.