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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: Completed Phase 2 study of Non-Hodgkin's Lymphoma, sponsored by Hoffmann-La Roche.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Overall response was defined as Complete Response (CR), Complete Response/Unconfirmed (CRu) or Partial Response (PR) as assessed by investigator at end of induction treatment. Computed tomography imaging was used for the primary assessment of tumor response per 1999 criteria by Cheson. CR was defined as the disappearance of all clinical and radiographic evidence of disease, disease-related symptoms and normalization of biochemical abnormalities of NHL. CRu was CR plus one or more of the follow
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2008-01 |
| Est. Completion | 2013-03 |
| Phase | Phase 2 |
What the finished NCT00576758 record still lists
NCT00576758 is an interventional study that assigns participants to a tested intervention. The registered 175 participants enrollment target is mid-sized for trials with a published cap, below the 219-participant average among 63 other Non-Hodgkin's Lymphoma trials with a reported enrollment target (20% lower).
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 names 20 study sites across 12 states, led by 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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Where NCT00576758's enrollment target sits among peer trials
175 11th of 63 higher than 53 of 63 other Non-Hodgkin's Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Hodgkin's Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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