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NCT01059630 · ClinicalTrials.gov registry record · Phase 3
A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma (GADOLIN)
A Phase 3 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 3
- Development phase
- 413
- Enrollment target
NCT01059630 is a Phase 3 study that has completed, run by Genentech. The registered enrollment target is 413 participants.
The verdict
NCT01059630, a Phase 3 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 413 participants
- Enrollment target
Study Summary
This open-label, multicenter, randomized Phase III study will investigate the efficacy, safety, pharmacokinetics and pharmacoeconomics of obinutuzumab (RO5072759, GA101) combined with bendamustine followed by continued obinutuzumab treatment (maintenance monotherapy) compared with bendamustine alone treatment in participants with rituximab-refractory indolent Non-Hodgkin's lymphoma (iNHL). The end of study was defined to when safety follow-up for all patients had been completed (2 years' safety follow-up from last dose).
Interventions
- DRUG Obinutuzumab
- DRUG Bendamustine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 413 participants |
| Start Date | 2010-04-30 |
| Est. Completion | 2018-11-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01059630
The ClinicalTrials.gov registry entry for NCT01059630 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 413 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Obinutuzumab is the first listed.
NCT01059630 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01059630 about?
NCT01059630 is a clinical study titled "A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma (GADOLIN)". This open-label, multicenter, randomized Phase III study will investigate the efficacy, safety, pharmacokinetics and pharmacoeconomics of obinutuzumab (RO5072759, GA101) combined with bendamustine followed by continued obinutuzumab treatment (maintenance monotherapy) compared with bendamustine alone...
What is the current status of trial NCT01059630?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 413 participants. The study started on 2010-04-30. Estimated completion is 2018-11-30.
What interventions are being tested in trial NCT01059630?
The interventions under investigation include: Obinutuzumab (DRUG), Bendamustine (DRUG).
Who is sponsoring clinical trial NCT01059630?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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