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NCT01287741 · ClinicalTrials.gov registry record · Phase 3
A Study of Obinutuzumab in Combination With CHOP Chemotherapy Versus Rituximab With CHOP in Participants With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA)
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,418
- Enrollment target
NCT01287741: Clinical Trial Phase 3 study, sponsored by Hoffmann-La Roche.
NCT01287741 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 1,418 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01287741, a Phase 3 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,418 participants
- Enrollment target
Study Summary
This open-label, randomized, parallel group study will evaluate the efficacy and safety of obinutuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone or prednisone (CHOP) chemotherapy versus rituximab (MabThera/Rituxan) with CHOP in previously untreated participants with cluster of differentiation 20 (CD20)-positive diffuse large B-cell lymphoma (DLBCL). Participants will be randomized to receive either obinutuzumab 1000 milligrams (mg) intravenously (IV) every 21 days or rituximab 375 milligrams per square meter (mg/m\^2) IV every 21 days for 8 cycles, in addition to 6-8 cycles of CHOP chemotherapy IV every 21 days. Participants randomized to the obinutuzumab arm will receive an additional two doses on Days 8 and 15 of Cycle 1. Anticipated time on study treatment is 24 weeks.
Primary Outcome
Kaplan Meier estimate of the median PFS was defined as the time at which half of the participants have progressed (progressive disease \[PD\]). Progression-free survival was defined as the time from randomization until the first documented day of disease progression or relapse, using a modified version of the Revised Response Criteria for Malignant Lymphoma, or death from any cause, whichever occurred first, on the basis of investigator assessments. Progression was defined as at least 50% increa
Interventions
- DRUG Obinutuzumab
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- DRUG Rituximab
- DRUG Vincristine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,418 participants |
| Start Date | 2011-07-26 |
| Est. Completion | 2018-01-31 |
| Phase | Phase 3 |
Why NCT01287741 stopped before completion
NCT01287741 is an interventional study that assigns participants to a tested intervention. Its 1,418 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (84% higher).
The record links to 0 conditions, and to 5 interventions - of which Obinutuzumab is the first listed.
NCT01287741 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01287741 about?
NCT01287741 is a clinical study titled "A Study of Obinutuzumab in Combination With CHOP Chemotherapy Versus Rituximab With CHOP in Participants With CD20-Positive Diffuse Large B-Cell Lymphoma (GOYA)". This open-label, randomized, parallel group study will evaluate the efficacy and safety of obinutuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisolone or prednisone (CHOP) chemotherapy versus rituximab (MabThera/Rituxan) with CHOP in previously untreated participant...
What is the current status of trial NCT01287741?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,418 participants. The study started on 2011-07-26. Estimated completion is 2018-01-31.
What interventions are being tested in trial NCT01287741?
The interventions under investigation include: Obinutuzumab (DRUG), Cyclophosphamide (DRUG), Doxorubicin (DRUG), Rituximab (DRUG), Vincristine (DRUG).
Who is sponsoring clinical trial NCT01287741?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01287741's enrollment target sits among peer trials
1,418 169th of 2000 higher than 1,832 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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