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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 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 1,418 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01287741
The ClinicalTrials.gov registry entry for NCT01287741 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 1,418 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Obinutuzumab is the first listed.
NCT01287741 reports 0 study locations.
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.
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