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NCT01414855 · ClinicalTrials.gov registry record · Phase 2
A Study of Obinutuzumab [RO5072759 (GA101)] in Combination With CHOP Chemotherapy in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma (GATHER)
A Phase 2 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT01414855 is a Phase 2 study that has completed, run by Genentech. The registered enrollment target is 100 participants.
The verdict
NCT01414855, a Phase 2 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study Summary
This open-label, multicenter study will evaluate the efficacy and safety of obinutuzumab \[RO5072759 (GA101)\] in combination with CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) chemotherapy in patients with advanced diffuse large B-cell lymphoma. Patients will receive 8 cycles of obinutuzumab (1000 mg intravenously on Day 1 of each 21-day cycle, during Cycle 1 obinutuzumab will also be infused on Days 8 and 15) in combination with CHOP chemotherapy on Day 1 of cycles 1 to 6. A substudy will investigate the drug-drug interaction of obinutuzumab with CHOP chemotherapy agents. For the substudy, an additional cohort of approximately 15 patients are planned to be enrolled at a subset of investigational sites.
Interventions
- DRUG prednisone
- DRUG obinutuzumab
- DRUG cyclophosphamide
- DRUG doxorubicin
- DRUG vincristine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2011-08-31 |
| Est. Completion | 2016-12-23 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01414855
The ClinicalTrials.gov registry entry for NCT01414855 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 100 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 5 interventions - of which prednisone is the first listed.
NCT01414855 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01414855 about?
NCT01414855 is a clinical study titled "A Study of Obinutuzumab [RO5072759 (GA101)] in Combination With CHOP Chemotherapy in Patients With Previously Untreated Advanced Diffuse Large B-Cell Lymphoma (GATHER)". This open-label, multicenter study will evaluate the efficacy and safety of obinutuzumab \[RO5072759 (GA101)\] in combination with CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) chemotherapy in patients with advanced diffuse large B-cell lymphoma. Patients will receive 8 cycles of obi...
What is the current status of trial NCT01414855?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2011-08-31. Estimated completion is 2016-12-23.
What interventions are being tested in trial NCT01414855?
The interventions under investigation include: prednisone (DRUG), obinutuzumab (DRUG), cyclophosphamide (DRUG), doxorubicin (DRUG), vincristine (DRUG).
Who is sponsoring clinical trial NCT01414855?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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