WHO ICTRP trial
A Study of RO5072759 (GA101) in Combination With CHOP Chemotherapy Versus…
EUCTR2010-024194-39-GB · EU Clinical Trials Register · Not Recruiting
Key facts
| Trial ID | EUCTR2010-024194-39-GB |
|---|---|
| Public title | A Study of RO5072759 (GA101) in Combination With CHOP Chemotherapy Versus MabThera/Rituxan (Rituximab) With CHOP in Patients With CD20-Positive Diffuse Large B-Cell Lymphoma |
| Scientific title | A PHASE III, MULTICENTER, OPEN-LABEL, RANDOMIZED TRIAL COMPARING THE EFFICACY OF GA101 (RO5072759) IN COMBINATION WITH CHOP (G-CHOP) VERSUS RITUXIMAB AND CHOP (R-CHOP) IN PREVIOUSLY UNTREATED PATIENTS WITH CD20 POSITIVE DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL) - GOYA |
| Primary sponsor | F. Hoffmann-La Roche Ltd. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Not Recruiting |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | United States;Slovakia;Thailand;Spain;Ukraine;Korea, Democratic People's Republic of;Austria;United Kingdom;Italy;Czech Republic;Hungary;Canada;Poland;Denmark;Australia;Germany;Japan |
| Conditions | PREVIOUSLY UNTREATED PATIENTS WITH CD20-POSITIVE DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL) MedDRA version: 20.0 Level: HLT Classification code 10012819 Term: Diffuse large B-cell lymphomas System Organ Class: 100000004943 MedDRA version: 20.0… |
| Interventions | Product Name: Obinutuzumab (GA101) Product Code: RO5072759 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Obinutuzumab CAS Number: 949142-50-1 Current Sponsor code: RO5072759/F06 Other descriptive name… |
| Registration date | Oct 3, 2011 |
| Target size | 1400 |
| Secondary IDs | BO21005;NCT01287741;2010-024194-39-ES |
| Registry page | clinicaltrialsregister.eu |
At a glance
- Yes Results available
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: