Trials / Completed
CompletedNCT01649856
A Study of Subcutaneous Versus Intravenous MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in Patients With Previously Untreated CD20-Positive Diffuse Large B-Cell Lymphoma
A Comparative, Randomized, Parallel-group, Multi-center, Phase IIIB Study to Investigate the Efficacy of Subcutaneous (SC) Rituximab Versus Intravenous (IV) Rituximab Both in Combination With CHOP (R-CHOP) in Previously Untreated Patients With CD20-positive Diffuse Large B-cell Lymphoma (DLBCL)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 572 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This multicenter, randomized, open label parallel-group study will evaluate the efficacy and safety of subcutaneous versus intravenous MabThera/Rituxan (rituximab) in combination with CHOP chemotherapy in patients with previously untreated CD20-positive diffuse large B-Cell lymphoma. Patients will be randomized to receive either MabThera/Rituxan 1400 mg subcutaneously or MabThera/Rituxan 375 mg/m2 intravenously on Day 1 of each cycle for 8 cycles, in combination with 6-8 cycles of CHOP chemotherapy. Anticipated time on study treatment is 6 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CHOP | CHOP chemotherapy: cyclophosphamide, doxorubicin, vincristine, prednisone/prednisolone; 6 or 8 cycles |
| DRUG | rituximab [MabThera/Rituxan] | The first rituximab dose will be administered intravenously on Day of Cycle 1 at a dose of 375 mg/m2. Subsequent doses of 1400 mg are administered subcutaneously on Day 1 of each cycle, for a further 7 cycles |
| DRUG | rituximab [MabThera/Rituxan] | 375 mg/m2 intravenously on Day 1 of each cycle, 8 cycles |
Timeline
- Start date
- 2012-08-24
- Primary completion
- 2014-10-21
- Completion
- 2016-09-16
- First posted
- 2012-07-25
- Last updated
- 2017-10-11
- Results posted
- 2016-02-12
Locations
186 sites across 27 countries: Algeria, Argentina, Belgium, Brazil, Bulgaria, Canada, Colombia, Finland, France, Greece, Ireland, Israel, Italy, Netherlands, Peru, Poland, Portugal, Russia, Saudi Arabia, Serbia, South Africa, Spain, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, Venezuela
Source: ClinicalTrials.gov record NCT01649856. Inclusion in this directory is not an endorsement.