Trials / Completed
CompletedNCT02213263
A Study Of PF-05280586 (Rituximab-Pfizer) Or MabThera® (Rituximab-EU) For The First-Line Treatment Of Patients With CD20-Positive, Low Tumor Burden, Follicular Lymphoma (REFLECTIONS B328-06)
A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF PF-05280586 VERSUS RITUXIMAB FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH CD20-POSITIVE, LOW TUMOR BURDEN, FOLLICULAR LYMPHOMA
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 394 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will compare the safety and effectiveness of PF-05280586 versus rituximab-EU in patients with CD20-positive, low tumor burden follicular lymphoma. The primary hypothesis to be tested in this study is that the effectiveness of PF-05280586, as measured by the Overall Response Rate, is similar to that of rituximab-EU.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PF-05280586 | PF-05280586 (rituximab-Pfizer) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22 |
| BIOLOGICAL | MabThera® | MabThera® (rituximab-EU) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22 |
Timeline
- Start date
- 2014-09-30
- Primary completion
- 2017-10-23
- Completion
- 2018-04-19
- First posted
- 2014-08-11
- Last updated
- 2019-06-20
- Results posted
- 2018-10-30
Locations
423 sites across 30 countries: United States, Austria, Belarus, Belgium, Brazil, Croatia, France, Georgia, Germany, Greece, India, Italy, Japan, Lebanon, Mexico, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, South Africa, South Korea, Spain, Switzerland, Thailand, Turkey (Türkiye), Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT02213263. Inclusion in this directory is not an endorsement.