| 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 |
| 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. |
| Not Provided |
| Interventional |
| Phase 3 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment |
| Follicular Lymphoma |
- 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
|
|
|
| Not Provided |
| |
| Recruiting |
| 394 |
| April 25, 2018 |
| October 23, 2017 (Final data collection date for primary outcome measure) |
|
Inclusion Criteria:
- Confirmed diagnosis of low tumor burden, CD20-positive follicular lymphoma
- Ann Arbor Stage II, III, or IV
Exclusion Criteria:
- Not a candidate for treatment with rituximab as a single-agent
- Evidence of transformation to a high grade or diffuse large B-cell lymphoma
- Any previous systemic therapy for B-cell NHL, including chemotherapy, immunotherapy, or steroids
- Any prior treatment with rituximab
- Active, uncontrolled infection
|
| Sexes Eligible for Study: |
All |
|
| 18 Years and older (Adult, Senior) |
| No |
|
| Austria, Belarus, Belgium, Brazil, Croatia, France, Georgia, Germany, Greece, India, Italy, Japan, Korea, Republic of, Lebanon, Mexico, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russian Federation, South Africa, Spain, Switzerland, Thailand, Turkey, Ukraine, United Kingdom, United States |
| |
| |
| NCT02213263 |
B3281006
2014-000132-41 ( EudraCT Number )
REFLECTIONS ( Other Identifier: Alias Study Number ) |
| Yes |
| Not Provided |
| Not Provided |
| Pfizer |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| December 2017 |
