Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02213263 | 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) | PHASE3 | COMPLETED | 394 | — | — | Sep 30, 2014 | Apr 19, 2018 | Jun 20, 2019 | 423 | United States, Austria +28 |
ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) in accordance with the revised response criteria for malignant lymphoma (Cheson 2007). CR was defined as disappearance of all evidence of disease. PR was defined as regression of measureable disease and no new sites.
| Arm | Type | Description |
|---|---|---|
| PF-05280586 | EXPERIMENTAL | - |
| MabThera® | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| PF-05280586 | BIOLOGICAL | PF-05280586 (rituximab-Pfizer) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22 |
| MabThera® | BIOLOGICAL | MabThera® (rituximab-EU) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22 |
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 * An...