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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01419665 | GP2013 in the Treatment of Patients With Previously Untreated, Advanced Stage Follicular Lymphoma (ASSIST_FL) | PHASE3 | COMPLETED | 629 | — | — | Dec 1, 2011 | Jan 22, 2018 | May 14, 2021 | 153 | Argentina, Australia +24 |
ORR is defined as the proportion of patients whose best overall disease response was either CR or PR during the combination treatment period based on blinded independent central radiology review.
| Arm | Type | Description |
|---|---|---|
| GP2013 | EXPERIMENTAL | Type: Biological/Vaccine |
| rituximab | ACTIVE_COMPARATOR | Type: Biological/Vaccine |
| Name | Type | Description |
|---|---|---|
| GP2013 | BIOLOGICAL | Type: Biological/Vaccine |
| rituximab | BIOLOGICAL | Type: Biological/Vaccine |
Inclusion Criteria: * Patient with previously untreated advanced stage, CD20-positive FL * Patient with ECOG performance status 0, 1 or 2. Exclusion Criteria: * Patient with Grade 3b (aggressive) FL or any histology other than FL grade 1, 2 or 3a * Patient who has previously received any prior th...