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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05371093 | Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma | PHASE3 | ACTIVE NOT_RECRUITING | 231 | — | — | Sep 22, 2022 | Oct 1, 2030 | Oct 15, 2025 | 52 | United States, France +5 |
PFS is defined as the time from randomization to disease progression or death due to any cause.
| Arm | Type | Description |
|---|---|---|
| Axicabtagene Ciloleucel | EXPERIMENTAL | Participants will receive cyclophosphamide 500 mg/m\^2/day intravenously (IV) and fludarabine 30 mg/m\^2/day IV lymphodepleting chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10\^8 anti-CD19 CAR T cells will be administered. |
| Standard of Care Therapy | ACTIVE_COMPARATOR | Participants will receive the investigator's choice of one of the following therapies/dosing schedules: * Rituximab plus lenalidomide (R\^2) for 12 cycles (28-day cycle) * Cycle 1: lenalidomide 20 mg/day on Day 1 through Day 21; rituximab 375 mg/m\^2 on Day 1, Day 8, Day 15, and Day 22 * Cycle 2 through Cycle 5: lenalidomide 20 mg/day on Day 1 through Day 21; Rituximab 375 mg/m2 on Day 1 * Cycle 6 through Cycle 12: lenalidomide 20 mg/day on Day 1 through Day 21 * Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for 6 cycles (21-day cycle) * rituximab 375 mg/m\^2 on Day 1 * cyclophosphamide 750 mg/m\^2 on Day 1 * doxorubicin 50 mg/m\^2 on Day 1 * vincristine 1.4 mg/m\^2 (maximum 2 mg) on Day 1 * prednisone 40 mg/m\^2 on Day 1 through Day 5 * Rituximab plus bendamustine (BR) for 6 cycles (28-day cycle) * rituximab 375 mg/m\^2 on Day 1 * bendamustine 90 mg/m\^2 on Day 1 and Day 2 |
| Name | Type | Description |
|---|---|---|
| Axicabtagene Ciloleucel | BIOLOGICAL | A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells |
| Cyclophosphamide | DRUG | Administered intravenously |
| Fludarabine | DRUG | Administered intravenously |
| Lenalidomide | DRUG | Administered orally |
| Rituximab | DRUG | Administered intravenously |
| Doxorubicin | DRUG | Administered intravenously |
| Vincristine | DRUG | Administered intravenously |
| Prednisone | DRUG | Administered orally |
| Bendamustine | DRUG | Administered intravenously |
Key Inclusion Criteria: * Histologically-confirmed follicular lymphoma (FL) (Grade 1, 2, or 3a) * Relapsed/refractory (R/r) disease after first-line chemoimmunotherapy and high-risk disease with relapse or progression within 24 months of the initial course of chemoimmunotherapy (ie, POD24), Or r/r ...