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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05888493 | A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma | PHASE3 | ACTIVE NOT_RECRUITING | 109 | — | — | Oct 2, 2023 | Feb 20, 2031 | Apr 17, 2026 | 30 | Australia, Austria +9 |
Progression free survival (PFS) based on Lugano response criteria, defined as time from randomization to the first of the following events to occur: * progressive disease (by BIRC) * death from any cause
| Arm | Type | Description |
|---|---|---|
| Tisagenlecleucel | EXPERIMENTAL | Participants randomized to the tisagenlecleucel treatment strategy will receive a single infusion of 0.6 to 6 x 10\^8 CAR-positive viable T-cells |
| R2 or R-CHOP | ACTIVE_COMPARATOR | Participants randomized to Standard of Care treatment will receive either R2 or R-CHOP based on investigator choice of therapies, and this has to be determined prior to randomization. |
| Name | Type | Description |
|---|---|---|
| Tisagenlecleucel | BIOLOGICAL | Tisagenlecleucel is a solution for infusion of 0.6 to 6 x 10\^8 CAR-positive viable T-cells taken intravenously (i.v.). |
| Lenalidomide and rituximab (R2) in 28-day cycles for up to 12 cycles. | DRUG | Lenalidomide 20 mg daily on days 1-21 for up to 12 cycles Rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1 and day 1 of cycles 2-5 |
| Rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone or prednisolone (R-CHOP) in 21-day cycles for 6 to 8 cycles | DRUG | Rituximab 375 mg/m2 i.v. on day 1 Cyclophosphamide 750 mg/m2 i.v. day 1 Doxorubicin 50 mg/m2 i.v. day 1 Vincristine 1.4 mg/2 (capped at 2 mg) i.v. day 1 Prednisone or prednisolone 40 mg/m2 PO days 1-5 |
| Lymphodepleting chemotherapy | DRUG | Fludarabine (25 mg/m\^2 intravenously \[i.v.\] daily for 3 doses) OR Cyclophosphamide (250 mg/m\^2 i.v. daily for 3 doses starting with the first dose of fludarabine). OR Bendamustine 90 mg/m\^2 i.v. daily for 2 days (If there was previous grade IV hemorrhagic cystitis with cyclophosphamide, or the participant demonstrated resistance to a previous cyclophosphamide-containing regimen) |
| Corticosteroids and/or Radiation (Bridging therapy) | OTHER | Corticosteroids and/or Radiation |
Inclusion Criteria: 1. Age ≥ 18 years at the date of signing the informed consent form. 2. Follicular lymphoma grade 1, 2, or 3A confirmed histologically after latest relapse (local assessment). 3. Relapsed or refractory disease after a second or later line of systemic therapy including an anti-CD2...