A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma (LEDA)
A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma (LEDA)
ClinicalTrials.gov ID: NCT05888493
Sponsor: Novartis Pharmaceuticals
Information provided by: Novartis (Novartis Pharmaceuticals) (Responsible Party)
Last Update Posted: 2024-03-22
Brief Summary:
This trial will compare tisagenlecleucel to standard of care in adult participants with relapsed or refractory (r/r) follicular lymphoma.
Detailed Description:
The purpose of this phase III study is to verify the clinical benefit of tisagenlecleucel for the treatment of r/r FL by comparing the tisagenlecleucel treatment strategy to standard of care therapy in patients with r/r FL after two or more lines of systemic therapy, with progression-free survival (PFS) as the primary endpoint.
The primary objective is to demonstrate superiority of the tisagenlecleucel treatment strategy over standard of care (SOC) therapy with respect to progression-free survival (PFS) determined by blinded independent review committee (BIRC) based on the Lugano response criteria.
Participants randomized to Arm A (tisagenlecleucel treatment) will receive a single infusion of 0.6 to 6 x 10^8 CAR-positive viable T-cells.
Participants randomized to Arm B (Standard of Care) will receive R2 or R-CHOP based on investigator choice and this has to be determined prior to randomization.
Intervention / Treatment:
- Biological: Tisagenlecleucel
- Drug: Lenalidomide and rituximab (R2) in 28-day cycles for up to 12 cycles.
- Drug: Rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone or prednisolone (R-CHOP) in 21-day cycles for 6 to 8 cycles
- Drug: Lymphodepleting chemotherapy
- Other: Corticosteroids and/or Radiation (Bridging therapy)
| Category | Value |
|---|---|
| Study Start (Actual) |
2023-10-02
|
| Primary Completion (Estimated) | 2028-07-24 |
| Study Completion (Estimated) | 2029-02-07 |
| Enrollment (Estimated) | 108 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
CCTL019E2301
2023-503452-27-00 (Registry Identifier) (REGISTRY: EU CT Number) |