Study Description
This trial will compare tisagenlecleucel to standard of care in adult participants with
relapsed or refractory (r/r) follicular lymphoma. 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.
Interventions
Corticosteroids and/or Radiation (Bridging therapy)
Lenalidomide and rituximab (R2) in 28-day cycles for up to 12 cycles.
Lymphodepleting chemotherapy
Rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone or prednisolone (R-CHOP) in 21-day cycles for 6 to 8 cycles
Tisagenlecleucel
Eligibility Criteria
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-CD20 antibody and an alkylating agent.
4. Disease that is both active on Positron emission tomography (PET) scan (defined as a
score of 4 or 5 on the Deauville 5-point scale) and measurable on Computed
tomography (CT) scan.
5. ECOG performance status of 0, 1 or 2 at screening.
6. Adequate hematologic, renal, hepatic and pulmonary organ function at screening.
7. Must meet the institutional criteria to undergo leukapheresis (unless historical
leukapheresis is available).
8. Must be eligible for treatment with the selected standard of care regimen.
Exclusion Criteria:
1. Follicular lymphoma grade 3B or evidence of histologic transformation.
2. Prior treatment with anti-CD19 therapy, gene therapy, or adoptive T-cell therapy.
3. Active CNS involvement by malignancy.
4. Clinically significant active infection, presence of Human immunodeficiency virus
(HIV) antibody or active hepatitis B or C.
5. Active neurological autoimmune or inflammatory disorders (e.g., Guillain-Barré
syndrome).
6. Investigational medicinal product within the last 30 days or five half-lives
(whichever is longer) prior to randomization.
7. Clinically significant cardiovascular conditions such as acute coronary syndrome,
significant cardiac arrhythmias, heart failure or decreased LVEF.
Other protocol defined inclusion/exclusion criteria may apply
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