A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma (NCT05888493) — Canada Trial Details

Condition(s) studied

Follicular Lymphoma (FL)

Investigational drug(s) / intervention(s)

Tisagenlecleucel →Lenalidomide and rituximab (R2) in 28-day cycles for up to 12 cycles.Rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone or prednisolone (R-CHOP) in 21-day cycles for 6 to 8 cyclesLymphodepleting chemotherapyCorticosteroids and/or Radiation (Bridging therapy)

Tisagenlecleucel: 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.: 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: 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: 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): Corticosteroids and/or Radiation

Study summary

This trial will compare tisagenlecleucel to standard of care in adult participants with relapsed or refractory (r/r) follicular lymphoma.

Eligibility

Sex

ALL

Min age

18 Years

Max age

100 Years

Healthy volunteers

No

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

Primary outcome measure(s)

Progression-free survival (PFS) determined by blinded independent review committee (BIRC) — 5 years
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

Trial sites (30)

Facility	City	Region
Novartis Investigative Site	Camperdown	New South Wales
Novartis Investigative Site	Clayton	Victoria
Novartis Investigative Site	Melbourne	Victoria
Novartis Investigative Site	Nedlands	Western Australia
Novartis Investigative Site	Salzburg	Austria
Novartis Investigative Site	Montreal	Quebec
Novartis Investigative Site	Ostrava	Poruba
Novartis Investigative Site	Budapest	Hungary
Novartis Investigative Site	Poznan	Greater Poland Voivodeship
Novartis Investigative Site	Gliwice	Silesian Voivodeship
Novartis Investigative Site	Gdansk	Poland
Novartis Investigative Site	Lodz	Poland
Novartis Investigative Site	Singapore	Singapore
Novartis Investigative Site	Bratislava	Slovakia
Novartis Investigative Site	Seoul	South Korea
Novartis Investigative Site	Seoul	South Korea
Novartis Investigative Site	Seoul	South Korea
Novartis Investigative Site	Seoul	South Korea
Novartis Investigative Site	Seoul	South Korea
Novartis Investigative Site	Santiago Compostela	A Coruna
Novartis Investigative Site	L'Hospitalet de Llobregat	Barcelona
Novartis Investigative Site	Santander	Cantabria
Novartis Investigative Site	El Palmar	Murcia
Novartis Investigative Site	Barcelona	Spain
Novartis Investigative Site	Córdoba	Spain
Novartis Investigative Site	Madrid	Spain
Novartis Investigative Site	Salamanca	Spain
Novartis Investigative Site	Kaohsiung City	Taiwan
Novartis Investigative Site	Taichung	Taiwan
Novartis Investigative Site	Taipei	Taiwan

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