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

NCT05888493

Active Not RecruitingPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: Follicular Lymphoma (FL)

Interventions: 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 cycles, Lymphodepleting chemotherapy, Corticosteroids and/or Radiation (Bridging therapy)

Countries: Australia, Austria, Canada, Czechia, Hungary, Poland, Singapore, Slovakia

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

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (30)

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