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A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma
Sponsor: Novartis Pharmaceuticals
Summary
This trial will compare tisagenlecleucel to standard of care in adult participants with relapsed or refractory (r/r) follicular lymphoma.
Official title: A Randomized, Open-label, Multi-center Phase III Trial Comparing Tisagenlecleucel to Standard of Care in Adult Participants With Relapsed or Refractory Follicular Lymphoma (FL)
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
109
Start Date
2023-10-02
Completion Date
2031-02-20
Last Updated
2026-03-24
Healthy Volunteers
No
Conditions
Interventions
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
Locations (30)
Novartis Investigative Site
Camperdown, New South Wales, Australia
Novartis Investigative Site
Clayton, Victoria, Australia
Novartis Investigative Site
Melbourne, Victoria, Australia
Novartis Investigative Site
Nedlands, Western Australia, Australia
Novartis Investigative Site
Salzburg, Austria
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Ostrava, Poruba, Czechia
Novartis Investigative Site
Budapest, Hungary
Novartis Investigative Site
Poznan, Greater Poland Voivodeship, Poland
Novartis Investigative Site
Gliwice, Silesian Voivodeship, Poland
Novartis Investigative Site
Gdansk, Poland
Novartis Investigative Site
Lodz, Poland
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Bratislava, Slovakia
Novartis Investigative Site
Seoul, Korea, 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, Spain
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, Spain
Novartis Investigative Site
Santander, Cantabria, Spain
Novartis Investigative Site
El Palmar, Murcia, Spain
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