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ACTIVE NOT RECRUITING
NCT05888493
PHASE3

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

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

Tisagenlecleucel

Tisagenlecleucel is a solution for infusion of 0.6 to 6 x 10\^8 CAR-positive viable T-cells taken intravenously (i.v.).

DRUG

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

DRUG

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

DRUG

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)

OTHER

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