A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma
NCT ID: NCT05888493
Last Updated: 2025-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
108 participants
INTERVENTIONAL
2023-10-02
2031-01-18
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tisagenlecleucel
Participants randomized to the tisagenlecleucel treatment strategy will receive a single infusion of 0.6 to 6 x 10\^8 CAR-positive viable T-cells
Tisagenlecleucel
Tisagenlecleucel is a solution for infusion of 0.6 to 6 x 10\^8 CAR-positive viable T-cells taken intravenously (i.v.).
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
R2 or R-CHOP
Participants randomized to Standard of Care treatment will receive either R2 or R-CHOP based on investigator choice of therapies, and this has to be determined prior to randomization.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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TRIHEALTH Good Samarithan Hospital
Cincinnati, Ohio, United States
VA Tennessee Valley Healthcare System
Nashville, Tennessee, United States
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
Linz, , Austria
Novartis Investigative Site
Salzburg, , Austria
Novartis Investigative Site
Toronto, Ontario, Canada
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
Bucharest, , Romania
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, Spain
Novartis Investigative Site
L'Hospitalet de Llobregat, Barcelona, Spain
Novartis Investigative Site
Santander, Cantabria, Spain
Novartis Investigative Site
Salamanca, Castille and León, Spain
Novartis Investigative Site
Barcelona, Catalonia, 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
Kaohsiung City, , Taiwan
Novartis Investigative Site
Taichung, , Taiwan
Novartis Investigative Site
Taipei, , Taiwan
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Facility Contacts
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Role: primary
Other Identifiers
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2023-503452-27-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CCTL019E2301
Identifier Type: -
Identifier Source: org_study_id
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