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

🧪 Interventions in This Study

• Tisagenlecleucel (BIOLOGICAL)
• Lenalidomide and rituximab (R2) in 28-day cycles for up to 12 cycles. (DRUG)
• Rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone or prednisolone (R-CHOP) in 21-day cycles for 6 to 8 cycles (DRUG)
• Lymphodepleting chemotherapy (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (30 Sites)

Showing the first 25 of 30 sites.

• 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,
• Novartis Investigative Site — Montreal, Quebec
• Novartis Investigative Site — Ostrava, Poruba
• Novartis Investigative Site — Budapest,
• Novartis Investigative Site — Poznan, Greater Poland Voivodeship
• Novartis Investigative Site — Gliwice, Silesian Voivodeship
• Novartis Investigative Site — Gdansk,
• Novartis Investigative Site — Lodz,
• Novartis Investigative Site — Singapore,
• Novartis Investigative Site — Bratislava,
• Novartis Investigative Site — Seoul,
• Novartis Investigative Site — Seoul,
• Novartis Investigative Site — Seoul,
• Novartis Investigative Site — Seoul,
• Novartis Investigative Site — Seoul,
• 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,
• Novartis Investigative Site — Córdoba,

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Follicular Lymphoma (FL)

• A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Adult Participants With Previously Untreated Follicular Lymphoma — Tucson, Arizona
• Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Previously Untreated Follicular Lymphoma — Fresno, California
• A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Chemotherapy for Adult Participants With Follicular Lymphoma — Plantation, Florida
• Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma — Tucson, Arizona

Explore by condition: All Follicular Lymphoma (FL) clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.