Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma

Completed · Phase 2

Conditions studied: Follicular Lymphoma

In brief

This is a multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in adult patients with relapsed or refractory FL.

Key facts

Study ID

NCT03568461

Run by

Novartis Pharmaceuticals

People needed

98

Starts

2018-11-12

Expected to finish

2025-05-28

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Refractory or relapsed Follicular Lymphoma (Grade 1, 2, 3A)
• Radiographically measurable disease at screening

You may not qualify if…

• Evidence of histologic transformation
• Follicular Lymphoma Grade 3B
• Prior anti-CD19 therapy
• Prior gene therapy
• Prior adoptive T cell therapy
• Prior allogeneic hematopoietic stem cell transplant
• Active CNS involvement by malignancy
• Other protocol-defined Inclusion/Exclusion criteria may apply.

Where it is running

• City of Hope National Medical Center — Duarte, California, United States
• UCSF Medical Center — San Francisco, California, United States
• H Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• Uni of Chi Medi Ctr Hema and Onco — Chicago, Illinois, United States
• Univ of Kansas Hosp and Med Ctr — Kansas City, Kansas, United States
• Michigan Med University of Michigan — Ann Arbor, Michigan, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• University of Pennsylvania Clinical — Philadelphia, Pennsylvania, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Novartis Investigative Site — Camperdown, New South Wales, Australia
• Novartis Investigative Site — Melbourne, Victoria, Australia
• Novartis Investigative Site — Herston, Australia
• Novartis Investigative Site — Linz, Austria
• Novartis Investigative Site — Ghent, Belgium
• Novartis Investigative Site — Paris, France
• Novartis Investigative Site — Pierre-Bénite, France
• Novartis Investigative Site — Munich, Bavaria, Germany
• Novartis Investigative Site — Cologne, North Rhine-Westphalia, Germany
• Novartis Investigative Site — Ulm, Germany
• Novartis Investigative Site — Bologna, BO, Italy
• Novartis Investigative Site — Milan, MI, Italy
• Novartis Investigative Site — Sapporo, Hokkaido, Japan
• Novartis Investigative Site — Sendai, Miyagi, Japan
• Novartis Investigative Site — Fukuoka, Japan
• Novartis Investigative Site — Amsterdam, North Holland, Netherlands

Full record on ClinicalTrials.gov

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