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

CompletedPhase 2

Sponsor: Novartis Pharmaceuticals

Conditions: Follicular Lymphoma

Interventions: tisagenlecleucel

Countries: United States, Australia, Austria, Belgium, France, Germany, Italy, Japan

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

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Locations (30)

Duarte, California, United States
San Francisco, California, United States
Tampa, Florida, United States
Chicago, Illinois, United States
Kansas City, Kansas, United States
Ann Arbor, Michigan, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Houston, Texas, United States
Camperdown, New South Wales, Australia
Melbourne, Victoria, Australia
Herston, Australia
Linz, Austria
Ghent, Belgium
Paris, France
Pierre-Bénite, France
Munich, Bavaria, Germany
Cologne, North Rhine-Westphalia, Germany
Ulm, Germany
Bologna, BO, Italy
Milan, MI, Italy
Sapporo, Hokkaido, Japan
Sendai, Miyagi, Japan
Fukuoka, Japan
Amsterdam, North Holland, Netherlands
Oslo, Norway, Norway
Madrid, Spain
Seville, Spain
Birmingham, West Midlands, United Kingdom
London, United Kingdom