IRB #

STUDY00018849

Title

A Phase II, single arm, multicenter open label trial to
determine the efficacy and safety of tisagenlecleucel
(CTL019) in adult patients with refractory or relapsed
follicular lymphoma

Principal Investigator

Sarah Nagle

Study Purpose

The purpose of the study is to learn about a cell therapy called CTL019 that may be helpful in treating Follicular Lymphoma. It is also known as tisagenlecleucel, and commercially these cells are called KymriahTM. CTL019 will be called the “study T cells” throughout this form. We do not know if the study T cells will work. The study T cells have not been approved by the Food and Drug Administration (FDA) to be used for relapsed or refractory follicular lymphoma.

We are hoping to find out if the treatment with study T cells in adult participants with follicular lymphoma is a safe and effective option.

Medical Condition(s)

Relapsed/Refractory Follicular Lymphoma

Eligibility Criteria

- Greater than 18 years of age
- Relapsed or Refractory Follicular Lymphoma
- No prior anti-CD19, gene, or adoptive T cell therapies
- No prior allogeneic stem cell transplant
- No active CNS involvement
- No active neurological autoimmune or inflammatory disorders (such as Guillan-Barre syndrome or Amyotrophic Lateral Sclerosis)
- You cannot be pregnant or nursing

Age Range

18 - 120

Healthy Volunteers Needed

No

Duration of Participation

Your participation in the study will consist of 26 to 30 visits over 2 to 4 years. Visits will last up to 6 to 8 hours on infusion days and 1-3 hours on non-infusion days. Upon completion of this study, we will ask to follow your health over the next 15 years by asking you to participate in a separate, long term safety follow up study for participants who have been exposed to study T cells.

Minors Included

No

Contact

Knight Cancer Intake Center: (503) 494-7999
Clinical Trials Information Line: (503) ­494-­1080 or trials@ohsu.edu

Sponsor

Novartis Pharmaceuticals, Inc.

Recruitment End

07/31/2021

Compensation Provided

No


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