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



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:November 12, 2018
End Date:August 24, 2022
Contact:Novartis Pharmaceuticals
Email:novartis.email@novartis.com
Phone:1-888-669-6682

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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

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


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
We found this trial at
6
sites
Duarte, California 91010
Principal Investigator: Leslie Popplewell
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1150 East Medical Center Drive
Ann Arbor, Michigan 48109
Principal Investigator: Monalisa Ghosh
Phone: 734-615-4762
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Ann Arbor, MI
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Chicago, Illinois 60637
Principal Investigator: Peter Riedell
Phone: 773-834-8980
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Chicago, IL
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Herston, Queensland
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Herston,
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Houston, Texas 77030
Principal Investigator: Nathan Fowler
Phone: 713-792-2171
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Houston, TX
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Philadelphia, Pennsylvania 19104
Principal Investigator: Stephen Schuster
Phone: 215-615-6721
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Philadelphia, PA
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