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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.
This single-arm, open label study had the following sequential phases: Screening, Pretreatment, Treatment and Follow-up. In the Pre-treatment phase, the patient could undergo bridging therapy (optional) and lymphodepleting (LD) chemotherapy. Treatment and Follow-up Phase included tisagenlecleucel infusion, and safety and efficacy follow-up for at least 24 months. For all the patients who received tisagenlecleucel infusion, additional survival follow-up was to be performed to determine survival status every 3 months.
Age
18 - 100 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
November 12, 2018
Primary Completion Date
November 24, 2020
Completion Date
May 28, 2025
Last Updated
October 7, 2025
98
ACTUAL participants
tisagenlecleucel
BIOLOGICAL
Lead Sponsor
Novartis Pharmaceuticals
NCT06337318
NCT05006716
Data Source & Attribution
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