Spots Global Cancer Trial Database for Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma
Official 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
Study ID: NCT03568461
Conditions
Interventions
Study Description
Brief Summary: This is a multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in adult patients with relapsed or refractory FL.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(1), Duarte, California, United States
UCSF Medical Center ., San Francisco, California, United States
H Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
University of Chicago Medical Center Hematology and Oncology, Chicago, Illinois, United States
University of Kansas Hospital and Medical Center DeptofUofKansas CancerCenter-2, 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 Perelman Center for Adv Med, Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center SC, Houston, Texas, United States
Novartis Investigative Site, Herston, Queensland, Australia
Novartis Investigative Site, Melbourne, Victoria, Australia
Novartis Investigative Site, Camperdown, , Australia
Novartis Investigative Site, Linz, , Austria
Novartis Investigative Site, Gent, , Belgium
Novartis Investigative Site, Paris 10, , France
Novartis Investigative Site, Pierre Benite, , France
Novartis Investigative Site, Koeln, , Germany
Novartis Investigative Site, Muenchen, , Germany
Novartis Investigative Site, Ulm, , Germany
Novartis Investigative Site, Bologna, BO, Italy
Novartis Investigative Site, Milano, MI, Italy
Novartis Investigative Site, Fukuoka city, Fukuoka, Japan
Novartis Investigative Site, Sapporo city, Hokkaido, Japan
Novartis Investigative Site, Sendai city, Miyagi, Japan
Amsterdam UMC, locatie AMC, Amsterdam, , Netherlands
Novartis Investigative Site, Oslo, , Norway
Novartis Investigative Site, Sevilla, Andalucia, Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Birmingham, , United Kingdom
Novartis Investigative Site, London, , United Kingdom
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
