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

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

ClinicalTrials.gov Identifier: NCT03568461

Novartis Reference Number: CCTL019E2202

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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

Condition 
Follicular Lymphoma
Phase 
Phase 2
Overall status 
Active, not recruiting
Enrollment count 
97 participants
Start date 
Nov 12, 2018
Completion date 
May 25, 2022
Gender 
All
Age(s)
18 Years and older (Adult, Older Adult)

Interventions

Biological
tisagenlecleucel
single infusion

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

Study Locations

United States
City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(1)
-
Duarte, 91010 3000
California
United States
UCSF Medical Center
-
San Francisco, 94143
California
United States
H Lee Moffitt Cancer Center and Research Institute
-
Tampa, 33612
Florida
United States
University of Chicago Medical Center Hematology and Oncology
-
Chicago, 60637
Illinois
United States
University of Kansas Hospital and Medical Center DeptofUofKansas CancerCenter-2
-
Kansas City, 66160
Kansas
United States
Michigan Medicine University of Michigan
-
Ann Arbor, 48109 5271
Michigan
United States
Oregon Health and Science University
-
Portland, 97239
Oregon
United States
University of Pennsylvania Clinical Studies Unit Perelman Center for Adv Med
-
Philadelphia, 19104
Pennsylvania
United States
MD Anderson Cancer Center SC
-
Houston, 77030
Texas
United States
Australia
Novartis Investigative Site
-
Herston, 4029
Queensland
Australia
Novartis Investigative Site
-
Melbourne, 3000
Victoria
Australia
Novartis Investigative Site
-
Camperdown, NSW
-
Australia
Austria
Novartis Investigative Site
-
Linz, 4020
-
Austria
Belgium
Novartis Investigative Site
-
Gent, 9000
-
Belgium
France
Novartis Investigative Site
-
Paris, 75010
-
France
Novartis Investigative Site
-
Pierre Benite Cedex, 69495
-
France
Germany
Novartis Investigative Site
-
Koeln, 50937
-
Germany
Novartis Investigative Site
-
Muenchen, 81377
-
Germany
Novartis Investigative Site
-
Ulm, 89081
-
Germany
Italy
Novartis Investigative Site
-
Bologna, 40138
BO
Italy
Novartis Investigative Site
-
Milano, 20132
MI
Italy
Japan
Novartis Investigative Site
-
Fukuoka city, 812-8582
Fukuoka
Japan
Novartis Investigative Site
-
Sapporo city, 060 8648
Hokkaido
Japan
Novartis Investigative Site
-
Sendai city, 980 8574
Miyagi
Japan
Netherlands
Amsterdam UMC, locatie AMC
-
Amsterdam, 1105 AZ
-
Netherlands
Norway
Novartis Investigative Site
-
Oslo, NO-0424
-
Norway
Spain
Novartis Investigative Site
-
Sevilla, 41013
Andalucia
Spain
Novartis Investigative Site
-
Madrid, 28041
-
Spain
United Kingdom
Novartis Investigative Site
-
Birmingham, B15 2TH
-
United Kingdom
Novartis Investigative Site
-
London, SE5 9RS
-
United Kingdom

Have a question?

Call 1-999-669-6682 or email [email protected]