臨床研究等提出・公開システム

Date of registration	Jan. 31, 2019
Last modified on	June. 12, 2023
Trial ID	jRCT1080224541

Scientific 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 (r/r) follicular lymphoma
Public Title	Efficacy and safety of tisagenlecleucel in adult patients with refractory or relapsed follicular lymphoma

Contact for Scientific Queries	Name	Hirano Takamitsu
	Contact Name for Scientific Queries	Novartis Pharma. K.K.
	Address	Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan
	Phone Number	+81-120-003-293
	E-mail Address	rinshoshiken.toroku2@novartis.com

Contact for Public Queries	Name	Hirano Takamitsu
	Contact Name for Public Queries	Novartis Pharma. K.K.
	Address	Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan
	Phone Number	+81-120-003-293
	E-mail Address	rinshoshiken.toroku2@novartis.com

Recruitment Status	completed

Date of First Enrolment		Nov. 12, 2018
Target Sample Size		9
Study Type		Interventional
Study Design	Study Design	Phase II, single-arm, multi-center, open-label study for r/r FL patients
Study Design	Objective	treatment purpose
Phase		2
Key inclusion & exclusion 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
	Minimum Age	18age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Follicular Lymphoma
Intervention(s)		A single intravenous (i.v.) infusion of CTL019.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy CRR (Complete response rate)
Secondary Outcome		Evaluate Overall Response Rate (ORR), duration of response (DOR) , relapse free survival (RFS), progression free survival (PFS), and overall survival (OS) Safety Immunogenicity and cellular kinetics

Primary Sponsor	Novartis Pharma. K.K.
Secondary Sponsor

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	Hokkaido University Hospital IRB
Address of IRB	Kita14, Nishi5, Kita-Ku, Sapporo, Hokkaido
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Oct. 23, 2018

Secondary ID No.	NCT03568461
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-194610
Name of Other Registries

Countries / Regions of Recruitment	Japan/Asia except Japan/North America/South America/Europe/Oceania

History of Changes

No	Publication date
5	June. 12, 2023	(this page)	Changes
4	Sept. 05, 2022	Detail	Changes
3	June. 04, 2020	Detail	Changes
2	Sept. 17, 2019	Detail	Changes
1	Feb. 07, 2019	Detail

List of change history