臨床研究等提出・公開システム

Date of registration	Oct. 02, 2013
Last modified on	May. 07, 2021
Trial ID	jRCT2080222241

Scientific Title	-
Public Title	-

Completion Date or Terminated date	Jan. 22, 2018
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Novartis Pharma.K.K
	Address
	Phone Number	+81-120-003-293
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Novartis Pharma.K.K
	Address
	Phone Number	+81-120-003-293
	E-mail Address

Recruitment Status	completed

Date of First Enrolment		Sept. 12, 2013
Target Sample Size		618
Study Type		Interventional
Study Design	Study Design	A Randomized, Controlled, Double-Blind Phase III Trial
Study Design	Objective	treatment purpose
Phase		3
Key inclusion & exclusion criteria	Inclusion Criteria	Inclusion Criteria: - Patient with previously untreated advanced stage, CD20-positive FL - >= 18 years old - Patient with ECOG performance status 0, 1 or 2.
	Exclusion Criteria	Exclusion Criteria: - Patient who has previously received any prior therapy for lymphoma - Patient with evidence of any uncontrolled, active infection (viral, bacterial or fungal). - Patient with any malignancy within 5 years prior to date of randomization, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma or non-melanomatous skin cancer. - Other protocol-defined inclusion/exclusion criteria may apply
	Minimum Age	No limit
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Follicular lymphoma
Intervention(s)		investigational material(s) Generic name etc : GP2013 INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : iv control material(s) Generic name etc : rituximab INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : iv
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		efficacy efficacy
Secondary Outcome		safety efficacy pharmacokinetics efficacy, safety, pharmacokinetics

Primary Sponsor	Sandoz.K.K
Secondary Sponsor	Novartis Pharma.K.K

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	-
Address of IRB	-
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	July. 11, 2013

Secondary ID No.	NCT03814785
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-132290
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
3	May. 07, 2021	(this page)	Changes
2	July. 28, 2016	Detail	Changes
1	Oct. 02, 2013	Detail

List of change history