臨床研究等提出・公開システム

Date of registration	Feb. 18, 2020
Last modified on	Jan. 27, 2022
Trial ID	jRCT2080225077

Scientific Title	A PHASE I STUDY OF RO7082859 IN PATIENTS WITH B-CELL NON-HODGKIN'S LYMPHOMA
Public Title	A PHASE I STUDY OF RO7082859 IN PATIENTS WITH B-CELL NON-HODGKIN'S LYMPHOMA

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Chugai Pharmaceutical Co., Ltd.
	Address
	Phone Number
	E-mail Address	clinical-trials@chugai-pharm.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	Chugai Pharmaceutical Co., Ltd.
	Address
	Phone Number
	E-mail Address	clinical-trials@chugai-pharm.co.jp

Recruitment Status	completed

Date of First Enrolment		Mar. 02, 2020
Target Sample Size		12
Study Type		Interventional
Study Design	Study Design	Open-label, dose escalation
Study Design	Objective	treatment purpose
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	- CD20 positive B cell NHL that is recurrent or refractory to standard therapy or for which no standard therapy exists. - Pathologically confirmed B cell NHL. - ECOG PS of 0 or 1. - Life expectancy =>12 weeks from the date of enrollment. - Major organ function meets all criteria.
	Exclusion Criteria	- Pregnant or lactating woman. - Current or previous autoimmune disease. - Positive test result for human immunodeficiency virus antibody, hepatitis B surface antigen, HBs antibody, hepatitis B core antibody, or hepatitis C virus antibody. - Current or previous clinically significant liver disease. - Current central nervous system lymphoma, metastases to the CNS, or meningeal metastases. - History of previous therapy with allogenic hematopoietic stem cell transplantation or solid organ transplantation. - History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or fusion proteins.
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Non Hodgkin's Lymphoma
Intervention(s)		investigational material(s) Generic name etc : RO7082859 INN of investigational material : glofitamab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : 2.5 mg or more weekly or 3 weekly Generic name etc : obinutuzumab INN of investigational material : obinutuzumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : 1000 mg as an IV infusion Generic name etc : Tocilizumab INN of investigational material : Tocilizumab Therapeutic category code : 639 Other biological preparations Dosage and Administration for Investigational material : 8mg/kg as an IV infusion control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety pharmacokinetics other other(DLT) NCI CTCAE
Secondary Outcome		safety efficacy pharmacokinetics other other (ADA) Revised Response Criteria for Malignant Lymphoma

Primary Sponsor	Chugai Pharmaceutical Co., Ltd.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	The institutional review board of the Cancer Institute Hospital of the Japanese Foundation for Cancer Research
Address of IRB	3-8-31, Ariake, Koto, Tokyo 135-8550, Japan
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Jan. 20, 2020

Secondary ID No.	JapicCTI-205172
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
7	Jan. 27, 2022	(this page)	Changes
6	Aug. 10, 2021	Detail	Changes
5	May. 06, 2021	Detail	Changes
4	Aug. 28, 2020	Detail	Changes
3	May. 07, 2020	Detail	Changes
2	Mar. 06, 2020	Detail	Changes
1	Feb. 21, 2020	Detail

List of change history