UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A single center, prospective and randomized controlled study of the efficacy and safety of MGN-3/BioBran for patients with B-cell non-Hodgkin's lymphoma after CR
Title of the study (Brief title)	A study of the efficacy and safety of MGN-3/BioBran for patients with B-cell non-Hodgkin's lymphoma after CR
Region	Japan

Condition
Condition	B-cell non-Hodgkin's lymphoma
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Examine the efficacy and safety of MGN-3/BioBran for patients with B-cell non-Hodgkin's lymphoma after CR
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in the number of white blood cells, lymphocytes, T cells, B cells and Treg cells, and adverse event, after administration of MGN-3/BioBran for 12 weeks,
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	patients receive 1 g of MGN-3/BioBran 3 times a day after taking a meal for 12 weeks
Interventions/Control_2	patients receive 1 g of placebo 3 times a day after taking a meal for 12 weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	-patients with B-cell non-Hodgkin's lymphoma -CR confirmed by his/her attending doctor -within 1 year after achievement of a CR -life expectancy of 1 year or more
Key exclusion criteria	-have immune suppressive agent, infectious diseases, or auto immune diseases -are allergic to rice bran
Target sample size	20

Research contact person
Name of lead principal investigator	Sohsuke Meshitsuka
Organization	Japanese Red Cross Medical Center
Division name	Division of Hematology
Address	4-1-22 Hiroo, Shibuya, Tokyo
TEL	03-3400-1311
Email	sohmeshi@ims.u-tokyo.ac.jp

Public contact
Name of contact person	Sohsuke Meshitsuka
Organization	Japanese Red Cross Medical Center
Division name	Division of Hematology
Address	4-1-22 Hiroo, Shibuya, Tokyo
TEL	03-3400-1311
Homepage URL
Email	sohmeshi@ims.u-tokyo.ac.jp

Sponsor
Institute	Japanese Red Cross Medical Center, Division of Hematology
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	598
Org. issuing International ID_1	Japanese Red Cross Medical Center
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	日本赤十字社医療センター（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 10 Month 22 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 05 Month 20 Day
Anticipated trial start date	2015 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 10 Month 19 Day
Last modified on	2018 Year 10 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039342