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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034569
Receipt No. R000039342
Scientific Title 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
Date of disclosure of the study information 2018/10/22
Last modified on 2018/10/19

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Basic information
Public title 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
Acronym A study of the efficacy and safety of MGN-3/BioBran for patients with B-cell non-Hodgkin's lymphoma after CR
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Sohsuke Meshitsuka
Organization Japanese Red Cross Medical Center
Division name Division of Hematology
Zip code
Address 4-1-22 Hiroo, Shibuya, Tokyo
TEL 03-3400-1311
Email sohmeshi@ims.u-tokyo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sohsuke Meshitsuka
Organization Japanese Red Cross Medical Center
Division name Division of Hematology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2015 Year 05 Month 20 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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