UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034569 |
|---|---|
| Receipt number | 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 14:39:57 |
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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
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
sohmeshi@ims.u-tokyo.ac.jp
Sponsor or person
Institute
Japanese Red Cross Medical Center, Division of Hematology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039342
