UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008210 |
|---|---|
| Receipt number | R000009679 |
| Scientific Title | Safety and efficacy of Tranilast for the treatment of relapsed or resistant lymphoid tumors; a pilot study |
| Date of disclosure of the study information | 2012/06/19 |
| Last modified on | 2014/01/24 13:34:16 |
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Basic information
Public title
Safety and efficacy of Tranilast for the treatment of relapsed or resistant lymphoid tumors; a pilot study
Acronym
Tranilast for lymphoid tumors; a pilot study
Scientific Title
Safety and efficacy of Tranilast for the treatment of relapsed or resistant lymphoid tumors; a pilot study
Scientific Title:Acronym
Tranilast for lymphoid tumors; a pilot study
Region
| Japan |
Condition
Condition
relapsed or resistant lymphoid tumors
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the safety and efficacy of Tranilast for the treatment of relapsed or resistant lymphoid tumors
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety of 2 weeks administration of Tranilast for patients with lymphoid tumors
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tranilast 100mg TID, 200mg TID, 300mg TID
Interventions/Control_2
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
1, Relapsed or resistant lymphoid tumor
2, Aged 20 years or over
3, ECOG PS 0-3
4, Written informed consent
Key exclusion criteria
1, Allergy to Tranilast
2, Severe uncontrollable diabetes or infection
3, Active double cancers
4, Pregnant or lactating women or women of childbearing potential
5, AST,ALT>5xULN, T-Bil 3XULN
6, Cre>3xULN
7, Psychosis
8, Inadequate condition as diagnosed by primary physician
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuya Fukuda |
Organization
Tokyo Medical and Dental University
Division name
Department of Hematology
Zip code
Address
1-5-45 Yushima, Bunkyo-ku
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokyo Medical and Dental University
Division name
Department of Hematology
Zip code
Address
TEL
Homepage URL
fuku.hema@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Department of Hematology, Tokyo Medical and Dental University
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
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 19 | Day |
Last modified on
| 2014 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009679
