UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017469 |
|---|---|
| Receipt number | R000020126 |
| Scientific Title | Pathological analysis of side effecte to the treatment of adult T-cell leukemia |
| Date of disclosure of the study information | 2015/05/08 |
| Last modified on | 2015/05/08 18:01:52 |
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Basic information
Public title
Pathological analysis of side effecte to the treatment of adult T-cell leukemia
Acronym
Pathological analysis of side effecte to the treatment of adult T-cell leukemia
Scientific Title
Pathological analysis of side effecte to the treatment of adult T-cell leukemia
Scientific Title:Acronym
Pathological analysis of side effecte to the treatment of adult T-cell leukemia
Region
| Japan |
Condition
Condition
Adult T-cell leukemia
Classification by specialty
| Hematology and clinical oncology | Infectious disease |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Various inflammatory markers, including Galectin 9 in the plasma of ATL patients treated with CCR4 antibody drug is measured to examine the expression of inflammatory factors. It will help towards the elucidation of the biological reaction by anti-CCR4 antibody drug administration to ATL disease patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of the immune response of the anti-CCR4 antibody drug proceeds for the ATL, new side reaction diagnostic and therapeutic methods is likely to be developed.
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
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine | Other |
Interventions/Control_1
Anti-CCR4 antibody drug administration
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients ,who has the announcement of the ATL, with relapsed or refractory of CCR4-positive adult T-cell leukemia lymphoma and relapsed or refractory of CCR4-positive cutaneous T-cell lymphoma (5 cases) with an anti-CCR4 antibody drug administration's with relapsed or refractory of CCR4-positive adult T-cell leukemia lymphoma and relapsed or refractory of CCR4-positive cutaneous T-cell lymphoma (5 cases) with an anti-CCR4 antibody drug administration's
Key exclusion criteria
Minor
Adult person who dose not have enough judgment
Unconscious adult person
Adult person who required attention for thedisease notification
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yugo Ashino |
Organization
Tohoku University
Division name
Division of Emerging Infectious Diseases, Graduate School of Medicine
Zip code
Address
1-1 Seiryo-machi, Aoba-ku,Semdai
TEL
022-717-8220
ya82@rid.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yugo Ashino |
Organization
Tohoku University
Division name
Division of Emerging Infectious Diseases, Graduate School of Medicine
Zip code
Address
1-1 Seiryo-machi, Aoba-ku,Semdai
TEL
022-717-8220
Homepage URL
ya82@rid.med.tohoku.ac.jp
Sponsor or person
Institute
Division of Emerging Infectious Diseases, Graduate School of MedicineTohoku University
Institute
Department
Personal name
Funding Source
Organization
donation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kumamoto morito sougo hospital
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
| 2015 | Year | 05 | Month | 08 | 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
| 2014 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 28 | 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
| 2015 | Year | 05 | Month | 08 | Day |
Last modified on
| 2015 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020126
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
