UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010590 |
|---|---|
| Receipt number | R000012375 |
| Scientific Title | Consideration of combination therapy with both vorinostat and ultraviolet therapy for cutaneous T-cell lymphoma patients |
| Date of disclosure of the study information | 2013/04/24 |
| Last modified on | 2014/10/15 18:54:43 |
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Basic information
Public title
Consideration of combination therapy with both vorinostat and ultraviolet therapy for cutaneous T-cell lymphoma patients
Acronym
Consideration of combination therapy with both vorinostat and ultraviolet therapy for cutaneous T-cell lymphoma patients
Scientific Title
Consideration of combination therapy with both vorinostat and ultraviolet therapy for cutaneous T-cell lymphoma patients
Scientific Title:Acronym
Consideration of combination therapy with both vorinostat and ultraviolet therapy for cutaneous T-cell lymphoma patients
Region
| Japan |
Condition
Condition
Cutaneous T-cell lymphoma, Mycosis fungoides, Sezary's syndrome
Classification by specialty
| Hematology and clinical oncology | Dermatology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the feasibility, safety and efficacy of the combination therapy with both vorinostat and ultraviolet therapy for cutaneous T-cell lymphoma patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Feasibility
Key secondary outcomes
Safety
Response rate
Alleviation of itch
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 | Device,equipment |
Interventions/Control_1
Vorinostat 400mg/day, p.o.
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)Histopathologically proven CTCL patients
2)Clinical stage is 1B or higher
3)Patients who don't respond to ultraviolet therapy
4)Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
5)Adequate hematologic, hepatic, renal, and cardiac function
a)Absolute neutrophil count 1,500/mm3
b)Platelet >=100,000/mm3
c)Hemoglobin >=10.0g/dL
d)AST and ALT <=100IU/L
e)Creatinine <=1.5mg/dL
6)Patients who have given informed consent
Key exclusion criteria
1)Patients who have treated with vorinostat
2)During treatment with systemic steroid
3)During treatment with retinoids
4)Carrier of HBV, HCV, HIV and so on
5)Patients who have severe comorbidity
6)During treatment with anti-cancer agents
7)Female who are pregnant or nursing, male hope to impregnate
8)Patients who have past history of severe allergy for vorinostat
9)Patients who are judged inappropriate to be enrolled in this study by the doctor in charge.
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Amagai |
Organization
Keio University, School of Medicine
Division name
Depertment of Dermatology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
amagai@a7.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeru Funakoshi |
Organization
Keio University, School of Medicine
Division name
Depertment of Dermatology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
takeruf@a8.keio.jp
Sponsor or person
Institute
Department of Dermatology, Okayama University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2013 | Year | 04 | Month | 24 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 03 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | 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
| 2013 | Year | 04 | Month | 24 | Day |
Last modified on
| 2014 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012375
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
