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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000024532
Receipt No. R000028222
Scientific Title Efficacy and safety of bexarotene combined with phototherapy in Japanese patients with Cutaneous T-cell Lymphomas
Date of disclosure of the study information 2016/10/24
Last modified on 2018/05/08

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Basic information
Public title Efficacy and safety of bexarotene combined with phototherapy in Japanese patients with Cutaneous T-cell Lymphomas
Acronym Efficacy and safety of bexarotene combined with phototherapy in Japanese patients with Cutaneous T-cell Lymphomas
Scientific Title Efficacy and safety of bexarotene combined with phototherapy in Japanese patients with Cutaneous T-cell Lymphomas
Scientific Title:Acronym Efficacy and safety of bexarotene combined with phototherapy in Japanese patients with Cutaneous T-cell Lymphomas
Region
Japan

Condition
Condition Cutaneous T-Cell Lymphomas
Classification by specialty
Dermatology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy and safety of bexarotene combined with phototherapy for cutaneous T-cell lymphoma patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Modified Severity-weighted Assessment Tool (mSWAT)
Physician's Global Assessment (PGA)
Key secondary outcomes Safety: adverse events, hematology, blood chemistry, computed tomography of the abdomen and pelvis, ophthalmologic slit lamp examinations
Efficacy: LDH, sIL-2R, biopsy, response rate, duration of response, amount of irradiation and UV dose

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 Patients are p.o. administrated a 300 mg/m2 dose of bexarotene once daily for 24 weeks.
Patients are treated with psoralen baths preceding treatment with UVA radiation 5 times weekly. The initial dose of UVA was 0.5 J/cm2, dose increment of 0.5 J/cm2 each radiation. The maximum dose was 4.0 J/cm2.
The initial dose of narrowband UVB administered is 50-70% of the MPD or 0.7 J/cm2. The dose of NB-UVB for the subsequent NB-UVB sessions is elevated 20% increments with each successive treatment session. The maximum dose is 2.0 J/cm2.
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 Subjects must have met all of the following inclusion criteria:
1. A clinical diagnosis of cutaneous T-cell lymphomas confirmed by biopsy to be histologically consistent with CTCL diagnosis by dermatopathologist
2. Age >= 20, written approval of patient
Key exclusion criteria 1. Contraindications (severe liver failure, known hypersensitivity to bexarotene, systemic therapy with vitamin A or oral retinoid therapy at the entry in this study, hypervitaminosis A)
2. Patients with pregnancy, breast-feeding or intent to become pregnant
3. Principal investigator or subinvestigator judged inadequate
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akimichi Morita
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Geriatric and Environmental Dermatology
Zip code
Address 1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
TEL 052-853-8261
Email amorita@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akimichi Morita
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Geriatric and Environmental Dermatology
Zip code
Address 1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
TEL 052-853-8261
Homepage URL
Email amorita@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University Graduate School of Medical Sciences
Department of Geriatric and Environmental Dermatology
Institute
Department

Funding Source
Organization Minophagen Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Osaka City University Graduate School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 名古屋市立大学,大阪市立大学

Other administrative information
Date of disclosure of the study information
2016 Year 10 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 Completed
Date of protocol fixation
2016 Year 10 Month 05 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 24 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
2016 Year 10 Month 24 Day
Last modified on
2018 Year 05 Month 08 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028222

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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